There are not too many drugs that improve overall survival in prostate cancer.  Right now, the list is pretty short: Taxotere.

So the announcement that researchers have survival improvement with a new drug, cabazitaxel, is pretty exciting for us oncologists.

It's easy to become discouraged, but once in a while we get something to be happy about.  Today is one of those moments.

The study looked at 755 men, who had progressed with hormone-refractory prostate cancer after conventional taxotere treatment.  For these men, we do try mitoxantrone and other treatments, but these haven't been shown to improve survival.  Also, for some, taxotere is challenging to take.  Hormone-refractory metastatic prostate cancer is mostly a problem of older men, so making a chemotherapy decision in a 90 year old man can be very challenging.  The only word about toxicity is that it causes neutropenia, low white blood cell counts.  That was from the abstract, which at least is up on the ASCO website.

We might hear more after the presentation, which is scheduled for tomorrow.

Here is a quote from the press release:

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% [HR=0.70 (95% CI: 0.59-0.83); P<0.0001] with a clinically meaningful improvement in the median overall survival of 15.1 months in the cabazitaxel combination arm vs. 12.7 months in the mitoxantrone combination arm. Patients who received the combination treatment with cabazitaxel also experienced a significant increase in median progression-free survival [2.8 months vs. 1.4 months [HR=0.74 (95% CI: 0.64 - 0.86); P<0.0001].

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 with 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% 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).