Genitourinary Cancers

The US Food and Drug Administration (FDA) has approved a 45 mg for 6-month administration formulation of leuprolide acetate for depot suspension (Lupron Depot, Abbott) for palliative treatment of advanced prostate cancer. This dosing option adds to the existing formulations, which are injected every 1 month, 3 months, and 4 months.

Based on results of the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial, the US Food and Drug Administration (FDA) has updated the Warnings and Precautions sections of the labels for the 5-alpha reductase inhibitor (5-ARI) drug class. These trials showed that daily use of finaseride and dutasteride reduced overall incidence of prostate cancer (mainly low-grade), but increased the incidence of high-grade prostate cancers.

For women with stage II to III estrogen receptor–rich, HER2-negative breast cancer, neoadjuvant aromatase inhibitor (AI) therapy can increase the likelihood of successful breast-conservation surgery. According to phase 2 results of American College of Surgeons Oncology Group Z1031, exemestane, letrozole, and anastrozole are biologically equivalent and therefore likely to achieve similar adjuvant activities. The researchers concluded that because this is a low-toxicity approach, neoadjuvant AI therapy is a reasonable standard of care for selected members of this population.

The Centers for Medicare & Medi caid Services (CMS) has re leased a proposed decision memo that suggests it will cover the cost of sipuleucel-T (Provenge), the immunotherapy vaccine approved in April 2010 for men with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer, for on-label use. CMS contractors will have discretion as to whether they will cover it for off-label use.