Pub Date : 2016-04-29DOI: 10.1515/9781503611023-004
Kathryn L. Nasstrom
{"title":"Editor’s Introduction","authors":"Kathryn L. Nasstrom","doi":"10.1515/9781503611023-004","DOIUrl":"https://doi.org/10.1515/9781503611023-004","url":null,"abstract":"","PeriodicalId":44122,"journal":{"name":"Oral History Review","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2016-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66841196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"历史学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.17925/OHR.2016.12.01.22
A. Zelenetz
The escalating cost of cancer care is placing an increasing burden on healthcare systems worldwide, largely a result of expensive biologic therapies. With the patents on many biologics expiring, interest in biosimilars is rising. Biosimilars of biologic agents used for cancer treatment and supportive care are making their appearance in the US; this article therefore aims to increase understanding of the biosimilars concept. Biosimilars are very comparable to their reference products, but because of their size and complexity, are not identical. However, the inherent structural differences between biologics and their reference products may not translate to clinically meaningful differences in efficacy and safety. Biosimilars offer potential cost savings but present a challenge in terms of establishing a regulatory pathway. Regulatory approval requires comparative analytical and clinical studies in order to characterize and demonstrate the absence of clinically meaningful differences between biosimilars and their reference products. Initial approval may not include interchangeability, as additional evidence may be required before a biosimilar can be designated interchangeable with its reference product. A framework for the approval of biosimilars was established by the European Medicines Agency (EMA) in 2006 with the first biosimilar approved in April, 2006. Thus, the experience in Europe provides valuable insights into the use of biosimilars. The widespread use of biosimilars has the potential to reduce healthcare expenditure, as well as improving patient access without compromising patient outcomes, but clinician education and acceptance is crucial.
{"title":"Biosimilars in Oncology","authors":"A. Zelenetz","doi":"10.17925/OHR.2016.12.01.22","DOIUrl":"https://doi.org/10.17925/OHR.2016.12.01.22","url":null,"abstract":"The escalating cost of cancer care is placing an increasing burden on healthcare systems worldwide, largely a result of expensive biologic therapies. With the patents on many biologics expiring, interest in biosimilars is rising. Biosimilars of biologic agents used for cancer treatment and supportive care are making their appearance in the US; this article therefore aims to increase understanding of the biosimilars concept. Biosimilars are very comparable to their reference products, but because of their size and complexity, are not identical. However, the inherent structural differences between biologics and their reference products may not translate to clinically meaningful differences in efficacy and safety. Biosimilars offer potential cost savings but present a challenge in terms of establishing a regulatory pathway. Regulatory approval requires comparative analytical and clinical studies in order to characterize and demonstrate the absence of clinically meaningful differences between biosimilars and their reference products. Initial approval may not include interchangeability, as additional evidence may be required before a biosimilar can be designated interchangeable with its reference product. A framework for the approval of biosimilars was established by the European Medicines Agency (EMA) in 2006 with the first biosimilar approved in April, 2006. Thus, the experience in Europe provides valuable insights into the use of biosimilars. The widespread use of biosimilars has the potential to reduce healthcare expenditure, as well as improving patient access without compromising patient outcomes, but clinician education and acceptance is crucial.","PeriodicalId":44122,"journal":{"name":"Oral History Review","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67596990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"历史学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.17925/OHR.2016.12.01.47
A. Elfiky
{"title":"A Clinical Perspective of Adrenocortical Carcinoma","authors":"A. Elfiky","doi":"10.17925/OHR.2016.12.01.47","DOIUrl":"https://doi.org/10.17925/OHR.2016.12.01.47","url":null,"abstract":"","PeriodicalId":44122,"journal":{"name":"Oral History Review","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67597087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"历史学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.17925/OHR.2016.12.01.29
N. Khushalani, V. Sondak
{"title":"The Future of Melanoma Immunotherapy","authors":"N. Khushalani, V. Sondak","doi":"10.17925/OHR.2016.12.01.29","DOIUrl":"https://doi.org/10.17925/OHR.2016.12.01.29","url":null,"abstract":"","PeriodicalId":44122,"journal":{"name":"Oral History Review","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67597026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"历史学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.17925/OHR.2016.12.01.41
J. Hubbard, A. Grothey
{"title":"Cancer Stem Cells and Cancer Stem Cell Inhibitors in Gastrointestinal Cancers","authors":"J. Hubbard, A. Grothey","doi":"10.17925/OHR.2016.12.01.41","DOIUrl":"https://doi.org/10.17925/OHR.2016.12.01.41","url":null,"abstract":"","PeriodicalId":44122,"journal":{"name":"Oral History Review","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67597072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"历史学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.17925/OHR.2016.12.02.71
N. Daver, R. Assi
M yeloproliferative neoplasms (MPNs), including primary myelofibrosis and myelofibrosis (MF) evolving from a pre-existing MPN (post polycythemia veraand post essential thrombocythemia-myelofibrosis) are clonal hematopoietic stem cell disorders with heterogeneous symptoms, mutational profile, transformation risk and prognosis. Given the potentially chronic disease course, the goal of therapy in MF is to alleviate associated signs and symptoms, including reduction in spleen size, weight gain, improved performance status, and control of constitutional symptoms, leading to a prolonged survival and reduced transformation to leukemia.
