In phase III trial, the taxane drug improves survival after failure of docetaxel-based therapy

-- Jeff Muise

Friday, October 1, 2010 (Last Updated: 10/04/2010)

FRIDAY, Oct. 1 (HealthDay News) -- Men with advanced prostate cancer that has resisted prior chemotherapy with docetaxel survive a median 2.4 months longer if they take cabazitaxel instead of mitoxantrone, according to the results of a phase III trial published in the Oct. 2, cancer-themed issue of The Lancet.

Johann Sebastian de Bono, of the Royal Marsden NHS Foundation Trust in Sutton, U.K., and colleagues randomized 755 men with metastatic castration-resistant prostate cancer, whose disease had progressed despite a docetaxel-containing regimen, to treatment with prednisone plus intravenous infusions of either mitoxantrone or the taxane drug cabazitaxel. The study end points included overall survival, progression-free survival, and safety.

The researchers found that median overall survival was 15.1 months in the cabazitaxel group compared with 12.7 months in the mitoxantrone group, while median progression-free survival was 2.8 months in the cabazitaxel group and 1.4 months in the mitoxantrone group. Neutropenia occurred in 82 percent of the men taking cabazitaxel, versus 58 percent taking mitoxantrone, while diarrhea occurred in 6 and <1 percent of the cabazitaxel and mitoxantrone patients, respectively. Also, 8 percent of patients taking cabazitaxel had febrile neutropenia compared with 1 percent of patients taking mitoxantrone.

"Cabazitaxel is the first treatment to prolong survival for metastatic castration-resistant prostate cancer in the post-docetaxel setting. We now envision that if patients with metastatic castration-resistant prostate cancer have progressive disease after 12 weeks of docetaxel treatment, as recommended by the amended Prostate Cancer Clinical Trials Working Group guidelines, then cabazitaxel treatment will be the standard of care," the authors write.

The study was funded by Sanofi-Aventis. Several study authors reported serving as paid consultants for or being employees of Sanofi-Aventis.

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Specialties Hematology & Oncology

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