NEW ORLEANS—An international phase III study has found the combination of gemcitabine(Drug information on gemcitabine) (Gemzar) plus paclitaxel(Drug information on paclitaxel) to be superior to single-agent paclitaxel in the front-line treatment of metastatic breast cancer, producing a 22% reduction in risk of death, according to Kathy S. Albain, MD, professor of medicine, Loyola University, Chicago, who presented the results at the 40th Annual Meeting of the American Society of Clinical Oncology (abstract 510). "The gemcitabine/paclitaxel regimen showed very promising survival vs paclitaxel alone, when given in an every-3-week schedule. I believe the data firmly place gemcitabine/paclitaxel as a new standard treatment," Dr. Albain said.
The study evaluated the gemcitabine/paclitaxel combination in 529 breast cancer patients with no prior treatment in the metastatic setting. Patients were enrolled between August 1999 and April 2002 at 98 study centers in 19 countries.
Patients were randomized to gemcitabine 1,250 mg/m2 on days 1 and 8 plus paclitaxel 175 mg/m2 on day 1 or to paclitaxel 175 mg/m2 on day 1 every 21 days until disease progression.
Preliminary results from this study were presented at ASCO last year (O’Shaughnessy J et al: Proc ASCO 22:7, 2003, abstract 25). At that time, Dr. O’Shaughnessy reported that the combination conveyed significant benefits in terms of time to progression, progression-free survival, objective response rates, and quality of life, without compromising tolerability.
The updated findings added an overall survival benefit to the data reported last year. The analysis was based upon the occurrence of approximately 75% (n = 343) of the deaths needed (n = 440) for the planned final overall survival report, which is expected in early 2005. The median follow-up was 15.6 months.
Survival Results
There were 160 deaths in 267 patients in the combination arm, and 183 in 262 patients treated with paclitaxel alone. Median overall survival rates were 18.5 months and 15.8 months, respectively. One-year survival was 70.7% vs 60.9%, and 18-month survival was 50.7% vs 41.9%. The reduction in risk of death was 22% with the combination (P = .018), Dr. Albain reported. In multivariate analysis, the risk reduction was 26% (P = .006).
