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.
OBJECTIVE
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.


CONCLUSIONS
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.
Cella
David
D
Northwestern University Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center, Chicago, IL, USA. d-cella@northwestern.edu
Huang
Helen Q
HQ
Monk
Bradley J
BJ
Wenzel
Lari
L
Benda
Jo
J
McMeekin
D Scott
DS
Cohn
David
D
Ramondetta
Lois
L
Boardman
Cecelia H
CH
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage; D019772:Topotecan / Q000008:administration & dosage; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
D003841:Deoxycytidine; D014747:Vinblastine; D019772:Topotecan; D017239:Paclitaxel; D002945:Cisplatin; D000077235:Vinorelbine; D000093542:Gemcitabine