Feasibility and Tolerability of Anlotinib Plus PD-1 Inhibitors for Previously-Treated Advanced Non-Small Cell Lung
Hai-Li Wang1, Shi-Xia Zhou1, Jing Kuang1
1Department of Oncology, the Second Affiliated Hospital of Zhengzhou University, Zhengzhou, 450014, People's Republic of China.
Objective:
Anlotinib demonstrated encouraging therapeutic activity as third-line treatment for patients with advanced non-small cell lung cancer (NSCLC). Programmed cell death protein 1 (PD-1) inhibitors also exhibited promising and durable response against previously-treated advanced NSCLC. Therefore, the present study aimed to determine the feasibility and safety of anlotinib plus PD-1 inhibitors for previously-treated NSCLC in clinical practice.
Methods:
This retrospective study included 56 patients with advanced NSCLC treated with systemic treatment previously. Patients included were treated with anlotinib plus PD-1 inhibitors in clinical practice. Therapeutic outcomes of the patients were evaluated radiologically using target lesions, and the prognostic outcomes were generated by follow-up. Adverse reactions experienced throughout the treatment were documented and analyzed.
Results:
Between August 2018 and November 2022, 56 patients with advanced NSCLC were eligible to participate in this study consecutively. Therapeutic outcomes resulted in an overall response rate of 28.6% [95% confidence interval (CI): 17.3%-42.2%] and a disease control rate of 91.1% (95% CI: 80.4%-97.0%). Furthermore, this combination regimen among the 56 patients yielded a median progression-free survival (PFS) of 6.5 months (95% CI: 4.81-8.19) and a median overall survival (OS) of 15.8 months (95% CI: 10.23-21.37), respectively. And the median duration of response (DoR) among patients who responded was 8.3 months (95% CI: 4.38-12.22). Additionally, adverse reactions of all grades throughout the treatment were observed in 50 patients (89.3%), and adverse reactions of grade ≥3 were detected in 23 patients (41.1%). Fatigue, hypertension, diarrhea, nausea, and vomiting were the most common adverse reactions. Association analysis between PFS and baseline characteristic subgroups indicated that ECOG score and number of metastatic lesions might be potential predictors of PFS in the exploratory analysis.
Conclusion:
Anlotinib plus PD-1 inhibitors demonstrated a tolerable safety profile and encouraging therapeutic activity as subsequent-line therapy in patients with advanced NSCLC. This conclusion should be confirmed in prospective large-scale clinical trials subsequently.
Insights
Anlotinib combined with PD-1 inhibitors shows promising results for advanced non-small cell lung cancer (NSCLC) patients previously treated. This combination therapy offers a tolerable safety profile and encouraging therapeutic activity in subsequent-line treatment.
Area of Science:
- Oncology
- Immunotherapy
- Pharmacology
Background:
- Anlotinib shows efficacy in third-line advanced non-small cell lung cancer (NSCLC).
- Programmed cell death protein 1 (PD-1) inhibitors offer durable responses in previously treated advanced NSCLC.
- Combination therapy may enhance treatment outcomes for advanced NSCLC.
Purpose of the Study:
- To evaluate the feasibility and safety of anlotinib plus PD-1 inhibitors.
- To assess the therapeutic activity of this combination in previously-treated advanced NSCLC patients.
- To identify potential predictors of progression-free survival (PFS).
Main Methods:
- Retrospective study of 56 advanced NSCLC patients.
- Patients received anlotinib plus PD-1 inhibitors as systemic treatment.
- Outcomes assessed via radiological evaluation, follow-up, and adverse event documentation.
Main Results:
- Overall response rate (ORR) was 28.6%, disease control rate (DCR) was 91.1%.
- Median PFS was 6.5 months, median overall survival (OS) was 15.8 months.
- Common adverse events included fatigue, hypertension, and gastrointestinal issues; 41.1% experienced grade ≥3 adverse reactions.
Conclusions:
- Anlotinib plus PD-1 inhibitors demonstrate a tolerable safety profile and encouraging activity in advanced NSCLC.
- This combination can be considered for subsequent-line therapy.
- Prospective large-scale trials are needed to confirm these findings.
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