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Fuat Beyazit and Erdogan Koc",authors:[{id:"123323",title:"Dr.",name:"Fuat",middleName:null,surname:"Beyazit",fullName:"Fuat Beyazit",slug:"fuat-beyazit"},{id:"137258",title:"Dr.",name:"Erdogan",middleName:null,surname:"Koc",fullName:"Erdogan Koc",slug:"erdogan-koc"}]},{id:"35529",title:"Tourism Life Cycle Assessment (LCA): Proposal of a New Methodological Framework for Sustainable Consumption and Production",slug:"tourism-life-cycle-assessment-lca-a-new-methodological-framework-for-sustainable-consumption-and-pro",signatures:"Camillo De Camillis, Paul Peeters, Luigia Petti and Andrea Raggi",authors:[{id:"120456",title:"Dr.",name:"Camillo",middleName:null,surname:"De Camillis",fullName:"Camillo De Camillis",slug:"camillo-de-camillis"},{id:"120458",title:"Prof.",name:"Paul",middleName:null,surname:"Peeters",fullName:"Paul Peeters",slug:"paul-peeters"},{id:"120459",title:"Prof.",name:"Luigia",middleName:null,surname:"Petti",fullName:"Luigia Petti",slug:"luigia-petti"},{id:"120460",title:"Prof.",name:"Andrea",middleName:null,surname:"Raggi",fullName:"Andrea Raggi",slug:"andrea-raggi"}]},{id:"35530",title:"Economic Impact of Tourism - A Review of Literatures on Methodologies and Their Uses: 1969-2011",slug:"economic-impact-of-tourism-a-review-of-literatures-on-methodologies-and-their-uses-1969-2009",signatures:"Mohammad Nurul Huda Mazumder, Abdullah Al-Mamun, Abul Quasem Al-Amin and Muhammad Mohiuddin",authors:[{id:"118439",title:"Mr.",name:"Mohammad",middleName:null,surname:"Mazumder",fullName:"Mohammad Mazumder",slug:"mohammad-mazumder"},{id:"138029",title:"Mr.",name:"Abdullah",middleName:null,surname:"Al-Mamun",fullName:"Abdullah Al-Mamun",slug:"abdullah-al-mamun"},{id:"138030",title:"Dr.",name:"Abul Quasem",middleName:null,surname:"Al-Amin",fullName:"Abul Quasem Al-Amin",slug:"abul-quasem-al-amin"},{id:"138031",title:"Mr.",name:"Muhammad",middleName:null,surname:"Mohiuddin",fullName:"Muhammad Mohiuddin",slug:"muhammad-mohiuddin"}]},{id:"35531",title:"Carrying Capacity of Tourism System: Assessment of Environmental and Management Constraints Towards Sustainability",slug:"carrying-capacity-of-tourism-system-assessment-of-environmental-and-management-constraints-towards-s",signatures:"Valentina Castellani and Serenella Sala",authors:[{id:"119162",title:"Dr.",name:"Serenella",middleName:null,surname:"Sala",fullName:"Serenella Sala",slug:"serenella-sala"},{id:"119278",title:"Dr.",name:"Valentina",middleName:null,surname:"Castellani",fullName:"Valentina Castellani",slug:"valentina-castellani"}]},{id:"35532",title:"Reputational Damage to Tourism Industry from Earthquakes - Impact and Analysis of Mass Media Information",slug:"harmful-rumor-on-tourism-industry-caused-by-earthquake-impact-of-mass-media-information-and-analysis",signatures:"Mitsuyoshi Nagao and Azuma Ohuchi",authors:[{id:"116129",title:"Dr.",name:"Mitsuyoshi",middleName:null,surname:"Nagao",fullName:"Mitsuyoshi Nagao",slug:"mitsuyoshi-nagao"}]},{id:"35533",title:"The Tourist Potential of the Minho-Lima Region (Portugal)",slug:"the-tourism-potential-of-the-minho-lima-northern-portugal-region-",signatures:"José Cadima Ribeiro and Laurentina Cruz Vareiro",authors:[{id:"115965",title:"Prof.",name:"José",middleName:null,surname:"Cadima Ribeiro",fullName:"José Cadima Ribeiro",slug:"jose-cadima-ribeiro"},{id:"118377",title:"PhD.",name:"Laurentina",middleName:"Maria Da Cruz",surname:"Vareiro",fullName:"Laurentina Vareiro",slug:"laurentina-vareiro"}]},{id:"35534",title:"Long-Term Impacts of Non-Sustainable Tourism and Urban Development in Small Tropical Islands Coastal Habitats in a Changing Climate: Lessons Learned from Puerto Rico",slug:"long-term-impacts-of-non-sustainable-tourism-and-urban-development-in-tropical-coastal-habitats-in-a",signatures:"Edwin A. Hernández- Delgado, Carlos E. Ramos-Scharrón, Carmen R. Guerrero-Pérez, Mary Ann Lucking, Ricardo Laureano, Pablo A. Méndez-Lázaro and Joel O. Meléndez-Díaz",authors:[{id:"105547",title:"Dr.",name:"Carlos",middleName:null,surname:"Ramos-Scharron",fullName:"Carlos Ramos-Scharron",slug:"carlos-ramos-scharron"},{id:"108403",title:"Dr.",name:"Edwin",middleName:null,surname:"Hernandez- Delgado",fullName:"Edwin Hernandez- Delgado",slug:"edwin-hernandez-delgado"},{id:"118359",title:"BSc.",name:"Mary Ann",middleName:null,surname:"Lucking",fullName:"Mary Ann Lucking",slug:"mary-ann-lucking"},{id:"118360",title:"Mr.",name:"Ricardo",middleName:null,surname:"Laureano",fullName:"Ricardo Laureano",slug:"ricardo-laureano"},{id:"151525",title:"MSc.",name:"Carmen",middleName:null,surname:"Guerrero-Perez",fullName:"Carmen Guerrero-Perez",slug:"carmen-guerrero-perez"},{id:"151526",title:"Dr.",name:"Pablo",middleName:null,surname:"Mendez-Lazaro",fullName:"Pablo Mendez-Lazaro",slug:"pablo-mendez-lazaro"}]},{id:"35535",title:"Nautical Tourism and Its Function in the Economic Development of Europe",slug:"nautical-tourism-in-the-function-of-the-economic-development-of-europe",signatures:"Tihomir Luković",authors:[{id:"115398",title:"Dr.",name:"Tihomir",middleName:null,surname:"Lukovic",fullName:"Tihomir Lukovic",slug:"tihomir-lukovic"}]},{id:"35536",title:"Sustainability in the Management of World Cultural Heritage",slug:"sustainability-in-the-management-of-world-cultural-heritage",signatures:"Devi Roza Kausar",authors:[{id:"114864",title:"Dr.",name:"Devi",middleName:null,surname:"Kausar",fullName:"Devi Kausar",slug:"devi-kausar"}]},{id:"35537",title:"Tourism in Rural Areas: Foundation, Quality and Experience",slug:"tourism-in-rural-areas-foundation-quality-and-experience",signatures:"Sandra Maria Correia Loureiro",authors:[{id:"112943",title:"Prof.",name:"Sandra",middleName:"Maria Correia",surname:"Loureiro",fullName:"Sandra Loureiro",slug:"sandra-loureiro"}]},{id:"35538",title:"Islands and Tourism Development: A Viewpoint of Tourism Stakeholders of Lesvos Island",slug:"islands-and-tourism-development-a-viewpoint-of-tourism-stakeholders-of-lesvos-island-greece",signatures:"Kostas Rontos, Eleni Kitrinou, Dimitrios Lagos and Mihail Diakomihalis",authors:[{id:"111311",title:"Prof.",name:"Kostas",middleName:null,surname:"Rontos",fullName:"Kostas Rontos",slug:"kostas-rontos"},{id:"111729",title:"Prof.",name:"Mihail",middleName:null,surname:"Diakomihalis",fullName:"Mihail Diakomihalis",slug:"mihail-diakomihalis"},{id:"117320",title:"Dr.",name:"Eleni",middleName:null,surname:"Kitrinou",fullName:"Eleni Kitrinou",slug:"eleni-kitrinou"},{id:"117322",title:"Prof.",name:"Dimitrios",middleName:null,surname:"Lagos",fullName:"Dimitrios Lagos",slug:"dimitrios-lagos"}]}]}]},onlineFirst:{chapter:{type:"chapter",id:"64560",title:"Myelodysplastic Syndromes: An Update on Pathophysiology and Management",doi:"10.5772/intechopen.82166",slug:"myelodysplastic-syndromes-an-update-on-pathophysiology-and-management",body:'\n
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1. Introduction
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The myelodysplastic syndromes (MDS) comprise an heterogeneous group of malignant hematopoietic stem cell disorders characterized by dysplastic and ineffective blood cell production and a variable risk of transformation to acute leukemia. Based on the United States Surveillance, Epidemiology, and End Results (SEER) Program, the incidence of MDS is about 4.1–4.6 cases per 100,000 population per year, with approximately 86% of patients aged ≥60 years at time of diagnosis (median age 76 years). The incidence rate is higher in men than women. [1] The prevalence is slightly lower in Europe with reported 1.24–3.7 cases per 100,000 population per year, also with observed male predominance.[2, 3] With an aging population and improved awareness of disease, it is likely that the number of new patients diagnosed with MDS each year will increase in the future.
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Pathogenesis of MDS is incompletely understood. Studies have revealed age, male gender, alcohol, cigarette smoking, ionizing radiation, chemotherapy such as alkylating agents and topoisomerase II inhibitor, immunosuppressive therapy, viral infection, benzene and other environmental/occupational exposures as possible implicating factors. [4, 5, 6, 7, 8] However, disease caused by these risk factors are estimated to account for only 20–30% of cases, which are described as secondary MDS, with remainders as primary MDS [4]. The major subsets of secondary MDS are therapy-related MDS (t-MDS) and MDS with predisposition to familial myeloid neoplasm.
