Weekly treatment of dose-dense paclitaxel and carboplatin improved long-term PFS and OS in women with three forms of advanced gynecologic cancer compared with conventional treatment, according to long-term follow-up of study results first published nearly 3 years ago.
Noriyuki Katsumata, MD, of the department of medical oncology at the Nippon Medical School Musashikosugi Hospital in Kawasaki, Japan, and colleagues enrolled 637 eligible patients with stage II to stage IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer in the phase 3 trial.
They were randomly assigned to one of two treatment regimens.
Of the 631 patients eligible for evaluation, 319 were assigned to the conventional regimen of carboplatin plus paclitaxel 180 mg/m² on day 1, and 312 were assigned to carboplatin plus dose-dense paclitaxel (180 mg/m²) on days 1, 8 and 15.
The treatments were repeated every 3 weeks for six cycles. Responding patients underwent an additional three cycles.
The initial results, published in The Lancet in September 2009, showed the dose-dense regimen extended PFS and OS, and may represent a new treatment option in women with advanced ovarian cancer.
Updated results suggested there continues to be a survival benefit associated with the dose-dense regimen.
After a median follow-up of 6.4 years, the results showed a highly statistically significant improvement in median PFS among patients in the dose-dense regimen (28.2 vs. 17.5 months; HR=0.76; 95% CI, 0.62-0.91; P=.0037).
OS at 3 years was higher for patients assigned to the dose-dense regimen (72.1% vs. 65.1%; HR=0.75; 95% CI, 0.57-0.98; P=.03), according to the initial study results.
According to the follow-up results, OS at 5 years continued to be higher among patients assigned to the dose-dense regimen (58.7% vs. 51.1%; HR=0.79; 95% CI, 0.63-0.99; P=.039).
- Katsumata N. Abstract #5003.
- Katsumata N. The Lancet. 2009;374:1331-1338.
- The researchers received funding from Bristol-Myers Squibb.