Transcutaneous oxygen values and associated clinical interpretation
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More than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\\n\\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\\n\\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\\n\\nAdditionally, each book published by IntechOpen contains original content and research findings.
\\n\\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\\n\\n\\n\\n
\\n"}]',published:!0,mainMedia:null},components:[{type:"htmlEditorComponent",content:'
Simba Information has released its Open Access Book Publishing 2020 - 2024 report and has again identified IntechOpen as the world’s largest Open Access book publisher by title count.
\n\nSimba Information is a leading provider for market intelligence and forecasts in the media and publishing industry. The report, published every year, provides an overview and financial outlook for the global professional e-book publishing market.
\n\nIntechOpen, De Gruyter, and Frontiers are the largest OA book publishers by title count, with IntechOpen coming in at first place with 5,101 OA books published, a good 1,782 titles ahead of the nearest competitor.
\n\nSince the first Open Access Book Publishing report published in 2016, IntechOpen has held the top stop each year.
\n\n\n\nMore than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\n\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\n\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\n\nAdditionally, each book published by IntechOpen contains original content and research findings.
\n\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\n\n\n\n
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Globally, diabetes mellitus has grown to pandemic proportions, affecting 194 million people worldwide and is expected to increase in prevalence to 344 million by the year 2030 (Wild, et al., 2004). Of these patients, between 2 and 6% will develop a diabetic foot ulcer (DFU) yearly (Ramsey, et al., 1999). The onset of a DFU often precipitates a complex chain of events that may lead to limb loss. Infected DFUs account for 20% of hospital visits for this patient population (Bouter, et al. 1993) and precede roughly 85% of lower extremity amputations in patients with diabetes (Pecoraro, et al. 1990). The long-term outcome for a diabetic patient after a major limb amputation is grave with 50% of these patients deceased at 5 years (Moulik, et al. 2003). Additionally, the cost to treat this disease places a significant strain on the health-care system. The cost to manage these foot disorders is estimated at several billion dollars annually (Wild, et al. 2004), while the individual cost of a major limb amputation is estimated at almost $45,000 (Apelqvist, et al. 1994). With the combination of excessive cost to treat diabetes complications coupled with the major detrimental health effects on individual patients, it is necessary to develop and employ new technological methods to predict healing of diabetic foot ulcers.
\n\t\t\tOnce a diabetic patient develops a pedal ulceration it becomes incumbent on the physician to evaluate the ulcer’s healing potential. Much research has focused on the prediction of diabetic foot ulcer healing. Clinically, it has been shown that a 50% decrease in area over a 4-week period with standard wound care adequately predicts ulcer healing at 12 weeks (Sheehan, et al., 2006). The disadvantage of this method, however, is the delay in treatment that occurs as a result of the natural time deferment in this process. As such, newer technologies have utilized the determination of microcirculation to predict ulcer healing. This chapter focuses on the application of these new technologies to determine microvascular circulation and predict diabetic foot ulcer healing.
\n\t\t\tLarge artery (macrocirculatory) disease has been well documented elsewhere with disease at the infrapopliteal region (Bembi, et al. 2006) causing loss of tissue perfusion and critical limb ischemia and gangrene. Various noninvasive vascular testing modalities exist to determine large vessel luminal disease. These include dual mode ultrasound, segmental leg pressures, ankle brachial indices, pulse volume recordings, toe pressures, and toe brachial indices. The above tests have been found to yield useful clinical data regarding large vessel disease and often function as safe precursors to more advanced imaging techniques such as magnetic resonance arteriography. These methods also assist with surgical revascularization planning. However, the options for assessment of microvascular disease are comparatively sparse. This chapter will focus on the following noninvasive modalities to evaluate microvascular disease and predict ulcer healing: Transcutaneous Oxygen Pressure, Skin Perfusion Pressure, Laser Speckle Perfusion Imaging, and Hyperspectral Imaging.
\n\t\tThe pathogenesis of macrocirculatory disease has been discussed in depth elsewhere. Microcirculation includes the capillaries, arterioles, and venules. These microvessels are arranged in two horizontal network patterns with a superficial subpapillary plexus and a deeper cutaneous plexus with capillary blood flow providing nutrition and arteriovenous shunts that serve a thermoregulatory function (Chao & Cheing, 2009). The nutritional capillaries are organized into functional units within the papillary layer of the dermis. A precapillary sphincter is situated just upstream of the capillary which controls vasodilation and constriction (LaFontaine, et al., 2006). Arteriovenous anastomoses exist between the arterioles and venules to allow normal shunting of blood under physiologic conditions. The internal vessel lumen is lined with a single-layer-thick endothelium. This endothelium lies on a basement membrane which is normally thicker in the foot than other body locations due to the increased hydrostatic pressure associated with stance (LaFontaine, et al., 2006). Blood flow to the skin runs through this arteriovenous system supplying nutrition, oxygen, and regulating temperature through an increase or decrease of blood flow to the dermal papilla.
\n\t\t\tBlood flow to the skin is controlled by the peripheral sympathetic nervous system via vasodilatory cholinergic and vasoconstrictor adrenergic nerve fibers (Chao & Cheing, 2009) as well as vasoactive substances such as nitric oxide. Additionally, the endothelial basement membrane regulates blood flow and the local inflammatory response via vasoactive substances (Guerci, et al. 2001).
\n\t\t\tThe pathogenesis of microvascular disease in diabetics is complex and multifactorial. Hyperglycemia is considered the most important risk factor (LaFontaine, et al., 2006) and is noted to occur in two stages, a reversible functional stage and a structural adaptation and remodeling stage leading to a thickened basement membrane and capillary failure (LaFontaine, et al., 2006). The hemodynamic hypothesis of microangiopathic disease was first described by Parving, et al (Parving, et al. 1983). Blood flow dysregulation, caused by neuropathic changes to the sympathetic nerve fibers, is mediated by hyperglycemia. The resulting stimulation of the polyol pathway decreases nitric oxide production, increasing blood flow and capillary pressure. This increased pressure leads to thickening of the basement membrane which resists vasodilation and increases capillary permeability with ensuing chronic edema.
\n\t\t\tA second mechanism that has gained experimental support is the “capillary steal syndrome” (Uccioli, et al. 1992). This is thought to result from sympathetic denervation with chronic vasodilation, resulting in an increased blood flow through the arteriovenous shunt away from the arterioles in the papillary dermis. As blood moves more rapidly toward the postcapillary venule, nutrition, metabolite, and oxygen exchange are significantly reduced (Boulton, et al, 1982).
\n\t\t\tIt is unknown which pathway is dominant or if another mechanism is responsible, though there is most likely a combination of both pathogenic pathways that end with functional ischemia, reduced nutritional capacity, and increased metabolic end products that function together to limit healing capacity in the face of skin ulceration.
\n\t\tLarge vessel disease is evaluated through several noninvasive methods including dual mode ultrasound, segmental leg pressures, ankle brachial indices, pulse volume recordings, toe pressures, toe brachial indices, magnetic resonance angiography, and computed tomographic angiography. However, these modalities only characterize blockages of large arteries and do not assist with prediction of direct wound healing on the lower extremity. Contemporary microvascular technologies utilize the above pathogenic principles to evaluate microangiopathic changes and predict ulcer healing. The following discussion will review the currently available methods to clinically assess microvascular blood flow and predict the healing potential of diabetic foot ulcers.
\n\t\t\n\t\t\t\tPhysiology of test. Transcutaneous oxygen pressure (TcPO2) measures excess oxygen diffusion from red blood cells as they pass through the capillary circulation. This pressure reflects the metabolic state of the adjacent interstitial spaces. TcPO2 is measured via electrochemical reduction at a cathode placed against the skin.
\n\t\t\t\n\t\t\t\tMethod. Transcutaneous oxygen pressures are measured by placing a heated probe against the skin. The standard 44 degrees Celsius causes vasodilation and a local reactive hyperthermia (Figures 1 and 2). Oxygen defusing across the skin and toward the cathode in the probe is reduced. This reduction is proportional to the number of oxygen molecules (Mathieu and Mani 2007) and is measured as oxygen pressure. Common locations of measurement include the dorsum of the foot, anteromedial calf approximately 10 cm below the patella, and the thigh 10 cm above the patella. The subclavicular region is often used as a reference point due to its close anatomic location to coronary perfusion and low likelihood of arterial insufficiency. Pressure measurements may be enhanced by having the patient exercise, increasing the metabolic demand and need for oxygen. Placing the leg in a dependent position additionally augments oxygenation, providing further information about the arterial reserves available. TcPO2 measurement may also be performed in patients in which arterial claudication is suspected. In this situation normal oxygen metabolic demands are sufficiently supplied. However, when stress is applied to the extremity, oxygen demands increase and exceed the oxygen supplied by the now insufficient arterial flow (Franzeck, et al. 1982). To test this, transcutaneous oxygen tension measurements may be performed while the patient exercises. It is also important to consider that resting TcPO2 measurement is more likely to diagnose disease in more severe occlusions due to the lack of metabolic demand when the patient is at rest during the examination. Byrne, et al. compared transcutaneous oxygen measurement with angiography. They found TcPO2 to have a sensitivity of 100% following exercise but falling to 77% at rest (Byrne, et al. 1984). This striking drop in sensitivity argues for standard exercise TcPO2 testing.
\n\t\t\t\n\t\t\t\tInterpretation of Findings. Normal limb TcPO2 values are 50- 60mmHg, though values greater than 55mmHg at any site regardless of age are considered normal (Cina, et al, 1984). Wound healing is considered unimpaired at pressures less than 40mmHg (White, et al. 1982). Pressures of 20mmHg are seen in legs with rest pain, ischemic ulcers, and/or gangrene, while pressures below 20mmHg usually require amputation (Oh, et al. 1987) (Table 1).
\n\t\t\tTranscutaneous oximetry measurement technique. (a) chest and (b) foot.
Courtesy of Casa Colina Centers for Rehabilitation Wound Care and Hyperbaric Medicine Program.
\n\t\t\tStandard TCPO2 report. Courtesy of Casa Colina Centers for Rehabilitation Wound Care and Hyperbaric Medicine Program.
TcPO2 Value | \n\t\t\t\t\t\tInterpretation | \n\t\t\t\t\t
"/50 mmHg | \n\t\t\t\t\t\tNormal | \n\t\t\t\t\t
40mmHg | \n\t\t\t\t\t\tUnimpaired wound healing | \n\t\t\t\t\t
<30 mmHg | \n\t\t\t\t\t\tImpaired wound healing | \n\t\t\t\t\t
20mmHg | \n\t\t\t\t\t\tPredicted rest pain, ischemic ulceration, gangrene. | \n\t\t\t\t\t
<20mmHg | \n\t\t\t\t\t\tAmputation likely | \n\t\t\t\t\t
Transcutaneous oxygen values and associated clinical interpretation
As noted above, TcPO2 measurement is most clinically relevant for assessing oxygenation in patients with more advanced arterial occlusion or performing the test with exercise. Additionally, since the results are not affected by sclerosis of the tunica media of arteries this is a viable test in patients with diabetes and renal disease (Hauser, et al. 1984). TcPO2 may also be used in conjunction with hyperbaric oxygen therapy.