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The risk for MDS and AML is increased in certain familial predisposition syndromes, such as inherited bone marrow failure disorders like Diamond-Blackfan syndrome, Fanconi anemia, dyskeratosis congenital, Shwachman-Diamond syndrome, and Down syndrome, Noonan syndrome/Noonan syndrome-like disorders and neurofibromatosis [9]. Accurate diagnosis and recognition of these syndromic disorders allows opportunities to improve clinical care. Genetic counseling should be offered to family members of affected individual. One should avoid using heterozygous sibling as bone marrow transplant donor. Recently, a growing number of germline mutations including CEBPA, DDX41, ANKRD26, ETV6, GATA2, RUNX1 were identified to associate with familial thrombocytopenia and development of MDS and acute leukemia in up to 40% of patients [10, 11]. Special attention should be noted that many patients with familial MDS and acute leukemia predisposition syndromes develop disease in adulthood rather than childhood. To increase awareness of this entity of disease, myeloid neoplasm with above mentioned germline predisposition was incorporated into the updated WHO 2016 classification [12].
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2. Diagnosis
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2.1. Clinical presentation
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MDS usually presents as cytopenia in one or more lineage. Fatigue, dyspnea on exertion, infection, easy bruising or bleeding are the most common symptoms. Lymphadenopathy and hepatosplenomegaly are infrequent and should raise suspicion for chronic myelomonocytic leukemia (CMML) [13, 14]. It has been estimated that various autoimmune features such as subacute vasculitis, fever, arthritis, peripheral edema, and pulmonary infiltrates, may be present in up to 10% of patients [15, 16, 17, 18]. Certain autoimmune syndromes have correlated with distinct cytogenetic abnormalities; including Behcet’s disease with trisomy 8, Sweet’s syndrome and pyoderma gangrenosum with del(5q) [19]. Acquired hemoglobin H disease has been documented in approximately 8% of cases of MDS [20, 21, 22]. An acquired somatic mutation of ATRX, an X-linked gene encoding a chromatin-associated protein, has been linked to this entity, [21] as have acquired deletions of the alpha globin loci.
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2.2. Pathology evaluation and WHO criteria
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Bone marrow aspiration and biopsy are critical to the diagnosis of MDS. In general, the marrow is normo- or hypercellular due to ineffective hematopoiesis. However, up to 20% of MDS patients have hypocellular marrow, making it difficult to distinguish from aplastic anemia or paroxysmal nocturnal hematuria [23, 24]. Dysplastic neutrophils are commonly found in the peripheral blood smear. These cells may demonstrate reduced segmentation, increased size, the so-called pseudo-Pelger-Huet cell [25], often accompanied by reduced or absent granulation [26], and are associated with del(17)p [27]. Hypersegmentation with greater than 5 nuclear lobes is another feature of neutrophil dysplasia [28]. Red cells are usually normocytic or macrocytic, although ring sideroblasts, ovalomacrocytosis, teardrops, stomatocytes or acanthocytes may be seen [28]. Platelet morphology is usually normal, but micromegakaryocytes, mononuclear megakaryocytes, dumbbell-shaped nuclei, multinuclearity with multiple isolated nuclei (“Pawn ball” changes) may be seen [29].
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Classification of MDS has been a challenge. In 1982, the French-American-British (FAB) Cooperative Group published the first seminal classification system that distinguished five subcategories of MDS based on marrow morphological criteria and myeloblasts proportions: refractory anemia, refractory anemia with ring sideroblasts (RARS), refractory anemia with excess of blasts (RAEB), RAEB “in transformation” (RAEB-T), and chronic myelomonocytic leukemia (CMML) [30]. Presence of more than 30% blasts in the bone marrow was defined as AML.
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In 2001, World Health Organization (WHO) published new classification system on myeloid malignancy with modifications to the FAB system: The diagnosis of AML requires 20% myeloblasts. RAEB-T is classified as AML, and CMML is categorized as a new entity of myeloid neoplasms with both MDS and myeloproliferative features. In addition, MDS with isolated del(5q) is acknowledged as distinctive features in forms of disease with a low blast count, severe anemia and thrombocytosis (5q- syndrome) [31]. The revised 2008 WHO criteria maintained these modifications [32]. In the absence of definitive morphologic features of MDS, MDS-defining cytogenetic abnormalities were included in the diagnostic criteria (Table 1). The presence of chromosome 7, Y, or del(20q) does not meet criteria as an MDS-defining abnormality.
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Unbalanced abnormalities
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Balanced abnormalities
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−7 or del(7q)
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t(11;16)(q23;p13.3)
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−5 or del(5q)
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t(3;21)(q26.2;q22.1)
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i(17q) or t(17p)
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t(1;3)(p36.3;q21.1)
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−13 or del(13q)
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t(2;11)(p21;q23)
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del(11q)
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inv(3)(q21q26.2)
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del(12p) or t(12p)
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t(6;9)(p23;q34)
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del(9q)
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idic(X)(q13)
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Table 1.
Recurring chromosomal abnormalities considered as presumptive evidence of MDS in the setting of persistent cytopenia or undetermined origin in the absence of definitive morphologic features of MDS, according to World Health Organization 2008 and 2016 criteria.
Complex karyotype (3 or more chromosomal abnormalities) involving one or more of the above abnormalities.
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The 2016 revision of WHO (Table 2) incorporated rapidly accumulating molecular genetic information into the classification [12]. The same cytogenetic abnormalities listed in the 2008 WHO classification remain MDS-defining in a cytopenic patient. Given recent data showing 1 chromosomal abnormality in addition to the del(5q) poses no adverse effect [33, 34, 35], the entity “5q- syndrome” may be diagnosed if there is 1 additional cytogenetic abnormality besides the del(5q), unless that abnormality is monosomy 7 or del(7q). Mutations like SF3B1, TET2, SRSF2, ASXL1, DNMT3A, RUNX1, U2AF1, TP53, and EZH2 can be found in 80–90% MDS patients [36, 37]. Importantly, acquired clonal mutations identical to those seen in MDS can occur in the hematopoietic cells of healthy older individuals without MDS, so-called “clonal hematopoiesis of indeterminate potential” (CHIP), or patients with mild cytopenia but without dysplastic changes or specific cytogenetic and/or genetic abnormalities considered as presumptive evidence of MDS (idiopathic cytopenia of undetermined significance, ICUS) [38, 39]. Although some CHIP and ICUS subsequently develop MDS, there have not been sufficient data to support using the presence of aforementioned mutations as surrogate diagnostic marker of MDS. Based on the link between ring sideroblasts and an SF3B1 mutation, MDS with ring sideroblasts and multilineage dysplasia, marked thrombocytosis, lacking excess blasts or an isolated del(5q) abnormality is included into the category of MDS with ring sideroblasts, and correlates with a favorable prognosis [40, 41, 42, 43].
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Myeloproliferative neoplasms
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Myeloid/lymphoid neoplasms with eosinophilia and rearrangement of PDGFRA, PDGFRB, or FGFR1, or with PCM1-JAK2
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Myelodysplastic/myeloproliferative neoplasms (MDS/MPN) Chronic myelomonocytic leukemia(CMML) Atypical chronic myeloid leukemia (aCML), BCR-ABL1 Juvenile myelomonocytic leukemia (JMML) MDS/MPN with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) MDS/MPN, unclassifiable
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Myelodysplastic syndrome MDS with single lineage dysplasia MDS with ring sideroblasts (MDS-RS) MDS-RS and single lineage dysplasia MDS-RS and multilineage dysplasia MDS with multilineage dysplasia MDS with excess blasts MDS with isolated del(5q) MDS, unclassifiable Provisional entity: Refractory cytopenia of childhood
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Myeloid neoplasms with germline predisposition
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Acute myeloid leukemia (AML) and related neoplasms Includes AML with myelodysplasia-related changes and therapy-related myeloid neoplasms
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Blastic plasmacytoid dendritic cell neoplasm
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Acute leukemias of ambiguous lineage
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B-lymphoblastic leukemia/lymphoma
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T-lymphoblastic leukemia/lymphoma
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Table 2.
Classification of myeloid neoplasms and acute leukemia, according to World Health Organization 2016 criteria.
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2.3. Differential diagnosis
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MDS must be distinguished from other marrow dysplasia secondary to reversible causes, such as folate and vitamin B12 deficiency, viral infections (e.g. HIV), antibiotics, benzene, ethanol, or lead poisoning. Other primary bone marrow disorders presenting as pancytopenia, such as aplastic anemia, paroxysmal nocturnal hematuria, hairy cell leukemia, large granular lymphocytic leukemia can be distinguished by marrow morphology, flow cytometry features and gene mutation profile [8].
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2.4. Risk stratification
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The natural history of MDS in patients varies. The heterogeneity reflects both known and unknown differences in the pathophysiology of specific disease subtypes and patient related characteristics. Several prognostic scoring systems were developed and validated for MDS patients. In 1996, the International Prognostic Scoring System (IPSS) was developed by the International MDS Risk Analysis Workshop based on FAB classification [44]. Based on percent bone marrow blasts, specific cytogenetic abnormalities, and the number of cell lines involved with dysplasia and cytopenia, individual patient are placed into 4 groups: low, intermediate-1, intermediate-2, and high. The median survival in these four risk categories is 5.7 years for low risk, 3.5 years for intermediate-1 risk, 1.2 years for intermediate-2 risk, and 0.4 year for high risk.
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In 2012, a revised IPSS (IPSS-R) was developed based upon data from 7012 patients with primary MDS diagnosed using the FAB or WHO classifications [45]. It incorporated new cytogenetic categories [35], and differentially weighed the degree of cytopenias in newly diagnosed patients. Patient age is an optional variable that can be incorporated to predict overall survival, but not evolution to AML. Individual patient was categorized into five risk groups: very low, low, intermediate, high and very high risk, that translates into median survival of 8.8, 5.3, 3.0, 1.6 and 0.8 years respectively. IPSS-R is simple to use, and is perhaps the most commonly used prognostication system today. However, there are several potential limitations to the IPSS-R. Both IPSS and IPSS-R were developed using data from patients who were observed without treatment. While outcomes might be different now that a variety of interventions are available, an analysis of a separate population suggested that the predictive value of the IPSS-R also applies to those treated with lenalidomide and azacitidine. [46] The prognosticating system only considered patients with de novo MDS. It is well recognized that patients with secondary MDS are more likely to have shorter survival. Much of this reflects the association between secondary MDS and “unfavorable cytogenetics”. In addition, the IPSS-R seems to be most reliable at predicting outcomes at initial disease diagnosis, as the hazards in mortality and leukemia transformation diminishes over time in higher-risk but remains stable in lower-risk patients [47]. With increasing knowledge of MDS clonal genetics, the future risk stratification system might incorporate the prognostic value of mutation profile, which will be discussed in the next section.
