Meaningful changes in quality of life (QoL) in patients with gastric cancer: Exploratory analyses from RAINBOW and REGARD.

Abstract

4047 Background: EORTC QLQ-C30 is a well-established QoL instrument for cancer patients (pts), but there is limited information for gastric cancer. To identify priority domains and describe meaningful changes, we explored data from 2 randomized ramucirumab phase 3 trials in pts with previously treated gastric or gastroesophageal junction cancer. Methods: Pts completed QLQ-C30 v3.0 at baseline and Q6W while on study. Data from all treatment arms were pooled (N=1020). Changes from baseline in QoL domains were compared by best overall response (BOR) and ECOG performance status (PS) using analysis of covariance. Odds ratios (ORs) for BOR and PS outcome groups per QoL unit (point) change were estimated by cumulative logit regression modeling, with OR≤0.85 considered meaningful. Results: Changes from baseline in QoL domains were significantly associated with BOR and PS outcomes (Table). ORs for BOR and PS outcomes for these domains were statistically significant (p<0.05) and suggested changes of 10-15 points predict clinical outcomes. Conclusions: QLQ-C30 is sensitive to clinical outcomes in advanced gastric cancer patients, particularly in global QoL, functional status and disease symptoms of fatigue, pain, and appetite loss. These analyses can inform trial designs and interpretation of results. [Table: see text]