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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

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dc.contributor.author김혜련-
dc.contributor.author조병철-
dc.contributor.author홍민희-
dc.date.accessioned2023-07-12T02:24:53Z-
dc.date.available2023-07-12T02:24:53Z-
dc.date.issued2023-02-
dc.identifier.issn0008-543X-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/195298-
dc.description.abstractBackground: 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.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherWiley-
dc.relation.isPartOfCANCER-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols / adverse effects-
dc.subject.MESHBevacizumab / adverse effects-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung* / drug therapy-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung* / genetics-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung* / pathology-
dc.subject.MESHDisease-Free Survival-
dc.subject.MESHErbB Receptors / genetics-
dc.subject.MESHErlotinib Hydrochloride-
dc.subject.MESHHumans-
dc.subject.MESHLung Neoplasms* / drug therapy-
dc.subject.MESHLung Neoplasms* / genetics-
dc.subject.MESHLung Neoplasms* / pathology-
dc.subject.MESHMutation-
dc.subject.MESHProtein Kinase Inhibitors / adverse effects-
dc.titleA 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.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorYoungjoo Lee-
dc.contributor.googleauthorHye Ryun Kim-
dc.contributor.googleauthorMin Hee Hong-
dc.contributor.googleauthorKi Hyeong Lee-
dc.contributor.googleauthorKeon Uk Park-
dc.contributor.googleauthorGeon Kook Lee-
dc.contributor.googleauthorHyae Young Kim-
dc.contributor.googleauthorSoo-Hyun Lee-
dc.contributor.googleauthorKun Young Lim-
dc.contributor.googleauthorSung Jin Yoon-
dc.contributor.googleauthorByoung Chul Cho-
dc.contributor.googleauthorJi-Youn Han-
dc.identifier.doi10.1002/cncr.34553-
dc.contributor.localIdA01166-
dc.contributor.localIdA03822-
dc.contributor.localIdA04393-
dc.relation.journalcodeJ00434-
dc.identifier.eissn1097-0142-
dc.identifier.pmid36451343-
dc.subject.keywordEGFR mutation-
dc.subject.keywordanti-angiogenesis-
dc.subject.keywordbrain metastasis-
dc.subject.keywordnonsmall cell lung cancer-
dc.subject.keywordtargeted therapy-
dc.contributor.alternativeNameKim, Hye Ryun-
dc.contributor.affiliatedAuthor김혜련-
dc.contributor.affiliatedAuthor조병철-
dc.contributor.affiliatedAuthor홍민희-
dc.citation.volume129-
dc.citation.number3-
dc.citation.startPage405-
dc.citation.endPage414-
dc.identifier.bibliographicCitationCANCER, Vol.129(3) : 405-414, 2023-02-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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