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WHO prognostic scoring system (WPSS) was designed to include information on red blood cell (RBC) transfusion need and cytogenetic information [48]. A subset of patients in the study cohort had data from multiple time points for a time-dependent analysis, therefore had the advantage over the IPSS of being able to be used at any time during the disease course.
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The MD Anderson Cancer Center (MADCC) MDS model was developed based on a retrospective analysis of 856 patients with de novo or therapy-related MDS [49]. Age, cytogenetics, degree of anemia and thrombocytopenia, bone marrow blast percentage were identified as prognostic markers. Subsequently it was prospectively validated in 1915 patients, accounted for the duration of MDS and prior therapy [49]. One should take note that the MDACC model should only be applied to the population of patients with lower-risk (low or intermediate-1 IPSS) MDS, and patients who received various of MDS treatment, from which it was derived [50].
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3. Pathogenesis
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The pathogenesis of MDS is considered as a multistep process involving sequential acquisition of oncogenic mutations [51, 52]. The interplay between genetically altered HSCs and an abnormal bone marrow microenvironment may allow for selection of a predominant dysplastic clone [51, 52, 53, 54, 55, 56].
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3.1. Clonal heterogeneity and evolution
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MDS is driven by a multistep process characterized by recurrent mutations affecting basic cellular pathways, including RNA splicing, epigenome regulation, myeloid transcription coordination, DNA damage response and growth factor signaling. It has been long recognized that HSC with certain pathogenic alterations has a competitive advantage and drives clonal expansion at the stem cell level. Clonal cytogenetic abnormalities are detected in up to 50% of de novo MDS cases and 80% of therapy-related cases [57, 58]. Over the past decade, a number of large, MDS-focused sequencing studies further demonstrated that MDS is a genetically complex and heterogeneous disease [36, 37, 42, 59, 60, 61].
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However, clonality alone is not sufficient to cause or diagnose disease, because increased clonal hematopoiesis can remain functionally intact [38, 39]. Recently published data on a large cohort of cytopenia (ICUS) patients delineated the natural history of patients with clonal vs. nonclonal cytopenia [62]. Patients with clonal ICUS had a much higher rate of progression than patient with nonclonal ICUS. Spliceosome gene mutations such as SF3B1 SRSF2 and U2AF1 and co-mutation patterns involving TET2, DNMT3A or ASXL1 had clinical characteristics resemble low-risk MDS patients, and higher progression to myeloid neoplasm when comparing with patient with somatic TET2, DNMT3A and ASXL1 mutation alone [39].
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The diversity of clinical MDS phenotypes associated with specific mutations may be related to differential coregulation of the HSC self-renewal and lineage-specific differentiation capacity. Accurate prediction of the natural history of individual patient is certainly of high clinic interest. Our growing knowledge suggests that individual mutations occur in highly stereotyped order and strong patterns of co-mutation association and exclusivity (Figure 1) [36, 60, 63]. Mutations affecting epigenetic modifier genes (DNMT3A, TET2, ASXL1, EZH2, etc.) or RNA spliceosome components (SF3B1, SRSF2, and U2AF1) tend to arise in the initiation and early progression phase of MDS and rarely occur at the time of transformation. By contrast, mutations in growth factor signaling pathways (NRAS, KRAS, PTPN11, FLT3, etc.) are rarely found in early phase of disease, and instead, they are frequently acquired and expanded in subclones at time of progression to high-grade MDS or secondary AML [63, 64, 65, 66]. A recent study [67] suggested that at the time of secondary AML transformation, the founding clone persisted at high variant allele fraction, but there was selective emergence and dominance of at least one genetically distinct subclone. In t-MDS, mutations in PPM1D or TP53 were present in 46% of patients, and they were the only gene mutations that were significantly associated with t-MDS [63, 68, 69, 70, 71].
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Figure 1.
Gene mutations have stereotyped positions in the MDS clonal hierarchy. Recent knowledge suggests that individual mutations occurs in highly stereotyped order and strong patterns of co-mutation association and exclusivity (Mutations affecting epigenetic modifier genes (DNMT3A, TET2, ASXL1, EZH2, etc.) or RNA spliceosome components (SF3B1, SRSF2, and U2AF1) tend to arise in the initiation and early progression phase of MDS and rarely occur at the time of transformation. Mutations in growth factor signaling pathways (NRAS, KRAS, PTPN11, FLT3, etc.) are frequently acquired and expanded in subclones at time of progression to high-grade MDS or secondary AML.
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Various studies have also assessed the value of risk stratification based on MDS mutation profile [36, 42, 72]. TP53, ETV6, ASXL1, EZH2 and RUNX1 mutation confers adverse outcomes that are independent of IPSS risk assessment. SF3B1, which is frequently mutated in patients with ring sideroblasts, is associated with distinct and favorable clinical features [37, 38, 40].
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3.2. Bone marrow microenvironment
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HSC and genetically altered HSC all reside in a highly complex and dynamic cellular microenvironment in the bone marrow, that is composed of endothelial cells, multipotent mesenchymal stem cells, and sympathetic nerve fibers. There have been many in vivo studies demonstrated the concept of niche-induced disease initiation of MDS [73, 74] or AML [75, 76]. Evidence to support this in humans is mainly based on the not-so-rare occurrence of donor-derived leukemia in bone marrow transplant recipients, where changes in the preexisting niche in the host is thought to be leukemogenic [77]. In the review by Pleyer et al., [78] a variety of functional and molecular alterations were observed in ex vivo expanded mesenchymal stromal cells from MDS and AML patients, including their differentiation potential and HSC supportive activities, as well as chromosomal aberrations, transcriptional, and epigenetic changes. In vivo evidence also suggested that endothelial cells-specific gene alterations causes myeloproliferative disorders [79, 80].
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3.3. Dysregulated immune pathways
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Regulators of inflammation and innate immunity have always been thought to play an important role in pathogenesis of malignancies, but only until recent have the specific immune effectors and their cell-intrinsic functional roles in MDS stem cell biology been elucidated [81, 82]. Therapeutic targeting of over-activated innate immune components such as Toll-like receptors [83], IL-1 receptor–associated kinase/tumor necrosis factor receptor–associated factor-6 [84], IL8/CXCR2 [85], and IL1RAP [86] signaling pathways in MDS HSCs is being attempted pre-clinically.
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4. Treatment
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Treatment for MDS is guided by clinical symptoms, disease risk classification, patient age, comorbidities and performance status. Supportive care with transfusion and timely treatment of infection with antibiotics are important adjuncts for all MDS patients. Incorporating iron chelation therapy for patients requiring chronic transfusion and all candidates for allogeneic stem cell transplant is being increasingly emphasized to prevent cardiac and liver damage from iron overload [87, 88]. Pharmacologic treatment is usually reserved for symptomatic patients. Treatment goal for lower-risk MDS patients is to minimize symptoms, improve quality of life, and avoid toxicity from therapy. Erythropoiesis stimulating agent (ESA) can be used for symptomatic anemia and a low serum erythropoietin [89, 90, 91, 92]. Together with low-dose G-CSF, hemoglobin improvement can be seen in up to 40% of lower-risk patients [93, 94]. Immunosuppressive therapy with antithymocyte globulin and cyclosporine A can produce response in a selected subset of patients. Those most likely to benefit are younger than 60 years, with less than 5% bone marrow blasts, hypoplastic MDS, presence of a paroxysmal nocturnal hemoglobinuria clone, trisomy 8, human leukocyte antigen DR15 positive, and with short duration of transfusion dependence [95]. Low-dose lenalidomide at 10 mg daily is FDA-approved for lower-risk MDS characterized as the 5q- syndrome. Transfusion independence was achieved in 67% of patients in the phase 2 trial [96], and 56% in the phase 3 trial [97]. For ESA refractory lower-risk MDS patients without 5q- syndrome, lenalidomide in combination with ESA also demonstrated efficacy at reducing transfusion need [98, 99, 100]. So far, the only FDA approved therapies for higher-risk MDS are the HMAs azacitidine and decitabine. The use of these agents results in complete (CR) and partial response (PR) each in 10–20% patients, with median duration of response about 10 months [101, 102, 103, 104]. An additional 20–30% patients achieve hematologic improvement without an objective response. Despite survival benefit demonstrated with azacitidine in high-risk patients [101], HMAs are not curative. For young and fit patients, allogeneic stem cell transplant is the only curative treatment option. Therefore, there remains a significant unmet therapeutic need beyond HMAs. Novel agents under clinical investigation and the use of allogeneic stem cell transplant will be discussed here.
\n
\n
4.1. Next-generation hypomethylating agents
\n
HMAs are S-phase specific. Conventional HMAs all have a very short half-lives (less than 30 min) due to rapid clearance of azanucleoside by cytidine deaminase. The focus of newer generation HMA development has been to meet the need of prolonged drug exposure, allowing greater drug incorporation into DNA.
\n
Oral film-coated azacitidine (CC-486) was first studied in an open-label pilot trial. It demonstrated 17% mean bioavailability after a single dose at 80 mg [105]. In a subsequent phase 1 dose finding study in MDS, CMML and AML patients, overall response rate was 73% in previously untreated patients, and 35% in previously treated patients [106]. Extended dosing schedule of CC-486 for 14 or 21 days is being evaluated in a phase 3 trial (NCT01566695) in lower-risk MDS [107]. CC-486 is also being studied in combination with immune check point inhibitor in the second line setting (NCT02281084).