\n\t\t\tSeveral limitations exist with the use of TcPO2. TcPO2 cannot be measured under certain physical conditions (edema, dry flaky skin, maceration, callused or plantar skin, cellulitis, or skin over bones and tendons) (Dooley, et al. 1996). These conditions tend to decrease the sensitivity of the probe to detect skin perfusion. Since the electrode probe is placed on intact adjacent skin rather than directly on the wound itself this method does not measure oxygen tension within the wound. The need to warm the extremity causes temperature differences between sites and subjects leading to false readings. TcPO2 is reliable in the normal but not in the low range, resulting in a high false positive rate for critical limb ischemia (Byrne, et al. 1984). Mechanical pressures on the electrode alter the TcPO2 value. Additionally, a significant amount of time is necessary to obtain pressure measurements with calibration, sensor maintenance and skin preparation delaying a reliable reading upwards of 45 minutes. TcPO2 is therefore site restrictive and operator sensitive.
\n\t\t\t\n\t\t\t\tUlcer healing predictive value. TcPO2 has a wound healing predictive accuracy of 83% and is unaffected by diabetic status or chronic renal failure (Padberg, et al., 1996). In reference to the appropriate time to perform lower extremity salvage surgery using TcPO2 measurements after surgical intervention for arterial occlusion, Arroyo et al. found an optimal waiting period of at least three days and preferably one week before intervention (Arroyo, et al. 2002). In regards to predicting amputation healing Katsamouris and colleagues found that a level of 40mmHg at the anterior skin surface was predictive of successful healing after partial foot and lower leg amputations (Katsamouris, et al. 1984). Similarly, Ballard and colleagues successfully used TcPO2 measurements to determine the severity of foot ischemia and guide treatment. They found that a transmetatarsal TcPO2 level of 30mmHg or greater successfully predicted healing with conservative care in 31/36 (86%) of diabetic patients (Ballard, et al. 1995).
\n\t\t\n\t\t\t\tPhysiology of test. Skin perfusion pressure (SPP) utilizes a laser doppler and pressure cuff to evaluate reactive hyperemia. SPP measures the pressure at which blood flow first returns to the capillary during the controlled release of occlusive pressure.
\n\t\t\tMethod. A laser sensor is placed on the desired location while a pressure cuff is placed at the ankle. The cuff is inflated until occlusion of the arterial flow to the extremity occurs and is then released. As arteriolar flow is restored and the subsequent reactive hyperemia occurs, the laser sensor reads the resulting arteriolar pressures.Interpretation of Findings. Skin perfusion pressures greater than 40mmHg are considered non-ischemic while marginal ischemia is noted between 30 and 40mmHg. The wound is unlikely to heal below a pressure of 30mmHg (Castronuovo, et al., 1997).
\n\t\t\tThe advantages of SPP are the following: it can be used in the presence of edema and in the plantar foot, no calibration is needed, no maintenance is required, no skin warming is necessary, and it is faster than TcPO2 measurement (2-3 minutes per site).
\n\t\t\tThe limitations of SPP are that it provides data regarding the limited area of skin under the sensor. Multiple separate readings are necessary to obtain a global understanding of pedal microvasculature.
\n\t\t\t\n\t\t\t\tUlcer healing predictive value. SPP predicts a 90% healing ability above 30mmHg (Castronuovo, et al., 1997) and has a 100% negative predictive value (Adera, et al. 1995). In patients with critical limb ischemia SPP was 80% accurate in diagnosing this condition (Castronuovo, et al., 1997). Similarly, Faris and colleagues found SPP was useful in predicting healing of ulcers or gangrene of the feet in 35 of 40 diabetic patients with levels above 40mmHg. Conversely healing was unlikely if the SPP was less than 40mmHg (Faris, et al. 1985). Yamada, et al. studied a larger cohort of 211 patients with ischemic limbs. However, this cohort was not restricted to diabetic patients alone. As with the above mentioned studies, this group also found a threshold of 40mmHg as predictive of healing ulceration or gangrene but with a slightly lower sensitivity and specificity (72% and 88%, respectively) (Yamada, et al. 2008). In 85 limbs of 71 patients referred to a vascular laboratory, skin perfusion pressure measurement was found to correlate closely with toe pressure measurements (Tsai, et al. 2000), allowing substitution of SPP for toe pressures. This is a significant benefit in certain circumstances since it may be impractical to determine toe pressures due to the commonality of wounds on the toes.
\n\t\t\n\t\t\t\tPhysiology of test. Skin with wounds requires a greater amount of oxygen, without which healing will not occur. Hence, both oxygen delivery (measured by oxyhemoglobin) and oxygen extraction (measured by deoxyhemoglobin) into the wounded tissue can function as indicators of a wound’s capacity to heal. This is done with the use of hyperspectral imaging (CombiVu-R System, HyperMed, Waltham, MA) which uses a spectral separator to vary the wavelength of light admitted to a detector. Red blood cells in the skin are struck with this variable light which is reflected back toward the detector. Since the wavelengths of light absorbed and emitted by oxygenated red blood cells (RBCs with oxyhemoglobin) differs by that emitted by deoxygenated red blood cells (RBCs with deoxyhemoglobin) the machine is able to detect the respective levels of these molecules with a high level of accuracy (Gillies, et al 2004, Greenman, et al. 2005). The data is then compared using a computer with standardized data for these molecules, and an image is provided with a color bar legend for comparison, and colored scans are used to demonstrate levels of oxygenation (Gilles, et al. 2004).
\n\t\t\t\n\t\t\t\tMethod. Patients are placed supine, and scans are obtained from various areas of the lower extremity, including the wound site. The imaging technology does not require contact with the skin. An approximately 30 second scan is obtained at a 12 inch distance from the site in question. Images are displayed on a computer screen with a color bar for comparison. Oxyhemoglobin levels are associated with varying colors while deoxyhemoglobin is demonstrated by varying levels of brightness. Numerical values are also placed on the color bar, measured in AUs (astronomical units) (Figures 3 and 4)
\n\t\t\t\n\t\t\t\tInterpretation of Findings. A healing index has been suggested for the use of ulcer healing prediction based on the ratio of oxyhemoglobin to deoxyhemoglobin. Higher levels of both molecules correlate with a greater potential for healing (Khaodhiar, et al., 2007). In general a healing index greater than zero predicts an ulcer will heal while a negative healing index demonstrates an ulcer that is unlikely to heal.
\n\t\t\tHyperspectral imaging provides multiple advantages including the lack of contact with skin, global examination of lower extremity microvascular supply, immediate accurate ulcer healing prediction, use on glabrous and nonglabrous skin, and ease of use and interpretation with a healing index.
\n\t\t\tDisadvantages of HSI are that few studies currently exist to fully validate the use of this modality. A thicker border surrounding the wound decreases the ability of HSI to discriminate well from poorly vascularized tissues. It is currently recommended to use a border thickness of 0.5 to 1 cm (Nouvong, et al., 2009).
\n\t\t\t\n\t\t\t\tUlcer healing predictive value. Khaodhiar and colleagues found the following ulcer healing predictive values in a pilot study of HSI: sensitivity 93%, specificity 86%, positive predictive value 93%, and negative predictive value 86% (Khaodhiar, et al., 2007). A larger prospective clinical study by Nouvong, et al. found similar prediction values of 86% sensitivity, 88% specificity, and 96% positive predictive value (Nouvong, et al., 2009). This modality compares strongly with clinical observations to predict wound healing. Sheehan and colleagues in their study of clinical healing indicators found a 91% sensitivity, 58% specificity, 58% positive predictive value, and 91% negative predictive value using the percent change in area over a four week time period to predict ulcer healing (Sheehan, et al., 2006). Comparing HSI with clinical indicators demonstrates hyperspectral imaging is superior to following the clinical course in predicting the potential healing and nonhealing of diabetic foot ulcers.
\n\t\t\tHyperspectral imaging system.
a) visible and (b) hyperspectral images of a healing diabetic foot ulcer and (c) visible and (d) hyperspectral images of non-healing diabetic foot ulcer.
The assessment of microangiopathic disease is a new science with early clinical applications. As new technologies are developed physicians will increasingly be able to extract information about the vascular status of potentially ischemic areas while providing a greater understanding of the pathophysiology of the diabetic lower extremity.
\n\t\t\t\n\t\t\t\tLaser Speckle Perfusion Imaging. This new technology employs the principle of laser scatter contrast imaging. In this technique a laser illuminates an area of tissue which produces a backscattered light. This light forms a pattern of light and dark areas called a speckle pattern (Draijer, et al. 2009). In 2007 a new device, the Full-Field Laser Perfusion Imager (FLPI) (Moor Instruments, Essex, UK), was released for commercial use (McGuire & Howdieshell, 2010). This device images skin to a depth no greater than 1 mm and results in images of blood flow within the skin (McGuire and Howdieshell 2010). The presence or absence of blood in the microvasculature indicates the ability to heal. This new technology is advantageous in providing real-time video images of microvascular blood flow (Thompson and Andrews 2010) and represents the potential future ability to view the dynamic microvascular environment within the skin. Future research is necessary to determine the predictive value of laser speckle perfusion imaging in wound healing and amputation level prediction.
\n\t\tColon cancer is a major cause of morbidity in the world and the second most common cause of cancer death. Most patients undergo curative resection of the primary colon cancer and removal of regional lymph nodes. Colon cancer mortality rates have improved over the years with the advancement of surgical techniques, diagnostic modalities and systemic therapy (Figure 1). Most important prognostic determinant is the stage of the cancer. The original pathological staging system used for colon cancer was the Dukes staging system which was based on the extent of penetration of the cancer through the bowel wall and whether there was involvement of regional lymph nodes (Table 1). It was originally described for rectal cancer but applied to colon cancer as well [1].
\nColon cancer related mortality from 1975 to 2010, (A) in males and (B) in females. Figures are from International Agency for Research on Cancer, global cancer observatory website [2].
Stage | \nDescription | \n
---|---|
Dukes A | \nTumor confined to within submucosa | \n
Dukes B1 | \nTumor penetrates muscularis propria but not through bowel wall | \n
Dukes B2 | \nTumor penetrates through bowel wall | \n
Dukes C1 | \nTumor not through bowel wall with lymph node metastases | \n
Dukes C2 | \nTumor through bowel wall with lymph node metastases | \n
Dukes staging system for colorectal cancer.
Staging of colon cancer has been further refined in detail and standardized according to the AJCC (American Joint Committee for Cancer)/UICC (Union for International Cancer Control) TNM staging system of which the latest version is the eighth edition which was adopted in 2018 [3]. The tumor and node definitions are shown in Table 2. Primary tumor and nodal factors define the stages as shown in Table 3.
