Long-term results from a phase II study of single agent paclitaxel (Taxol (R)) in previously platinum treated patients with advanced ovarian cancer: The Nordic experience

Background: Owing to the wide spread perception of a possible benefit from paclitaxel in the second-line situation the Nordic Gynecologic Oncology Gro up (NGOG) conducted two prospective phase II studies of paclitaxel single a gent treatment (175 mg/m(2), three-hour i.v. infusion with standard pre-med ication every third week) in patients with relapsing or progressing epithel ial ovarian cancer following platinum. Patients and methods: Between 1992-1994 138 patients in total were enrolled of whom 136 received paclitaxel and were included in the toxicity and surv ival analysis, while 112 were evaluable for response. Results: The overall response rate (CR + PR) was 28% with 16 patients achie ving a CR (14%). The estimated median (range) time to progression was 4.1 ( 0.7-60.7) months. The projected four-year overall survival was 7%, with a m edian (range) of 9.6 (0.3-60.7) months. A multivariate logistic regression analysis showed that platinum resistance, and WHO performance status at bas eline, independently correlated with survival at all three time points (med ian survival time 9.6, 18, and 24 months). Patients with platinum sensitive tumors and WHO performance status 0 had a median survival of 25.6 months c ompared to 7.0 months for the rest of the patients (P less than or equal to 0.0001). No serious toxicity was registered. Conclusion: Paclitaxel could safely be administered in an outpatient settin g using this schedule. Patients with platinum sensitive tumors and a good p erformance status were most likely to survive. However, these patients are also most likely to respond to re-treatment with a platinum compound. With reference to the reasonably good tumor control and limited toxicity observe d in this study, we conclude that paclitaxel single agent therapy is a viab le option in the salvage situation, which in some patients can give long-la sting responses. However, although responses call be induced in a significa nt number of patients, the survival figures remain poor.