\n
ASTX727 is a novel formulation of oral decitabine paired with an oral cytidine deaminase inhibitor E7727 to overcome the rapid clearance from cytidine deaminase in gut and liver. In the early phase studies with intermediate- or high-risk MDS, ASTX727 (35 mg decitabine, 100 mg E7227) successfully emulated the pharmacokinetic profile of intravenous decitabine [108, 109]. In the phase 2 trial, clinical benefit was observed in 62% patients, with 16% CR, 28% marrow complete response (mCR), and 18% hematologic improvement [109].
\n
Another strategy to circumvent the rapid degradation of azanucleotide is to develop a novel formulation that is relatively resistant to cytidine deamination. Guadecitabine (SGI-110) is a novel dinucleotide of decitabine and deoxyguanosine, linked by a phosphodiester bond, that leads to a slower release of the active decitabine moiety, prolonging cellular exposure to the drug [110]. In the phase 2 study with guadecitabine in intermediate and high risk MDS and CMML patients, CR was observed in 7/49 treatment naïve patients (14%) while CR + mCR were observed in 11/53 previously treated patients (21%) [111].
\n
\n
\n
4.2. Histone deacetylase inhibition
\n
Both DNA-promoter hypomethylation as well as post-translational modification of histone tails (e.g., deacetylation) lead to transcriptional silencing of tumor-suppressor genes and genes involved in differentiation and apoptosis [112, 113]. Histone deacetylase inhibitors (HDACi) have limited single-agent efficacy in both high risk MDS and AML [114, 115, 116]. Preclinical evidence supported synergy between HMAs and HDACi [117]. However, a few phase 2 randomized clinical trials failed to demonstrate improvement in response rates or survival when azacitidine was combined with HDACi entinostat, vorinostat, valproic acid, or pracinostat [118, 119, 120, 121, 122]. Currently, a few clinical trials in MDS are ongoing using HDACi in combination with other novel agents such as immune checkpoint inhibitors (NCT 02936752) or pracinostat in combination with azacitidine using different dosing scheme (NCT 03151304). At this moment, how to best incorporate HDACi in MDS treatment remains uncertain.
\n
\n
\n
4.3. Other epigenetic modification agents
\n
Beyond targeting DNA methylation and HDAC recruitment, there has also been an increasing effort to develop epigenetic modification agents targeting posttranslation or posttranscription pathways, to mitigate malignant myeloid transformation in MDS.
\n
Bromodomain and extraterminal (BET) proteins are epigenetic readers that recognize acetylated lysine tails of histones, and thus areas of open chromatin structure. It has been suggested that AML relies on BET protein BRD4 [123, 124], therefore led to great interest in utilizing BET inhibitors in myeloid malignancy. Various clinical trials are investigating the use of JQ1, the first selective BET inhibitor, in myeloid malignancy including MDS (NCT 02158858, NCT 02308761).
\n
Overexpression of the mono and dimethyl lysine demethylase, LSD1 has been implicated in myeloid malignancies [125]. Clinical trials are ongoing evaluating LSD1 inhibitors in combination with ATRA or HMA in previously treated AML and MDS patients (NCT02273102, NCT02717884, NCT02929498).
\n
\n
\n
4.4. Immune checkpoint inhibition
\n
Upregulation of immune checkpoint molecules like PD-1/PDL-1 and CTLA4 is commonly observed in many malignancies, including AML and MDS [126, 127] to evade immune surveillance. However, preliminary experience suggested limited activity of immune checkpoint inhibitor use as single agent after HMA failure in MDS patients [128]. Several clinical trials are ongoing evaluating the efficacy of immune checkpoint inhibitors plus HMAs or HDACis (NCT02530463, NCT03092674, NCT02775903, NCT03094637, NCT02599649).
\n
\n
\n
4.5. Other targeted therapies: extrapolating experience from AML
\n
Based on the mutation profile, FLT3 inhibitor and IDH1/2 inhibitors are now FDA approved for AML. However, these mutations are less common in MDS [129]. The early phase ½ studies of IDH1 and IDH2 inhibitors included MDS patients, with reported response [130, 131]. Especially given their tolerability profile and single agent activity, these agents deserves further investigation in MDS.
\n
Spliceosome mutations, such as SF3B1, SRSF2 and U2AF1 are the most common mutations in MDS [37]. Based on the encouraging activity in preclinical study [132], there is now a phase 1 study in myeloid malignancies including MDS, with splicing modulator H3B-8800, an oral modulator of the SF3B complex (NCT02841540).
\n
Venetoclax, a selective BCL-2 inhibitor was granted breakthrough designation by FDA in combination with decitabine in 2017 for treatment–naive AML patients age greater than 65 years. This decision was based on result from two ongoing phase ½ clinical trials [133]. This combination is now being evaluated in higher-risk MDS in both frontline and HMA failure settings (NCT02966782, NCT02942290).
\n
\n
\n
4.6. Management of anemia in lower-risk MDS
\n
Luspatercept and sotatercept are modified activin receptor type II (ActRII) chimeric fusion proteins that consist of the modified extracellular domain of ActRIIB and ActRIIA respectively, trap TGF-β superfamily ligands to promote late-stage erythropoiesis [134, 135]. In the phase 2 trial of luspatercept for patients with lower-risk MDS who were ineligible for or refractory to ESAs, RBC transfusion independence was seen in 38% patients, and 63% hematologic improvement [136]. Similar efficacy was seen in the phase 2 trial for sotatercept, with 47% hematologic response in patients with high transfusion burden, and 58% with low transfusion burden [137]. Ongoing phase 3 clinical trial is evaluating the efficacy of ActRII antagonist in lower-risk MDS and MDS with ring sideroblasts who require regular RBC transfusions (NCT 02631070).
\n
Rigosertib is a PI3K and polo-like kinase pathways small-molecule inhibitor. In the recent phase 2 study for transfusion-dependent lower-risk MDS patients, 20 of 62 (32%) patients achieved transfusion independence lasting for more than 8 weeks [138]. Validation of these results in future clinical trials is anticipated.
\n
Roxadustat is a drug which acts as a HIF prolyl-hydroxylase inhibitor and thereby increases endogenous production of erythropoietin, which stimulates production of hemoglobin and RBCs. Roxadustat is shown to be safe and effective as anemia treatment for patient with underlying chronic kidney disease, not on dialysis [139]. A phase 3 trial is ongoing to evaluate the efficacy of roxadustat in low-risk MDS patients with low transfusion burden (NCT03263091).
\n
\n
\n
4.7. Allogeneic stem cell transplant
\n
Allogeneic stem cell transplant is the only curative therapy for MDS, but restricted to younger and fit patients. Disease free survival rates are approximately 30–50%. Treatment failure is attributed by transplant-related mortality in low-risk patients, and relapse in higher-risk patients [140]. In general, bone marrow transplant is offered to intermediate-2 and high-risk MDS patients. Over the past decade, reduced-intensity conditioning transplant made more older patients eligible for transplant [141]. An ongoing clinical trial is comparing the efficacy of reduced intensity allogeneic stem cell transplant to HMA in patients aged 50–75 with higher-risk disease [142]. In the study by Della Porta et al. [143], IPSS-R was prognostic for outcomes of patients in the high and very high-risk groups, but not in the low- and intermediate-risk groups.
\n
There have been emerging data on the prognostic value of mutation profile and minimal residual disease pre- and post-transplantation. It was shown that only a minority of patients with MDS was in deep hematologic remission by flow cytometry minimal residual disease (MRD) and cytogenetic analysis before transplant [144]. For myeloablative conditioning, MRD positive and MRD negative patients had similar post-transplant outcome. However, relapse rate was higher for MRD positive patient who received non-myeloablative conditioning. Multiple studies have shown that TP53 mutation is an independent marker for short survival post-transplant [59, 61, 145]. EZH2, ETV6, RUNX1, ASXL1, JAK2, and mutations in the RAS signaling pathway have all been implicated to associate with short relapse-free interval post-transplant [59, 61, 145, 146].
\n
\n
\n
\n
5. Conclusion
\n
Over the past decade, knowledge was gained in understanding the pathogenesis of MDS. However, many gaps remain to change the natural history of MDS. With increasing number of novel treatments under investigation, it is likely that we are getting closer to more therapeutics options for MDS in the near future.
\n
\n
Conflict of interest
Wanxing Chai-Ho reports no conflict-of-interest.
Gary Schiller receives research funding from Forma, Janssen, Onconova, Pfizer, Incyte and BioMed Valley Discoveries, and receives consulting fees from Agios, Amgen, Astellas, Bioline RX, Celgene, Gamida, Fanssen, Karyopharm, Leukemia Lymphoma Society, Medallion, Medeor, Merck, Pharmacyclics, Sanofi, Seattle Genetics, Spectrum, Stanford University Health, Sunesis, and Takeda.
