P-285 Q-TWiST analysis for pembrolizumab plus chemotherapy versus chemotherapy as first-line treatment for patients with advanced esophageal cancer in the KEYNOTE-590 study

In the phase 3 KEYNOTE-590 study (NCT03189719), first-line pembrolizumab plus chemotherapy provided statistically significant and clinically meaningful improvement in OS PFS, maintained HRQoL, was associated with a manageable safety profile versus patients locally advanced, unresectable or metastatic esophageal cancer Siewert type 1 gastro-esophageal junction adenocarcinoma. The objective of this analysis to assess Quality-adjusted Time Without Symptoms disease progression Toxicity treatment (Q-TWiST) among receiving + study. Q-TWiST divided survival time into health states: grade 3+ toxicity before death (TOX), without symptoms toxicities (TWiST), from (REL). calculated as restricted mean spent each state, weighted by health-state utility for that particular combined. Average weights state were based on pooled EQ-5D score using base case Utility[TWiST], 1.0; Utility[TOX], 0.5; Utility[REL], 0.5. Treatment difference 95% CIs generated non-parametric bootstrapping method. Data are reported all randomized PD-L1 combined positive (CPS) ≥10. Relative gains ≥10% ≥15% have been established “clinically important” “clearly important,” respectively, literature. cutoff, July 2, 2020. at month 33, had 1.51 (95% CI, 0.10-2.95) longer TWiST (5.95 vs 4.44 months), 1.59 0.76-2.43) TOX (3.71 2.12 0.01 -1.93-1.85) shorter REL (6.16 6.18 months) chemotherapy. For Q-TWIST patients, between arms favored arm 2.30 months 1.27-3.40; 10.89 8.59 representing 18.1% relative gain. CPS ≥10, those 2.24 0.08-4.44) (6.35 4.11 2.16 0.82-3.52) (4.39 2.23 0.19 -2.44-2.99) (5.98 5.80 3.41 1.92-4.84; 11.54 8.13 28.1% Pembrolizumab demonstrated quality-adjusted analyses compared advanced cancer.