Phase 3 trial: Cabazitaxel improves survival in patients with metastatic hormone-refractory prostate cancer

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today results from a Phase 3 trial which demonstrated cabazitaxel, an investigational compound, plus prednisone/prednisolone significantly improved overall survival and progression-free survival in patients with metastatic (advanced) hormone-refractory prostate cancer whose disease progressed following treatment with docetaxel-based chemotherapy. The TROPIC trial compared the combination of cabazitaxel plus prednisone/prednisolone to the active agent mitoxantrone plus prednisone/prednisolone.

For many patients with metastatic hormone-refractory prostate cancer, their disease continues to progress despite prior chemotherapy. Currently, there are no approved therapies to treat these patients.  

"These are significant results in the development of this investigational drug," said Dr. Oliver Sartor, North American principal investigator, Piltz Professor for Cancer Research at Tulane Medical School, New Orleans. "Improved overall survival was demonstrated in this trial – and these are the first data to show a statistical improvement in overall survival in patients with this difficult-to-treat and aggressive form of prostate cancer."  

TROPIC was designed to assess patients with metastatic hormone-refractory prostate cancer whose disease had progressed following treatment with docetaxel-based chemotherapy. Results showed that the combination of cabazitaxel and prednisone/prednisolone significantly reduced the risk of death by 30%>

The most frequent grade 3/4 hematological adverse events with cabazitaxel included neutropenia (81.7%), febrile neutropenia (7.5%) and infections (10.2%); the most frequent grade 3/4 non-hematological adverse events included nausea (1.9%), vomiting (1.9%) and diarrhea (6.2%). Most frequent treatment-emergent adverse events leading to discontinuation in the cabazitaxel arm were neutropenia (2.4%), hematuria (1.3%), diarrhea (1.1%) and fatigue (1.1%). Grade 3/4 peripheral neuropathy occurred in 0.5% of patients in the cabazitaxel arm vs. 0.3% in the mitoxantrone arm. Deaths due to adverse events were 4.9% in the cabazitaxel arm (predominantly due to neutropenia and its complications) vs. 1.9% in the mitoxantrone arm.

"These are compelling results which we are looking forward to sharing with the health care and oncology community," said Debasish Roychowdhury, M.D., Senior Vice President, Global Oncology, sanofi-aventis. "Providing new options and hope for patients with serious diseases, such as metastatic hormone-refractory prostate cancer, is what drives our ongoing commitment to researching and exploring novel anti-cancer compounds and to bringing these medicines to patients."  

Results will be presented by Dr. Sartor in San Francisco, CA on March 5 at the 2010 Genitourinary Cancers Symposium sponsored by the American Society for Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO).




The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Precision-guided treatment boosts outcomes in children with high-risk cancers