BACKGROUND

The combination of nivolumab and ipilimumab, which act on different immune checkpoint molecules, is a promising first-line treatment strategy for advanced nonsmall cell lung cancer (NSCLC). However, real-world clinical data on this regimen, particularly regarding the relationship between adverse events (AEs) and efficacy, are inadequate.

METHODS

This real-world retrospective study was conducted on patients with advanced or recurrent NSCLC treated using a combination of nivolumab and ipilimumab as a first-line treatment. We extracted the data of consecutive eligible patients from four institutions in Japan between December 2020 and November 2022.

RESULTS

The study population comprised 184 patients who received nivolumab plus ipilimumab (median follow up period: 13.0 months [0.3-35.0]). In total, 81.0% (n = 149) of the patients were men, and the median age was 72.0 years (range: 46-80). The median progression-free survival (PFS) and overall survival (OS) were 6.6 months (95% confidence interval [CI]: 4.7-8.2) and 17.4 months (95% CI: 11.9-20.4), respectively. Skin disorders, liver dysfunction, thyroid dysfunction, and pneumonitis were the most common adverse events (AEs), with AEs occurring in 154 patients (83.7%). The median PFS in the AE group was longer than that in the non-AE group (8.2 vs. 2.6 months, p < 0.0001). The median OS in the AE group was also better than that in the non-AE group (19.3 vs. 6.1 months, p < 0.0001). Multivariate logistic regression analysis identified smoking history and high PD-L1 expression as factors related to the incidence of grade 3 and 4 AEs, respectively. The incidence of multiple AEs revealed a significant association with a longer PFS and OS. Skin disorders, adrenal insufficiency, and eosinophilia were the AEs with the greatest impact on survival.

CONCLUSIONS

Patients who experienced AEs had significantly longer PFS. Among AEs, the occurrence of skin disorders, adrenal insufficiency, and eosinophilia were likely to prolong PFS and OS.