Adjuvant nivolumab: good quality-of-life

Presented by

Prof. Eric Van Cutsem, University of Leuven, Belgium

Conference

ASCO GI 2021

Trial

Phase 3, CheckMate 577

New results from the phase 3 CheckMate 577 trial showed favourable oesophageal-specific and health-related quality-of-life (QoL) data with adjuvant nivolumab versus placebo in patients with oesophageal/gastroesophageal (GEJ) cancer.

Prof. Eric Van Cutsem (University of Leuven, Belgium) presented the results [1]: “It was previously reported that nivolumab is the first adjuvant therapy to provide a statistically significant and clinically meaningful improvement in disease-free survival versus a placebo in resected oesophageal/GEJ cancer following neoadjuvant chemoradiotherapy.”

The primary endpoint of the phase 3 CheckMate 577 trial (NCT02743494) was disease-free survival (DFS), with secondary endpoints of overall survival (OS) and OS rates at 1, 2, and 3 years. Of the 794 patients enrolled, 532 were randomised to receive nivolumab, and 262 patients were randomised to the placebo arm. The current presentation focused on health-related QoL data. The investigators used the FACT-E and EQ-5D-3L patient-reported outcome questionnaires to determine health-related QoL, general- and disease-related symptoms, and functioning disease burden. The questionnaires were administered at baseline, every 4 weeks during the 12-month treatment, and at post-treatment follow-up visits. Completion rates for patient reports at baseline were 95%, and approximately 90% at 12 months.

At baseline, mean health-related QoL scores were similar in both groups. After 1 year, both groups reported significant improvements. Scores were similar in the nivolumab and placebo groups for the following: FACT-E total score (133.4 vs 134.03, respectively), EQ-5D Visual Analogue Scale (70.4 vs 69.1, respectively), and EQ-5D Utility Index (0.82 vs 0.831, respectively). Scores for the oesophageal cancer subscale were also comparable in both groups (50.2 vs 50.1, respectively).

Prof. van Cutsem concluded that patients treated with adjuvant nivolumab did not experience a reduction in health-related QoL, further supporting clinical data to demonstrate benefit and tolerability for adjuvant nivolumab in patients with resected oesophageal /GEJ cancer.

Van Cutsem E, et al. Checkmate 577:Health-related quality of life (HRQoL) in a randomized, double-blind phase III study of nivolumab (NIVO) versus placebo (PBO) as adjuvant treatment in patients (pts) with resected esophageal or gastroesophageal junction cancer (EC/GEJC). ASCO Gastrointestinal Cancers Symposium 2021, 15-17 January. Abstract 167.

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