Prospective observational study to evaluate efficacy and safety of immunotherapy (IO) in elderly (eld) patients (pts) with non-small cell lung cancer (NSCLC) undergoing comprehensive geriatric assessment (CGA).

Abstract

e20603 Background: Even though NSCLC prevalence is increasing in the eld population, they are underrepresented in clinical trials, including those involving IO. This study aims to assess the effectiveness and safety of IO as 1 st line treatment in eld pts with NSCLC undergoing CGA. Methods: A prospective study of pts ≥70 years old was performed at the University Hospital of Larissa. Clinical and demographic data were derived from pts’ medical records. Pts were screened (G8 tool) and categorized as fit, vulnerable (vln) and frail by CGA. Immune-related adverse events (irAEs) were graded according to Common Terminology Classification Adverse Events version 5.0. Kaplan-Meier survival curves and Cox regression for PFS/OS between groups were performed. Results: Overall, 129 pts with a mean age of 74.8 (range 70-92) were enrolled. Pts were predominantly male (92%) with squamous histology (50%) that received either monotherapy IO (7%) or chemotherapy+IO (93%). Pts had a G8 mean score of 8.8 (range 2-14) and were categorized as fit (27%), vln (41%) and frail (32%). CGA revealed that 46% of the pts needed assistance with IADLs ; all had ≥1 comorbidities (mean 4; range 1-10) and took ≥1 medications (mean 5; range 1-11); 67% experienced weight loss >3kg in the past 3 months (mo); 14% had cognitive impairment on Mini-Mental State Examination and 7% suffered at least one fall. Both median OS and median PFS were significantly higher in fit pts compared with vln and frail [OS: 30 vs 20 and 5 mo, respectively (resp), p<0.001; PFS: 16 vs 10 and 3 mo, resp, p=0.001]. Pts with Cumulative Illness Rating Scale-Geriatric 3-4 score had significantly shorter PFS/OS (8/13 mo, resp) compared with pts with lower scores (p=0.04/p=0.009, resp). Antiplatelet use (37.2% of pts) was linked to improved PFS/OS (13/20 mo, p=0.036/p=0.036, resp). Pts with a baseline albumin of ≥3.5 g/dL had improved PFS/OS compared to those with <3.5 g/dL (13 vs 5 mo, p<0.01; 20 vs 10 mo, p<0.01, resp). Overall, 30% of the pts experienced severe (grade 3-4) irAEs (SirAEs). Fit pts were at a lower risk for developing a SirAEs (Relative Risk: 0.73). Notably, pts aged ≥75 years had a lower incidence of SirAEs compared to pts <75 years old. Pts that experienced SirAEs exhibited worse survival outcomes compared to pts without (PFS: 7 vs 13 mo, p=0.001; OS: 10 vs 20 mo, p=0.002). Toxicity-related treatment discontinuation rate was higher in frail pts (52.8% vs 23.6%). Conclusions: Although, IO maintains efficacy in eld pts with NSCLC, our findings suggest that frailty, comorbidities and low albumin levels are correlated with worse survival outcomes. Frail pts also experienced more SirAEs and toxicity-related treatment discontinuations. These findings emphasize the necessity of a CGA rather than relying only on chronological age for guiding treatment decisions in the eld population.