Immunotherapy in elderly patients (>= 75 yrs) with advanced non-small cell lung cancer (NSCLC): A multicenter Italian experience

Background: Immunotherapy with anti PD-1 antibodies (mAbs) is the standard of care for the treatment of advanced Non-Small-Cell Lung Cancer (NSCLC). A conspicuous group of patients with advanced NSCLC are more than 75 years old. However, no randomized controlled trial exploring anti PD-1 therapy in older individuals has been published until now and few experiences in clinical practice have been reported. We therefore performed a multicenter retrospective analysis on NSCLC elderly patients treated with anti PD-1 therapy. Methods: We collected data from seven centers. Inclusion criteria were a diagnosis of advanced NSCLC, age ≥75 years, and treatment with anti-PD-1mAbs (pembrolizumab or nivolumab) in first or following lines. Primary end-points of the study were efficacy, in terms of Disease Control Rate (DCR), Overall Response Rate (ORR), Progression-Free Survival (PFS), and safety, by means of immune-related adverse events (irAEs). Results: The Clinical records of 72 patients followed since 2015 were analyzed. Median age was 77 years (75-86), males ware more frequently represented (60/72, 83%). A current or previous smoking history was found in 67/72 (93%) patients. Very old individuals (> 80 years old) were 21/72 (29%) and ECOG PS was 0-1 for 49/72 patients (63%). Non-squamous histology was prevalent 45/72, (62%). Brain metastases were found in 6/72 (8%) patients. Most of the patients (58/72, 81%) received nivolumab. For 68 patients, data on DCR, ORR were available. 39/68 (54%) had a DCR, while 17/68 (24%) had an ORR. Less than 10% of the patients had oligoprogression or pseudoprogression (8,3 and 9,7 % respectively). Overall immune-related adverse events occurred in 9/72 (14%) of individuals, 4/10 (40%) of them grade 3/4, being hematological and liver toxicities the most frequent ones (4 and 3%, respectively). At time of analysis, median PFS was 4,4 months (0.5-25 SD 5,53). In the Cox regression analysis, PFS was significantly influenced by DCR and smoking status (p = 0,0001, OR 17 95% CI 5,4 -52,3 and p = 0,001, OR 11 95% CI 2,6-45, respectively). Conclusions: In our cohort of elderly patients, anti PD-1 agents demonstrated to have a good toxicity profile and an efficacy comparable with the younger population. Legal entity responsible for the study: I conducted the study recording and collecting clinical data from other colleagues and computing statistical part with other specialists of the San Paolo Hospital in Milan. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.