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Efficacy and Safety of Afatinib Plus Bevacizumab as First-Line Treatment for Advanced NSCLC Patients With Epidermal
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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