The oncologist
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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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Neuropathic pain--pain resulting from a lesion, damage, or dysfunction of the somatosensory nervous system--can arise through several distinct etiologies ranging from toxicity, surgery, radiation, and trauma to congenital disorders. Neuropathic pain is widely recognized as a common consequence of cancer and results from administration of several common oncology drugs. It not only impacts quality of life, but it also impacts patient outcomes because of resulting treatment delays, dose reductions, and discontinuations. ⋯ Despite its widely recognized importance, there is a paucity of reliable information available regarding the incidence, prevalence of patient-and physician-reported severity, and time course of cancer-related neuropathic pain. To address this severe knowledge gap, we need new, high-quality, population-based studies of individual cancer pain syndromes and conditions. However, in order to gather this information, we also need substantial improvements in the specific classification of cancer-related neuropathic syndromes and better validated diagnostic tools that can help to elucidate the incidence, prevalence, severity, and potential economic impact of cancer-associated neuropathies.
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This paper examines the issue of prices, relative to value, for cancer drugs. The analysis focuses on the effects on manufacturer pricing incentives of insurance coverage, specifically, the effectiveness of patient cost sharing, incentives created by reimbursement rules for physician-dispensed drugs, and payer ability and incentives to negotiate discounts. For pharmacy-dispensed cancer drugs, both Medicare Part D prescription drug plans (PDPs) and private payers' pharmacy benefit managers are increasingly placing these drugs on specialty tiers that offer no leverage for negotiating discounts and imply often unaffordable cost sharing for patients who lack catastrophic coverage. ⋯ S. data. Making such outcomes-adjusted prices available in the U. S. would be helpful to physicians, payers, and patients and indirectly constrain pricing to align with value.