Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: A Gynecologic Oncology Group study

Bradley J. Monk, Michael W. Sill, D. Scott McMeekin, David E. Cohn, Lois M. Ramondetta, Cecelia H. Boardman, Jo Benda, David Cella

Research output: Contribution to journalArticle

388 Scopus citations

Abstract

Purpose: Assess toxicity and efficacy of cisplatin (Cis) doublet combinations in advanced and recurrent cervical carcinoma. Patients and Methods: Patients were randomly assigned to paclitaxel 135 mg/m2 over 24 hours plus Cis 50 mg/m2 day 2 every 3 weeks (PC, reference arm); vinorelbine 30 mg/m2 days 1 and 8 plus Cis 50 mg/m2 day 1 every 3 weeks (VC); gemcitabine 1,000 mg/m2 day 1 and 8 plus Cis 50 mg/m2 day 1 every 3 weeks (GC); or topotecan 0.75 mg/m2 days 1, 2, and 3 plus Cis 50 mg/m2 day 1 every 3 weeks (TC). Survival was the primary end point with a 33% improvement relative to PC considered important (85% power, alpha - 5%). Quality-of-life data were prospectively collected. Results: A total of 513 patients were enrolled when a planned interim analysis recommended early closure for futility. The experimental-to-PC hazard ratios of death were 1.15 (95% CI, 0.79 to 1.67) for VC, 1.32 (95% CI, 0.91 to 1.92) for GC, and 1.26 (95% CI, 0.86 to 1.82) for TC. The hazard ratios for progression-free survival (PFS) were 1.36 (95% CI, 0.97 to 1.90) for VC, 1.39 (95% CI, 0.99 to 1.96) for GC, and 1.27 (95% CI, 0.90 to 1.78) for TC. Response rates (RRs) for PC, VC, GC, and TC were 29.1%, 25.9%, 22.3%, and 23.4%, respectively. The arms were comparable with respect to toxicity except for leucopenia, neutropenia, infection, and alopecia. Conclusion: VC, GC, and TC are not superior to PC in terms of overall survival (OS). However, the trend in RR, PFS, and OS favors PC. Differences in chemotherapy scheduling, pre-existing morbidity, and toxicity are important in individualizing therapy.

Original languageEnglish (US)
Pages (from-to)4649-4655
Number of pages7
JournalJournal of Clinical Oncology
Volume27
Issue number28
DOIs
StatePublished - Oct 1 2009

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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