Prospective evaluations of continuous weekly paclitaxel regimen in recurrent platinum-resistant epithelial ovarian cancer.

Background: Paclitaxel administered on a weekly basis has been reported to possess both anti-angiogenic and apoptotic-inducing effects. We investigated the activity of a weekly continuous paclitaxel regimen in patients with recurrent platinum-resistant ovarian cancer.

Methods: Patients with recurrent ovarian cancer and documented platinum-resistant disease were treated with weekly intravenous paclitaxel (60-80 mg/m(2)) continuously for up to 24 weeks over an 18-month period. Prospective data collection included: information on patients' demographics together with disease- and treatment-related toxicities. Response was evaluated using radiographic and Ca125 criteria. Chi-square tests were used to test for significant associations between categorical variables. Progression-free survival and overall survival time from commencement of weekly treatment were estimated using the Kaplan-Meier method. All P values less than 0.05 were considered to be statistically significant.

Results: Thirty-four patients were treated on protocol. Five patients (15%) reported grade 3/4 neurotoxicity at the end of 12 weeks. No dose reduction or treatment delay was required. No significant hematologic toxicity was observed. Responses were evaluable in thirty-two patients. Complete response was observed in three patients (9%), and another 14 patients showed a partial response (44%). Seven patients (22%) had disease stabilization. The estimated median progression-free survival and overall survival were 6.10 months (95% CI:3.81-8.39) and 10.43 months (95% CI: 8.49-12.38) respectively from the start of the regimen.

Conclusion: Continuous weekly paclitaxel is a well-tolerated and active regimen in patients with recurrent platinum-resistant ovarian cancer.