A Novel Strategy for Treating Elderly Patients with Advanced Non-Small Cell Lung Cancer: Exploring the Efficacy and Safety of Anlotinib Combined with PD-1/PD-L1 Inhibitors.

This study aimed to explore whether the combination of anlotinib and immunotherapy is an effective and safe alternative to chemotherapy for clinical treatment. Provide a new treatment plan for elderly patients who are unwilling to undergo chemotherapy, intolerant to chemotherapy, or have poor ECOG PS scores. This is a single-center retrospective investigation that collected clinical data of 58 elderly aNSCLC patients treated with anlotinib monotherapy or anlotinib plus PD-1/PD-L1 inhibitor combination therapy at Nanjing Chest Hospital during the period from January 1, 2020 to December 31, 2023, with the study being subject to a limited sample size. Fifty-eight elderly patients were evaluated after two cycles of anlotinib monotherapy and combined therapy. In the monotherapy group of 28 patients, the ORR and DCR were 25.0% (7/28) and 78.6% (22/28), respectively. Besides, the mPFS and the mOS reached up to 5.4 months (95% CI, 4.4-6.4 months) and 11.2 months (95% CI, 7.2-15.2 months), respectively. In the group with combination therapy of 30cases, the ORR for this group was calculated at 30.0% (9/30), the DCR was higher, at 86.7% (26/30), the mPFS and the mOS were determined to be 8.5 months (95% CI, 7.3-9.7 months) and 17.8 months (95% CI, 13.2-22.4 months), respectively. In multivariate COX analysis, brain metastasis and treatment methods were found to be independent risk factors for PFS alongside OS. Both groups had a comparable overall incidence of adverse events (AEs), at 70.0% and 64.3% respectively, with no statistically significant difference noted in the rate of grade 3 and above adverse events (23.3% versus 17.9%). Anlotinib combined with immunotherapy demonstrated superior efficacy and better tolerability than anlotinib alone. The combination of anlotinib and immunotherapy may provide a "chemo-free" treatment mode for elderly patients with non-small cell lung cancer who refuse or cannot tolerate chemotherapy and have poor ECOG PS scores.