\n',keywords:"myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), bone marrow transplant, hypomethylating agent, somatic mutation",chapterPDFUrl:"https://cdn.intechopen.com/pdfs/64560.pdf",chapterXML:"https://mts.intechopen.com/source/xml/64560.xml",downloadPdfUrl:"/chapter/pdf-download/64560",previewPdfUrl:"/chapter/pdf-preview/64560",totalDownloads:1028,totalViews:502,totalCrossrefCites:0,dateSubmitted:"August 29th 2018",dateReviewed:"October 22nd 2018",datePrePublished:"November 27th 2018",datePublished:"February 20th 2019",dateFinished:null,readingETA:"0",abstract:"Myelodysplastic syndromes (MDS) comprise a set of clonal hematopoietic stem cell (HSC) disorders characterized by ineffective hematopoiesis that manifest as cytopenia of variable severity. The result often is an increased risk of infection, transfusion dependence, and a potential to transform to acute myeloid leukemia (AML). For the past decade, hypomethylating agents remain the only FDA-approved therapy. Given that MDS is more prevalent in the elderly who often have comorbid conditions, supportive care remains the mainstay of therapy. Curative treatments are restricted to younger, healthy individuals with histocompatible-matched donors for allogeneic transplant able to tolerate more intensive chemotherapeutic treatment. Understanding of the pathophysiology of MDS advanced over the past decade, which leads to an increasing array of new agents under clinical investigation. This review focuses on our recent enhanced understanding of MDS molecular biology, and promising novel agents that go beyond the hypomethylating agent.",reviewType:"peer-reviewed",bibtexUrl:"/chapter/bibtex/64560",risUrl:"/chapter/ris/64560",signatures:"Wanxing Chai-Ho and Gary J. Schiller",book:{id:"7138",title:"Recent Developments in Myelodysplastic Syndromes",subtitle:null,fullTitle:"Recent Developments in Myelodysplastic Syndromes",slug:"recent-developments-in-myelodysplastic-syndromes",publishedDate:"February 20th 2019",bookSignature:"Ota Fuchs",coverURL:"https://cdn.intechopen.com/books/images_new/7138.jpg",licenceType:"CC BY 3.0",editedByType:"Edited by",editors:[{id:"36468",title:"Dr.",name:"Ota",middleName:null,surname:"Fuchs",slug:"ota-fuchs",fullName:"Ota Fuchs"}],productType:{id:"1",title:"Edited Volume",chapterContentType:"chapter",authoredCaption:"Edited by"}},authors:[{id:"272031",title:"Dr.",name:"Wanxing",middleName:null,surname:"Chai-Ho",fullName:"Wanxing Chai-Ho",slug:"wanxing-chai-ho",email:"wchaiho@mednet.ucla.edu",position:null,institution:null},{id:"272174",title:"Dr.",name:"Gary",middleName:null,surname:"Schiller",fullName:"Gary Schiller",slug:"gary-schiller",email:"gschiller@mednet.ucla.edu",position:null,institution:null}],sections:[{id:"sec_1",title:"1. Introduction",level:"1"},{id:"sec_2",title:"2. Diagnosis",level:"1"},{id:"sec_2_2",title:"2.1. Clinical presentation",level:"2"},{id:"sec_3_2",title:"2.2. Pathology evaluation and WHO criteria",level:"2"},{id:"sec_4_2",title:"2.3. Differential diagnosis",level:"2"},{id:"sec_5_2",title:"2.4. Risk stratification",level:"2"},{id:"sec_7",title:"3. Pathogenesis",level:"1"},{id:"sec_7_2",title:"3.1. Clonal heterogeneity and evolution",level:"2"},{id:"sec_8_2",title:"3.2. Bone marrow microenvironment",level:"2"},{id:"sec_9_2",title:"3.3. Dysregulated immune pathways",level:"2"},{id:"sec_11",title:"4. Treatment",level:"1"},{id:"sec_11_2",title:"4.1. Next-generation hypomethylating agents",level:"2"},{id:"sec_12_2",title:"4.2. Histone deacetylase inhibition",level:"2"},{id:"sec_13_2",title:"4.3. Other epigenetic modification agents",level:"2"},{id:"sec_14_2",title:"4.4. Immune checkpoint inhibition",level:"2"},{id:"sec_15_2",title:"4.5. Other targeted therapies: extrapolating experience from AML",level:"2"},{id:"sec_16_2",title:"4.6. Management of anemia in lower-risk MDS",level:"2"},{id:"sec_17_2",title:"4.7. Allogeneic stem cell transplant",level:"2"},{id:"sec_19",title:"5. Conclusion",level:"1"},{id:"sec_23",title:"Conflict of interest",level:"1"}],chapterReferences:[{id:"B1",body:'Ma X. Epidemiology of myelodysplastic syndromes. The American Journal of Medicine. 2012;125(7 Suppl):S2-S5. DOI: 10.1016/j.amjmed.2012.04.014\n'},{id:"B2",body:'Sant M, Allemani C, Tereanu C, et al. HAEMACARE Working GroupIncidence of hematologic malignancies in Europe by morphologic subtype: Results of the HAEMACARE project. Blood. 2010;116(19):3724-3734. DOI: 10.1182/blood-2010-05-282632\n'},{id:"B3",body:'Smith A, Howell D, Patmore R, et al. Incidence of haematological malignancy by sub-type: A report from the Haematological Malignancy Research Network. British Journal of Cancer. 2011;105(11):1684-1692. 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Blood. 2017;130:1689\n'},{id:"B139",body:'Besarab A, Provenzano R, Hertel J, et al. Randomized placebo-controlled dose-ranging and pharmacodynamics study of roxadustat (FG-4592) to treat anemia in nondialysis-dependent chronic kidney disease (NDD-CKD) patients. Nephrology, Dialysis, Transplantation. 2015;30(10):1665-1673. DOI: 10.1093/ndt/gfv302\n'},{id:"B140",body:'Sierra J, Perez WS, Rozman C, et al. Bone marrow transplantation from HLA-identical siblings as treatment for myelodysplasia. Blood. 2002;100(6):1997-2004\n'},{id:"B141",body:'Alyea EP, Kim HT, Ho V, et al. Comparative outcome of nonmyeloablative and myeloablative allogeneic hematopoietic cell transplantation for patients older than 50 years of age. Blood. 2005;105:1810-1814. DOI: 10.1182/blood-2004-05-1947\n'},{id:"B142",body:'Saber W, Le Rademacher J, Sekeres M, et al. Multicenter biologic assignment trial comparing reduced-intensity allogeneic hematopoietic cell transplant to hypomethylating therapy or best supportive care in patients aged 50 to 75 with intermediate-2 and high-risk myelodysplastic syndrome: Blood and marrow transplant clinical trials network #1102 study rationale, design, and methods. Biology of Blood and Marrow Transplantation. 2014;20(10):1566-1572. DOI: 10.1016/j.bbmt.2014.06.010\n'},{id:"B143",body:'Della Porta MG, Alessandrino EP, Bacigalupo A, et al. Predictive factors for the outcome of allogeneic transplantation in patients with MDS stratified according to the revised IPSS-R. Blood. 2014;123(15):2333-2342. DOI: 10.1182/blood-2013-12-542720\n'},{id:"B144",body:'Festuccia M, Deeg HJ, Gooley TA, et al. Minimal identifiable disease and the role of conditioning intensity in hematopoietic cell transplantation for MDS and AML evolving from MDS. Biology of Blood and Marrow Transplantation. 2016;22(7):1227-1233. DOI: 10.1016/j.bbmt.2016.03.029\n'},{id:"B145",body:'Bejar R, Stevenson KE, Caughey B, et al. Somatic mutations predict poor outcome in patients with myelodysplastic syndrome after hematopoietic stem-cell transplantation. Journal of Clinical Oncology. 2014;32(25):2691-2698. DOI: 10.1200/JCO.2013.52.3381\n'},{id:"B146",body:'Bejar R, Stevenson K, Abdel-Wahab O, et al. Clinical effect of point mutations in myelodysplastic syndromes. The New England Journal of Medicine. 2011;364(26):2496-2506. DOI: 10.1056/NEJMoa1013343\n'}],footnotes:[],contributors:[{corresp:null,contributorFullName:"Wanxing Chai-Ho",address:null,affiliation:'
UCLA Department of Medicine, Division of Hematology and Oncology, David Geffen School of Medicine, University of California, Los Angeles, CA, USA
'},{corresp:"yes",contributorFullName:"Gary J. Schiller",address:"gschiller@mednet.ucla.edu",affiliation:'
UCLA Department of Medicine, Division of Hematology and Oncology, David Geffen School of Medicine, University of California, Los Angeles, CA, USA
'}],corrections:null},book:{id:"7138",title:"Recent Developments in Myelodysplastic Syndromes",subtitle:null,fullTitle:"Recent Developments in Myelodysplastic Syndromes",slug:"recent-developments-in-myelodysplastic-syndromes",publishedDate:"February 20th 2019",bookSignature:"Ota Fuchs",coverURL:"https://cdn.intechopen.com/books/images_new/7138.jpg",licenceType:"CC BY 3.0",editedByType:"Edited by",editors:[{id:"36468",title:"Dr.",name:"Ota",middleName:null,surname:"Fuchs",slug:"ota-fuchs",fullName:"Ota Fuchs"}],productType:{id:"1",title:"Edited Volume",chapterContentType:"chapter",authoredCaption:"Edited by"}}},profile:{item:{id:"153202",title:"Dr.",name:"Xia",middleName:null,surname:"Xin",email:"xinx@sdu.edu.cn",fullName:"Xia Xin",slug:"xia-xin",position:null,biography:null,institutionString:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",totalCites:0,totalChapterViews:"0",outsideEditionCount:0,totalAuthoredChapters:"3",totalEditedBooks:"0",personalWebsiteURL:null,twitterURL:null,linkedinURL:null,institution:{name:"Shandong University",institutionURL:null,country:{name:"China"}}},booksEdited:[],chaptersAuthored:[{title:"Dispersion and Property Manipulation of Carbon Nanotubes by Self-Assemibles of Amphiphilic Molecules",slug:"dispersion-and-property-manipulation-of-carbon-nanotubes-by-self-assemibles-of-amphiphilic-molecules",abstract:null,signatures:"Xia Xin , Guiying Xu and Hongguang Li",authors:[{id:"153202",title:"Dr.",name:"Xia",surname:"Xin",fullName:"Xia Xin",slug:"xia-xin",email:"xinx@sdu.edu.cn"},{id:"153695",title:"Prof.",name:"Guiying",surname:"Xu",fullName:"Guiying Xu",slug:"guiying-xu",email:"xuguiying@sdu.edu.cn"},{id:"162861",title:"Prof.",name:"Hongguang",surname:"Li",fullName:"Hongguang Li",slug:"hongguang-li",email:"hgli@licp.cas.cn"}],book:{title:"Physical and Chemical Properties of Carbon Nanotubes",slug:"physical-and-chemical-properties-of-carbon-nanotubes",productType:{id:"1",title:"Edited Volume"}}},{title:"Supramolecular Materials Based on Ionic Self‐Assembly: Structure, Property, and Application",slug:"supramolecular-materials-based-on-ionic-self-assembly-structure-property-and-application",abstract:"The technique of ionic self‐assembly (ISA), on the basis of electrostatic interactions, is a powerful tool to create new material nanostructures and chemical objects due to its advantages of facility, reliability, cost saving, flexibility, and universality. It has attracted great attention because of its promising applications in catalysis, drug delivery, and molecular detection. This review focuses on recent advances in the construction of self‐assemblies with different morphologies on the basis of ISA strategy and its applications. The ISA method provides an opportunity to generate complex and hierarchical assemblies with tunable properties, which is regarded as a very promising case of supramolecular chemistry.",signatures:"Jinglin Shen, Shiling Yuan and Xia Xin",authors:[{id:"153202",title:"Dr.",name:"Xia",surname:"Xin",fullName:"Xia Xin",slug:"xia-xin",email:"xinx@sdu.edu.cn"},{id:"204831",title:"Dr.",name:"Jinglin",surname:"Shen",fullName:"Jinglin Shen",slug:"jinglin-shen",email:"jinglinshen@163.com"},{id:"204832",title:"Prof.",name:"Shiling",surname:"Yuan",fullName:"Shiling Yuan",slug:"shiling-yuan",email:"shilingyuan@sdu.edu.cn"}],book:{title:"Molecular Self-assembly in Nanoscience and Nanotechnology",slug:"molecular-self-assembly-in-nanoscience-and-nanotechnology",productType:{id:"1",title:"Edited Volume"}}},{title:"Lyotropic Liquid Crystals Incorporated