\nT—Primary tumor | \n|
---|---|
TX | \nPrimary tumor cannot be assessed | \n
T0 | \nNo evidence of primary tumor | \n
Tis | \nCarcinoma in situ: intramucosal (involvement of lamina propria with no extension through muscularis mucosae) | \n
T1 | \nTumor invades submucosa (through muscularis mucosae but not into the muscularis propria) | \n
T2 | \nTumor invades muscularis propria | \n
T3 | \nTumor invades through muscularis propria into pericolorectalic (subserosal) tissues | \n
T4 | \nTumor invades the visceral peritoneum or invades or adheres to adjacent organ or structure | \n
T4a | \nTumor penetrates to the surface of the visceral peritoneum (including gross perforation of the bowel through areas of inflammation to the surface of the visceral peritoneum) | \n
T4b | \nTumor directly invades or adheres to other organs or structures | \n
N - Regional lymph node | \n|
NX | \nRegional lymph nodes cannot be assessed | \n
NO | \nNo regional lymph nodes metastases | \n
N1 | \nOne to three regional nodes are positive (tumor in lymph nodes measuring >0.2 mm), or any number of tumor deposits are present and all identifiable lymph nodes are negative | \n
N1a | \nOne regional lymph node is positive | \n
N1b | \nTwo or three regional lymph nodes are positive | \n
N1c | \nNo regional lymph nodes are positive, but there are tumor deposits in the \n
| \n
N2 | \nFour or more regional lymph nodes are positive | \n
N2a | \nFour to six regional lymph nodes are positive | \n
N2b | \nSeven or more regional lymph nodes are positive | \n
M - Distant metastasis | \n|
Mo | \nNo distant metastasis by imaging, etc.; no evidence of tumor in distant sites or organs | \n
M1 | \nMetastasis to one or more distant sites or organs or peritoneal metastasis is identified | \n
The tumor, node, metastasis (TNM) staging system.
Stage | \nT | \nN | \nM | \n
---|---|---|---|
0 | \nTis | \nN0 | \nM0 | \n
I | \nT1 \n | \nN0 \n | \nM0 \n | \n
T2 | \nN0 | \nM0 | \n|
IIA | \nT3 | \nN0 | \nM0 | \n
IIB | \nT4a | \nN0 | \nM0 | \n
IIC | \nT4b | \nN0 | \nM0 | \n
IIIA | \nT1-T2 \n | \nN1/N1c \n | \nM0 \n | \n
T1 | \nN2a | \nM0 | \n|
IIIB | \nT3-T4a \n | \nN1/N1c \n | \nM0 \n | \n
T2-T3 \n | \nN2a \n | \nM0 \n | \n|
T1-T2 | \nN2b | \nM0 | \n|
IIIC | \nT4a \n | \nN2a \n | \nM0 \n | \n
T3-T4a \n | \nN2b \n | \nM0 \n | \n|
T4b | \nN1-N2 | \nM0 | \n
Prognostic stage groups.
The risk of recurrence increases with the stage, especially when there are nodal metastases. Postoperative adjuvant chemotherapy is utilized to eradicate the micrometastases which reduce the risk of recurrence and improve the cure rate. The role of adjuvant chemotherapy is well defined I stage III colon cancer; however, it remains controversial in stage II. This chapter reviews the role of adjuvant therapies in resected colon cancer.
\nAbout 70–80% of patients diagnosed with localized non-metastatic colorectal cancer undergo curative resection which is the main modality of treatment for those with good performance status and acceptable comorbidities. This is achieved by surgical resection of the primary tumor, anastomosis of the bowel and removal of 12 or more regional lymph nodes. The aim of oncological resection is the complete removal of the tumor and potential lymphovascular spread with a clear margin of at least 5 cm proximally and distally for colon cancer, and minimal proximal margin of 5 cm and distal of 2 cm for rectal carcinoma. Circumferential/radial margin clearance of at least 1 mm is considered optimal. Endoscopic resection involves complete tumor resection and adjacent tissue in one block. This may be acceptable for those accept vigorous close surveillance and potential need for further surgical resection or those who are non-surgical candidates.
\n5FU is an antimetabolite drug that inhibits DNA and RNA synthesis by acting as a false substrate in purine and pyrimidine synthesis thereby interfering in the S phase of the tumor cell cycle. It is metabolized by the rate limiting enzyme dihydropyrimidine dehydrogenase. The main toxicities are related to mucosal inflammation and this presents clinically as mucositis, stomatitis and diarrhea. It can also cause nausea and myelosuppression. Rarely, it can cause cardiotoxicity presumably by inducing coronary artery spasm.
\nCapecitabine is an oral fluropyrimidine prodrug which is taken up inside the tumor cells and metabolized to the active 5FU product by thymidine phosphorylase. Repeated oral administration mimicks the pharmacokinetics of protracted infusional 5FU. The side effects are similar to 5FU in term of mucositis and diarrhea but hand-foot syndrome or palmar-plantar erythrodysesthesia with redness, tenderness and swelling of these areas is a common toxicity experienced.
\nOxaliplatin is a third-generation platinum drug which acts as an alkylating agent in causing DNA damage by intrastrand crosslinks. The drug is not nephrotoxic or ototoxic but the main side effect is cold related dysesthesia which can lead to cumulative sensory neuropathy. It is moderately emetogenic and myelosuppressive. It exhibits synergy with fluoropyrimidines and so is normally used in combination with this class of cytotoxics.
\nLevamisole is an anti-helminthic drug that is used in veterinary medicine. It was found to have effects on phagocytosis and chemotactic responses of neutrophils as well as on stimulation of lymphocyte proliferation, differentiation and cytotoxicity suggesting an immunomodulatory effect. Preclinical studies suggested an antimetastatic effect in tumor xenograft models.
\nThe initial Leicester trial randomized patients after curative surgery either to observation, 5FU, or 5FU plus levamisole. 5FU was administered intravenously for # days following surgery, and then orally once weekly for 6 months; levamisole was administered for only three postoperative days. After 5 years of follow-up, the survival of patients randomized to 5FU plus levamisole was significantly prolonged compared with 5FU alone (p = 0.02) or observation (p = 0.045).
\nLevamisole alone, given intermittently for 1 year, did not produce a survival benefit in an EORTC trial with Dukes C colon cancer patients [4]. In the NCCTG trial levamisole was inferior to the combination with 5FU [5].
\nTwo trials the US Intergroup 0035 and the Netherlands Adjuvant Colorectal Cancer Project (NACCP) study both found a significant benefit of 5FU and levamisole in the adjuvant therapy of resected colon cancer compared to observation [6]. A subsequent meta-analysis of these two studies found that after adjustment for the total planned 5FU dose the effect of levamisole became non-significant. Subsequent trials disproved the benefit of levamisole in adjuvant therapy of colon cancer [7, 8].
\nLeucovorin is an active metabolite of folic acid which works by enhancing enzymatic binding of 5FU onto thymidylate synthetase to prolong the half-life of 5 U and therefore potentiates the 5FU. It is not a cytotoxic agent on its own. Rarely, it can cause rash or itch.
\nClinical trials compared 5FU-leucovorin regimens to 5FU-levamisole regimens and disproved the benefit of levamisole. The INT-0089 and QUASAR studies have demonstrated that there is no difference in outcome between the use of high dose or low dose leucovorin [7, 8].
\nStage 1 colon cancer is often an incidental finding in those patients undergoing polypectomy. Therefore, pedunculated polyps should be resected with excision of the stalk down to the base. When stage 1 colon cancer is found in a polyp that was completely excised with clear margin of more than 2 mm, further surgical excision may not be required, provided there are no high risk features such as lymphovascular invasion, poor cell differentiation, and malignant invasion beyond stalk. Such patients with high risk features should undergo further excision like segmental resection for complete staging. Sessile polyps with invasive cancers also can be managed with segmental colon resection unless they can be removed in one piece [9]. An estimated 5% of resected polyps and 20% of unresectable polyps contain invasive cancer [10]. Five-year survival rate for stage 1 colon cancer is more than 95%, and adjuvant therapy is not indicated [11].
\nThe role of adjuvant chemotherapy in stage II is not clearly defined. 5-year disease free survival for these patients is more than 80%. Because of this relatively good prognosis, benefit from adjuvant 5FU-based chemotherapy is small and remains questionable given many of the trials are underpowered. In order to demonstrate a larger benefit or to unravel small differences with statistical significance, a highly efficacious therapy or trials with larger samples are needed. To detect an absolute improvement in survival at 5 years by 4% with more than 90% power, 4700 patients with stage II colon cancer would be required. A retrospective study based on SEER-Medicare linked database explored the outcome of more than 3000 patients without any adverse features depending whether they received chemotherapy within 3 months after surgery or not. Interestingly, 27% of patients received adjuvant therapy in this group without much evidence to support it [12]. They reported a 5-year survival of 75% for those who did not receive chemotherapy versus 78% in those who received therapy. High grade, younger age, low comorbidities and white race were more likely to receive chemotherapy. After adjusting for known variables there was no difference in survival (HR 0.91, 95% CI 0.77–1.09).
\nA number of trials have tried to address the role of adjuvant therapy in stage II colon cancer with conflicting results. QUASAR (Quick and Simple and Reliable), a large UK study investigated the role of adjuvant 5FU in this randomized controlled trial [13]. This study enrolled more than 3000 patients with (91%) stage II cancers (node-negative) which also included 30% rectal cancer. After a median follow up of 5.5 years, there was about 20% reduction in the relative risk of death (any cause mortality HR 0.82; 95% CI 0.70–0.95; p < 0.008) in those treated with chemotherapy compared to placebo controlled arm which translated into small but significant absolute survival benefit of 3.6% (95% CI 1.0–6.0). Despite significant results, number of pitfalls in this trial has raised questions with regard to the benefit seen. The median number of lymph nodes removed in this study was 6 (in more than 60% of patients <12 lymph nodes were removed) which is well below current standards. In addition, there was a group of patients who received radiation therapy (14%) and another proportion received portal vein infusion therapy (6%), which are not standard practice.
\nThere were a number of meta-analyses which support the use of adjuvant therapy in stage II colon cancer including NSABP, NCCTG and IMPACT. International Multicenter Pooled Analysis of Colon Cancer Trial (IMPACT) was a pooled analysis of randomized trials, showed a 2% improvement in 5-year overall survival. In another analysis of more than 150,000 patients with stage II colon cancer from National Cancer Database reported survival advantage of adjuvant therapy (HR 0.76; p < 0.001) [14]. Gill et al. analyzed pooled individual patient data of 3302 patients with stage II and stage III colon cancers. Although there was a statistically significant improvement in disease free survival (by 4%), overall survival difference (absolute benefit of 5%) was not significant [15]. The Adjuvant Colon Cancer End Points (ACCENT) collaboration analyzed individual patient data with regard to long term outcome after adjuvant therapy. Among 6900 patients with stage II cancers, there was 5% improvement survival at 8 years [16].
