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-base d therapy. Several agents have demonstrated activity after failure of plati num-containing regimens. Response rate in true platinum refractory disease up to 20% but with poor long-term survival, has been reported by single dru g paclitaxel. In an effort to improve response rate and survival duration o btainable with single drug paclitaxel, we have combined paclitaxel with dox orubicin for the treatment of patients refractory to cisplatin-cyclophospha mide. Patients and methods: Between October 1994 and November 1996, 23 patients w hereof 21 refractory to cisplatin-cyclophosphamide were enrolled for toxici ty and survival analysis after recieving the combination doxorubicin 50 mg/ m(2) and paclitaxel 135 mg/m(2) every third week for four courses, Respondi ng patients continued on single drug paclitaxel 175 mg/m(2) every third wee k until unacceptable toxicity or tumor progression occurred. Results: The objective response rate (CR + PR) was 33%, 95% CI (14.6-57). T he median duration of response was 8.5 months (range 4.0-62.5+) and the med ian overall survival was 15.5 months (range 4.0-63.5+). No serious toxicity was registered. Conclusion: Doxorubicin combined with paclitaxel could safely be administer ed using this schedule. This study shows that some patients obtaining CR ca n 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 surv ival probability of 15% is impressive. However, although responses can be i nduced in a significant number of patients, the survival figures remain poo r.