Impact on survival of 12 versus 3 monthly cycles of paclitaxel (175 mg/m2 ) administered to patients with advanced ovarian cancer who attained a complete response to primary platinum-paclitaxel: Follow-up of a Southwest Oncology Group and Gynecologic Oncology Group phase 3 trial

• Published in: Gynecologic oncology 2009-08, Vol.114 (2), p.195-198
• Main Authors: Markman, Maurie, Liu, P.Y, Moon, James, Monk, Bradley J, Copeland, Larry, Wilczynski, Sharon, Alberts, David
• Format: Article
• Language: English
• Subjects: Advanced ovarian cancer; Antineoplastic Agents, Phytogenic - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Carboplatin - administration & dosage; Chemotherapy; Cisplatin - administration & dosage; Disease-Free Survival; Drug Administration Schedule; Female; Follow-Up Studies; Hematology, Oncology and Palliative Medicine; Humans; Maintenance chemotherapy; Obstetrics and Gynecology; Ovarian Neoplasms - drug therapy; Paclitaxel - administration & dosage; Phase 3 trial; Proportional Hazards Models
• ISSN: 0090-8258; 1095-6859
• DOI: 10.1016/j.ygyno.2009.04.012

Abstract Objectives A SWOG/GOG phase 3 trial exploring the impact of 12-monthly cycles of paclitaxel given to patients with advanced ovarian cancer who achieved a complete response to primary chemotherapy was discontinued by the Data Safety and Monitoring Committee when a prospectively defined interim analysis revealed a highly statistically significant improvement in progression-free survival (PFS). At study closure, it was too early to assess the impact on overall survival. Methods Patients ( n = 296) received either 3 or 12 monthly cycles of paclitaxel (175 mg/m2 over 3 h). Results Of the 146 patients on the 3-cycle arm, 9 (6%) received > 3 cycles. Median (12 versus 3 cycles; intention-to-treat analysis) updated PFS (all pts) 22 versus 14 months, p = 0.006; overall survival (all pts) 53 versus 48 months, p = 0.34. Conclusion Twelve cycles of single agent maintenance paclitaxel significantly improves PFS. Explanations for the lack of a favorable influence on overall survival include: (a) treatment at relapse equalized outcome; (b) the sample size was insufficient to reveal a difference; (c) “crossover” of patients from 3 cycles to longer treatment masked a potential difference. An ongoing phase 3 trial will hopefully provide a definitive answer to the question of the impact of this maintenance strategy on overall survival.