CHICAGO– Quality of life at baseline and during treatment is an important prognostic factor in women with ovarian cancer, confirms an analysis reported at the annual meeting of the Society of Gynecologic Oncology.
Patients’ baseline quality of life score was independently associated with both progression-free and overall survival among 1,152 women participating in the Gynecologic Oncology Group (GOG) 218 trial, a randomized phase III trial comparing chemotherapy with versus without bevacizumab (Avastin), reported Dr. Neil T. Phippen of Walter Reed National Military Medical Center, Bethesda, Md.
Dr. Neil T. Phippen
Quality of life was assessed at six time points with FACT-O TOI (the Functional Assessment of Cancer Therapy–Ovarian Trial Outcome Index), on which possible scores range from 0-104 and higher scores indicate better quality of life. Women were included in analyses if they had completed the questionnaire at two or more time points.
Patients whose FACT-O TOI scores improved during treatment had a 4- to 5-month longer progression-free survival and a 20- to 25-month longer overall survival than counterparts whose scores worsened.
“Coupled with previously published data establishing quality of life as an independent predictor of survival across cancer sites, our results underscore the importance of quality of life surveillance in phase III clinical trials and support the inclusion of quality of life as an important component of composite clinical trial endpoints currently under development,” Dr. Phippen commented.
“Considering the independent prognostic value of the baseline FACT-O TOI score and the trend in the FACT-O TOI, methods to improve compliance with this evaluation metric are needed,” he maintained.
Patient-reported quality of life has been shown to be independently prognostic in at least five other cancers, according to Dr. Phippen. In advanced ovarian cancer, baseline FACT-O score (J. Clin. Oncol. 2005;23:5605-12) and the physical well-being scale of this score (Gynecol. Oncol. 2012;124:379-82) have previously been linked to overall survival.
In the new study, multivariate analysis that included potential confounders (age, performance status, stage, suboptimal debulking, and history of stroke or MI) showed that each 1-point decrease in baseline FACT-O TOI score was associated with significantly worse progression-free survival (hazard ratio, 1.005) and overall survival (HR, 1.0008), reported Dr. Phippen, who disclosed that he had no relevant conflicts of interest.
Additionally, within the group with lowest-quartile FACT-O TOI scores (indicating poorest quality of life), relative to peers who had a worsening of scores during treatment, women who had an improvement had significantly better progression-free survival (12.7 vs. 8.6 months) and overall survival (40.8 vs. 16 months).
Similarly, within the group having scores in higher quartiles, women who had an improvement in score during treatment again had significantly better progression-free survival (16.7 vs. 11.1 months) and overall survival (54.4 vs. 33.6 months).