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Archive > Volume 33 Issue 2 > 2026,33(2):155-162. DOI:10.3872/j.issn.1007-385X.2026.02.006 Prev Next
Clinical Research
Efficacy and safety of anlotinib combined with ICI as first-line treatment for advanced lung squamous cell carcinoma: a single-center retrospective cohort study of 37 patients
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Abstract:
[Abstract] Objective: To explore the efficacy and safety of anlotinib combined with immune checkpoint inhibitors (ICI) as first-line treatment for advanced lung squamous cell carcinoma (LUSC). Methods: In this single-center retrospective cohort study, 37 consecutive treatment-na?ve advanced LUSC patients treated at Fuzhou Pulmonary Hospital of Fujian between October 2018 and December 2023 were enrolled. All patients received anlotinib (8, 10, or 12 mg/d; administered for 2 weeks followed by 1 week off) combined with PD-1/PD-L1 inhibitors. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included objective response rate (ORR), disease control rate (DCR), and treatment-related adverse event (TRAE). Results: With a median follow-up of 15.2 months, the ORR reached 54.1% (20/37), the DCR was 97.3% (36/37), the median PFS was 11.8 months (95% CI: 8.3-NA), and the 12-month PFS rate was 48.6%. Exploratory subgroup analyses showed that that patients receiving anlotinib at 12 mg demonstrated significantly longer median PFS (not reached vs 7.5 months; HR = 0.09, 95% CI: 0.01-0.67; P < 0.01) and a higher ORR (100% vs 42.9%, P < 0.01) compared to those receiving 8 or 10 mg. Stage-stratified analysis showed that the ORR of patients in stage ⅢB/ⅢC disease was significantly better than those in stage Ⅳ (84.6% vs 41.7%, P = 0.02). In terms of safety, 62.2% (23/37) of the patients developed TRAE, mainly grade 1-2 hypertension (29.7%[11/37]) and hand-foot syndrome (21.6%[8/37]). Three patients (8.1%) discontinued treatment due to grade 3 TRAE. Conclusion: Anlotinib combined with ICI as a first-line treatment regimen for advanced LUSC demonstrates promising therapeutic efficacy and manageable safety profiles. Notably, in exploratory analyses, the 12 mg dose group exhibited potential signals of superior efficacy, and patients with earlier-stage disease showed a higher ORR. These findings warrant further validation through large-scale prospective studies.
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