Combination chemotherapy with paclitaxel and platinum is the most effective regimen for advanced ovarian cancer. Second-line chemotherapy with paclitaxel (135 mg/m2, 24 h) and carboplatin (AUC 5-6) is also effective for patients who relapse on the same regimen after 6 months or more. However, it has been shown that the same efficacy and less myelosuppression can be achieved with a 3-h infusion of paclitaxel (135 mg/m2), and that dose intensification of carboplatin to an AUC values larger than 4-6 is meaningless. Therefore, we decided to conduct a pilot study of paclitaxel (135 mg/m2, 3 h) and carboplatin (AUC 4-5) for ovarian cancer patients who had relapsed or were resistant to a platinum-containing regimen without paclitaxel. Eligibility criteria included patients with relapsed or resistant ovarian cancer (no specified duration from prior therapy), age 16-75 years, with performance status 0-2, and adequate bone marrow, renal, and hepatic function. Paclitaxel was administered at a fixed dose of 135 mg/m2 followed by one of two carboplatin doses (AUC 4 or 5). Specific doses were alternated between individual patients by the order in which they entered the study. Treatment was repeated every 3 weeks, and more than 4 cycles were administered. A total of 11 patients were enrolled. Carboplatin was administered to 6 patients at an AUC of 4 and to 5 patients at an AUC of 5. The age of patients ranged from 18 to 65 years (median: 54). Other patient data (number of patients): serous (8), non serous (3), patients with measurable disease (9), assessable/CA 125 (3), study drug administration less than 6 months after prior therapy (5), study drug administration 6 months or more after prior therapy (6). Response was defined by CT and CA 125 level. CR was observed in 25% (2/8), PR in 38% (3/8), NC in 25% (2/8), and PD in 13% (1/8) of the patients. The response rate with assessable patients was 100% (3/3), and the overall response rate was 73% (8/11). Two patients with grade 1 tachycardia and grade 4 thrombocytopenia, respectively, refused further treatment after 2 cycles. No other patients experienced grade 4 hematologic toxicity or grade 3 non-hematologic toxicity. The median survival duration after paclitaxel and carboplatin therapy was 21+ months (6-26+ months). This regimen is easy to manage in heavily pretreated patients and seems to have good efficacy. To further assess the efficacy, a phase II study is needed.

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