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.
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).
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).
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.
Clinical trial identification
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.
Has not received any funding.
All authors have declared no conflicts of interest.