Phase III Trial of Four Cisplatin-Containing Doublet Combinations in Stage IVB, Recurrent, or Persistent Cervical Carcinoma: A Gynecologic Oncology Group Study

被引:565
作者
Monk, Bradley J.
Sill, Michael W.
McMeekin, D. Scott
Cohn, David E.
Ramondetta, Lois M.
Boardman, Cecelia H.
Benda, Jo
Cella, David
机构
[1] Univ Calif Irvine, Div Gynecol Oncol, Dept Obstet & Gynecol, Chao Family Comprehens Canc Ctr, Orange, CA 92868 USA
[2] SUNY Buffalo, Gynecol Oncol Grp, Stat & Data Ctr, Roswell Pk Canc Inst, Buffalo, NY USA
[3] SUNY Buffalo, Dept Biostat, Buffalo, NY USA
[4] Univ Oklahoma, Oklahoma City, OK USA
[5] Ohio State Univ, Columbus, OH 43210 USA
[6] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA
[7] Virginia Commonwealth Univ, Richmond, VA USA
[8] Univ Iowa, Iowa City, IA USA
[9] Evanston NW Healthcare, Ctr Outcomes Res & Educ, Evanston, IL USA
[10] Northwestern Univ, Feinberg Sch Med, Chicago, IL 60611 USA
关键词
SQUAMOUS-CELL CARCINOMA; GUIDELINES; TOPOTECAN;
D O I
10.1200/JCO.2009.21.8909
中图分类号
R73 [肿瘤学];
学科分类号
100214 [肿瘤学];
摘要
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/m(2) over 24 hours plus Cis 50 mg/m(2) day 2 every 3 weeks (PC, reference arm); vinorelbine 30 mg/m(2) days 1 and 8 plus Cis 50 mg/m(2) day 1 every 3 weeks (VC); gemcitabine 1,000 mg/m2 day 1 and 8 plus Cis 50 mg/m(2) day 1 every 3 weeks (GC); or topotecan 0.75 mg/m(2) days 1, 2, and 3 plus Cis 50 mg/m(2) 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.
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收藏
页码:4649 / 4655
页数:7
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