Long-term results from a phase II study of paclitaxel combined with doxorubicin in recurrent platinum refractory ovarian cancer

Background: There is still a need for newer non-cross-resistant agents and combinations to be tried in cases of failure after first line platinum-based therapy. Several agents have demonstrated activity after failure of platinum-containing regimens. Response rate in true platinum refractory disease up to 20% but with poor long-term survival, has been reported by single drug paclitaxel. In an effort to improve response rate and survival duration obtainable with single drug paclitaxel, we have combined paclitaxel with doxorubicin for the treatment of patients refractory to cisplatin-cyclophosphamide. Patients and methods: Between October 1994 and November 1996, 23 patients whereof 21 refractory to cisplatin-cyclophosphamide were enrolled for toxicity and survival analysis after recieving the combination doxorubicin 50 mg/m(2) and paclitaxel 135 mg/m(2) every third week for four courses, Responding patients continued on single drug paclitaxel 175 mg/m(2) every third week until unacceptable toxicity or tumor progression occurred. Results: The objective response rate (CR + PR) was 33%, 95% CI (14.6-57). The median duration of response was 8.5 months (range 4.0-62.5+) and the median overall survival was 15.5 months (range 4.0-63.5+). No serious toxicity was registered. Conclusion: Doxorubicin combined with paclitaxel could safely be administered using this schedule. This study shows that some patients obtaining CR can be rendered disease-free for a substantial period of time, sometimes five years or more. A median overall survival of 15.5 months with a 5-year survival probability of 15% is impressive. However, although responses can be induced in a significant number of patients, the survival figures remain poor.