NEW ORLEANSAn international phase III study has found the combination of
gemcitabine (Gemzar) plus 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
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
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.
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).