237 Background: The goal of palliative chemotherapy is to prolong survival and decrease the symptomatic disease burden while minimizing treatment toxicities to preserve or improve quality of life. We recently reported a trial of dose reduced capecitabine in elderly or frail patients with advanced colorectal cancer, demonstrating that dose reduced capecitabine was a safe and efficacious treatment option. We herein report the health related quality of life (HRQoL) outcomes for the trial. Methods: A single arm multi-centered phase I/II trial of dose reduced capecitabine assessed capecitabine in 221 patients in at least one of the following subgroups: Age > 65, ECOG-PS ≥1, elevated LDH, and prior pelvic RT. Capecitabine was given at 2000 mg/m2 days 1-14 q21 days; or 1500 mg/m2 for patients with prior pelvic RT, as determined in the phase I portion of the study. Phase II participant (182 pts) were asked to complete FACT-G questionnaires at enrollment, after each cycle of capecitabine and once after cessation of the study drug, if possible. Results: 157 pts completed a baseline questionnaire (86%), and 137 pts (75%) completed a baseline and at least one subsequent questionnaire. The mean baseline score was 81.6, out of a possible 108. The mean score peaked at 92 after cycle 10. The mean change from baseline was always positive, with the maximum change (4.0), occurring after cycle 12. The number of patients who achieved the minimal important difference, a meaningful improvement in HRQoL, ranged from 30% to 45% during treatment cylces. The differences in HRQoL between capecitabine doses were minimal and did not reach significance. Patients who did not achieve disease control also reported an improvement in mean score from baseline (+3.9) after cycle 2. Changes in subscale mean scores for physical and social/family wellbeing were minimal (-1.2 to +0.5) while emotion and function subscale mean scores never decreased with the peak subscale change from baseline being +3.5. Conclusions: HRQoL improved on capecitabine therapy at 2000 or 1500 mg/m2 daily, further supporting its use in elderly and less fit patients with advanced colorectal cancer.
How health-related quality of life assessment should be used in advanced colorectal cancer clinical trials