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).

Authors

Eric Van Cutsem

Eric Van Cutsem

University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium

Eric Van Cutsem , Prianka Singh , James M. Cleary , Ronan Joseph Kelly , Markus H. Moehler , Jaroslaw Kuzdzal , Guillermo Mendez , Satoru Motoyama , Elena Elimova , Cecile Grootscholten , Xiaowu Sun , Fiona Taylor , Rachael Lawrance , Brad Padilla , Alejandro Moreno-Koehler , Jenny Zhang , Steven I. Blum , Jaffer A. Ajani

Organizations

University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium, Bristol Myers Squibb, Princeton, NJ, Dana Farber Cancer Institute, Boston, MA, The Charles A. Sammons Center at Baylor University Medical Center, Dallas, TX, Johannes Gutenberg-University Clinic, Mainz, Germany, Jagiellonian University, John Paul II Hospital, Cracow, Poland, Fundacion Favaloro, Buenos Aires, Argentina, Akita University Hospital, Akita, Japan, Princess Margaret Cancer Centre, Toronto, ON, Canada, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands, Adelphi Values, Boston, MA, Adelphi Values, Bollington, MA, United Kingdom, The University of Texas MD Anderson Cancer Center, Houston, TX

Research Funding

Pharmaceutical/Biotech Company
Bristol Myers Squibb

Background: NIVO is the first adjuvant therapy to provide a statistically significant and clinically meaningful improvement in disease-free survival (DFS) versus PBO in resected EC/GEJC following neoadjuvant chemoradiotherapy as demonstrated by CheckMate 577. NIVO was well tolerated with an acceptable safety profile. This analysis provides additional information on the exploratory HRQoL endpoints in this clinical trial. Methods: The effect of NIVO versus PBO on HRQoL, including general and disease-related symptoms, functioning, disease burden, and overall QoL, was assessed using FACT-E and EQ-5D-3L patient-reported outcome (PRO) questionnaires administered at baseline (BL), every 4 weeks during the 12-month treatment period, and at post-treatment follow-up visits (up to 2 years after last dose). Longitudinal change from BL in PRO scores over 12 months was assessed using descriptive statistics. Additionally, mixed model for repeated measures and time to deterioration analyses evaluated the difference between treatment with NIVO and PBO (data not shown). Results: 794 pts with EC/GEJC were randomized 2:1 to NIVO (n = 532) or PBO (n = 262). PRO completion rates were ≥ 95% at BL and ~ 90% at 12 months on treatment. Mean (SD) BL HRQoL scores were similar between treatment arms for the FACT-E total score (NIVO: 133.40 [20.97]; PBO: 134.03 [20.40]); esophageal cancer subscale (ECS; NIVO: 50.2 [9.3]; PBO: 50.1 [8.9]); EQ-5D Visual Analogue Scale (NIVO: 70.4 [22.3]; PBO: 69.1 [24.1]); and EQ-5D Utility Index (NIVO: 0.820 [0.179]; PBO: 0.831 [0.163]) based on the UK value set. Descriptive analyses showed a trend for increases from baseline at most time points through week 49 for both NIVO and PBO treatment groups for FACT-E total score, ECS, and EQ-5D Visual Analogue Scale and Utility Index. Conclusions: Preliminary results from CheckMate 577 demonstrated that pts on NIVO treatment showed trends of improvement in both esophageal-specific and general HRQoL. Similar trends were also observed in pts treated with PBO over 1 year. Pts treated with NIVO did not experience a reduction in HRQoL, further supporting clinical data to demonstrate treatment benefit and tolerability for adjuvant NIVO in pts with resected EC/GEJC. Clinical trial information: NCT02743494

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Abstract Details

Meeting

2021 Gastrointestinal Cancers Symposium

Session Type

Rapid Oral Abstract Session

Session Title

Rapid Abstract Session: Esophageal and Gastric Cancer

Track

Esophageal and Gastric Cancer

Sub Track

Patient-Reported Outcomes and Real-World Evidence

Clinical Trial Registration Number

NCT02743494

Citation

J Clin Oncol 39, 2021 (suppl 3; abstr 167)

DOI

10.1200/JCO.2021.39.3_suppl.167

Abstract #

167

Abstract Disclosures