\nGiven the conflicting data, adjuvant therapy in stage II colon cancer remains controversial. Several clinicopathological features and molecular markers are associated with poor prognosis in stage II colon cancers. These include T4 primary, bowel obstruction of peroration, poorly differentiated phenotype (including signet ring cells and mucinous) high pre-operative carcinoembryonic antigen (CEA), inadequate lymph node sampling (<13 nodes), lymphovascular space invasion and perineural invasion [17, 18]. Although most expert groups consider these factors as high risk features in stage II colon cancer, some discrepancy exist among their definition for high risk stage colon cancer [19, 20, 21]. While most expert groups recommend to consider these adverse factors when considering adjuvant therapy, there is limited evidence to suggest that the presence of one or risk factors are more likely to benefit from adjuvant therapy. In the landmark MOSAIQ trial, 434 patients were considered high risk stage II colon cancer. Although there was trend towards better disease-free survival in the FOLFOX arm compared to 5FU arm, overall survival was essentially similar [22]. The decision regarding adjuvant therapy in this setting will need to be individualized and take into account the patient’s preferences regarding therapy.
\nTwo large phase III trials explored the role of oxaliplatin in stage II colon cancer; MOSAIC and NSABP C-07 which have virtually shown the lack of benefit of oxaliplatin in stage II colon cancer [22, 23]. Forty percent and 27% of patients were stage II in MOSAIC and NSABP C07 trials, respectively. An updated 10-year follow up report of MOSAIC confirmed the lack of benefit from oxaliplatin in stage II colon cancer. In fact there was a trend towards adverse outcome in low-risk stage II in MOSAIC, while there is a non-significant trend of improvement in disease free survival (7%) and overall survival (2%) [22]. No disease-free survival or overall survival benefit was seen in NSABP C-07 trial in patients with stage II colon cancer [23]. Therefore oxaliplatin is unlikely to benefit most patients with stage II colon cancer; however, it may be appropriate to discuss oxaliplatin in those with extremely high risk features, given the findings from MOSAIC.
\nPatients with node positive colon cancer are at higher risk of recurrence with a 5-year overall survival estimate of 40–60%. Adjuvant therapy is indicated for most patients with stage III disease to eliminate micro metastases and to improve disease free survival and overall survival. Combination 5FU/leucovorin and oxaliplatin regimen is the standard of care unless they are medically unfit to receive intensive chemotherapy where single agent 5FU/Leucovorin may be appropriate.
\nA landmark study in the 1990s established the benefit of adjuvant therapy in resected stage III colon cancer where 5FU/levamisole for 12 months decreased recurrence and improved survival [5]. Results remained significant at 5 years with a 41% reduction in recurrence and 33% reduction in death [24]. However subsequently leucovorin has emerged as an effective potentiator of anti-tumor activity of 5FU, whereas levamisole lacked significant biological activity. 5-FU is metabolized in cancer cells to 5-fluorouridine 5′-monophosphate (FUMP), by uridine monophosphate synthetase, with a resultant active form, 5-fluoro-2′-deoxyuridine 5′-monophosphate (FdUMP). FdUMP then forms a ternary complex with thymidylate synthase in the presence of reduced tetrahydro folate (5,10-CH2-THF) which eventually inhibit DNA replication. Leucovorin is metabolized into 5,10-CH2-THF and enhance formation of thymidylate synthase/5FU ternary complex and anti-tumor activity. Subsequent studies confirmed the lack of utility of levamisole and efficacy of leucovorin in combination with 5FU in adjuvant therapy of colon cancer [25].
\nTwo large randomized studies established the role of oxaliplatin in the adjuvant treatment of stage III colon cancer. Multicentre International Study of Oxaliplatin/5FU/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIQ) utilized a 2 hour bolus infusional 5FU followed by 22 hours 5FU infusion along with oxaliplatin in a 2 weekly cycle (FOLFOX4) for 6 months in resected colon cancer patients (60% stage III and 40% stage II). A total of 2246 patients were randomized to receive either FOLFOX4 or 5FU/leucovorin. In the intention to treat population FOLFOX4 significantly improved 5-year disease free survival (73.3% 67.4%) compared to 5FU/leucovorin (HR 0.80, 95% CI 0.68–0.93; p = 0.003). Overall survival at 6 years was 78.5% versus 76.0% (HR 0.84; 95% CI, 0.71–1.00; p = 0.04). In a subgroup analysis, there was 4.2% improvement by the addition of oxaliplatin in 6-year overall survival in stage III disease (72.9% versus 68.7%, HR =0.80; 95% CI =0.65–0.97; p = 0.023), however, no overall survival benefit was evident by the addition of oxaliplatin in stage II cancer (85% versus 83.3%, p = 0.65). In a 10-year updated analysis, results essentially remained consistent. Oxaliplatin was approved for adjuvant treatment of colon cancer and is the standard of care for most patients with stage III colon cancer. The FOLFOX4 regimen is associated with more toxicity compared to 5FU/leucovorin, notably grade 3/4 neutropenia was 41% in FOLFOX4 compared to 5% in 5FU/leucovorin and grade 3/4 diarrhea was 11% versus 7%. Oxaliplatin was associated with cold related dysesthesia and mostly reversible peripheral sensory neuropathy. Grade 3 neuropathy was reported in 12% of patients who received FOLFOX4. Although considered reversible, minority of patients may suffer long term or permanent sensory loss. About 30% of patients still had residual numbness at 12 months (5.9% grade 2/3) with another 24% experiencing some degree of neuropathy at 18 months from the end of treatment (3.9% grade 2/3).
\nA large second study confirmed the efficacy of oxaliplatin in adjuvant therapy for stage III colon cancer. NSABP C-07 enrolled 2409 patients with stage III (71%) and stage II (29%) colon cancer. They were randomized to receive either combination 5FU/leucovorin/oxaliplatin (FLOX) or 5FU/leucovorin. A weekly bolus 5FU Roswell Park regimen was used here instead of infusional 5FU. FLOX regimen improved disease-free survival compared to control arm (69.4% versus 64.2%; HR 0.82; 95% CI 0.72–0.93; p = 0.002), however overall survival differences were not statistically different. (HR 0.88; 95% CI 0.72–1.02; P = 0.08) No interaction was seen between treatment on the stage, however treatment effect did vary by age overall survival significantly improved in patients younger than 70 (HR 0.80; 95% CI 0.68–0.95; p = 0.01) with no effect seen in older patients [23]. However, FLOX regimen was associated with high incidence of grade 3/4 diarrhea (38% versus 32%) and hospitalization (5.5% versus 3%). Given the lack of survival benefit and toxicity with bolus 5FU regimen, infusional 5FU regimens like FOLFOX have become standard of care.
\nThe XELOXA trial supported the benefit of oxaliplatin in combination with capecitabine. In this randomized trial, 1866 patients with stage III colon cancer were either treated with capecitabine/oxaliplatin or bolus 5FU/leucovorin regimen (Mayo clinic or Roswell Park) for 6 months. After a median follow up of 7 years disease free survival (63% versus 56%, HR 0.80; 95% CI; 0.69–0.93; p = 0.004) and overall survival (73% versus 67%, HR 0.83; 95% CI 0.70–0.93; p = 0.04) improved significantly compared to 5FU/leucovorin.
\nIn all three trials oxaliplatin was associated with significant neurotoxicity which can be acute or chronic. Acute cold related neurotoxicity present as paresthesia or dysesthesia of hands and feet or muscular cramps including laryngospasm. This is often reversible but tends to recur with each treatment. On the other hand chronic neuropathy causes primarily a sensory neuropathy in limbs is thought to be due to accumulation of platinum products in dorsal root ganglia in a dose -dependent manner. About 10–15% of patients experience severe neuropathy after cumulative dose of 780–850 mg/m2. Other clinical factors are implicated in the onset of neuropathy, but none shows strong association. Patents with existing other comorbidities such as diabetes, hypertension and smoking may be associated with higher incidence of neuropathy from oxaliplatin, these results were not statistically significant. But patients with diabetes seem to develop neuropathy at lower cumulative dose [26]. Another report suggests that incidence neuropathy may be less XELOX 3-wekely (130 mg/m2) regimen than FOLFOX 2-weekly (85 mg/m2) regimen [27]. Therefore, choice of oxaliplatin in the adjuvant treatment of colon cancer should be based on individual assessment of risk of recurrence and other clinical factors.
\nAdjuvant and neoadjuvant radiotherapy is routinely used in the treatment of rectal cancer and has an impact on reducing the local recurrence rate and therefore improving local control. However, the use of this modality in non-rectal colon cancer is controversial and not supported by randomized controlled trials. It is however considered in the situation of T4 tumor which invades surrounding structures such as the bladder or the abdominal wall where there is a perceived high risk of local recurrence of the tumor. A retrospective analysis of 21,789 patients with T4 colon cancer using the US SEER (Surveillance, Epidemiology and End Results) database found 1001 patient who received radiotherapy [28]. After adjustment for sex, age, N stage and tumor grade the relative risk of death from cancer at 5-years was 0.88 (95CI 0.8008–0.9779, p = 0.0165) in patients who received radiotherapy.
\nLiver is the commonest site of metastases in colon cancer. Unlike many other solid organ cancers, metastasectomy improves survival in colorectal cancer, where 5-year overall survival may reach 50%. The best postoperative management strategy is not well defined, however, often perioperative chemotherapy is utilized in the form of FOLFOX or CAPOX with agents like irinotecan, anti-EGFR, or anti-VEFG therapy often added for eligible patients in the neoadjuvant setting if downstaging was necessary. In the EORTC 40983 trial, perioperative chemotherapy was associated with 7.3% absolute increase in 3-year progression-free survival, however there was no difference in overall survival [29, 30]. Another Japanese study also did not show overall survival benefit with adjuvant chemotherapy [31]. Given the established role of adjuvant therapy in stage III colon cancer, despite lack of strong evidence many expert groups support perioperative or postoperative chemotherapy for resectable colorectal cancer metastases.
\nColon cancers that lack mismatch repair enzyme (dMMR) exhibit high microsatellite instability (MSI-High) and are associated with better prognosis compared to those with proficient mismatch repair enzymes (pMMR). Consistently, frequency of dMMR is higher in stage II colon cancer (20%) compared stage III (12%) and stage IV (4%) [32]. In a seminal study by Ribic et al., reported the prognostic differences between dMMR and pMMR in 570 patients from 5 different trials of 5FU based adjuvant chemotherapy (stage II and III) [33]. Five-year overall survival was significantly better in dMMR compared to pMMR(HR 0.31; 95% CI, 0.14–0.72;p = 0.004). Furthermore, there was no survival difference between dMMR and pMMR among those who received adjuvant chemotherapy (HR 1.07; 95% CI, 0.62–1.86; p = 0.80). The benefit of adjuvant chemotherapy was restricted to those with pMMR only. Although not all studies are consistent, a systemic review of 32 trials supported the above finding [34]. The key enzyme involved 5FU metabolism in cancer cells, thymidylate synthase, is found to be overexpressed in dMMR colon cancers which confer resistance to 5FU based therapy. Therefore, most patients with stage II colon cancer would not benefit from 5FU (only) based adjuvant therapy. Nevertheless, the role of dMMR in adjuvant therapy for stage III colon cancer is less clear. Despite lack of prospective data, retrospective studies support the use of oxaliplatin based adjuvant therapy, although Sinicrope et al. reported reduced distant recurrence in stage III cancers after treatment with 5FU [35, 36].