with Different Kinds of Carbon Nanomaterials or Biomolecules",slug:"lyotropic-liquid-crystals-incorporated-with-different-kinds-of-carbon-nanomaterials-or-biomolecules",abstract:"Liquid crystals (LCs) are considered as the “fourth state of matter,” which can display properties between crystals and isotropic liquids. LCs can be classified into lyotropic liquid crystals (LLCs) and thermotropic liquid crystals (TLCs), among which LLCs are a kind of self-assemblies formed by amphiphile molecules in a given solvent within certain concentration ranges. The structures and properties of LLCs can be tuned by the incorporation of various kinds of additives, which represents an interesting and novel route for realizing functional composites. This review focuses on recent progress on LLCs-based materials assembled with diverse additives including carbon nanotubes, graphene, graphene oxide, and biomolecules. The thermal stability and mechanical strength of the host LLCs can be greatly improved after the guests are incorporated. In addition, new functions such as conductivity, photothermal effect, and bioactivity can be introduced by the incorporation of the guests, which significantly widens the applications of LLCs-based hybrids in nanotechnology, electrochemistry, drug delivery, and life science.",signatures:"Zhaohua Song, Yanzhao Yang and Xia Xin",authors:[{id:"153202",title:"Dr.",name:"Xia",surname:"Xin",fullName:"Xia Xin",slug:"xia-xin",email:"xinx@sdu.edu.cn"},{id:"215461",title:"Ms.",name:"Zhaohua",surname:"Song",fullName:"Zhaohua Song",slug:"zhaohua-song",email:"maxluck2013@126.com"},{id:"215462",title:"Prof.",name:"Yanzhao",surname:"Yang",fullName:"Yanzhao Yang",slug:"yanzhao-yang",email:"yzhyang@sdu.edu.cn"}],book:{title:"Liquid Crystals",slug:"liquid-crystals-recent-advancements-in-fundamental-and-device-technologies",productType:{id:"1",title:"Edited Volume"}}}],collaborators:[{id:"27748",title:"Prof.",name:"Ruhong",surname:"Zhou",slug:"ruhong-zhou",fullName:"Ruhong Zhou",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null},{id:"31369",title:"Prof.",name:"Jong-Beom",surname:"Baek",slug:"jong-beom-baek",fullName:"Jong-Beom Baek",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/no_image.jpg",biography:null,institutionString:null,institution:{name:"Ulsan National Institute of Science and Technology",institutionURL:null,country:{name:"Korea, South"}}},{id:"38981",title:"Dr.",name:"Eun-Soo",surname:"Park",slug:"eun-soo-park",fullName:"Eun-Soo Park",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null},{id:"41448",title:"Mr.",name:"In-Yup",surname:"Jeon,",slug:"in-yup-jeon",fullName:"In-Yup Jeon,",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null},{id:"152413",title:"Prof.",name:"Charles",surname:"Chusuei",slug:"charles-chusuei",fullName:"Charles Chusuei",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null},{id:"152523",title:"Prof.",name:"Dong Wook",surname:"Chang",slug:"dong-wook-chang",fullName:"Dong Wook Chang",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null},{id:"152965",title:"Dr.",name:"Bo",surname:"Xu",slug:"bo-xu",fullName:"Bo Xu",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Nanjing University",institutionURL:null,country:{name:"China"}}},{id:"153160",title:"Prof.",name:"Jiang",surname:"Yin",slug:"jiang-yin",fullName:"Jiang Yin",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null},{id:"163180",title:"Ms.",name:"Hyun-Jung",surname:"Choi",slug:"hyun-jung-choi",fullName:"Hyun-Jung Choi",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null},{id:"163464",title:"Prof.",name:"Zhiguo",surname:"Liu",slug:"zhiguo-liu",fullName:"Zhiguo Liu",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:null}]},generic:{page:{slug:"publication-agreement-chapters",title:"Publication Agreement - Book Chapter",intro:'
IntechOpen aims to ensure that original material is published while at the same time giving significant freedom to our Authors. To that end we maintain a flexible Copyright Policy guaranteeing that there is no transfer of copyright to the publisher and Authors retain exclusive copyright to their Work.
',metaTitle:"Publication Agreement - Chapters",metaDescription:"IN TECH aims to guarantee that original material is published while at the same time giving significant freedom to our authors. For that matter, we uphold a flexible copyright policy meaning that there is no transfer of copyright to the publisher and authors retain exclusive copyright to their work.\n\nWhen submitting a manuscript the Corresponding Author is required to accept the terms and conditions set forth in our Publication Agreement as follows:",metaKeywords:null,canonicalURL:"/page/publication-agreement-chapters",contentRaw:'[{"type":"htmlEditorComponent","content":"
The Corresponding Author (acting on behalf of all Authors) and INTECHOPEN LIMITED, incorporated and registered in England and Wales with company number 11086078 and a registered office at 5 Princes Gate Court, London, United Kingdom, SW7 2QJ conclude the following Agreement regarding the publication of a Book Chapter:
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1. DEFINITIONS
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Corresponding Author: The Author of the Chapter who serves as a Signatory to this Agreement. The Corresponding Author acts on behalf of any other Co-Author.
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Co-Author: All other Authors of the Chapter besides the Corresponding Author.
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IntechOpen: IntechOpen Ltd., the Publisher of the Book.
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Book: The publication as a collection of chapters compiled by IntechOpen including the Chapter. Chapter: The original literary work created by Corresponding Author and any Co-Author that is the subject of this Agreement.
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2. CORRESPONDING AUTHOR'S GRANT OF RIGHTS
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2.1 Subject to the following Article, the Corresponding Author grants and shall ensure that each Co-Author grants, to IntechOpen, during the full term of copyright and any extensions or renewals of that term the following:
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An irrevocable, worldwide, royalty-free, perpetual, transferable, sublicensable, non-exclusive right to publish, communicate to the public, reproduce, republish, transmit, sell, distribute and otherwise use and make available the Chapter in whole, partial or adapted from and/or incorporated in or in conjunction with other works, in electronic and print editions of the Publication and in derivative works and on any platform owned and/or operated by IntechOpen, throughout the world, in all languages, and in all media and formats now known or later developed.
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An irrevocable, worldwide, royalty-free, perpetual, transferable, sublicensable, non-exclusive right to create and store electronic archival copies of the Chapter, including the right to deposit the Chapter in open access digital repositories.
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An irrevocable, worldwide, royalty-free, perpetual, transferable, sublicensable, non-exclusive right to license others to reproduce, translate, republish, transmit and distribute the Chapter in whole, partial or adapted from and/or incorporated in or in conjunction with other works under the condition that the Corresponding Author and each Co-Author is attributed (currently this is carried out by publishing the Chapter under a Creative Commons Attribution 3.0 Unported License).
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The aforementioned licenses shall survive the expiry or termination of this Agreement for any reason.
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2.2 The Corresponding Author (on their own behalf and on behalf of any Co-Author) reserves the following rights to the Chapter but agrees not to exercise them in such a way as to adversely affect IntechOpen's ability to utilize the full benefit of this Publication Agreement: (i) reprographic rights worldwide, other than those which subsist in the typographical arrangement of the Chapter as published by IntechOpen; and (ii) public lending rights arising under the Public Lending Right Act 1979, as amended from time to time, and any similar rights arising in any part of the world.
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The Corresponding Author confirms that they (and any Co-Author) are and will remain a member of any applicable licensing and collecting society and any successor to that body responsible for administering royalties for the reprographic reproduction of copyright works.
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Subject to the license granted above, copyright in the Chapter and all versions of it created during IntechOpen's editing process (including the published version) is retained by the Corresponding Author and any Co-Author.
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Subject to the license granted above, the Corresponding Author and any Co-Author retains patent, trademark and other intellectual property rights to the Chapter.
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2.3 All rights granted to IntechOpen in this Article are assignable, sublicensable or otherwise transferrable to third parties without the Corresponding Author's or any Co-Author’s specific approval.
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2.4 The Corresponding Author (on their own behalf and on behalf of each Co-Author) will not assert any rights under the Copyright, Designs and Patents Act 1988 to object to derogatory treatment of the Chapter as a consequence of IntechOpen's changes to the Chapter arising from translation of it, corrections and edits for house style, removal of problematic material and other reasonable edits.
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3. CORRESPONDING AUTHOR'S DUTIES
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3.1 When distributing or re-publishing the Chapter, the Corresponding Author agrees to credit the Book in which the Chapter has been published as the source of first publication, as well as IntechOpen. The Corresponding Author warrants that each Co-Author will also credit the Book in which the Chapter has been published as the source of first publication, as well as IntechOpen, when they are distributing or re-publishing the Chapter.
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3.2 When submitting the Chapter, the Corresponding Author agrees to:
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Comply with all instructions and guidelines provided by IntechOpen;
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Produce the Chapter with all due skill, care and diligence, and in accordance with good scientific practice;
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Submit all the corrections in due time as defined during the publishing process schedule.
