Paclitaxel-cisplatin combination in advanced ovarian cancer: a phase II study

Background. To date there have been four large randomized studies in Western countries examining the role of combining cisplatin and paclitaxel as first-line treatment for ovarian cancer. A phase II study of paclitaxel and cisplatin in Japanese patients with advanced ovarian cancer was performed to determine the objective response rate and toxicity of this regimen. Methods. Previously untreated patients with stage III or IV ovarian cancer and a good performance status were eligible. Treatment consisted of paclitaxel 180 mg/m² administered as a 3-h intravenous (i.v.) infusion followed by cisplatin 60 mg/m² i.v. Treatment was repeated every 3 weeks for at least four cycles. Granulocyte colony-stimulating factor (G-CSF) was not routinely used. Results. Among 26 eligible patients, there were 4 complete and 17 partial responses, for an overall response rate of 80.8% (95% confidence interval [CI], 60.6% to 93.4%). One hundred and twenty-nine treatment cycles were administered to the 26 patients. Grade 4 neutropenia was observed in 64 treatment cycles (50%) and in 23 patients (88%). Thrombocytopenia was less common. The most common nonhematologic toxicities included neurotoxicity, fatigue, arthralgia/myalgia, and nausea/emesis. Conclusion. Paclitaxel plus cisplatin is a highly active regimen in patients with advanced ovarian cancer. The toxicities of this regimen are well tolerated. Received: September 1, 1999 / Accepted: January 11, 2000