Impact on survival of 12 versus 3 monthly cycles of paclitaxel (175mg/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 Oncolog

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作者：

M Markman，PY Liu，J Moon，BJ Monk，L Copeland，S Wilczynski，D Alberts

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摘要：

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. Patients ( n = 296) received either 3 or 12 monthly cycles of paclitaxel (175mg/m 2 over 3h). Of the 146 patients on the 3-cycle arm, 9 (6%) received > 3cycles. Median (12 versus 3cycles; intention-to-treat analysis) updated PFS (all pts) 22 versus 14months, p = 0.006; overall survival (all pts) 53 versus 48months, p = 0.34. Twelvecycles 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 3cycles 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.

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关键词：

Advanced ovarian cancer Chemotherapy Phase 3 trial Maintenance chemotherapy

DOI：

10.1016/j.ygyno.2009.04.012

被引量：

173

年份：

2009