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The Corresponding Author will be held responsible for the payment of the Open Access Publishing Fees.
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All payments shall be due 30 days from the date of the issued invoice. The Corresponding Author or the payer on the Corresponding Author's and Co-Authors' behalf will bear all banking and similar charges incurred.
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3.3 The Corresponding Author shall obtain in writing all consents necessary for the reproduction of any material in which a third-party right exists, including quotations, photographs and illustrations, in all editions of the Chapter worldwide for the full term of the above licenses, and shall provide to IntechOpen upon request the original copies of such consents for inspection (at IntechOpen's option) or photocopies of such consents.
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The Corresponding Author shall obtain written informed consent for publication from people who might recognize themselves or be identified by others (e.g. from case reports or photographs).
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3.4 The Corresponding Author and any Co-Author shall respect confidentiality rights during and after the termination of this Agreement. The information contained in all correspondence and documents as part of the publishing activity between IntechOpen and the Corresponding Author and any Co-Author are confidential and are intended only for the recipient. The contents may not be disclosed publicly and are not intended for unauthorized use or distribution. Any use, disclosure, copying, or distribution is prohibited and may be unlawful.
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4. CORRESPONDING AUTHOR'S WARRANTY
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4.1 The Corresponding Author represents and warrants that the Chapter does not and will not breach any applicable law or the rights of any third party and, specifically, that the Chapter contains no matter that is defamatory or that infringes any literary or proprietary rights, intellectual property rights, or any rights of privacy. The Corresponding Author warrants and represents that: (i) the Chapter is the original work of themselves and any Co-Author and is not copied wholly or substantially from any other work or material or any other source; (ii) the Chapter has not been formally published in any other peer-reviewed journal or in a book or edited collection, and is not under consideration for any such publication; (iii) they themselves and any Co-Author are qualifying persons under section 154 of the Copyright, Designs and Patents Act 1988; (iv) they themselves and any Co-Author have not assigned and will not during the term of this Publication Agreement purport to assign any of the rights granted to IntechOpen under this Publication Agreement; and (v) the rights granted by this Publication Agreement are free from any security interest, option, mortgage, charge or lien.
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The Corresponding Author also warrants and represents that: (i) they have the full power to enter into this Publication Agreement on their own behalf and on behalf of each Co-Author; and (ii) they have the necessary rights and/or title in and to the Chapter to grant IntechOpen, on behalf of themselves and any Co-Author, the rights and licenses expressed to be granted in this Publication Agreement. If the Chapter was prepared jointly by the Corresponding Author and any Co-Author, the Corresponding Author warrants and represents that: (i) each Co-Author agrees to the submission, license and publication of the Chapter on the terms of this Publication Agreement; and (ii) they have the authority to enter into this Publication Agreement on behalf of and bind each Co-Author. The Corresponding Author shall: (i) ensure each Co-Author complies with all relevant provisions of this Publication Agreement, including those relating to confidentiality, performance and standards, as if a party to this Publication Agreement; and (ii) remain primarily liable for all acts and/or omissions of each such Co-Author.
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The Corresponding Author agrees to indemnify and hold IntechOpen harmless against all liabilities, costs, expenses, damages and losses and all reasonable legal costs and expenses suffered or incurred by IntechOpen arising out of or in connection with any breach of the aforementioned representations and warranties. This indemnity shall not cover IntechOpen to the extent that a claim under it results from IntechOpen's negligence or willful misconduct.
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4.2 Nothing in this Publication Agreement shall have the effect of excluding or limiting any liability for death or personal injury caused by negligence or any other liability that cannot be excluded or limited by applicable law.
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5. TERMINATION
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5.1 IntechOpen has a right to terminate this Publication Agreement for quality, program, technical or other reasons with immediate effect, including without limitation (i) if the Corresponding Author or any Co-Author commits a material breach of this Publication Agreement; (ii) if the Corresponding Author or any Co-Author (being an individual) is the subject of a bankruptcy petition, application or order; or (iii) if the Corresponding Author or any Co-Author (being a company) commences negotiations with all or any class of its creditors with a view to rescheduling any of its debts, or makes a proposal for or enters into any compromise or arrangement with any of its creditors.
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In case of termination, IntechOpen will notify the Corresponding Author, in writing, of the decision.
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6. INTECHOPEN’S DUTIES AND RIGHTS
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6.1 Unless prevented from doing so by events outside its reasonable control, IntechOpen, in its discretion, agrees to publish the Chapter attributing it to the Corresponding Author and any Co-Author.
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6.2 IntechOpen has the right to use the Corresponding Author’s and any Co-Author’s names and likeness in connection with scientific dissemination, retrieval, archiving, web hosting and promotion and marketing of the Chapter and has the right to contact the Corresponding Author and any Co-Author until the Chapter is publicly available on any platform owned and/or operated by IntechOpen.
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6.3 IntechOpen is granted the authority to enforce the rights from this Publication Agreement, on behalf of the Corresponding Author and any Co-Author, against third parties (for example in cases of plagiarism or copyright infringements). In respect of any such infringement or suspected infringement of the copyright in the Chapter, IntechOpen shall have absolute discretion in addressing any such infringement which is likely to affect IntechOpen's rights under this Publication Agreement, including issuing and conducting proceedings against the suspected infringer.
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7. MISCELLANEOUS
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7.1 Further Assurance: The Corresponding Author shall and will ensure that any relevant third party (including any Co-Author) shall, execute and deliver whatever further documents or deeds and perform such acts as IntechOpen reasonably requires from time to time for the purpose of giving IntechOpen the full benefit of the provisions of this Publication Agreement.
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7.2 Third Party Rights: A person who is not a party to this Publication Agreement may not enforce any of its provisions under the Contracts (Rights of Third Parties) Act 1999.
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7.3 Entire Agreement: This Publication Agreement constitutes the entire agreement between the parties in relation to its subject matter. It replaces and extinguishes all prior agreements, draft agreements, arrangements, collateral warranties, collateral contracts, statements, assurances, representations and undertakings of any nature made by or on behalf of the parties, whether oral or written, in relation to that subject matter. Each party acknowledges that in entering into this Publication Agreement it has not relied upon any oral or written statements, collateral or other warranties, assurances, representations or undertakings which were made by or on behalf of the other party in relation to the subject matter of this Publication Agreement at any time before its signature (together "Pre-Contractual Statements"), other than those which are set out in this Publication Agreement. Each party hereby waives all rights and remedies which might otherwise be available to it in relation to such Pre-Contractual Statements. Nothing in this clause shall exclude or restrict the liability of either party arising out of its pre-contract fraudulent misrepresentation or fraudulent concealment.
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7.4 Waiver: No failure or delay by a party to exercise any right or remedy provided under this Publication Agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict the further exercise of that or any other right or remedy. No single or partial exercise of such right or remedy shall preclude or restrict the further exercise of that or any other right or remedy.
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7.5 Variation: No variation of this Publication Agreement shall be effective unless it is in writing and signed by the parties (or their duly authorized representatives).
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7.6 Severance: If any provision or part-provision of this Publication Agreement is or becomes invalid, illegal or unenforceable, it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible, the relevant provision or part-provision shall be deemed deleted.
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Any modification to or deletion of a provision or part-provision under this clause shall not affect the validity and enforceability of the rest of this Publication Agreement.
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7.7 No partnership: Nothing in this Publication Agreement is intended to, or shall be deemed to, establish or create any partnership or joint venture or the relationship of principal and agent or employer and employee between IntechOpen and the Corresponding Author or any Co-Author, nor authorize any party to make or enter into any commitments for or on behalf of any other party.
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7.8 Governing law: This Publication Agreement and any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with it or its subject matter or formation shall be governed by and construed in accordance with the law of England and Wales. The parties submit to the exclusive jurisdiction of the English courts to settle any dispute or claim arising out of or in connection with this Publication Agreement (including any non-contractual disputes or claims).
The Corresponding Author (acting on behalf of all Authors) and INTECHOPEN LIMITED, incorporated and registered in England and Wales with company number 11086078 and a registered office at 5 Princes Gate Court, London, United Kingdom, SW7 2QJ conclude the following Agreement regarding the publication of a Book Chapter:
\n\n
1. DEFINITIONS
\n\n
Corresponding Author: The Author of the Chapter who serves as a Signatory to this Agreement. The Corresponding Author acts on behalf of any other Co-Author.
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Co-Author: All other Authors of the Chapter besides the Corresponding Author.
\n\n
IntechOpen: IntechOpen Ltd., the Publisher of the Book.
\n\n
Book: The publication as a collection of chapters compiled by IntechOpen including the Chapter. Chapter: The original literary work created by Corresponding Author and any Co-Author that is the subject of this Agreement.
\n\n
2. CORRESPONDING AUTHOR'S GRANT OF RIGHTS
\n\n
2.1 Subject to the following Article, the Corresponding Author grants and shall ensure that each Co-Author grants, to IntechOpen, during the full term of copyright and any extensions or renewals of that term the following:
\n\n
\n\t
An irrevocable, worldwide, royalty-free, perpetual, transferable, sublicensable, non-exclusive right to publish, communicate to the public, reproduce, republish, transmit, sell, distribute and otherwise use and make available the Chapter in whole, partial or adapted from and/or incorporated in or in conjunction with other works, in electronic and print editions of the Publication and in derivative works and on any platform owned and/or operated by IntechOpen, throughout the world, in all languages, and in all media and formats now known or later developed.
\n\t
An irrevocable, worldwide, royalty-free, perpetual, transferable, sublicensable, non-exclusive right to create and store electronic archival copies of the Chapter, including the right to deposit the Chapter in open access digital repositories.
\n\t
An irrevocable, worldwide, royalty-free, perpetual, transferable, sublicensable, non-exclusive right to license others to reproduce, translate, republish, transmit and distribute the Chapter in whole, partial or adapted from and/or incorporated in or in conjunction with other works under the condition that the Corresponding Author and each Co-Author is attributed (currently this is carried out by publishing the Chapter under a Creative Commons Attribution 3.0 Unported License).
\n
\n\n
The aforementioned licenses shall survive the expiry or termination of this Agreement for any reason.
