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Genitourinary Cancers

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GlaxoSmithKline has received FDA approval for pazopanib (Votrient) for the treatment of patients with advanced renal cell carcinoma. The FDA’s approval of the angiogenesis inhibitor was based on data from a phase III clinical trial, which demonstrated that pazopanib reduced the risk of tumor progression or death by 54% compared with placebo and regardless of prior treatment.

The comparison of brachytherapy and surgery may be done on several levels. This review focuses the comparison on toxicity, the “soft” endpoints of biochemical relapse-free survival and clinical relapse-free survival, and the “hard” endpoint of prostate cancer–specific mortality.

Avastin (bevacizumab) plus interferon-alfa has been approved for the treatment of metastatic renal cell carcinoma, according to Genentech. Approval was based on phase III data from the AVOREN study, which showed a 67% increase in progression-free survival (10.2 months) compared to those who received interferon-alfa alone (5.4 months; hazard ratio = 0.60).

Ferring Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved the trade name Firmagon (degarelix for injection) for its prostate cancer treatment previously marketed under the generic name degarelix.

The optimal treatment for clinically localized prostate cancer is an ongoing subject of controversy.[1] As pointed out by Drs. Mirhadi and Sandler, no randomized trial has compared radical prostatectomy (RP) to radiation therapy (RT), and no study has definitively “proven” the superiority of one technique over the other. Therefore, we disagree with the author’s conclusion that RT “is the ‘only way to go’ when managing early-stage prostate cancer.”

Crawford and Hou[1] review the data on luteinizing hormone-releasing hormone (LHRH) antagonists in prostate cancer. They describe the results of a phase III trial comparing monthly degarelix to monthly leuprolide in men with advanced prostate cancer. Degarelix treatment was associated with a more rapid decline of serum testosterone, and was not associated with an initial surge of serum testosterone seen during the first few days of treatment with leuprolide. They discuss the role of this new form of medical gonadal suppression for the treatment of prostate cancer.

The recent US Food and Drug Administration (FDA) approval of degarelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, has renewed interest in this class of drugs as a prostate cancer therapy. Approval was based on a prospective phase III trial of 610 patients randomized to one of two dosing schedules of degarelix, or standard-of-care monthly leuprolide acetate monotherapy, with initial antiandrogen therapy allowed at the treating physician’s discretion for prevention of clinical flare.[1]

Physicians have known since 1941 that testosterone suppression benefits patients with symptomatic metastatic prostate cancer.[1] The pioneering study in this regard showed that estrogen therapy achieved comparable efficacy to castration by improving acid and alkaline phosphatase levels associated with relief of cancer-related symptoms. More than 6 decades later, however, many of the therapies subsequently developed for achieving androgen deprivation still suffer from serious limitations.

The National Comprehensive Cancer Network (NCCN) has added everolimus (Afinitor) to the NCCN Guidelines for Kidney Cancer as a category 1 option for patients with metastatic renal cell carcinoma following failure of tyrosine kinase inhibitors such as sunitinib (Sutent) and sorafenib (Nexavar). This recommendation comes on the heels of the recent US Food and Drug Administration (FDA) approval of everolimus.

Aureon Laboratories has released Prostate Px, a test to predict prostate cancer regression and disease recurrence at the time of diagnosis. The technology combines molecular biomarkers, histological and clinical information with advanced mathematics, said Ricardo Mesa-Tejada, MD, vice president of pathology and medical director of Aureon Laboratories.