\nLack of CDX2 was associated with lower 5-year survival rate compared to CDX2-positive tumors, especially in stage II tumors (49% versus 87%, p = 0.003). CDX2 was also predictive of treatment benefit with higher disease-free survival in CDX2-negative tumors in both stage II and III tumors. This need to be further validated in prospective studies. The presence of BRAF V600E mutation confers a poor prognosis in colon cancer; however, concomitant loss of one or more MMR enzymes (dMMR) seems to improve the survival. In an analysis of three adjuvant chemotherapy trials of stage II and III colon cancer, BRAF mutation was not prognostic, however overall survival was poor among those with pMMR [32]. While another study of 2299 patients from two NSABP trials showed similar results, where BRAF mutation was not predictive of oxaliplatin benefit [37]. The presence of RAS (KRAS and NRAS) mutation is associated with resistance to EGFR targeted therapy in metastatic colon cancer. Although the presence of KRAS mutation seems to confer poor prognosis, not all studies are consistent [32, 37, 38, 39]. Number of other molecular markers such as DCC, TP53, thymidylate synthase and POL-E are also found to have prognostic significance [40, 41, 42, 43]. Despite emerging evidence of these molecular markers, their predictive value is still not validated in clinical practice and they are not routinely considered in decision making regarding adjuvant therapy, except for MMR status.
\nGene expression profiling has been utilized to characterize colon cancers and to identify gene signatures that could be predictive and prognostic. A number of commercial assays are developed in the recent past (OncoDefender-CRC, ColonPRS, ColoPrint colon cancer recurrence assay, GeneFx colon) but none have been approved for routine use in clinical practice. The Oncotype-DX colon cancer assay is perhaps the most validated tool which is a 12-gene assay developed to predict the recurrence score in stage II colon cancer. It was validated using prospective data from large studies including QUASAR, CALGB9581 and SUNRISE [44, 45, 46]. Despite the ability in predicting the risk of recurrence with confidence, it is unclear whether patients in higher risk category will benefit from adjuvant chemotherapy. A treatment score was developed using the data from QUASAR, but it was not predictive of the treatment effect. At this stage the data are insufficient to recommend routine use of multi-gene assays when deciding adjuvant therapy for stage II colon cancer.
\nGene sequencing of colorectal cancer have identified number of common somatic mutations and these tumor-specific mutations can be utilized to detect the tumor DNA (ctDNA) in the cell free component of peripheral blood. Detectable ctDNA after surgical resection or after completion of adjuvant chemotherapy seem to be associated with high risk of recurrence. In a study of 230 patients with resected stage II colon cancer, 14 patients out of 178 who did not receive adjuvant chemotherapy had detectable ctDNA. Eleven of the 14 (79%) developed recurrence at a median follow up of 27 months. Among those who received chemotherapy 3/44 had detectable ctDNA and all of them have relapsed within 11 months [47]. In metastatic setting, changes in ctDNA correlate with radiological responses [48]. Consistently in the early stage colon cancer, patients who clear ctDNA after adjuvant therapy have favorable prognosis [49]. Currently available data suggest that ctDNA is robust marker of minimal residual disease after surgery or after adjuvant chemotherapy with good prognostic and predictive value. Although current assays used to detect ctDNA have high specificity and positive predictive value, the sensitivity of these assays need optimization. In addition, a consensus on the methodology and larger number of prospective trials are needed before their routine use in clinical practice.
\nAdjuvant therapy should be initiated as soon as patient has recovered from surgery with complete healing of surgical wounds which usually takes about 2–4 weeks. A meta-analysis in 2019 which included 34 comparative studies of resected colon cancer reported that delay in treatment beyond 6–8 weeks was associated with inferior survival (HR 1.27,95% CI 1.21–1.33; p < 0.001) [50]. Another review which included more than 15,000 patients concluded that a 4-week increase in time to initiate adjuvant chemotherapy was associated with a 14% relative decrease in disease free survival and overall survival [51]. A number of other studies have consistent findings suggesting inferior outcomes when chemotherapy was initiated more than 6–8 weeks. However, most of these studies are retrospective in nature and potentially biased by confounding factors such as comorbidities, post-operative complications, and emergency resections which are all likely to delay the recovery.
\nThe recommendations for duration of adjuvant therapy for colon cancer are evolving. Early adjuvant trials treated patients for 12 months with 5FU/levamisole which was the standard of care in 1990s. Subsequent studies revealed 6 months of therapy was at least comparable to 12 months which became the standard of care in late 1990s [25, 52]. MOSAIQ an NSABP C-07 trials utilized 6 months of oxaliplatin and 5FU based regimen which remained as standard practice until recently the IDEA (International Duration Evaluation of Adjuvant Chemotherapy) collaboration study explored non-inferiority of 3 months of adjuvant therapy versus 6 months. IDEA collaboration study was a prespecified exploratory combined analysis of six separate international randomized trials of 6 versus 3 months of oxaliplatin based adjuvant therapy. Although non-inferiority of 3-months was not proven in the intention to treat population, sub-group analysis revealed patients those who received capecitabine and oxaliplatin (CAPOX) for 3 months, 5-year disease free survival was non-inferior to 6 months, however 3 months of 5FU and oxaliplatin FOLFOX did not meet the non-inferiority margin [53, 54]. Among low risk patients (T1–3,N1) the 5-year overall survival benefit between 3 versus 6 months therapy was 89.6% versus 88.9% (absolute difference of 0.7%) whereas the absolute difference was 2.7 among higher risk patients (T4N2 and above). Therefore, in lower risk patients, 3 months of therapy is acceptable if CAPOX regimen was chosen, while 6 months of therapy should be offered with FOLFOX regimen for others with stage III disease with clear discussion with patients regarding the small added benefit and risk of long-term neuropathy. 5FU/Leucovorin without oxaliplatin is offered as adjuvant therapy in stage III colon cancer sometimes, when patients are medically unfit or elderly. Six months adjuvant therapy is the standard recommendation in this situation, given absence of prospective data comparing 3 months versus 6 months. Similarly, 6 months of 5FU based adjuvant therapy is standard in stage II colon cancer. However, patients with high risk stage II disease are sometimes treated with oxaliplatin based regimen. TOSCA trial investigated 3 months versus 6 months of adjuvant therapy in stage II and III colon cancer where one-third of them were stage II [55]. In the overall population, 6 months was superior to 3 months, however, 3 months of CAPOX regimen was non-inferior to 6 months. There were 1254 patients with high risk stage II disease in the IDEA collaborative study (including TOSCA study) which investigated the optimal duration of adjuvant therapy [56]. Investigators concluded that 3 months of CAPOX may be non-inferior to 6 months in high risk stage II cancers, reflecting the finding in stage III disease. Consistently 3 months of FOLFOX was not non-inferior to 6 months.
\nSystemic chemotherapy in older adults may possess unique challenges due to comorbidities, and age-related organ dysfunction which may limit their life expectancy. In addition the impact on quality of life from chemotherapy may be more prominent in older adults. Benefit of adjuvant chemotherapy in older adults is well established. A pooled analysis of seven randomized trials of adjuvant chemotherapy (5FU/levamisole or 5FU/leucovorin) in stage II and III found comparable overall survival and disease free survival benefit in patients of over 70 compared to those less than 70 [57]. Similar outcomes were seen in another analysis of prospective data from 85,934 patients [58]. Although it is not clearly determined whether older patients experience more toxicities from chemotherapy, an analysis of 37,568 patients from ACCENT database (Clinical Trials From the Adjuvant Colon Cancer Endpoints Database) reported early mortality was significantly higher among those who are >70 compared to younger patients [59]. A pooled analysis suggested no difference in toxicity from 5FU based therapy in older adults; however, it is important to consider that toxicity from 5FU may vary depending on the schedule, specially gastrointestinal side effects in older adults may be more frequent with bolus regimens compared to short term infusional regimens [60]. In addition capecitabine may be associated with more severe toxicities in older adults, especially in those with diminished renal function. In a phase 3 trial of stage III colon cancer, particular toxicities like diarrhea were higher among patients over 65 with capecitabine [61]. Similarly, in X-ACT trial which examined capecitabine versus bolus 5FU (Mayo clinic), treatment-related toxicity was higher in patients above 70 (51%) compared to those less than 70 (39%) [62].
\nAlthough oxaliplatin based adjuvant chemotherapy improves survival in stage III colon cancer, its role in older adults above 70 is debatable. Subset analysis of three large randomized trials failed to demonstrate survival advantage in older patients. In an updated analysis of the MOSAIQ study, addition of oxaliplatin did not improve survival in 315 patients above 70 years (HR 1.16; 95% CI, 0.83–1.7) [22]. NSABP C-07 study enrolled 396 patients over 70 years, and no added benefit was seen with oxaliplatin in either in disease free survival (HR 1.03; 95% CI 0.77–1.36) or overall survival (HR 1.18; 95% CI 0.68–1.62) [23]. Consistently XELOXA study failed to demonstrate benefit of oxaliplatin over capecitabine alone in patients above 70 years (Disease free survival: HR 0.86; 95% CI, 0.64–1.16 and overall survival: HR 0.98; 95% CI, 0.62–1.56) [63]. A pooled analysis of seven randomized trials from ACCENT database with more than 14,500 patients (including 2575 patients over 70 years) suggested no survival advantage of oxaliplatin in those above 70 years (Disease free survival: HR 0.94; 95% CI, 0.78–1.13; Overall Survival: HR, 1.04; 95% CI, 0.85–1.27) [64]. However, it is unclear as to why addition of oxaliplatin was beneficial in metastatic setting and not in early cancer setting. Therefore, with currently available data, oxaliplatin is not recommended for routine use in patients above 70 who need adjuvant therapy, however, in those with high risk cancer and medical fit with good life expectancy, the benefit and risk of oxaliplatin should be discussed.
