Efficacy and safety of anti-PD-1 immunotherapy in non-small-cell lung cancer (NSCLC) patients aged ≥75 years: an Italian, multicenter, retrospective study

Abstract Introduction Non-small cell lung cancer (NSCLC) is predominantly a disease of the elderly population. Over the past few years, immunotherapy with monoclonal antibodies named checkpoint inhibitors (ICIs) greatly improved the clinical management of a significant proportion of metastatic NSCLC patients. However, pivotal trials excluded older patients while, given the favorable clinical profile of ICIs, this treatment may reveal to be a most valuable option also for these patients. To this aim, a multicenter retrospective analysis was performed on NSCLC patients aged ≥75 years treated with anti PD-1/PD-L1 immunotherapy. Material and methods Inclusion criteria were: diagnosis of locally advanced or metastatic NSCLC (stage IIIB or IV, according to the AJCC classification system, version 8.0); age ≥75 years; treatment with anti-PD-1/PDL-1 mAbs in first or subsequent lines of treatment; absence of EGFR activating mutations or ALK and ROS-1 rearrangements. The primary end-points of the study were the efficacy, in terms of overall response rate (ORR), PFS and OS; and safety, by means of evaluations of the incidence of immune-related adverse events (irAEs) Results 86 patients were considered for the final analysis, 71 (82.6%) were male. Mean age was 78.5 (75-86, SD 3.12). 69/86 (80.2%) of patients had a performance status 0 or 1. Overall median PFS was 5.6 months, respectively (range 1-36, SD 7.5) while median OS was 10.1 months (1.7-34.8, SD 8). At the Cox regression analysis, the only parameter significantly associated with survival was the smoking status (p 0.008). No difference in survival was found between patients younger and older than 80 years Conclusions In the present real-world retrospective cohort, efficacy and toxicity profiles of ICIs in older patients with advanced NSCLC were comparable to those observed in younger patients enrolled in clinical trials.