Continue Paclitaxel After Complete Response in Ovarian Cancer

May 1, 2002

MIAMI, Florida-In women with advanced ovarian cancer who achieved a complete response (CR) with a platinum/paclitaxel (Taxol)-based chemotherapy regimen, continuing single-agent paclitaxel for 12 cycles prolonged the duration of progression-free survival, compared with a 3-cycle continuation, Maurie Markman, MD, of the Cleveland Clinic Foundation, said at the 33rd Annual Meeting of the Society of Gynecologic Oncologists (abstract 1).

MIAMI, Florida—In women with advanced ovarian cancer who achieved a complete response (CR) with a platinum/paclitaxel (Taxol)-based chemotherapy regimen, continuing single-agent paclitaxel for 12 cycles prolonged the duration of progression-free survival, compared with a 3-cycle continuation, Maurie Markman, MD, of the Cleveland Clinic Foundation, said at the 33rd Annual Meeting of the Society of Gynecologic Oncologists (abstract 1).

In this multicenter, phase III trial, conducted by the Southwest Oncology Group (SWOG), patients with a clinically defined complete response to platinum/paclitaxel were randomized to receive either 3 or 12 cycles of single-agent paclitaxel given every 28 days.

Dose Reduction

The initial paclitaxel dose was 175 mg/m² given over 3 hours, but this was decreased to 135 mg/m² in both arms due to a higher rate of early withdrawal in the 12-cycle arm, secondary to the development of peripheral neuropathy.

Among 222 evaluable patients with follow-up data, 54 had progressed as of September 2001. Median progression-free survival was 21 months for the 3-cycle arm vs 28 months for the 12-cycle arm (one-sided P value from an adjusted Cox model analysis: .0023; 12-cycle paclitaxel progression hazard ratio, 2.31).

Except for peripheral neuropathy, there were no significant differences in toxicity between the two arms.

Because the study had an early termination boundary of P = .005, these findings led the SWOG Data and Safety Monitoring Committee to discontinue the trial.

Whether use of extended single-agent paclitaxel improves the ultimate survival of this patient population remains to be determined, Dr. Markman said.