\nIrinotecan, via its active metabolite SN-38 inhibits topoisomerase 1 enzyme, causing inhibition of DNA replication and cell death. Irinotecan has well established activity in metastatic colorectal cancer in combination with 5FU/leucovorin and as single agent. However, three phase III randomized controlled trials have failed to show any benefit of irinotecan based regimens [65, 66, 67]. Bevacizumab and cetuximab have shown survival advantage in metastatic colon cancer when added to irinotecan or oxaliplatin based regimens. Bevacizumab is a vascular endothelial growth factor inhibitor, failed to show benefit when added to FOLFOX or capecitabine [68, 69, 70]. The NCCTG-N0147 trial examined the utility of cetuximab which is a mouse/human chimeric monoclonal antibody that targets the epidermal growth factor receptor, with FOLFOX compared to FOLFOX alone in resected colon cancer [71]. The trial was closed prematurely after the interim analysis showed no benefit of cetuximab. This was confirmed in another European PETACC8 trial which enrolled RAS wild-type patients [72]. Edrecolomab is a murine monoclonal antibody against EpCam antigen. Addition of edrecolomab to standard 5FU based adjuvant therapy did not improve disease-free survival or overall survival in stage III colon cancer [73]. Raltitrexed is a quinazoline folate analogue that acts as a direct and specific thymidylate synthase inhibitor which is often utilized in patients who experience cardiac toxicity with 5FU based therapy. PETACC1 trial examined the role of adjuvant raltitrexed in stage III colon cancer compared to 5FU/leucovorin. This trial was closed prematurely due to high rate of treatment related toxicity and death. However, an independent review found multiple incidences of protocol violations in relation to dose adjustment for renal function. Therefore, it may be appropriate to consider raltitrexed as an alternative to 5FU in patients with high risk stage III colon cancer who experience significant cardiac toxicity. Appropriate discussion about the evidence and potential toxicity is key in such instances [74, 75].
\nNon-steroidal anti-inflammatory (NSAID) drugs like aspirin or celecoxib have been examined as adjunctive therapies, however large randomized trial data are lacking. Most of the evidence supporting the use of aspirin in secondary prevention of colon cancer recurrence are from observational studies, though not all studies are consistent. Subset analysis of number of such studies have identified potential link to PIK3CA status, prostaglandin-endoperoxidase synthase 2 expression, and BRAF mutations. Although these data are interesting, they need to be confirmed in prospective trials. A large randomized controlled study examined the benefit of celecoxib in more than 2500 patients and there was no disease-free survival or overall survival benefit from the addition of celecoxib. Therefore updated 2013 American Society for Clinical Oncology (ASCO) guidelines did not endorse routine use of aspirin in this setting [76, 77]. Therefore, routine use of NSAIDs is not recommended currently until further studies are available. An association between serum vitamin D levels and resected colon cancer has been postulated; however, there is no high-quality evidence to support the routine use of vitamin D for this indication. Given the adverse of effect of vitamin D deficiency in skeletal system, it is not unreasonable to replace vitamin D in those who are deficient.
\nAim of surveillance after curative resection of primary colorectal cancer is to identify asymptomatic recurrences who may be a potential candidate for curative resection. Although most randomized trials suggest modest survival benefit, not all trials are consistent. The benefit Intensive versus less intensive follow up strategies is still debated. Accordingly, surveillance strategies vary among different expert groups. Multiple meta-analyses have been conducted in an attempt to rationalize the surveillance plan, the latest being Cochrane analysis 2019, which examined the data from 13,216 patients from 19 randomized trials and found there was no overall survival benefit from intensive surveillance. Intensive follow up resulted in higher rates of salvage surgeries with curative intent; however, this did not result in improved survival. Furthermore, these results were confounded by heterogeneity of the trials included in the meta-analyses. For example, definition of intensive versus less intensive follow up varied among the trials in terms of frequency of follow up [78]. In addition some trials included patents with stage I disease who have low rates of recurrence. Despite inconsistencies in the data, and the fact that curative metastasectomy improves survival in colorectal cancer patients, intensity of follow up should be tailored according to patient and cancer characteristics. Surveillance modalities include physical examination, carcino-embryonic antigen (CEA) and computerized tomography (CT) for surveillance. Follow up guidelines varies between the expert groups [79, 80]. A relatively intense follow up is reasonable for the first 3 years after the curative surgery, with 3–6 monthly physical examination and measurement of CEA. A 12 monthly CT scan is appropriate for the first 3 years and CT scans should be performed on any clinical suspicion thereafter. A colonoscopy is indicated after adjuvant therapy, if a complete colonoscopy was not performed at the time of surgery. Otherwise a routine colonoscopy should be performed at 12 months and then 5-yearly unless an adenomatous polyp is found which should prompt an earlier follow up colonoscopy.
\nColon cancer is one of the leading cause or morbidity and mortality in the world with incidence increasing, especially in younger population. Advances in systemic chemotherapeutic options have improved the survival. Adjuvant chemotherapy has been shown to reduce the risk of recurrence after resection of primary colon cancer; however, it is associated with chemotherapy related morbidity and mortality. Clinicopathological features and molecular characteristics of the tumor need to be carefully assessed and adjuvant therapy should be tailored accordingly in order to avoid futile treatment and serious toxicities. Advances in genomic profiling and evolution of detection of circulating tumor DNA are promising and may guide the choice and intensity of treatment in the future.
\nThe authors declare no conflicts of interests.
As an Open Access publisher, IntechOpen is dedicated to maintaining the highest ethical standards and principles in publishing. In addition, IntechOpen promotes the highest standards of integrity and ethical behavior in scientific research and peer-review. To maintain these principles IntechOpen has developed basic guidelines to facilitate the avoidance of Conflicts of Interest.
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\\n\\nA Conflict of Interest is a situation in which a person's professional judgment may be influenced by a range of factors, including financial gain, material interest, or some other personal or professional interest. For IntechOpen as a publisher, it is essential that all possible Conflicts of Interest are avoided. Each contributor, whether an Author, Editor, or Reviewer, who suspects they may have a Conflict of Interest, is obliged to declare that concern in order to make the publisher and the readership aware of any potential influence on the work being undertaken.
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\\n\\nAuthors are required to declare all potentially relevant non-financial, financial and material Conflicts of Interest that may have had an influence on their scientific work.
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\\n"}]'},components:[{type:"htmlEditorComponent",content:"In each instance of a possible Conflict of Interest, IntechOpen aims to disclose the situation in as transparent a way as possible in order to allow readers to judge whether a particular potential Conflict of Interest has influenced the Work of any individual Author, Editor, or Reviewer. IntechOpen takes all possible Conflicts of Interest into account during the review process and ensures maximum transparency in implementing its policies.
\n\nA Conflict of Interest is a situation in which a person's professional judgment may be influenced by a range of factors, including financial gain, material interest, or some other personal or professional interest. For IntechOpen as a publisher, it is essential that all possible Conflicts of Interest are avoided. Each contributor, whether an Author, Editor, or Reviewer, who suspects they may have a Conflict of Interest, is obliged to declare that concern in order to make the publisher and the readership aware of any potential influence on the work being undertaken.
\n\nA Conflict of Interest can be identified at different phases of the publishing process.
\n\nIntechOpen requires:
\n\nCONFLICT OF INTEREST - AUTHOR
\n\nAll Authors are obliged to declare every existing or potential Conflict of Interest, including financial or personal factors, as well as any relationship which could influence their scientific work. Authors must declare Conflicts of Interest at the time of manuscript submission, although they may exceptionally do so at any point during manuscript review. For jointly prepared manuscripts, the corresponding Author is obliged to declare potential Conflicts of Interest of any other Authors who have contributed to the manuscript.
\n\nCONFLICT OF INTEREST – ACADEMIC EDITOR
\n\nEditors can also have Conflicts of Interest. Editors are expected to maintain the highest standards of conduct, which are outlined in our Best Practice Guidelines (templates for Best Practice Guidelines). Among other obligations, it is essential that Editors make transparent declarations of any possible Conflicts of Interest that they might have.
\n\nAvoidance Measures for Academic Editors of Conflicts of Interest:
\n\nFor manuscripts submitted by the Academic Editor (or a scientific advisor), an appropriate person will be appointed to handle and evaluate the manuscript. The appointed handling Editor's identity will not be disclosed to the Author in order to maintain impartiality and anonymity of the review.
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\n\nAll Reviewers are required to declare possible Conflicts of Interest at the beginning of the evaluation process. If a Reviewer feels he or she might have any material, financial or any other conflict of interest with regards to the manuscript being reviewed, he or she is required to declare such concern and, if necessary, request exclusion from any further involvement in the evaluation process. A Reviewer's potential Conflicts of Interest are declared in the review report and presented to the Academic Editor, who then assesses whether or not the declared potential or actual Conflicts of Interest had, or could be perceived to have had, any significant impact on the review itself.
\n\nEXAMPLES OF CONFLICTS OF INTEREST:
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\n\nAuthors are required to declare all potentially relevant non-financial, financial and material Conflicts of Interest that may have had an influence on their scientific work.
\n\nAcademic Editors and Reviewers are required to declare any non-financial, financial and material Conflicts of Interest that could influence their fair and balanced evaluation of manuscripts. If such conflict exists with regards to a submitted manuscript, Academic Editors and Reviewers should exclude themselves from handling it.
\n\nAll Authors, Academic Editors, and Reviewers are required to declare all possible financial and material Conflicts of Interest in the last five years, although it is advisable to declare less recent Conflicts of Interest as well.
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\n\nAuthors should declare if they were or they still are Academic Editors of the publications in which they wish to publish their work.
\n\nAuthors should declare if they are board members of an organization that could benefit financially or materially from the publication of their work.
\n\nAcademic Editors should declare if they were coauthors or they have worked on the research project with the Author who has submitted a manuscript.
