Phase III Trial of Four Cisplatin-Containing Doublet Combinations in Stage IVB, Recurrent, or Persistent Cervical Carcinoma: A Gynecologic Oncology Group Study
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- 30 September 2009
- journal article
- research article
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 27 (28), 4649-4655
- https://doi.org/10.1200/JCO.2009.21.8909
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/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.Keywords
This publication has 18 references indexed in Scilit:
- The evolution of cost-effective screening and prevention of cervical carcinoma: implications of the 2006 consensus guidelines and human papillomavirus vaccinationAmerican Journal of Obstetrics and Gynecology, 2007
- Multimodality Therapy for Locally Advanced Cervical Carcinoma: State of the Art and Future DirectionsJournal of Clinical Oncology, 2007
- Invasive Cervical CancerPublished by Elsevier BV ,2007
- Cisplatin plus gemcitabine in previously treated squamous cell carcinoma of the cervix: A phase II study of the Gynecologic Oncology GroupGynecologic Oncology, 2006
- Gynecologic oncology group trials of chemotherapy for metastatic and recurrent cervical cancerCurrent Oncology Reports, 2005
- Randomized Phase III Trial of Cisplatin With or Without Topotecan in Carcinoma of the Uterine Cervix: A Gynecologic Oncology Group StudyJournal of Clinical Oncology, 2005
- Quality of Life Outcomes From a Randomized Phase III Trial of Cisplatin With or Without Topotecan in Advanced Carcinoma of the Cervix: A Gynecologic Oncology Group StudyJournal of Clinical Oncology, 2005
- Global Cancer Statistics, 2002CA: A Cancer Journal for Clinicians, 2005
- Phase II Study of Cisplatin and Vinorelbine in Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group StudyJournal of Clinical Oncology, 2004
- New Guidelines to Evaluate the Response to Treatment in Solid TumorsJNCI Journal of the National Cancer Institute, 2000