Originally published as JCO Early Release 10.1200/JCO.2009.21.9691 on August 24 2009

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Phase III Trial of Observation Versus Six Courses of Paclitaxel in Patients With Advanced Epithelial Ovarian Cancer in Complete Response After Six Courses of Paclitaxel/Platinum-Based Chemotherapy: Final Results of the After-6 Protocol 1

Sergio Pecorelli, Giuseppe Favalli, Angiolo Gadducci, Dionyssios Katsaros, Pierluigi Benedetti Panici, Amalia Carpi, Giovanni Scambia, Michela Ballardini, Oriana Nanni, PierFranco Conte

From the University of Brescia, Brescia; University of Pisa, Pisa; University of Turin, Turin; La Sapienza University; and Sacro Cuore Catholic University, Rome; Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola; University of Modena and Reggio Emilia, Modena; and Santa Maria Nuova Hospital, Reggio Emilia; Italy.

Corresponding author: PierFranco Conte, MD, Department of Oncology, Hematology and Respiratory Diseases, Division of Medical Oncology, University of Modena and Reggio Emilia, Via del Pozzo 71, 41100 Modena, Italy; e-mail: conte.pierfranco{at}unimore.it.

Purpose To assess whether six courses of paclitaxel are effective as consolidation treatment in patients with advanced epithelial ovarian cancer who are in complete response after first-line paclitaxel/platinum–based chemotherapy.

Patients and Methods Patients with stages IIb to IV disease in clinical or pathologic complete response after six courses of paclitaxel/platinum–based chemotherapy were randomly allocated to either observation (ie, control) or six courses of paclitaxel 175 mg/m² every 3 weeks (ie, maintenance).

Results Two hundred patients were randomly assigned from March 1999 to July 2006. Because of the low accrual rate, an unplanned interim analysis of futility according to the Bayesian approach was performed. Grade 2 or greater motor neurotoxicity and sensory neurotoxicity were reported in 11.3% and 28.0% of the paclitaxel-arm patients, respectively. After a median follow-up of 43.5 months, 107 patients (53%) had experienced relapse, and 48 patients (24%) had died. Two-year progression-free survival rates were 54% (95% CI, 43% to 64%) and 59% (95% CI, 49% to 69%; P = not significant) in the control and maintenance arms, respectively. Corresponding 2-year overall survival rates were 90% (95% CI, 84% to 97%) and 87% (95% CI, 80% to 94%; P = not significant), respectively. The Cox model showed that residual disease after initial surgery (macroscopic v no macroscopic residuum; hazard ratio [HR], 1.91; 95%CI, 1.21 to 3.03) and stage (IIIc to IV v others; HR, 3.10; 95% CI, 1.13 to 8.48) were independent prognostic factors for progression-free survival, whereas the treatment arm (maintenance v control) had no prognostic relevance.

Conclusion A consolidation treatment with six cycles of paclitaxel does not prolong progression-free survival or overall survival in patients in complete response after first-line paclitaxel/platinum–based regimens.

Deceased.

Written on behalf of the After 6 Italian Cooperative Group.

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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