The oncologist
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The U. S. Food and Drug Administration grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. ⋯ Overall survival is the gold standard for a registration trial designed to gain marketing approval; however, additional endpoints have been used in the approval of oncology drugs. Advantages of specific endpoints are discussed, including the accuracy of an endpoint's measurement and its relation to clinical benefit. Surrogate endpoints may be acceptable for "accelerated" approval, with a sponsor commitment to provide evidence of clinical benefit in a subsequent trial.
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Randomized Controlled Trial Multicenter Study
FDA approval summary: temsirolimus as treatment for advanced renal cell carcinoma.
This report summarizes the U. S. Food and Drug Administration (FDA)'s approval of temsirolimus (Torisel), on May 30, 2007, for the treatment of advanced renal cell carcinoma (RCC). ⋯ Common laboratory abnormalities were anemia, hyperglycemia, hyperlipidemia, and hypertriglyceridemia. Serious but rare cases of interstitial lung disease, bowel perforation, and acute renal failure were observed. Temsirolimus has demonstrated superiority in terms of OS and PFS over IFN-alpha and provides an additional treatment option for patients with advanced RCC.
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Integrative oncology is the synthesis of mainstream cancer care and evidence-based complementary therapies. Complementary strategies include massage therapies, acupuncture, fitness, and mind-body techniques, which take advantage of the reciprocal relationship between the mind and body. ⋯ Several studies have demonstrated, for example, that social context plays an important role in the perception of pain and that a patient's coping strategies can influence the persistence of pain. In this article, we briefly describe research illustrating the promise of integrative approaches for the treatment of cancer-related neuropathic pain.