The results of 2 phase 3 trials on treatment-related adverse events (AEs) in patients with non–small-cell lung cancer (NSCLC) showed that their frequency and associated costs were significantly higher with docetaxel than with nivolumab. The results were presented at ASCO 2016.
“Consistent with the higher frequency of treatment-related adverse events associated with docetaxel, we observed large estimated differences in the costs of managing treatment-related adverse events, favoring nivolumab. In addition to a benefit of lower adverse events linked to lower costs, data have shown patients on nivolumab experience an improvement in symptoms that might further offset costs associated with nivolumab,” said Meena Venkatachalam, MSc, Principal Consultant, Health Economic Modeling Unit, PAREXEL International, Waltham, MA, who presented the results.
Nivolumab was approved for the treatment of patients with metastatic NSCLC whose disease progressed with or after platinum-based doublet chemotherapy based on 2 randomized phase 2 trials, CheckMate 017 and CheckMate 057. In both trials, nivolumab was associated with a favorable safety profile compared with docetaxel.
Ms Venkatachalam and colleagues analyzed data from 260 patients from CheckMate 017, 129 of whom were randomized to docetaxel and 131 to nivolumab, and 555 patients from CheckMate 057, of whom 268 were randomized to docetaxel and 287 to nivolumab.
In both trials, the frequency of AEs requiring intervention was higher in patients receiving docetaxel than in those receiving nivolumab.
Across both studies, the most frequent grade 3 or 4 AEs in patients receiving docetaxel were neutropenia (N = 68), febrile neutropenia (N = 44), anemia (N = 11), leukopenia (N = 11), and decreased neutrophil count (N = 10).
The most frequent grade 3 or 4 AEs across both studies for patients receiving nivolumab were pneumonitis (N = 3), colitis, diarrhea, and pericardial effusion (N = 2 each).
Cost of Treatment-Related Adverse Events
Consistent with the higher frequency of treatment-related AEs in patients receiving docetaxel, the estimated cost of AEs requiring intervention was higher in patients taking docetaxel than in those taking nivolumab (Table).
Despite the steep differences in cost, Ms Venkatachalam reported that the estimates are likely conservative because of the lack of cost data for some AEs. The missing cost data included AEs across all disease grades, she said, with greater incidence of unknown costs in the docetaxel arms.
“The lower costs for treatment-related adverse event management associated with nivolumab should be considered when assessing the value of nivolumab in the advanced NSCLC patient population,” Ms Venkatachalam concluded.