OBJECTIVES : In the open-label, randomized Phase 3 CM078 trial involving predominantly Chinese patients with advanced NSCLC previously treated with platinum-based chemotherapy, nivolumab was associated with superior overall survival, favorable safety, reduced symptom burden, and improved health-related quality of life compared with docetaxel. This study examined the HCRU of patients during treatment with nivolumab versus docetaxel in CM078.

METHODS : Data on hospital admissions and non-protocol-specified visits (NPSVs)—the latter defined as hospital outpatient, emergency room, physician office, or other visits—were collected from all 504 randomized CM078 participants during treatment. The frequency and duration of hospital admissions and NPSVs were summarized and exposure-adjusted analysis was completed by modelling events using negative binomial regression accounting for the duration of treatment as an offset variable. Exposure-adjusted incidence rate ratios (IRRs) were derived to facilitate comparisons between treatment arms.

RESULTS : During treatment, 29% of patients experienced at least one hospitalization, while 16% experienced an NPSV. Adjusting for treatment exposure, the incidence of both hospital admission and NPSVs was significantly lower for patients treated with nivolumab versus docetaxel (hospitalizations: 1.7 versus 3.2 events/patient/year; IRR=0.54; 95% confidence interval [CI] 0.32, 0.90); NPSVs: 2.0 versus 7.4 events/patient/year; IRR=0.27; 95% CI 0.13, 0.53). The average duration of hospital stay was 14 days, which was not significantly different between treatment arms (IRR=1.39; 95% CI 0.72, 2.71).

CONCLUSIONS : Patients with advanced NSCLC require substantial use of health care resources, such as hospital and outpatient visits, whilst on treatment. In CM078, HCRU was consistently lower for patients treated with nivolumab compared to docetaxel with a 46% reduction in the rate of hospitalization and 73% reduction in the rate of NPSVs. These findings may have important implications for Chinese patients suffering from NSCLC and their families as well as private and government health insurers in China.