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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Combined modality therapy emerged from preclinical data showing that carefully chosen drugs could enhance the sensitivity of tumor cells to radiation while having nonoverlapping toxicities. Recent advances in molecular biology involving the identification of cellular receptors, enzymes, and pathways involved in tumor growth and immortality have resulted in the development of biologically targeted drugs. This review highlights the recent clinical data in support of newer generation cytotoxic chemotherapies and systemic targeted agents in combination with radiation therapy.
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In the majority of patients, existing therapies for neuropathic pain are far from effective. Furthermore, all current treatments are symptomatic rather than disease-modifying or curative. ⋯ In this article, we suggest a shift in emphasis of the drug discovery paradigm toward unbiased evaluation of the particular neurobiological mechanisms contributing to neuropathic pain in individual patients. Genomewide association studies and other discovery science approaches to identify significant novel targets should be given priority as should the development of increasingly sophisticated tools for measuring and categorizing neuropathic pain.
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Cancer-related neuropathic pain syndromes are common and serious complications of a patient's primary malignancy or its treatment, whether by surgery, radiation, or chemotherapy. They may compromise the patient's quality of life as well as their ability to receive effective treatment. In many patients, there may be more than one coexistent neuropathic pain syndrome, posing a diagnostic dilemma that, if unresolved, may result in the institution of therapies that are of limited scope or not targeted at the primary underlying pathophysiology. ⋯ Clinical assessment of cancer-related neuropathic pain poses some important challenges diagnostically as well as in defining a clear and reliable endpoint assessment in controlled clinical trials. Many different approaches have been applied to the development of assessment or diagnostic tools. Careful review of these methods has been helpful in developing a clearer vision for the future design and refinement of more reliable tools, and more importantly, validation of the clinical utility as well as the reliability of such tools when employed as endpoints in clinical trials focused on prevention, mitigation, or treatment of cancer neuropathic pain.