Chemotherapy-free anlotinib-based regimens in advanced non-small cell lung cancer: a real-world retrospective cohort...

Anlotinib is established as a standard later-line treatment for advanced non-small cell lung cancer (NSCLC). However, the real-world efficacy of anlotinib-based chemotherapy-free combinations-particularly in earlier lines of therapy-remains insufficiently characterized. This study aimed to evaluate the survival outcomes of anlotinib monotherapy versus combination regimens and assess the impact of treatment line on efficacy.

In this single-center, real-world retrospective cohort study, we analyzed 170 patients with advanced NSCLC. Patients were stratified into three cohorts: anlotinib monotherapy (Group A, n=62), anlotinib plus immunotherapy (Group A+I, n=57), and anlotinib plus targeted therapy (Group A+T, n=51). The primary endpoints were progression-free survival (PFS) and overall survival (OS), analyzed using Kaplan-Meier methods and Cox proportional hazards models.

The median PFS and OS for the entire cohort were 10 and 18.5 months, respectively. The objective response rate (ORR) and disease control rate (DCR) for the entire population were 17.6% and 84.8%, respectively. In the subgroups, the ORR was 18.8% (A+I) and 23.1% (A+T) vs. 10.5% (monotherapy), while the DCR was 93.8% (A+I) and 82.1% (A+T) vs. 76.3% (monotherapy). Compared with monotherapy, combination regimens demonstrated superior survival benefits. Specifically, the A+I group showed significantly reduced risks of progression [hazard ratio (HR): 0.461, P=0.001] and mortality (HR: 0.576, P=0.03). Similarly, the A+T group exhibited marked improvements in PFS (median 13.5 vs. 4.0 months; HR: 0.360, P<0.001) and OS (median 26.5 vs. 10.0 months; HR: 0.332, P<0.001). Subgroup analyses revealed that administering anlotinib in the first- or second-line setting yielded significantly longer PFS (22.5 vs. 8.5 months) and OS (37.0 vs. 14.0 months) compared to third-line use. Notably, among patients with driver mutations, the A+T regimen extended median OS to 26.5 months compared to 10.0 months in the monotherapy group. Lack of prior anti-angiogenic therapy was identified as an independent predictor for improved PFS.

Anlotinib-based, chemotherapy-free regimens demonstrate significantly greater efficacy than anlotinib monotherapy in advanced NSCLC. Furthermore, the upstream application of these regimens in earlier treatment lines is associated with markedly prolonged survival. These findings support anlotinib-based combinations as a promising chemotherapy-sparing strategy, particularly for patients unsuitable for or refusing chemotherapy.