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A randomized Phase 2 study to compare erlotinib with or without bevacizumab in previously untreated patients with advanced non-small cell lung cancer with EGFR mutation
DC Field | Value | Language |
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dc.contributor.author | 김혜련 | - |
dc.contributor.author | 조병철 | - |
dc.contributor.author | 홍민희 | - |
dc.date.accessioned | 2023-07-12T02:24:53Z | - |
dc.date.available | 2023-07-12T02:24:53Z | - |
dc.date.issued | 2023-02 | - |
dc.identifier.issn | 0008-543X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/195298 | - |
dc.description.abstract | Background: This study evaluated whether an addition of bevacizumab to erlotinib improves clinical outcomes in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC). Methods: This is an open-label, multicenter, randomized Phase 2 study in South Korea. Chemonaive patients with Stage IIIB/IV NSCLC with EGFR 19 deletion or L858R mutation were eligible. Asymptomatic brain metastasis (BM) was enrolled without local treatment. Patients received either erlotinib plus bevacizumab or erlotinib. Results: Between December 2016 and March 2019, 127 patients were randomly assigned to receive erlotinib plus bevacizumab (n = 64) or erlotinib (n = 63). Fifty-nine (46.5%) patients had baseline BM. Fewer patients in the erlotinib plus bevacizumab arm received radiotherapy for BM than in the erlotinib arm (10.3% vs. 40.0%). A trend toward longer progression-free survival (PFS) was observed in the erlotinib plus bevacizumab arm compared with the erlotinib alone arm; however, it was not statistically significant (median PFS, 17.5 months vs. 12.4 months; hazard ratio [HR], 0.74; 95% CI, 0.51-1.08; p = .119). The unplanned subgroup analysis showed a longer PFS with erlotinib plus bevacizumab in patients with BM (median PFS, 18.6 months vs. 10.3 months; HR, 0.54; 95% CI, 0.31-0.95; p = .032). Grade 3 or worse adverse events occurred in 56.6% of the erlotinib plus bevacizumab arm and 20.6% of the erlotinib arm. Conclusions: Although it was not statistically significant, a trend to improvement in PFS was observed in patients with erlotinib plus bevacizumab compared to erlotinib alone. Plain Language Summary: A randomized Phase 2 study compared erlotinib with or without bevacizumab in previously untreated patients with advanced non-small cell lung cancer with EGFR mutation. The erlotinib plus bevacizumab failed to improve median progression-free survival compared with the erlotinib alone. However, the progression-free survival benefit from erlotinib plus bevacizumab was found in patients with brain metastasis with no severe hemorrhagic adverse effects. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Wiley | - |
dc.relation.isPartOf | CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / adverse effects | - |
dc.subject.MESH | Bevacizumab / adverse effects | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / drug therapy | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / genetics | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / pathology | - |
dc.subject.MESH | Disease-Free Survival | - |
dc.subject.MESH | ErbB Receptors / genetics | - |
dc.subject.MESH | Erlotinib Hydrochloride | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lung Neoplasms* / drug therapy | - |
dc.subject.MESH | Lung Neoplasms* / genetics | - |
dc.subject.MESH | Lung Neoplasms* / pathology | - |
dc.subject.MESH | Mutation | - |
dc.subject.MESH | Protein Kinase Inhibitors / adverse effects | - |
dc.title | A randomized Phase 2 study to compare erlotinib with or without bevacizumab in previously untreated patients with advanced non-small cell lung cancer with EGFR mutation | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Youngjoo Lee | - |
dc.contributor.googleauthor | Hye Ryun Kim | - |
dc.contributor.googleauthor | Min Hee Hong | - |
dc.contributor.googleauthor | Ki Hyeong Lee | - |
dc.contributor.googleauthor | Keon Uk Park | - |
dc.contributor.googleauthor | Geon Kook Lee | - |
dc.contributor.googleauthor | Hyae Young Kim | - |
dc.contributor.googleauthor | Soo-Hyun Lee | - |
dc.contributor.googleauthor | Kun Young Lim | - |
dc.contributor.googleauthor | Sung Jin Yoon | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Ji-Youn Han | - |
dc.identifier.doi | 10.1002/cncr.34553 | - |
dc.contributor.localId | A01166 | - |
dc.contributor.localId | A03822 | - |
dc.contributor.localId | A04393 | - |
dc.relation.journalcode | J00434 | - |
dc.identifier.eissn | 1097-0142 | - |
dc.identifier.pmid | 36451343 | - |
dc.subject.keyword | EGFR mutation | - |
dc.subject.keyword | anti-angiogenesis | - |
dc.subject.keyword | brain metastasis | - |
dc.subject.keyword | nonsmall cell lung cancer | - |
dc.subject.keyword | targeted therapy | - |
dc.contributor.alternativeName | Kim, Hye Ryun | - |
dc.contributor.affiliatedAuthor | 김혜련 | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.contributor.affiliatedAuthor | 홍민희 | - |
dc.citation.volume | 129 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 405 | - |
dc.citation.endPage | 414 | - |
dc.identifier.bibliographicCitation | CANCER, Vol.129(3) : 405-414, 2023-02 | - |
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