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
ABSTRACT 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 saf...
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| Format: | Article |
| Language: | English |
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Wiley
2025-08-01
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| Series: | Thoracic Cancer |
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| Online Access: | https://doi.org/10.1111/1759-7714.70137 |
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| author | Huiyang Shi Miaohan Wang Junling Li Shi Jin Minglei Zhuo Jun Zhao Hongxia Zhang Meng Yang Qingfang Shi Haifeng Qin Guilan Dong Dongmei Lan Zhong Dai Yu Feng Haohua Zhu Jingyu Lu Kai Zhu Yuankai Shi Xingsheng Hu |
| author_facet | Huiyang Shi Miaohan Wang Junling Li Shi Jin Minglei Zhuo Jun Zhao Hongxia Zhang Meng Yang Qingfang Shi Haifeng Qin Guilan Dong Dongmei Lan Zhong Dai Yu Feng Haohua Zhu Jingyu Lu Kai Zhu Yuankai Shi Xingsheng Hu |
| author_sort | Huiyang Shi |
| collection | DOAJ |
| description | ABSTRACT 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 |
| format | Article |
| id | doaj-art-5ddc8acd66ff4385a2cb9f54c5e609e2 |
| institution | DOAJ |
| issn | 1759-7706 1759-7714 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Wiley |
| record_format | Article |
| series | Thoracic Cancer |
| spelling | doaj-art-5ddc8acd66ff4385a2cb9f54c5e609e22025-08-20T03:05:50ZengWileyThoracic Cancer1759-77061759-77142025-08-011615n/an/a10.1111/1759-7714.70137Efficacy 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 TrialHuiyang Shi0Miaohan Wang1Junling Li2Shi Jin3Minglei Zhuo4Jun Zhao5Hongxia Zhang6Meng Yang7Qingfang Shi8Haifeng Qin9Guilan Dong10Dongmei Lan11Zhong Dai12Yu Feng13Haohua Zhu14Jingyu Lu15Kai Zhu16Yuankai Shi17Xingsheng Hu18Department 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 ChinaDepartment 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 ChinaDepartment 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 ChinaNational Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Shenzhen ChinaPeking University Cancer Hospital/Beijing Institute of Cancer Prevention and Treatment, Key Laboratory of Malignant Tumor Pathogenesis and Transformation Research of Ministry of Education, First Department of Thoracic Cancer, Peking University Cancer Hospital/Beijing Cancer Prevention and Treatment Institute Beijing ChinaDepartment of Oncology Changzhi People's Hospital Affiliated to Changzhi Medical College Changzhi Shanxi ChinaDepartment of Oncology Luhe Hospital Affiliated to Capital Medical University Beijing ChinaNational Center for Respiratory Medicine; State Key Laboratory of Respiratory Health and Multimorbidity; National Clinical Research Center for Respiratory Diseases; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences; Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China‐Japan Friendship Hospital Beijing P. R. ChinaDepartment of Oncology Hengshui People's Hospital Hengshui Hebei ChinaDepartment of Oncology Beijing Gobroad Hospital Beijing ChinaDepartment of Oncology Tangshan People's Hospital Tangshan Hebei ChinaNational Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Shenzhen ChinaDepartment of Oncology Huanxing Cancer Hospital Beijing ChinaDepartment of Oncology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine Tsinghua University Beijing ChinaDepartment 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 ChinaDepartment 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 ChinaDepartment 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 ChinaDepartment 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 ChinaDepartment 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 ChinaABSTRACT 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.cnhttps://doi.org/10.1111/1759-7714.70137afatinib plus bevacizumabepidermal growth factor receptor mutationsfirst‐line treatmentnon‐small cell lung cancerpleural metastasis |
| spellingShingle | Huiyang Shi Miaohan Wang Junling Li Shi Jin Minglei Zhuo Jun Zhao Hongxia Zhang Meng Yang Qingfang Shi Haifeng Qin Guilan Dong Dongmei Lan Zhong Dai Yu Feng Haohua Zhu Jingyu Lu Kai Zhu Yuankai Shi Xingsheng Hu 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 Thoracic Cancer afatinib plus bevacizumab epidermal growth factor receptor mutations first‐line treatment non‐small cell lung cancer pleural metastasis |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | afatinib plus bevacizumab epidermal growth factor receptor mutations first‐line treatment non‐small cell lung cancer pleural metastasis |
| url | https://doi.org/10.1111/1759-7714.70137 |
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