No new safety concerns were identified with longer treatment with abiraterone acetate than in a previous study. Grade 3/4 adverse events for the abiraterone acetate arm vs placebo arm were hypertension, 3.9% vs 3.0%; hypokalemia 2.4% vs 1.9%; elevated ALT, 5.4% vs 0.8%; elevated AST, 3.0% vs 0.9%, and fatigue, 2% vs 2%.

The investigators concluded that abiraterone acetate plus prednisone produced a statistically significant improvement in rPFS and a strong trend for increased OS at this interim analysis. In this study, time to all landmarks—PSA progression, tumor/bone progression, chemotherapy, pain, ECOG PS decline, and death—favored abiraterone acetate.


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References

1. Ryan CJ, Smith MR, De Bono JS, et al. Interim analysis (IA) results of COU-AA-302, a randomized, phase III study of abiraterone acetate (AA) in chemotherapy-naive patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol. 2012;30(suppl; abstr LBA4518).

2. NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline). Prostate cancer. Version 3.2012. Available at: http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed July 10, 2012.

3. Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T Immunotherapy for Castration-Resistant Prostate Cancer. N Engl J Med. 2010;363(5):411-422.

4. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011;364(21):1995-2005.

5. Halabi S, Vogelzang NJ, Ou SS, Owzar K, Archer L, Small EJ. Progression-free survival as a predictor of overall survival in men with castrate-resistant prostate cancer. J Clin Oncol. 2009;27(17):2766-2771.

6. Scher HI, Halabi S, Tannock I, et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008;26(7):1148-1159.


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