MIAMI, FloridaIn 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.
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