{"title":"An Exciting New Era in the Treatment of Myeloproliferative Neoplasms","authors":"N. Daver, R. Assi","doi":"10.17925/OHR.2016.12.02.71","DOIUrl":"https://doi.org/10.17925/OHR.2016.12.02.71","url":null,"abstract":"M yeloproliferative neoplasms (MPNs), including primary myelofibrosis and myelofibrosis (MF) evolving from a pre-existing MPN (post polycythemia veraand post essential thrombocythemia-myelofibrosis) are clonal hematopoietic stem cell disorders with heterogeneous symptoms, mutational profile, transformation risk and prognosis. Given the potentially chronic disease course, the goal of therapy in MF is to alleviate associated signs and symptoms, including reduction in spleen size, weight gain, improved performance status, and control of constitutional symptoms, leading to a prolonged survival and reduced transformation to leukemia.","PeriodicalId":44122,"journal":{"name":"Oral History Review","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67597178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"历史学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.17925/OHR.2016.12.01.49
D. Sundi
{"title":"Pathways Forward in Candidate Selection for Systemic Therapy in Invasive Urothelial Cancer of the Bladder","authors":"D. Sundi","doi":"10.17925/OHR.2016.12.01.49","DOIUrl":"https://doi.org/10.17925/OHR.2016.12.01.49","url":null,"abstract":"","PeriodicalId":44122,"journal":{"name":"Oral History Review","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67597121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"历史学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.17925/OHR.2016.12.02.75
M. Bhutani, S. Usmani
I ndividual studies and meta-analyses highlight superior survival outcomes among those multiple myeloma patients achieving measurable residual disease (MRD) negative status. With the availability of next-generation flow cytomery and sequencing technologies, it is realistically possible to track MRD response in every patient. As the scientific evidence mounts, MRD is being established as a desired end-point for clinical trials. Future efforts should be directed at validating MRD as a surrogate biomarker for developing curative strategies and determining how MRD can be used to guide therapeutic decisions.
{"title":"Measurable (Minimal) Residual Disease—A Meaningful Biomarker in Multiple Myeloma","authors":"M. Bhutani, S. Usmani","doi":"10.17925/OHR.2016.12.02.75","DOIUrl":"https://doi.org/10.17925/OHR.2016.12.02.75","url":null,"abstract":"I ndividual studies and meta-analyses highlight superior survival outcomes among those multiple myeloma patients achieving measurable residual disease (MRD) negative status. With the availability of next-generation flow cytomery and sequencing technologies, it is realistically possible to track MRD response in every patient. As the scientific evidence mounts, MRD is being established as a desired end-point for clinical trials. Future efforts should be directed at validating MRD as a surrogate biomarker for developing curative strategies and determining how MRD can be used to guide therapeutic decisions.","PeriodicalId":44122,"journal":{"name":"Oral History Review","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67596789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"历史学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.17925/OHR.2016.12.02.89
T. Ballinger, J. Kremer, K. Miller
T riple negative breast cancer (TNBC) is associated with a poor prognosis compared to other types of breast cancer. The classification of 'triple negative' is not one homogenous tumor type, but rather is made up of multiple molecularly and biologically diverse tumor subtypes. At present, no approved targeted therapy exists and the standard remains cytotoxic chemotherapy. The identification of TNBC subtypes has provided a basis for identifying possible targeted therapeutic options. In addition, the recognition that some TNBCs share characteristics similar to tumors arising in patients with germline BRCA mutations has led to consideration of DNA damaging agents as a potential treatment option. Multiple investigational approaches are also underway, including immune checkpoint inhibition, poly (ADP-ribose) polymerase inhibition, and androgen receptor blockage. The limited options available for systemic treatment of TNBC will hopefully expand as more is learned about the complex biology and molecular targets of this group of breast cancers. This review will discuss the biology of TNBC, current treatment options, and promising experimental strategies.
{"title":"Triple negative breast cancer-review of current and emerging therapeutic strategies","authors":"T. Ballinger, J. Kremer, K. Miller","doi":"10.17925/OHR.2016.12.02.89","DOIUrl":"https://doi.org/10.17925/OHR.2016.12.02.89","url":null,"abstract":"T riple negative breast cancer (TNBC) is associated with a poor prognosis compared to other types of breast cancer. The classification of 'triple negative' is not one homogenous tumor type, but rather is made up of multiple molecularly and biologically diverse tumor subtypes. At present, no approved targeted therapy exists and the standard remains cytotoxic chemotherapy. The identification of TNBC subtypes has provided a basis for identifying possible targeted therapeutic options. In addition, the recognition that some TNBCs share characteristics similar to tumors arising in patients with germline BRCA mutations has led to consideration of DNA damaging agents as a potential treatment option. Multiple investigational approaches are also underway, including immune checkpoint inhibition, poly (ADP-ribose) polymerase inhibition, and androgen receptor blockage. The limited options available for systemic treatment of TNBC will hopefully expand as more is learned about the complex biology and molecular targets of this group of breast cancers. This review will discuss the biology of TNBC, current treatment options, and promising experimental strategies.","PeriodicalId":44122,"journal":{"name":"Oral History Review","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67596854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"历史学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.17925/OHR.2016.12.01.31
P. Saha, R. Nanda
{"title":"Immune Checkpoint Inhibition for Triple-negative Breast Cancer","authors":"P. Saha, R. Nanda","doi":"10.17925/OHR.2016.12.01.31","DOIUrl":"https://doi.org/10.17925/OHR.2016.12.01.31","url":null,"abstract":"","PeriodicalId":44122,"journal":{"name":"Oral History Review","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67597040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"历史学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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