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. 2024 Mar 25:15:29-40.
doi: 10.2147/LCTT.S444884. eCollection 2024.

Effectiveness and Safety of Anlotinib Combined with PD-1 Blockades in Patients with Previously Immunotherapy Treated Advanced Non-Small Cell Lung Cancer: A Retrospective Exploratory Study

Affiliations

Effectiveness and Safety of Anlotinib Combined with PD-1 Blockades in Patients with Previously Immunotherapy Treated Advanced Non-Small Cell Lung Cancer: A Retrospective Exploratory Study

Xue-Jun Dou et al. Lung Cancer (Auckl). .

Abstract

Objective: This study aimed to investigate the effectiveness and tolerability of anlotinib plus PD-1 blockades in patients with previously immunotherapy treated advanced non-small-cell lung cancer (NSCLC).

Methods: A total of 67 patients with previously immunotherapy treated advanced NSCLC who received anlotinib plus PD-1 blockades in clinical practice were screened retrospectively. All the PD-1 blockades used in this study were approved in China and consisted of sintilimab, camrelizumab, tislelizumab and pembrolizumab. Effectiveness and safety of anlotinib plus PD-1 blockades were assessed, and all patients were followed up regularly. Clinical significance between response status to previous immune-related treatment regimens and therapeutic outcomes of anlotinib plus PD-1 blockades was further explored.

Results: The best overall response among the 67 patients suggested that a partial response was observed in 16 patients, stable disease was noted in 41 patients and progressive disease was found in 10 patients, which yielded an objective response rate of 23.9% (95% CI: 14.3-35.9%) and a disease control rate of 85.1% (95% CI: 74.3-92.6%). Prognostic outcomes indicated that the median progression-free survival (PFS) was 6.1 months (95% CI: 2.37-9.83) and the median overall survival (OS) was 16.5 months (95% CI: 10.73-22.27). Exploratory analysis highlighted that patients who were intolerant to previous immune-related regimens (17 patients) might have a superior prognosis (median OS: 22.3 months vs 12.5 months, P=0.024). Additionally, adverse reactions with any grades during anlotinib plus PD-1 blockades administration were observed in 62 patients (92.5%), of which 31 patients (46.3%) had ≥grade 3 adverse reactions. Most common adverse reactions were fatigue, hypertension, diarrhea and hepatotoxicity.

Conclusion: Anlotinib plus PD-1 blockades demonstrated promising effectiveness and tolerable safety in patients with previously immunotherapy treated advanced NSCLC. Those who were intolerant to previous immune-related regimens might benefit significantly from treatment with anlotinib plus PD-1 blockades. This conclusion should be confirmed in future studies.

Keywords: PD-1 blockades; anlotinib; effectiveness; previously immunotherapy treated NSCLC; safety.

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Conflict of interest statement

The authors declare that there are no conflicts of interest.

Figures

Figure 1
Figure 1
Study profile of this retrospective study.
Figure 2
Figure 2
Waterfall plot for the best change in target lesion among the 67 patients with previously immunotherapy treated advanced NSCLC who received anlotinib plus PD-1 blockades administration (Blue columns represent PR, yellow columns represent SD and red columns represent PD during the best overall response).
Figure 3
Figure 3
Progression-free survival of the 67 patients with previously immunotherapy treated advanced NSCLC who received anlotinib plus PD-1 blockades administration.
Figure 4
Figure 4
Overall survival of the 67 patients with previously immunotherapy treated advanced NSCLC who received anlotinib plus PD-1 blockades administration.
Figure 5
Figure 5
Comparison of overall survival in the 67 patients with advanced NSCLC who received anlotinib plus PD-1 blockades administration according to the response status of previous immunotherapy.

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