A phase II trial of anlotinib plus EGFR-TKIs in advanced non-small cell lung cancer with gradual, oligo, or potential progression after EGFR-TKIs treatment (CTONG-1803/ALTER-L001)
Abstract Background The study is to evaluate the efficacy and safety of combined anlotinib and EGFR-tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC) who had gradual, oligo, or potential progression after previous EGFR-TKIs treatment. Methods We conducted...
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BMC
2025-01-01
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| Series: | Journal of Hematology & Oncology |
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| Online Access: | https://doi.org/10.1186/s13045-024-01656-0 |
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| author | Hua-Jun Chen Hai-Yan Tu Yanping Hu Yun Fan Guowu Wu Shundong Cang Yi Yang Nong Yang Rui Ma Gaowa Jin Ximing Xu Anwen Liu Shubin Tang Ying Cheng Yan Yu Chong-Rui Xu Qing Zhou Yi-Long Wu |
| author_facet | Hua-Jun Chen Hai-Yan Tu Yanping Hu Yun Fan Guowu Wu Shundong Cang Yi Yang Nong Yang Rui Ma Gaowa Jin Ximing Xu Anwen Liu Shubin Tang Ying Cheng Yan Yu Chong-Rui Xu Qing Zhou Yi-Long Wu |
| author_sort | Hua-Jun Chen |
| collection | DOAJ |
| description | Abstract Background The study is to evaluate the efficacy and safety of combined anlotinib and EGFR-tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC) who had gradual, oligo, or potential progression after previous EGFR-TKIs treatment. Methods We conducted an open-label, single-arm, multicenter, phase II trial in China. Eligible patients were 18–75 years old with histologically or cytologically confirmed NSCLC who were EGFR mutation positive and showed gradual, oligo, or potential progression after EGFR-TKIs. Anlotinib (12 mg/day) was administered orally for 2 weeks and then off 1 week in a 3-week cycle. EGFR-TKIs were continue used. The primary endpoint was progression-free survival (PFS). The secondary endpoints included 6- and 12-month PFS rate, objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety. Results From July 2019 to December 2022, 120 patients were enrolled. The median PFS (mPFS) was 9.1 months (95% CI 6.8–11.7). The PFS rates at 6 and 12 months was 68.5% and 38.8% respectively. For 86 patients with first-line 1st /2nd generation EGFR-TKIs, the mPFS was 9.2 months (95% CI 6.7–12.6). For 32 patients with first-line 3rd generation EGFR-TKIs, the mPFS was 10.3 months (95% CI 6.1–13.3). Overall ORR and DCR were 6.7% (95% CI 2.9–12.7) and 87.5% (95% CI 80.2–92.8), respectively. 52.5% of patients had grade 3 or higher treatment-emergent adverse events (TEAEs). Conclusion Anlotinib in combination with continuation of EGFR-TKIs prolonged the clinical benefit of EGFR-TKIs, demonstrating favorable survival outcomes and manageable toxicity in NSCLC treated with EGFR-TKIs and had specific progression modes, such as gradual progression. Trial registration NCT04007835. |
| format | Article |
| id | doaj-art-fb53d4ae403a4ec5989c37cf7186f6e6 |
| institution | Kabale University |
| issn | 1756-8722 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Hematology & Oncology |
| spelling | doaj-art-fb53d4ae403a4ec5989c37cf7186f6e62025-01-12T12:36:37ZengBMCJournal of Hematology & Oncology1756-87222025-01-0118111010.1186/s13045-024-01656-0A phase II trial of anlotinib plus EGFR-TKIs in advanced non-small cell lung cancer with gradual, oligo, or potential progression after EGFR-TKIs treatment (CTONG-1803/ALTER-L001)Hua-Jun Chen0Hai-Yan Tu1Yanping Hu2Yun Fan3Guowu Wu4Shundong Cang5Yi Yang6Nong Yang7Rui Ma8Gaowa Jin9Ximing Xu10Anwen Liu11Shubin Tang12Ying Cheng13Yan Yu14Chong-Rui Xu15Qing Zhou16Yi-Long Wu17Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Guangdong Lung Cancer Institute, Southern Medical UniversityGuangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Guangdong Lung Cancer Institute, Southern Medical UniversityDepartment of Thoracic Oncology, Hubei Cancer HospitalDepartment of Thoracic Oncology, Zhejiang Cancer HospitalDepartment of Medical Oncology, Meizhou People’s Hospital (Huangtang Hospital)Department of Oncology, Henan Provincial People’s HospitalDepartment of Thoracic Surgery, The Third People’s Hospital of ChengduDepartment of Oncology, The Second People’s Hospital of HunanDepartment of Thoracic Oncology, Liaoning Cancer Hospital & InstituteDepartment of Medical Oncology, Inner Mongolia Autonomous