Seminars in oncology
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Seminars in oncology · Oct 2011
ReviewRole of lenalidomide in the treatment of myelodysplastic syndromes.
Lenalidomide is characterized as an immunomodulatory drug (IMiD), a second-generation drug in this proprietary drug class with greater potency and a toxicity profile that is distinct from the lead compound, thalidomide. Clinical trials exploring its role in treating patients with myelodysplastic syndrome (MDS) revealed unique karyotype-specific activity in patients with interstitial deletion of the long arm of chromosome 5 (del(5q)). ⋯ We discuss the use of lenalidomide in non-del(5q) patients and efforts to optimize its activity, in addition to investigations exploring the role of lenalidomide in higher risk MDS and acute myeloid leukemia (AML). Finally, we highlight the current understanding of its mechanism of action, discussing the emerging insight into the underlying biology of del(5q) MDS and its linkage to potential targets of lenalidomide.
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Seminars in oncology · Oct 2011
ReviewAppraising the current role of chemotherapy for the treatment of sarcoma.
Sarcomas are a heterogeneous group of relatively rare mesenchymal neoplasms. They can be grouped into two general categories: soft tissue sarcoma (STS) and primary bone sarcoma, which are treated differently. Because sarcomas are relatively rare and complex with a wide variety of different histopathologic subtypes, evaluation by multidisciplinary teams who have expertise in the field is recommended. ⋯ Less intense and less toxic regimens are the focus of ongoing clinical research. Newer cytotoxic agents with an improved safety profile, such as trabectedin and palifosfamide, are currently in development. Future research needs to focus on identification of subpopulations of patients that are most likely to benefit from chemotherapy.
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Seminars in oncology · Aug 2011
ReviewStatistical considerations for the next generation of clinical trials.
In this article, we address some of the statistical issues associated with the next generation of oncology clinical trials. Specifically, we focus on two critical aspects of oncologic clinical trials: study endpoints and study design. In our discussion of study endpoints, we provide an overview of endpoints relevant to each phase of clinical trials (phases I, II, and III) and discuss some of the trends in selecting endpoints in recent years. ⋯ In our discussion of study design, we are particularly interested in the essential role of randomization, and discuss recently developed randomized phase II designs. We consider the role biomarkers play in the design of clinical trials and introduce study designs for biomarker evaluations. Finally, we briefly discuss the application of adaptive designs in clinical trials.