INTRODUCTION: Maintaining or improving health-related quality of life (HRQoL) is as important as extending survival in metastatic colorectal cancer. We report an HRQoL analysis from FRESCO-2 (NCT04322539). METHODS: Patients were randomized to fruquintinib +best supportive care (BSC
n = 461) or placebo +BSC (n = 230). Instruments of EORTC QLQ-C30 and 5-level EQ-5D, and ECOG performance status (PS) were assessed. Changes from baseline scores for QLQ-C30 and EQ-5D were evaluated and minimally important difference thresholds were used to define stable, improved, or deteriorated QoL. Time to deterioration (TTD) was assessed. RESULTS: With fruquintinib versus placebo, baseline QLQ-C30 global health status (GHS) and EQ-5D visual analog scale (VAS) scores were 65.2 versus 64.6 and 67.0 versus 66.6, respectively. Least-squares mean changes from baseline fluctuated throughout treatment. At end of treatment (EOT), mean scores with fruquintinib versus placebo were 53.8 versus 52.3 (QLQ-C30 GHS) and 58.9 versus 58.5 (EQ-5D VAS). For QLQ-C30 GHS, 38.3 % versus 36.5 % of patients receiving fruquintinib versus placebo had stable or improved scores at EOT
median TTD was 2.1 versus 1.8 months (HR, 0.9
95 % CI, 0.7-1.0). For EQ-5D VAS, 47.9 % versus 42.7 % had stable or improved scores at EOT
median TTD was 2.6 versus 1.9 months (HR, 0.8
95 % CI, 0.6-0.9). Median TTD to ECOG PS ≥ 2 or death within 30+ /7 days after EOT was 6.6 versus 2.9 months with fruquintinib versus placebo (HR, 0.6
95 % CI, 0.4-0.7). CONCLUSIONS: Fruquintinib delayed TTD of ECOG PS and did not negatively impact HRQoL versus placebo.