Paclitaxel, carboplatin, and oral etoposide as initial treatment for advanced ovarian carcinoma: a Minnie Pearl Cancer Research Network phase II trial.

Purpose: To evaluate the feasibility and toxicity of the combination of paclitaxel, carboplatin, and etoposide in the first-line treatment of patients with stage III or IV adenocarcinoma of the ovary.

Patients And Methods: Patients entering this trial received paclitaxel 200 mg/m(2), 1 h IV infusion, day 1; carboplatin AUC 6.0 IV, day 1; etoposide 50 mg alternating with 100 mg orally, days 1-10. Patients received 6 courses of treatment, administered at 21-day intervals. All patients were assigned a response category using clinical restaging criteria. The primary endpoints for this trial were progression-free and overall survival.

Results: Between October 1996 and April 2001, 52 patients were treated. The overall objective response rate for the 48 evaluable patients was 75%, with 46% complete responses. Amongst the 36 patients with suboptimal disease, median progression-free and overall survivals were 12 and 24 months, respectively. After a median follow-up of 64 months, the median progression-free and overall survival has not been reached for the optimal patients; 5-year progression-free survival is 57% for this group. Treatment-related myelosuppression was common, but myelosuppression-related complications were uncommon, as was grade 3/4 non-hematologic toxicity. No episodes of acute myelogenous leukemia have developed.

Conclusions: The combination of paclitaxel, carboplatin, and oral etoposide was feasible and effective in this patient population. Unlike previous reports, no episodes of acute leukemia were seen following this treatment. Definitive conclusions regarding the benefit of adding etoposide to a taxane/platinum combination will require a comparative trial.