The phase III CheckMate 067 study looked at patient-reported quality-of-life outcomes in patients with advanced melanoma undergoing immunotherapy treatment.
CHICAGO-Patient-reported quality of life did not deteriorate relative to baseline in patients with advanced melanoma undergoing extended treatment with nivolumab with or without ipilimumab, according to results of the phase III CheckMate 067 study (abstract 9551) presented during a poster session at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 31–June 4 in Chicago.
“Early data from the CheckMate 067 study showed maintenance of health-related quality of life (QOL) in patients with advanced melanoma treated with nivolumab or nivolumab plus ipilimumab based on 1-year data. However, long-term health-related QOL in these patients has not yet been evaluated,” wrote the authors led by Dirk Schadendorf, of University Hospital Essen in Germany.
The study included patients from 137 sites in 21 countries and represents the first QOL results from advanced melanoma patients who underwent these immunotherapy regimens for over a 4-year period.
In total, 945 patients were randomized to receive nivolumab plus placebo; nivolumab plus ipilimumab followed by nivolumab; or ipilimumab plus placebo. The investigators collected patient-reported outcomes data using the EORTC QLQ-C30, which includes 5 functional domains, 9 symptoms, and global health status, as well as the EQ-5D-3L, which includes a utility index and visual analog scale; assessment at baseline, week 1, and week 5 of each 6-week treatment cycle; and post-treatment follow-ups.
Of those randomized, 813 patients completed a baseline health-related QOL assessment and more than one post-baseline assessment (nivolumab, n = 278; nivolumab/ipilimumab, n = 274; ipilimumab, n = 261). The EQ-5D-3L questionnaire completion rates ranged from 89% to 92%. Of the 813 patients receiving treatment, more than 200 remained on treatment for the first year, more than 100 remained after 2 years, and more than 50 remained after 3 years.
The EQ-5D-3L utility assessment indicated that QOL was maintained during treatment and in off-treatment follow-up in all treatment arms. Global health status as indicated by the EORTC QLQ-C30 assessment and general QOL represented by the EQ-5D-3L visual analog responses were also maintained during treatment. The authors also conducted a mixed model analysis that confirmed the long-term maintenance of QOL over the course of treatment in all groups.
A subgroup analysis revealed a clinically meaningful decline in the BRAF mutation group at 1.25 years with ipilimumab alone and at 2 years with the nivolumab/ipilimumab combination.
The authors acknowledged that only a small proportion of the patients completed the assessments at years 2 and 3 of follow-up.