\n\n
2.2 The Corresponding Author (on their own behalf and on behalf of any Co-Author) reserves the following rights to the Chapter but agrees not to exercise them in such a way as to adversely affect IntechOpen's ability to utilize the full benefit of this Publication Agreement: (i) reprographic rights worldwide, other than those which subsist in the typographical arrangement of the Chapter as published by IntechOpen; and (ii) public lending rights arising under the Public Lending Right Act 1979, as amended from time to time, and any similar rights arising in any part of the world.
\n\n
The Corresponding Author confirms that they (and any Co-Author) are and will remain a member of any applicable licensing and collecting society and any successor to that body responsible for administering royalties for the reprographic reproduction of copyright works.
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Subject to the license granted above, copyright in the Chapter and all versions of it created during IntechOpen's editing process (including the published version) is retained by the Corresponding Author and any Co-Author.
\n\n
Subject to the license granted above, the Corresponding Author and any Co-Author retains patent, trademark and other intellectual property rights to the Chapter.
\n\n
2.3 All rights granted to IntechOpen in this Article are assignable, sublicensable or otherwise transferrable to third parties without the Corresponding Author's or any Co-Author’s specific approval.
\n\n
2.4 The Corresponding Author (on their own behalf and on behalf of each Co-Author) will not assert any rights under the Copyright, Designs and Patents Act 1988 to object to derogatory treatment of the Chapter as a consequence of IntechOpen's changes to the Chapter arising from translation of it, corrections and edits for house style, removal of problematic material and other reasonable edits.
\n\n
3. CORRESPONDING AUTHOR'S DUTIES
\n\n
3.1 When distributing or re-publishing the Chapter, the Corresponding Author agrees to credit the Book in which the Chapter has been published as the source of first publication, as well as IntechOpen. The Corresponding Author warrants that each Co-Author will also credit the Book in which the Chapter has been published as the source of first publication, as well as IntechOpen, when they are distributing or re-publishing the Chapter.
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3.2 When submitting the Chapter, the Corresponding Author agrees to:
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Comply with all instructions and guidelines provided by IntechOpen;
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Produce the Chapter with all due skill, care and diligence, and in accordance with good scientific practice;
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Submit all the corrections in due time as defined during the publishing process schedule.
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The Corresponding Author will be held responsible for the payment of the Open Access Publishing Fees.
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All payments shall be due 30 days from the date of the issued invoice. The Corresponding Author or the payer on the Corresponding Author's and Co-Authors' behalf will bear all banking and similar charges incurred.
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3.3 The Corresponding Author shall obtain in writing all consents necessary for the reproduction of any material in which a third-party right exists, including quotations, photographs and illustrations, in all editions of the Chapter worldwide for the full term of the above licenses, and shall provide to IntechOpen upon request the original copies of such consents for inspection (at IntechOpen's option) or photocopies of such consents.
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The Corresponding Author shall obtain written informed consent for publication from people who might recognize themselves or be identified by others (e.g. from case reports or photographs).
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3.4 The Corresponding Author and any Co-Author shall respect confidentiality rights during and after the termination of this Agreement. The information contained in all correspondence and documents as part of the publishing activity between IntechOpen and the Corresponding Author and any Co-Author are confidential and are intended only for the recipient. The contents may not be disclosed publicly and are not intended for unauthorized use or distribution. Any use, disclosure, copying, or distribution is prohibited and may be unlawful.
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4. CORRESPONDING AUTHOR'S WARRANTY
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4.1 The Corresponding Author represents and warrants that the Chapter does not and will not breach any applicable law or the rights of any third party and, specifically, that the Chapter contains no matter that is defamatory or that infringes any literary or proprietary rights, intellectual property rights, or any rights of privacy. The Corresponding Author warrants and represents that: (i) the Chapter is the original work of themselves and any Co-Author and is not copied wholly or substantially from any other work or material or any other source; (ii) the Chapter has not been formally published in any other peer-reviewed journal or in a book or edited collection, and is not under consideration for any such publication; (iii) they themselves and any Co-Author are qualifying persons under section 154 of the Copyright, Designs and Patents Act 1988; (iv) they themselves and any Co-Author have not assigned and will not during the term of this Publication Agreement purport to assign any of the rights granted to IntechOpen under this Publication Agreement; and (v) the rights granted by this Publication Agreement are free from any security interest, option, mortgage, charge or lien.
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The Corresponding Author also warrants and represents that: (i) they have the full power to enter into this Publication Agreement on their own behalf and on behalf of each Co-Author; and (ii) they have the necessary rights and/or title in and to the Chapter to grant IntechOpen, on behalf of themselves and any Co-Author, the rights and licenses expressed to be granted in this Publication Agreement. If the Chapter was prepared jointly by the Corresponding Author and any Co-Author, the Corresponding Author warrants and represents that: (i) each Co-Author agrees to the submission, license and publication of the Chapter on the terms of this Publication Agreement; and (ii) they have the authority to enter into this Publication Agreement on behalf of and bind each Co-Author. The Corresponding Author shall: (i) ensure each Co-Author complies with all relevant provisions of this Publication Agreement, including those relating to confidentiality, performance and standards, as if a party to this Publication Agreement; and (ii) remain primarily liable for all acts and/or omissions of each such Co-Author.
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The Corresponding Author agrees to indemnify and hold IntechOpen harmless against all liabilities, costs, expenses, damages and losses and all reasonable legal costs and expenses suffered or incurred by IntechOpen arising out of or in connection with any breach of the aforementioned representations and warranties. This indemnity shall not cover IntechOpen to the extent that a claim under it results from IntechOpen's negligence or willful misconduct.
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4.2 Nothing in this Publication Agreement shall have the effect of excluding or limiting any liability for death or personal injury caused by negligence or any other liability that cannot be excluded or limited by applicable law.
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5. TERMINATION
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5.1 IntechOpen has a right to terminate this Publication Agreement for quality, program, technical or other reasons with immediate effect, including without limitation (i) if the Corresponding Author or any Co-Author commits a material breach of this Publication Agreement; (ii) if the Corresponding Author or any Co-Author (being an individual) is the subject of a bankruptcy petition, application or order; or (iii) if the Corresponding Author or any Co-Author (being a company) commences negotiations with all or any class of its creditors with a view to rescheduling any of its debts, or makes a proposal for or enters into any compromise or arrangement with any of its creditors.
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In case of termination, IntechOpen will notify the Corresponding Author, in writing, of the decision.
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6. INTECHOPEN’S DUTIES AND RIGHTS
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6.1 Unless prevented from doing so by events outside its reasonable control, IntechOpen, in its discretion, agrees to publish the Chapter attributing it to the Corresponding Author and any Co-Author.
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6.2 IntechOpen has the right to use the Corresponding Author’s and any Co-Author’s names and likeness in connection with scientific dissemination, retrieval, archiving, web hosting and promotion and marketing of the Chapter and has the right to contact the Corresponding Author and any Co-Author until the Chapter is publicly available on any platform owned and/or operated by IntechOpen.
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6.3 IntechOpen is granted the authority to enforce the rights from this Publication Agreement, on behalf of the Corresponding Author and any Co-Author, against third parties (for example in cases of plagiarism or copyright infringements). In respect of any such infringement or suspected infringement of the copyright in the Chapter, IntechOpen shall have absolute discretion in addressing any such infringement which is likely to affect IntechOpen's rights under this Publication Agreement, including issuing and conducting proceedings against the suspected infringer.
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7. MISCELLANEOUS
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7.1 Further Assurance: The Corresponding Author shall and will ensure that any relevant third party (including any Co-Author) shall, execute and deliver whatever further documents or deeds and perform such acts as IntechOpen reasonably requires from time to time for the purpose of giving IntechOpen the full benefit of the provisions of this Publication Agreement.
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7.2 Third Party Rights: A person who is not a party to this Publication Agreement may not enforce any of its provisions under the Contracts (Rights of Third Parties) Act 1999.
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7.3 Entire Agreement: This Publication Agreement constitutes the entire agreement between the parties in relation to its subject matter. It replaces and extinguishes all prior agreements, draft agreements, arrangements, collateral warranties, collateral contracts, statements, assurances, representations and undertakings of any nature made by or on behalf of the parties, whether oral or written, in relation to that subject matter. Each party acknowledges that in entering into this Publication Agreement it has not relied upon any oral or written statements, collateral or other warranties, assurances, representations or undertakings which were made by or on behalf of the other party in relation to the subject matter of this Publication Agreement at any time before its signature (together "Pre-Contractual Statements"), other than those which are set out in this Publication Agreement. Each party hereby waives all rights and remedies which might otherwise be available to it in relation to such Pre-Contractual Statements. Nothing in this clause shall exclude or restrict the liability of either party arising out of its pre-contract fraudulent misrepresentation or fraudulent concealment.
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7.4 Waiver: No failure or delay by a party to exercise any right or remedy provided under this Publication Agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict the further exercise of that or any other right or remedy. No single or partial exercise of such right or remedy shall preclude or restrict the further exercise of that or any other right or remedy.
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7.5 Variation: No variation of this Publication Agreement shall be effective unless it is in writing and signed by the parties (or their duly authorized representatives).
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7.6 Severance: If any provision or part-provision of this Publication Agreement is or becomes invalid, illegal or unenforceable, it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible, the relevant provision or part-provision shall be deemed deleted.
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Any modification to or deletion of a provision or part-provision under this clause shall not affect the validity and enforceability of the rest of this Publication Agreement.
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7.7 No partnership: Nothing in this Publication Agreement is intended to, or shall be deemed to, establish or create any partnership or joint venture or the relationship of principal and agent or employer and employee between IntechOpen and the Corresponding Author or any Co-Author, nor authorize any party to make or enter into any commitments for or on behalf of any other party.
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7.8 Governing law: This Publication Agreement and any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with it or its subject matter or formation shall be governed by and construed in accordance with the law of England and Wales. The parties submit to the exclusive jurisdiction of the English courts to settle any dispute or claim arising out of or in connection with this Publication Agreement (including any non-contractual disputes or claims).
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Last updated: 2020-11-27
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