Journal of the National Cancer Institute
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J. Natl. Cancer Inst. · Feb 2010
ReviewReview of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.
The Office of Oncology Drug Products (OODP) in the Center for Drug Evaluation and Research at the US Food and Drug Administration began reviewing marketing applications for oncological and hematologic indications in July 2005. We conducted an overview of products that were reviewed by the OODP for marketing approval and the regulatory actions taken during July 2005 to December 2007. ⋯ During the study period, regulatory action was taken on 58 of the 60 marketing applications. Fifty-three applications were approved. A variety of clinical trial endpoints were used in the approval trials.
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J. Natl. Cancer Inst. · Feb 2010
ReviewDuctal carcinoma in situ of the breast: a systematic review of incidence, treatment, and outcomes.
The National Institutes of Health Office of Medical Applications of Research commissioned a structured literature review on the incidence, treatment, and outcomes of ductal carcinoma in situ (DCIS) as a background article for the State of the Science Conference on Diagnosis and Management of DCIS. ⋯ Scientific questions deserving further investigation include the relationship between mammography use and DCIS incidence and whether imaging technologies and treatment guidelines can be modified to focus on lesions that are most likely to become clinically problematic.
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J. Natl. Cancer Inst. · Jan 2010
ReviewCardiotoxicity of anticancer drugs: the need for cardio-oncology and cardio-oncological prevention.
Due to the aging of the populations of developed countries and a common occurrence of risk factors, it is increasingly probable that a patient may have both cancer and cardiovascular disease. In addition, cytotoxic agents and targeted therapies used to treat cancer, including classic chemotherapeutic agents, monoclonal antibodies that target tyrosine kinase receptors, small molecule tyrosine kinase inhibitors, and even antiangiogenic drugs and chemoprevention agents such as cyclooxygenase-2 inhibitors, all affect the cardiovascular system. One of the reasons is that many agents reach targets in the microenvironment and do not affect only the tumor. ⋯ There is a need for cooperation between these two areas and for the development of a novel discipline, which could be termed cardio-oncology or onco-cardiology. Here, we summarize the potential cardiovascular toxicities for a range of cancer chemotherapeutic and chemopreventive agents and emphasize the importance of evaluating cardiovascular risk when patients enter into trials and the need to develop guidelines that include collateral effects on the cardiovascular system. We also discuss mechanistic pathways and describe several potential protective agents that could be administered to patients with occult or overt risk for cardiovascular complications.