Abstract
In the randomized, double-blind phase II FIGHT study (NCT03694522), median progression-free survival (PFS) at primary analysis (data cutoff [DCO] September 2020) was 9.5 months (m) with BEMA + mFOLFOX6 vs 7.4m with PBO + mFOLFOX6 (hazard ratio [HR]: 0.68; 95% confidence interval [CI]: 0.44–1.04). At DCO in February 2021, median overall survival (OS) was 19.2m vs 13.5m, respectively (HR: 0.60; 95% CI: 0.38–0.94). This analysis assessed the impact of adding BEMA to mFOLFOX6 on HRQoL in FIGHT. Post-hoc HRQoL analyses (DCO February 2021) were based on the EORTC QLQ-C30 and EQ-5D-5L questionnaires, administered before/on study day 1, after 6 weeks (wks) from day 1, then every 8 wks while on treatment, and at the end of treatment visit. Changes from baseline in QLQ-C30 scales and EQ-5D (visual analogue scale [VAS]) and Utility Index) were analysed using mixed models for repeated measures. Time to first deterioration (of 10 points or more) or death (TTD) in the QLQ-C30 scales were assessed using Kaplan-Meier estimates and Cox models. 155 patients were randomized in FIGHT (77 to the BEMA arm, 78 to the PBO arm). Per protocol completion rates for QLQ-C30 and EQ-5D questionnaires remained high (>90%) in the two arms while on treatment. Least squares mean differences from baseline in QLQ-C30 and EQ-5D were similar between the treatment arms (Table), numerically favouring the BEMA arm in several scales (including social, role, cognitive and emotional functioning [fct], and VAS) after 6 wks. Study arms were also comparable with respect to TTD.Table: 1221PInstrumentScaleLeast squares mean difference (95% CI) vs baseline after 6 wks - BEMA vs PBOMedian TTD (in m) BEMA / PBOQLQ-C30 fct scales (MD >0 favours BEMA)Global health status/QoL-0.3 (-7.9; 7.2)5.5 / 6.0Physical fct1.6 (-4.8; 8.0)5.5 / 5.9Cognitive fct3.3 (-2.8; 9.3)5.1 / 3.9Emotional fct5.4 (-0.9; 11.7)10.5 / 7.4Role fct7.8 (-0.5; 16.1)5.7 / 3.9Social fct10.1 (1.6; 18.7)5.3 / 5.1QLQ-C30 symptom scales (MD < 0 favours BEMA)Pain-0.2 (-7.9; 7.5)5.7 / 5.2Fatigue1.8 (-5.2; 8.8)3.9 / 3.7Appetite loss2.3 (-8.2; 12.9)5.5 / 6.8Nausea/vomiting0.5 (-6.7; 7.7)5.3 / 6.0Sleep disturbance0.9 (-8.7; 10.5)8.8 / 6.1EQ-5D (MD >0 favours BEMA)VAS4.0 (-2.1; 10.1)-Utility index0.020 (-0.047; 0.087)- Open table in a new tab In FIGHT, the addition of BEMA to mFOLFOX6 improved clinical outcomes, with no deterioration in HRQoL. HRQoL will be further evaluated in the ongoing confirmatory phase III FORTITUDE-101 trial (NCT05052801).
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