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\n\nPolicy last updated: 2016-06-09
\n"}]},successStories:{items:[]},authorsAndEditors:{filterParams:{sort:"featured,name"},profiles:[{id:"105746",title:"Dr.",name:"A.W.M.M.",middleName:null,surname:"Koopman-van Gemert",slug:"a.w.m.m.-koopman-van-gemert",fullName:"A.W.M.M. Koopman-van Gemert",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/105746/images/5803_n.jpg",biography:"Dr. Anna Wilhelmina Margaretha Maria Koopman-van Gemert MD, PhD, became anaesthesiologist-intensivist from the Radboud University Nijmegen (the Netherlands) in 1987. She worked for a couple of years also as a blood bank director in Nijmegen and introduced in the Netherlands the Cell Saver and blood transfusion alternatives. She performed research in perioperative autotransfusion and obtained the degree of PhD in 1993 publishing Peri-operative autotransfusion by means of a blood cell separator.\nBlood transfusion had her special interest being the president of the Haemovigilance Chamber TRIP and performing several tasks in local and national blood bank and anticoagulant-blood transfusion guidelines committees. Currently, she is working as an associate professor and up till recently was the dean at the Albert Schweitzer Hospital Dordrecht. She performed (inter)national tasks as vice-president of the Concilium Anaesthesia and related committees. \nShe performed research in several fields, with over 100 publications in (inter)national journals and numerous papers on scientific conferences. \nShe received several awards and is a member of Honour of the Dutch Society of Anaesthesia.",institutionString:null,institution:{name:"Albert Schweitzer Hospital",country:{name:"Gabon"}}},{id:"83089",title:"Prof.",name:"Aaron",middleName:null,surname:"Ojule",slug:"aaron-ojule",fullName:"Aaron Ojule",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"University of Port Harcourt",country:{name:"Nigeria"}}},{id:"295748",title:"Mr.",name:"Abayomi",middleName:null,surname:"Modupe",slug:"abayomi-modupe",fullName:"Abayomi Modupe",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/no_image.jpg",biography:null,institutionString:null,institution:{name:"Landmark University",country:{name:"Nigeria"}}},{id:"94191",title:"Prof.",name:"Abbas",middleName:null,surname:"Moustafa",slug:"abbas-moustafa",fullName:"Abbas Moustafa",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/94191/images/96_n.jpg",biography:"Prof. Moustafa got his doctoral degree in earthquake engineering and structural safety from Indian Institute of Science in 2002. He is currently an associate professor at Department of Civil Engineering, Minia University, Egypt and the chairman of Department of Civil Engineering, High Institute of Engineering and Technology, Giza, Egypt. He is also a consultant engineer and head of structural group at Hamza Associates, Giza, Egypt. Dr. Moustafa was a senior research associate at Vanderbilt University and a JSPS fellow at Kyoto and Nagasaki Universities. He has more than 40 research papers published in international journals and conferences. He acts as an editorial board member and a reviewer for several regional and international journals. His research interest includes earthquake engineering, seismic design, nonlinear dynamics, random vibration, structural reliability, structural health monitoring and uncertainty modeling.",institutionString:null,institution:{name:"Minia University",country:{name:"Egypt"}}},{id:"84562",title:"Dr.",name:"Abbyssinia",middleName:null,surname:"Mushunje",slug:"abbyssinia-mushunje",fullName:"Abbyssinia Mushunje",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"University of Fort Hare",country:{name:"South Africa"}}},{id:"202206",title:"Associate Prof.",name:"Abd Elmoniem",middleName:"Ahmed",surname:"Elzain",slug:"abd-elmoniem-elzain",fullName:"Abd Elmoniem Elzain",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Kassala University",country:{name:"Sudan"}}},{id:"98127",title:"Dr.",name:"Abdallah",middleName:null,surname:"Handoura",slug:"abdallah-handoura",fullName:"Abdallah Handoura",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"École Supérieure des Télécommunications",country:{name:"Morocco"}}},{id:"91404",title:"Prof.",name:"Abdecharif",middleName:null,surname:"Boumaza",slug:"abdecharif-boumaza",fullName:"Abdecharif Boumaza",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Abbès Laghrour University of Khenchela",country:{name:"Algeria"}}},{id:"105795",title:"Prof.",name:"Abdel Ghani",middleName:null,surname:"Aissaoui",slug:"abdel-ghani-aissaoui",fullName:"Abdel Ghani Aissaoui",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/105795/images/system/105795.jpeg",biography:"Abdel Ghani AISSAOUI is a Full Professor of electrical engineering at University of Bechar (ALGERIA). He was born in 1969 in Naama, Algeria. He received his BS degree in 1993, the MS degree in 1997, the PhD degree in 2007 from the Electrical Engineering Institute of Djilali Liabes University of Sidi Bel Abbes (ALGERIA). He is an active member of IRECOM (Interaction Réseaux Electriques - COnvertisseurs Machines) Laboratory and IEEE senior member. He is an editor member for many international journals (IJET, RSE, MER, IJECE, etc.), he serves as a reviewer in international journals (IJAC, ECPS, COMPEL, etc.). He serves as member in technical committee (TPC) and reviewer in international conferences (CHUSER 2011, SHUSER 2012, PECON 2012, SAI 2013, SCSE2013, SDM2014, SEB2014, PEMC2014, PEAM2014, SEB (2014, 2015), ICRERA (2015, 2016, 2017, 2018,-2019), etc.). His current research interest includes power electronics, control of electrical machines, artificial intelligence and Renewable energies.",institutionString:"University of Béchar",institution:{name:"University of Béchar",country:{name:"Algeria"}}},{id:"99749",title:"Dr.",name:"Abdel Hafid",middleName:null,surname:"Essadki",slug:"abdel-hafid-essadki",fullName:"Abdel Hafid Essadki",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"École Nationale Supérieure de Technologie",country:{name:"Algeria"}}},{id:"101208",title:"Prof.",name:"Abdel Karim",middleName:"Mohamad",surname:"El Hemaly",slug:"abdel-karim-el-hemaly",fullName:"Abdel Karim El Hemaly",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/101208/images/733_n.jpg",biography:"OBGYN.net Editorial Advisor Urogynecology.\nAbdel Karim M. A. El-Hemaly, MRCOG, FRCS � Egypt.\n \nAbdel Karim M. A. El-Hemaly\nProfessor OB/GYN & Urogynecology\nFaculty of medicine, Al-Azhar University \nPersonal Information: \nMarried with two children\nWife: Professor Laila A. Moussa MD.\nSons: Mohamad A. M. El-Hemaly Jr. MD. Died March 25-2007\nMostafa A. M. El-Hemaly, Computer Scientist working at Microsoft Seatle, USA. \nQualifications: \n1.\tM.B.-Bch Cairo Univ. June 1963. \n2.\tDiploma Ob./Gyn. Cairo Univ. April 1966. \n3.\tDiploma Surgery Cairo Univ. Oct. 1966. \n4.\tMRCOG London Feb. 1975. \n5.\tF.R.C.S. Glasgow June 1976. \n6.\tPopulation Study Johns Hopkins 1981. \n7.\tGyn. Oncology Johns Hopkins 1983. \n8.\tAdvanced Laparoscopic Surgery, with Prof. Paulson, Alexandria, Virginia USA 1993. \nSocieties & Associations: \n1.\t Member of the Royal College of Ob./Gyn. London. \n2.\tFellow of the Royal College of Surgeons Glasgow UK. \n3.\tMember of the advisory board on urogyn. FIGO. \n4.\tMember of the New York Academy of Sciences. \n5.\tMember of the American Association for the Advancement of Science. \n6.\tFeatured in �Who is Who in the World� from the 16th edition to the 20th edition. \n7.\tFeatured in �Who is Who in Science and Engineering� in the 7th edition. \n8.\tMember of the Egyptian Fertility & Sterility Society. \n9.\tMember of the Egyptian Society of Ob./Gyn. \n10.\tMember of the Egyptian Society of Urogyn. \n\nScientific Publications & Communications:\n1- Abdel Karim M. El Hemaly*, Ibrahim M. Kandil, Asim Kurjak, Ahmad G. Serour, Laila A. S. Mousa, Amr M. Zaied, Khalid Z. El Sheikha. \nImaging the Internal Urethral Sphincter and the Vagina in Normal Women and Women Suffering from Stress Urinary Incontinence and Vaginal Prolapse. Gynaecologia Et Perinatologia, Vol18, No 4; 169-286 October-December 2009.\n2- Abdel Karim M. El Hemaly*, Laila A. S. Mousa Ibrahim M. Kandil, Fatma S. El Sokkary, Ahmad G. Serour, Hossam Hussein.\nFecal Incontinence, A Novel Concept: The Role of the internal Anal sphincter (IAS) in defecation and fecal incontinence. Gynaecologia Et Perinatologia, Vol19, No 2; 79-85 April -June 2010.\n3- Abdel Karim M. El Hemaly*, Laila A. S. Mousa Ibrahim M. Kandil, Fatma S. El Sokkary, Ahmad G. Serour, Hossam Hussein.\nSurgical Treatment of Stress Urinary Incontinence, Fecal Incontinence and Vaginal Prolapse By A Novel Operation \n"Urethro-Ano-Vaginoplasty"\n Gynaecologia Et Perinatologia, Vol19, No 3; 129-188 July-September 2010.\n4- Abdel Karim M. El Hemaly*, Ibrahim M. Kandil, Laila A. S. Mousa and Mohamad A.K.M.El Hemaly.\nUrethro-vaginoplasty, an innovated operation for the treatment of: Stress Urinary Incontinence (SUI), Detursor Overactivity (DO), Mixed Urinary Incontinence and Anterior Vaginal Wall Descent. \nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/ urethro-vaginoplasty_01\n\n5- Abdel Karim M. El Hemaly, Ibrahim M Kandil, Mohamed M. Radwan.\n Urethro-raphy a new technique for surgical management of Stress Urinary Incontinence.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/\nnew-tech-urethro\n\n6- Abdel Karim M. El Hemaly, Ibrahim M Kandil, Mohamad A. Rizk, Nabil Abdel Maksoud H., Mohamad M. Radwan, Khalid Z. El Shieka, Mohamad A. K. M. El Hemaly, and Ahmad T. El Saban.\nUrethro-raphy The New Operation for the treatment of stress urinary incontinence, SUI, detrusor instability, DI, and mixed-type of urinary incontinence; short and long term results. \nhttp://www.obgyn.net/urogyn/urogyn.asp?page=urogyn/articles/\nurethroraphy-09280\n\n7-Abdel Karim M. El Hemaly, Ibrahim M Kandil, and Bahaa E. El Mohamady. Menopause, and Voiding troubles. \nhttp://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly03/el-hemaly03-ss\n\n8-El Hemaly AKMA, Mousa L.A. Micturition and Urinary\tContinence. Int J Gynecol Obstet 1996; 42: 291-2. \n\n9-Abdel Karim M. El Hemaly.\n Urinary incontinence in gynecology, a review article.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/abs-urinary_incotinence_gyn_ehemaly \n\n10-El Hemaly AKMA. Nocturnal Enuresis: Pathogenesis and Treatment. \nInt Urogynecol J Pelvic Floor Dysfunct 1998;9: 129-31.