Cabazitaxel or mitoxantrone with prednisone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel
Final results of a multinational phase III TROPIC trial
An international Phase III randomized clinical trial has shown for the first time that the investigational drug cabazitaxel increases survival by 30% in men with metastatic prostate cancer that has progressed despite hormone therapy and docetaxel-based chemotherapy, compared with standard therapy.
"There are no effective treatments available to help men with metastatic castration-resistant prostate cancer whose disease continues to grow despite standard chemotherapy, and this large study shows an unequivocal survival benefit for patients who received cabazitaxel," said lead author Oliver Sartor, MD, Piltz Professor for Cancer Research at Tulane Cancer Center, New Orleans, USA. The study was presented at the 2010 Genitourinary Cancer Symposium (San Francisco, 5-7 March 2010), the event co-sponsored by the American Society for Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO).
The trial, called the TROPIC study (Treatment of Hormone-Refractory Metastatic Prostate Cancer Previously Treated with a Taxotere-Containing Regimen), was conducted at 132 centers in 26 countries and involved 755 men with metastatic castration-resistant prostate cancer (mCRPC). Patients were randomly assigned to receive cabazitaxel plus prednisone, or mitoxantrone with prednisone. Median number of treatment cycles was 6 for cabazitaxel-prednisone and 4 for mitoxantrone-prednisone.
After a median follow-up of 12.8 months, in the primary analysis based on the intent to treat population, patients receiving cabazitaxel-prednisone demonstrated a statistically significantly longer median overall survival compared to mitoxantrone-prednisone (15.1 months vs. 12.7 months, p < 0.0001). Progression-free survival, tumour response rates, PSA response, and PSA progression all favoured the cabazitaxel group; specific data on these endpoints will be presented at the 2010 ASCO Annual Meeting in Chicago. Men in the cabazitaxel group were more likely than those in the mitoxantrone group to experience febrile neutropenia: 7.5% versus 1.3%, respectively.
Findings from this study will form the basis of a submission to the U.S. Food and Drug Administration for marketing approval of cabazitaxel. Other studies are being planned to assess the effectiveness of cabazitaxel earlier in the course of prostate cancer treatment, before patients stop responding to docetaxel.
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