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

Maurie Markman, P. Y. Liu, James Moon, Bradley J. Monk, Larry Copeland, Sharon Wilczynski, David Alberts

Research output: Contribution to journalArticle

92 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)195-198
Number of pages4
JournalGynecologic oncology
Volume114
Issue number2
DOIs
StatePublished - Aug 1 2009

Keywords

  • Advanced ovarian cancer
  • Chemotherapy
  • Maintenance chemotherapy
  • Phase 3 trial

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

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