Patients (pts) with platinum-refractory R/M SCCHN have median survival ≤6 mo and suffer from their disease and its treatment. Accordingly, maintaining quality of life (QoL) is a key treatment goal. PRO data were collected as exploratory endpoints in CheckMate 141 (NCT02105636), a randomized, open-label, phase 3 trial comparing nivo to IC (methotrexate, docetaxel, or cetuximab) in 361 pts with platinum-refractory R/M SCCHN. We report the first comparative results for PRO for nivo and IC in R/M SCCHN.
The European Organisation for Research and Treatment of Cancer QoL Questionnaire (EORTC QLQ-C30), EORTC Head and Neck Cancer module (QLQ-H&N35), and EQ-5D were administered at baseline (BL), wk 9, and then at 6-wk intervals during treatment. A clinically relevant score change or difference was regarded as 10 points for the EORTC subscales. Analysis of covariance (ANCOVA) was applied to compare mean score changes between arms. Proportional hazards regression was used to evaluate time to clinically relevant score deterioration (TTD).
BL questionnaire completion rates for nivo and IC were ∼80% and ∼75%, respectively. Low IC completion rates precluded analysis of mean differences after wk 15. Overall, 129 pts completed a PRO measure at BL and during follow up. Nivo significantly delayed TTD (P < 0.05, 2-tailed) vs IC for global health; physical, role, cognitive, and social functioning; fatigue; dyspnea; and insomnia (EORTC QLQ-C30) as well as pain; sensory problems; and mouth opening problems (QLQ-H&N35). ANCOVA revealed statistically significant, clinically relevant differences favoring nivo at wks 9 and 15 for role and social functioning, fatigue, dyspnea, and appetite loss (EORTC QLQ-C30) as well as pain and sensory problems (QLQ-H&N35). Differences in mean values were observed for other PROs at wk 15 only.
Pts treated with nivo had delayed worsening of functioning and symptoms with PRO differences between arms favoring nivo up to ∼4 mo of follow up. These results, as assessed through wk 15, suggest that pts receiving nivo maintained functioning for longer and had less pain, fatigue, and dyspnea on treatment as compared with IC.
Clinical trial identification
NCT02105636; Study start date, May 2014
Legal entity responsible for the study
Sponsored by Bristol-Myers Squibb
K. Harrington: Personal fees and fees paid to research institution from BMS, during the study; Fees paid to research institution by AstraZeneca and Pfizer; Personal fees and fees paid to research institution from Merck and Amgen, outside submitted work. R.L. Ferris: Grants and consulting/advisory board member for AstraZeneca, Merck, and BMS; Consulting/advisory board member for Pfizer. J. Shaw: Employee and shareholder of Bristol-Myers Squibb. F. Taylor: Employee of Adelphi Values, a consulting firm paid by BMS to analyze clinical trial PRO data D. Turner-Bowker: Employee of Adelphi Values, which received funding to conduct this research. L. Morrissey: Employee of Adelphi Values, which was paid for the statistical analyses. K. Cocks: Employee of Adelphi Values, which is a paid consultant of BMS. N. Kiyota: Grants & personal fees from ONO Pharmaceutical Co, Ltd, during the study; Grants from Eisai Co, Ltd, and Nippon Boehringer Ingelheim Co, Ltd, outside submitted work; Payment for seminar participation from BMS, Merck Serono, and Bayer. M. Gillison: Consulting for BMS, Lilly, and Merck Inc. J. Guigay: Grants from and advisory board member for Merck; Grants from GSK; Advisory board member for BMS and Innate Pharma All other authors have declared no conflicts of interest.