Region People’s HospitalDepartment of Oncology, Renmin Hospital of Wuhan UniversityDepartment of Medical Oncology, The Second Affiliated Hospital of Nanchang UniversityDepartment of Oncology, The First People’s Hospital of NeijiangDepartment of Oncology, Jilin Cancer HospitalDepartment of Thoracic Medicine, Harbin Medical University Cancer HospitalGuangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Guangdong Lung Cancer Institute, Southern Medical UniversityGuangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Guangdong Lung Cancer Institute, Southern Medical UniversityGuangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Guangdong Lung Cancer Institute, Southern Medical UniversityAbstract Background The study is to evaluate the efficacy and safety of combined anlotinib and EGFR-tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC) who had gradual, oligo, or potential progression after previous EGFR-TKIs treatment. Methods We conducted an open-label, single-arm, multicenter, phase II trial in China. Eligible patients were 18–75 years old with histologically or cytologically confirmed NSCLC who were EGFR mutation positive and showed gradual, oligo, or potential progression after EGFR-TKIs. Anlotinib (12 mg/day) was administered orally for 2 weeks and then off 1 week in a 3-week cycle. EGFR-TKIs were continue used. The primary endpoint was progression-free survival (PFS). The secondary endpoints included 6- and 12-month PFS rate, objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety. Results From July 2019 to December 2022, 120 patients were enrolled. The median PFS (mPFS) was 9.1 months (95% CI 6.8–11.7). The PFS rates at 6 and 12 months was 68.5% and 38.8% respectively. For 86 patients with first-line 1st /2nd generation EGFR-TKIs, the mPFS was 9.2 months (95% CI 6.7–12.6). For 32 patients with first-line 3rd generation EGFR-TKIs, the mPFS was 10.3 months (95% CI 6.1–13.3). Overall ORR and DCR were 6.7% (95% CI 2.9–12.7) and 87.5% (95% CI 80.2–92.8), respectively. 52.5% of patients had grade 3 or higher treatment-emergent adverse events (TEAEs). Conclusion Anlotinib in combination with continuation of EGFR-TKIs prolonged the clinical benefit of EGFR-TKIs, demonstrating favorable survival outcomes and manageable toxicity in NSCLC treated with EGFR-TKIs and had specific progression modes, such as gradual progression. Trial registration NCT04007835.https://doi.org/10.1186/s13045-024-01656-0EGFR mutationAnlotinibGradual progressionOligo progressionNon-small cell lung cancer |
| spellingShingle | Hua-Jun Chen Hai-Yan Tu Yanping Hu Yun Fan Guowu Wu Shundong Cang Yi Yang Nong Yang Rui Ma Gaowa Jin Ximing Xu Anwen Liu Shubin Tang Ying Cheng Yan Yu Chong-Rui Xu Qing Zhou Yi-Long Wu A phase II trial of anlotinib plus EGFR-TKIs in advanced non-small cell lung cancer with gradual, oligo, or potential progression after EGFR-TKIs treatment (CTONG-1803/ALTER-L001) Journal of Hematology & Oncology EGFR mutation Anlotinib Gradual progression Oligo progression Non-small cell lung cancer |
| title | A phase II trial of anlotinib plus EGFR-TKIs in advanced non-small cell lung cancer with gradual, oligo, or potential progression after EGFR-TKIs treatment (CTONG-1803/ALTER-L001) |
| title_full | A phase II trial of anlotinib plus EGFR-TKIs in advanced non-small cell lung cancer with gradual, oligo, or potential progression after EGFR-TKIs treatment (CTONG-1803/ALTER-L001) |
| title_fullStr | A phase II trial of anlotinib plus EGFR-TKIs in advanced non-small cell lung cancer with gradual, oligo, or potential progression after EGFR-TKIs treatment (CTONG-1803/ALTER-L001) |
| title_full_unstemmed | A phase II trial of anlotinib plus EGFR-TKIs in advanced non-small cell lung cancer with gradual, oligo, or potential progression after EGFR-TKIs treatment (CTONG-1803/ALTER-L001) |
| title_short | A phase II trial of anlotinib plus EGFR-TKIs in advanced non-small cell lung cancer with gradual, oligo, or potential progression after EGFR-TKIs treatment (CTONG-1803/ALTER-L001) |
| title_sort | phase ii trial of anlotinib plus egfr tkis in advanced non small cell lung cancer with gradual oligo or potential progression after egfr tkis treatment ctong 1803 alter l001 |
| topic | EGFR mutation Anlotinib Gradual progression Oligo progression Non-small cell lung cancer |
| url | https://doi.org/10.1186/s13045-024-01656-0 |
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