Efficacy and Safety of Afatinib Plus Bevacizumab as First-Line Treatment for Advanced NSCLC Patients With Epidermal Growth Factor Receptor (EGFR) Mutations: A Multicenter, Phase II Trial
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Huiyang Shi1, Miaohan Wang1, Junling Li1
1Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Background:
Studies indicated that afatinib combined with angiogenesis inhibitor may achieve promising efficacy in non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations.
Methods:
This is a multicenter, Phase II trial to explore the efficacy and safety of afatinib plus bevacizumab at first-line setting for EGFR-mutant NSCLC patients. The primary end point was progression-free survival (PFS). The secondary end point included objective response rate (ORR), disease control rate (DCR) and safety.
Results:
Between July 11, 2020 and November 11, 2021, 54 treatment-naïve NSCLC patients were enrolled in the afatinib plus bevacizumab combination cohort. Meanwhile, 81 NSCLC patients with EGFR mutations treated with first-line afatinib monotherapy were retrospectively collected. The median follow-up time was 26.6 months. No significant difference in PFS was observed between the afatinib plus bevacizumab combination cohort and the afatinib monotherapy cohort (14.5 vs. 12.2 months, HR 0.87, p = 0.15), confirmed by propensity score matching (PSM) analysis. Patients with pleural metastasis (HR 0.56, 95% CI: 0.32-0.98, p < 0.05) and uncommon EGFR mutations (HR 0.61, 95% CI: 0.25-1.47, p = 0.05) experienced longer PFS in the combination cohort. ORR in the combination cohort is more favorable than in the afatinib monotherapy cohort (77.8% vs. 42.0%, p < 0.05). Diarrhea was the most common treatment-related adverse events (TRAEs). 11.1% (6/54) patients had grade ≥ 3 TRAEs when treated with afatinib plus bevacizumab.
Conclusion:
Afatinib combined with bevacizumab is well tolerated with moderate efficacy among patients with NSCLC, which might be a prospective strategy for patients with uncommon EGFR mutations and pleural metastasis.
Trial Registration:
www.chictr.org.cn.
Insights
Afatinib plus bevacizumab showed moderate efficacy in non-small cell lung cancer (NSCLC) with EGFR mutations. This combination may benefit patients with uncommon mutations or pleural metastasis, demonstrating good tolerability.
Area of Science:
- Oncology
- Medical Research
Background:
- Afatinib combined with an angiogenesis inhibitor shows potential in EGFR-mutated NSCLC.
- EGFR mutations are key drivers in non-small cell lung cancer.
Purpose of the Study:
- To evaluate the efficacy and safety of first-line afatinib plus bevacizumab in EGFR-mutated NSCLC patients.
- To compare outcomes with afatinib monotherapy.
Main Methods:
- A multicenter, Phase II trial involving 54 treatment-naïve NSCLC patients receiving afatinib plus bevacizumab.
- Retrospective collection of 81 NSCLC patients treated with afatinib monotherapy.
- Primary endpoint: progression-free survival (PFS); Secondary endpoints: objective response rate (ORR), disease control rate (DCR), and safety.
Main Results:
- No significant difference in median PFS between combination (14.5 months) and monotherapy (12.2 months) cohorts (HR 0.87, p=0.15).
- Patients with pleural metastasis and uncommon EGFR mutations showed longer PFS with combination therapy.
- Higher ORR in the combination cohort (77.8%) compared to monotherapy (42.0%, p<0.05).
- Diarrhea was the most common adverse event; 11.1% experienced grade ≥3 TRAEs.
Conclusions:
- Afatinib plus bevacizumab is well-tolerated with moderate efficacy in EGFR-mutated NSCLC.
- This combination may be a promising strategy for patients with uncommon EGFR mutations and pleural metastasis.
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