Abstract 810P
Background
Based on CheckMate 238 results, nivolumab was the first anti-programmed death-1 therapy reimbursed in Belgium and Luxemburg as an adjuvant treatment for adults with resected melanoma. This study aimed to describe effectiveness, safety and HRQoL of patients (pts) treated with adjuvant nivolumab in the real-world.
Methods
152 pts (125 prospective, 27 retrospective) were enrolled by 31-Dec-2020. Relapse-free survival (RFS), time to treatment discontinuation (TTD), and adverse events (AEs) were assessed before treatment initiation (baseline) to the end of available follow-up. Kaplan-Meier methods were used to assess time-to-event endpoints. For 125 prospectively enrolled pts HRQoL was assessed at baseline and at 3, 6, 9, 12, 18, and 24 months (mo) using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, Functional Assessment of Cancer Therapy Melanoma (FACT-M) and EQ-5D-3L. Change from baseline was analysed using a mixed model for repeated measures.
Results
At a minimum follow-up of 11.5 mo (median 18.5 mo), 12- and 18-mo RFS was 77.3% (95% confidence interval [CI] 69.8-83.2) and 71.8% (95% CI 63.5-78.6), respectively. Median TTD was 11 mo; 35 pts (23%) discontinued due to any grade AE. Twenty-one pts (14%) had grade 3/4 treatment-related AEs, with no treatment-related deaths. Completion of the HRQoL scales ranged from 96% at baseline to 87% at 18-mo. At all timepoints (TP) EORTC QLQ-C30 function and symptom scores were below thresholds for clinical importance. No clinically meaningful changes were found for the QLQ-C30 Global QoL nor for the subscales compared to the minimally important difference (MID) estimates for melanoma pts. The FACT-M scores were stable; the melanoma surgery scale reached the MID for improvement as from mo 3. The EQ-5D visual analogue scale and utility index did not exceed the MID thresholds at any TP.
Conclusions
Real-world effectiveness and safety were consistent with CheckMate 238. HRQoL remained close to baseline values after adjuvant nivolumab initiation with no clinical meaningful changes over time, suggesting that adjuvant nivolumab does not impact HRQoL in a real-world setting.
Clinical trial identification
NCT03771859.
Editorial acknowledgement
Vicky Ware, LATITUDE (Powered by AXON).
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
A. Rogiers: Financial Interests, Personal, Advisory Role: Bristol Myers Squibb, MSD. L. Willemot: Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb; Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. L. McDonald: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. H. Van Campenhout: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. K. Vouk: Financial Interests, Personal, Full or part-time Employment: Syneos Health. G. Berchem: Financial Interests, Personal and Institutional, Invited Speaker: Bristol Myers Squibb, Janssens, Roche; Financial Interests, Personal and Institutional, Funding: Janssens , Roche; Financial Interests, Institutional, Principal Investigator: Various. C. Jacobs: Financial Interests, Institutional, Funding: Bristol Myers Squibb; Financial Interests, Personal and Institutional, Other: Pierre Fabre; Financial Interests, Personal and Institutional, Principal Investigator: Bristol Myers Squibb. B. Neyns: Financial Interests, Personal and Institutional, Other: Roche, Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, AstraZeneca; Financial Interests, Institutional, Funding: Pfizer, Novartis, Roche, Merck-Serono. All other authors have declared no conflicts of interest.