Health-related quality of life outcomes associated with four cisplatin-based doublet chemotherapy regimens for stage IVB recurrent or persistent cervical cancer: A Gynecologic Oncology Group study

David Cella*, Helen Q. Huang, Bradley J. Monk, Lari Wenzel, Jo Benda, D. Scott McMeekin, David Cohn, Lois Ramondetta, Cecelia H. Boardman

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

28 Scopus citations

Abstract

Purpose: To assess the differences in health-related quality of life (HRQL) of 4 cisplatin containing doublet chemotherapy combinations in women with advanced/recurrent cervical carcinoma. Methods: Patients were randomized to three-week cycles of paclitaxel + cisplatin (PC); vinorelbine + C (VC); gemcitabine + C (GC); or topotecan + C (TC). We report HRQL results from data available on 434 eligible patients enrolled into this 513 patient trial. HRQL was assessed with the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) the FACT/Gynecologic Oncology Group (FACT/GOG) four-item neurotoxicity scale, and the 0-10 "worst pain" item from the Brief Pain Inventory, at baseline (pre-treatment), prior to beginning cycle 2, prior to beginning cycle 5, and at 9 months after enrollment. As reported by Monk et al. (2009) [13] VC, GC and TC were found not to be superior to PC with regard to progression-free survival or overall survival. Results: The trial was terminated early due to planned interim futility analysis, reducing power for HRQL analysis from 85% to 55%. Patients receiving VC, GC and TC doublets did not report significantly different HRQL, neuropathy, or pain from those who received the PC (control) doublet. Patients receiving PC tended to report worse neuropathy during treatment than patients who received other doublets (especially GC and TC), but the differences were not statistically significant. Conclusion: None of the 3 experimental doublets was different from PC in terms of HRQL during treatment. Long-term toxicity data are inconclusive. Except where patients may wish to reduce their risk of worsening pre-treatment neuropathy, PC remains the standard of care for this disease.

Original languageEnglish (US)
Pages (from-to)531-537
Number of pages7
JournalGynecologic oncology
Volume119
Issue number3
DOIs
StatePublished - Dec 2010

Keywords

  • Advanced
  • Cervical cancer
  • Chemotherapy
  • Clinical trial
  • Health-related quality of life
  • Phase III
  • Quality of life
  • Recurrent

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

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