OBJECTIVES: Nivolumab demonstrated survival, HRQoL, and HCRU benefits versus single-agent therapy of IC (methotrexate, docetaxel, or cetuximab) in patients with platinum-refractory R/M SCCHN in CheckMate 141 (NCT02105636). We investigated the correlation of HRQoL with HCRU.

METHODS: HRQoL was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30), EORTC head and neck cancer–specific module (QLQ-H&N35), and 3-level EQ-5D (EQ-5D-3L) questionnaire. Association of baseline HRQoL scores with HCRU (frequency of physician office visits, hospital outpatient visits, emergency department visits, hospital admissions, or other visits, as well as total events) was modeled using negative binomial regression while controlling for follow-up duration. The interaction of treatment with HRQoL score was fitted and removed from the model if nonsignificant. The effect of HCRU event frequency on time to HRQoL deterioration (per clinically meaningful change definitions) was assessed using Kaplan-Meier estimates stratified by HCRU events (0/1/≥2). This exploratory analysis used a 5% significance level.

RESULTS: There was no evidence of a differential effect of baseline HRQoL score by treatment group. Higher baseline QLQ-C30 global health status, cognitive functioning, and social functioning were significantly associated (P<0.05) with lower total HCRU event frequency. Higher symptom frequency (ie, QLQ-C30 symptoms of dyspnea and diarrhea as well as speech problems, social eating problems, social contact problems, coughing, feeling ill, and weight loss as measured by the QLQ-H&N35) were significantly associated (P<0.05) with more frequent total HCRU events. Baseline EQ-5D-3L scores were not associated with HCRU event frequency. Baseline HRQoL was associated with hospital admission frequency. There was no clear association of HCRU event frequency with time to HRQoL deterioration.

CONCLUSIONS: In CheckMate 141, worse baseline HRQoL was associated with higher HCRU regardless of treatment arm, suggesting that baseline HRQoL scores may be useful to identify patients that may utilize healthcare resources more frequently.