\n \n11-El Hemaly AKMA, Mousa L.A.E. Stress Urinary Incontinence, a New Concept. Eur J Obstet Gynecol Reprod Biol 1996; 68: 129-35. \n\n12- El Hemaly AKMA, Kandil I. M. Stress Urinary Incontinence SUI facts and fiction. Is SUI a puzzle?! http://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly/el-hemaly-ss\n\n13-Abdel Karim El Hemaly, Nabil Abdel Maksoud, Laila A. Mousa, Ibrahim M. Kandil, Asem Anwar, M.A.K El Hemaly and Bahaa E. El Mohamady. \nEvidence based Facts on the Pathogenesis and Management of SUI. http://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly02/el-hemaly02-ss\n\n14- Abdel Karim M. El Hemaly*, Ibrahim M. Kandil, Mohamad A. Rizk and Mohamad A.K.M.El Hemaly.\n Urethro-plasty, a Novel Operation based on a New Concept, for the Treatment of Stress Urinary Incontinence, S.U.I., Detrusor Instability, D.I., and Mixed-type of Urinary Incontinence.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/urethro-plasty_01\n\n15-Ibrahim M. Kandil, Abdel Karim M. El Hemaly, Mohamad M. Radwan: Ultrasonic Assessment of the Internal Urethral Sphincter in Stress Urinary Incontinence. The Internet Journal of Gynecology and Obstetrics. 2003. Volume 2 Number 1. \n\n\n16-Abdel Karim M. El Hemaly. Nocturnal Enureses: A Novel Concept on its pathogenesis and Treatment.\nhttp://www.obgyn.net/urogynecolgy/?page=articles/nocturnal_enuresis\n\n17- Abdel Karim M. El Hemaly. Nocturnal Enureses: An Update on the pathogenesis and Treatment.\nhttp://www.obgyn.net/urogynecology/?page=/ENHLIDH/PUBD/FEATURES/\nPresentations/ Nocturnal_Enuresis/nocturnal_enuresis\n\n18-Maternal Mortality in Egypt, a cry for help and attention. The Second International Conference of the African Society of Organization & Gestosis, 1998, 3rd Annual International Conference of Ob/Gyn Department � Sohag Faculty of Medicine University. Feb. 11-13. Luxor, Egypt. \n19-Postmenopausal Osteprosis. The 2nd annual conference of Health Insurance Organization on Family Planning and its role in primary health care. Zagaziz, Egypt, February 26-27, 1997, Center of Complementary Services for Maternity and childhood care. \n20-Laparoscopic Assisted vaginal hysterectomy. 10th International Annual Congress Modern Trends in Reproductive Techniques 23-24 March 1995. Alexandria, Egypt. \n21-Immunological Studies in Pre-eclamptic Toxaemia. Proceedings of 10th Annual Ain Shams Medical Congress. Cairo, Egypt, March 6-10, 1987. \n22-Socio-demographic factorse affecting acceptability of the long-acting contraceptive injections in a rural Egyptian community. Journal of Biosocial Science 29:305, 1987. \n23-Plasma fibronectin levels hypertension during pregnancy. The Journal of the Egypt. Soc. of Ob./Gyn. 13:1, 17-21, Jan. 1987. \n24-Effect of smoking on pregnancy. Journal of Egypt. Soc. of Ob./Gyn. 12:3, 111-121, Sept 1986. \n25-Socio-demographic aspects of nausea and vomiting in early pregnancy. Journal of the Egypt. Soc. of Ob./Gyn. 12:3, 35-42, Sept. 1986. \n26-Effect of intrapartum oxygen inhalation on maternofetal blood gases and pH. Journal of the Egypt. Soc. of Ob./Gyn. 12:3, 57-64, Sept. 1986. \n27-The effect of severe pre-eclampsia on serum transaminases. The Egypt. J. Med. Sci. 7(2): 479-485, 1986. \n28-A study of placental immunoreceptors in pre-eclampsia. The Egypt. J. Med. Sci. 7(2): 211-216, 1986. \n29-Serum human placental lactogen (hpl) in normal, toxaemic and diabetic pregnant women, during pregnancy and its relation to the outcome of pregnancy. Journal of the Egypt. Soc. of Ob./Gyn. 12:2, 11-23, May 1986. \n30-Pregnancy specific B1 Glycoprotein and free estriol in the serum of normal, toxaemic and diabetic pregnant women during pregnancy and after delivery. Journal of the Egypt. Soc. of Ob./Gyn. 12:1, 63-70, Jan. 1986. Also was accepted and presented at Xith World Congress of Gynecology and Obstetrics, Berlin (West), September 15-20, 1985. \n31-Pregnancy and labor in women over the age of forty years. Accepted and presented at Al-Azhar International Medical Conference, Cairo 28-31 Dec. 1985. \n32-Effect of Copper T intra-uterine device on cervico-vaginal flora. Int. J. Gynaecol. Obstet. 23:2, 153-156, April 1985. \n33-Factors affecting the occurrence of post-Caesarean section febrile morbidity. Population Sciences, 6, 139-149, 1985. \n34-Pre-eclamptic toxaemia and its relation to H.L.A. system. Population Sciences, 6, 131-139, 1985. \n35-The menstrual pattern and occurrence of pregnancy one year after discontinuation of Depo-medroxy progesterone acetate as a postpartum contraceptive. Population Sciences, 6, 105-111, 1985. \n36-The menstrual pattern and side effects of Depo-medroxy progesterone acetate as postpartum contraceptive. Population Sciences, 6, 97-105, 1985. \n37-Actinomyces in the vaginas of women with and without intrauterine contraceptive devices. Population Sciences, 6, 77-85, 1985. \n38-Comparative efficacy of ibuprofen and etamsylate in the treatment of I.U.D. menorrhagia. Population Sciences, 6, 63-77, 1985. \n39-Changes in cervical mucus copper and zinc in women using I.U.D.�s. Population Sciences, 6, 35-41, 1985. \n40-Histochemical study of the endometrium of infertile women. Egypt. J. Histol. 8(1) 63-66, 1985. \n41-Genital flora in pre- and post-menopausal women. Egypt. J. Med. Sci. 4(2), 165-172, 1983. \n42-Evaluation of the vaginal rugae and thickness in 8 different groups. Journal of the Egypt. Soc. of Ob./Gyn. 9:2, 101-114, May 1983. \n43-The effect of menopausal status and conjugated oestrogen therapy on serum cholesterol, triglycerides and electrophoretic lipoprotein patterns. Al-Azhar Medical Journal, 12:2, 113-119, April 1983. \n44-Laparoscopic ventrosuspension: A New Technique. Int. J. Gynaecol. Obstet., 20, 129-31, 1982. \n45-The laparoscope: A useful diagnostic tool in general surgery. Al-Azhar Medical Journal, 11:4, 397-401, Oct. 1982. \n46-The value of the laparoscope in the diagnosis of polycystic ovary. Al-Azhar Medical Journal, 11:2, 153-159, April 1982. \n47-An anaesthetic approach to the management of eclampsia. Ain Shams Medical Journal, accepted for publication 1981. \n48-Laparoscopy on patients with previous lower abdominal surgery. Fertility management edited by E. Osman and M. Wahba 1981. \n49-Heart diseases with pregnancy. Population Sciences, 11, 121-130, 1981. \n50-A study of the biosocial factors affecting perinatal mortality in an Egyptian maternity hospital. Population Sciences, 6, 71-90, 1981. \n51-Pregnancy Wastage. Journal of the Egypt. Soc. of Ob./Gyn. 11:3, 57-67, Sept. 1980. \n52-Analysis of maternal deaths in Egyptian maternity hospitals. Population Sciences, 1, 59-65, 1979. \nArticles published on OBGYN.net: \n1- Abdel Karim M. El Hemaly*, Ibrahim M. Kandil, Laila A. S. Mousa and Mohamad A.K.M.El Hemaly.\nUrethro-vaginoplasty, an innovated operation for the treatment of: Stress Urinary Incontinence (SUI), Detursor Overactivity (DO), Mixed Urinary Incontinence and Anterior Vaginal Wall Descent. \nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/ urethro-vaginoplasty_01\n\n2- Abdel Karim M. El Hemaly, Ibrahim M Kandil, Mohamed M. Radwan.\n Urethro-raphy a new technique for surgical management of Stress Urinary Incontinence.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/\nnew-tech-urethro\n\n3- Abdel Karim M. El Hemaly, Ibrahim M Kandil, Mohamad A. Rizk, Nabil Abdel Maksoud H., Mohamad M. Radwan, Khalid Z. El Shieka, Mohamad A. K. M. El Hemaly, and Ahmad T. El Saban.\nUrethro-raphy The New Operation for the treatment of stress urinary incontinence, SUI, detrusor instability, DI, and mixed-type of urinary incontinence; short and long term results. \nhttp://www.obgyn.net/urogyn/urogyn.asp?page=urogyn/articles/\nurethroraphy-09280\n\n4-Abdel Karim M. El Hemaly, Ibrahim M Kandil, and Bahaa E. El Mohamady. Menopause, and Voiding troubles. \nhttp://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly03/el-hemaly03-ss\n\n5-El Hemaly AKMA, Mousa L.A. Micturition and Urinary\tContinence. Int J Gynecol Obstet 1996; 42: 291-2. \n\n6-Abdel Karim M. El Hemaly.\n Urinary incontinence in gynecology, a review article.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/abs-urinary_incotinence_gyn_ehemaly \n\n7-El Hemaly AKMA. Nocturnal Enuresis: Pathogenesis and Treatment. \nInt Urogynecol J Pelvic Floor Dysfunct 1998;9: 129-31.\n \n8-El Hemaly AKMA, Mousa L.A.E. Stress Urinary Incontinence, a New Concept. Eur J Obstet Gynecol Reprod Biol 1996; 68: 129-35. \n\n9- El Hemaly AKMA, Kandil I. M. Stress Urinary Incontinence SUI facts and fiction. Is SUI a puzzle?! http://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly/el-hemaly-ss\n\n10-Abdel Karim El Hemaly, Nabil Abdel Maksoud, Laila A. Mousa, Ibrahim M. Kandil, Asem Anwar, M.A.K El Hemaly and Bahaa E. El Mohamady. \nEvidence based Facts on the Pathogenesis and Management of SUI. http://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly02/el-hemaly02-ss\n\n11- Abdel Karim M. El Hemaly*, Ibrahim M. Kandil, Mohamad A. Rizk and Mohamad A.K.M.El Hemaly.\n Urethro-plasty, a Novel Operation based on a New Concept, for the Treatment of Stress Urinary Incontinence, S.U.I., Detrusor Instability, D.I., and Mixed-type of Urinary Incontinence.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/urethro-plasty_01\n\n12-Ibrahim M. Kandil, Abdel Karim M. El Hemaly, Mohamad M. Radwan: Ultrasonic Assessment of the Internal Urethral Sphincter in Stress Urinary Incontinence. The Internet Journal of Gynecology and Obstetrics. 2003. Volume 2 Number 1. \n\n13-Abdel Karim M. El Hemaly. Nocturnal Enureses: A Novel Concept on its pathogenesis and Treatment.\nhttp://www.obgyn.net/urogynecolgy/?page=articles/nocturnal_enuresis\n\n14- Abdel Karim M. El Hemaly. Nocturnal Enureses: An Update on the pathogenesis and Treatment.\nhttp://www.obgyn.net/urogynecology/?page=/ENHLIDH/PUBD/FEATURES/\nPresentations/ Nocturnal_Enuresis/nocturnal_enuresis",institutionString:null,institution:{name:"Al Azhar University",country:{name:"Egypt"}}},{id:"113313",title:"Dr.",name:"Abdel-Aal",middleName:null,surname:"Mantawy",slug:"abdel-aal-mantawy",fullName:"Abdel-Aal Mantawy",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Ain Shams University",country:{name:"Egypt"}}}],filtersByRegion:[{group:"region",caption:"North America",value:1,count:5681},{group:"region",caption:"Middle and South America",value:2,count:5161},{group:"region",caption:"Africa",value:3,count:1683},{group:"region",caption:"Asia",value:4,count:10200},{group:"region",caption:"Australia and 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