Efficacy and safety of anlotinib monotherapy or combination therapy in the treatment of patients with advanced non-small cell lung cancer: a retrospective real-world study conducted in East China.

Background: Non-small cell lung cancer (NSCLC) is one of the leading causes of cancer-related mortality worldwide. Despite significant advancements in chemotherapy, targeted therapy, and immunotherapy, the prognosis for advanced NSCLC remains poor. The development of resistance to standard treatments and the lack of effective therapeutic options for heavily pretreated patients underscore the urgent need for novel treatment strategies. Angiogenesis plays a pivotal role in tumor growth and metastasis, making it a critical target in cancer therapy. Anlotinib, a novel multi-target tyrosine kinase inhibitor, has demonstrated potent anti-tumor activity in patients with advanced NSCLC.

Methods: The retrospective analysis was conducted on clinical data from 82 patients with advanced NSCLC who received either anlotinib monotherapy or combination therapy. Patients were divided into two groups based on different treatment modalities: anlotinib monotherapy group (30 patients) and anlotinib combination therapy group (52 patients). The anlotinib combination therapy group received anlotinib in combination with immune checkpoint inhibitors (ICIs), chemotherapy, or targeted drugs. The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), and adverse events.

Results: Although the difference in ORR between the two groups was not statistically significant (P > 0.05), the DCR was notably higher in the combination therapy group compared to the monotherapy group (86.5% vs. 66.7%, P < 0.05). In the anlotinib combination therapy group, patients demonstrated a significantly longer PFS compared to those in the anlotinib monotherapy group (median PFS: 20.0 m vs. 9.3 m, P = 0.030). The PFS% at 12, 18, and 24 months in the anlotinib combination therapy group were 65.38%, 55.77%, and 28.85%, respectively, all significantly higher than in the anlotinib monotherapy group (P < 0.05). In the combination therapy regimen, anlotinib combined with ICIs significantly prolonged patients' PFS (median PFS: 25.4 m vs. 9.3 m, P < 0.05). Subgroup analysis results indicated that in subgroups of male patients, patients with a history of hypertension, patients with ≥ 3 lines of treatment, and patients without a history of anti-angiogenic therapy, the PFS in the anlotinib combination therapy group was significantly better than in the anlotinib monotherapy group (P < 0.05). Although the incidence of bleeding and skin adverse reactions was higher in the anlotinib combination therapy group compared to the monotherapy group, the difference was not statistically significant (P > 0.05).

Conclusion: Anlotinib combination therapy was associated with improved PFS in advanced NSCLC patients, with a tolerable safety profile.