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Open-label, multi-center, phase II study of adjuvant pemetrexed plus cisplatin for completely resected stage IB to IIIA adenocarcinoma of the lung: APICAL trial

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dc.contributor.author김은영-
dc.contributor.author이상훈-
dc.date.accessioned2023-03-10T01:35:19Z-
dc.date.available2023-03-10T01:35:19Z-
dc.date.issued2022-08-
dc.identifier.issn2218-6751-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/193248-
dc.description.abstractBackground: We aimed to evaluate the efficacy of postoperative adjuvant pemetrexed plus cisplatin (Pem-Cis) in pathologic stage IB-IIIA lung adenocarcinoma (LUAD) patients. Methods: A prospective, phase II study was performed in seven institutions in South Korea. Patients with completely resected stage IB-IIIA LUAD received pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2). Adjuvant treatments were administered every 3 weeks for 4 cycles. The primary endpoint was to prove the Pem-Cis's superiority in terms of 2-year disease-free survival rate (DFSR) compared with historical control without adjuvant chemotherapy (50%). Results: Between August 2015 and February 2018, 105 patients were enrolled in this study. Approximately 31.4% (n=33), 43.8% (n=46), and 24.8% (n=26) of patients had pathologic stage IB, II, and IIIA, respectively. Most of the patients underwent lobectomy (n=98, 93.3%). Moreover, 41.1% and 12.1% of the patients had epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase rearrangement. Four cycles of Pem-Cis were administered in 99 patients (94.3%). At a median follow-up of 57.7 months, the 2-year DFSR was 78.1%. Multivariable analysis showed that pathologic stage IIIA and EGFR mutation were significant risk factors for DFS. Grade 3 adverse events occurred in 10 patients (9.5%), and leukopenia (n=3, 2.9%) was the most common adverse event. Conclusions: Adjuvant Pem-Cis is superior to historical control without adjuvant treatment in terms of 2-year DFSR; the proportion of patients with stage IB and driver mutations were higher than that of patients in previous trials. Pem-Cis showed favorable tolerability as adjuvant chemotherapy (clinicaltrial.gov; Identifier: NCT02498860).-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherPioneer Bioscience Publishing Company-
dc.relation.isPartOfTRANSLATIONAL LUNG CANCER RESEARCH-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleOpen-label, multi-center, phase II study of adjuvant pemetrexed plus cisplatin for completely resected stage IB to IIIA adenocarcinoma of the lung: APICAL trial-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorCheol-Kyu Park-
dc.contributor.googleauthorHyung-Joo Oh-
dc.contributor.googleauthorSeung Soo Yoo-
dc.contributor.googleauthorShin Yup Lee-
dc.contributor.googleauthorSang Hoon Lee-
dc.contributor.googleauthorEun Young Kim-
dc.contributor.googleauthorSung Yong Lee-
dc.contributor.googleauthorJuwhan Choi-
dc.contributor.googleauthorMin Ki Lee-
dc.contributor.googleauthorMi-Hyun Kim-
dc.contributor.googleauthorTae Won Jang-
dc.contributor.googleauthorChaeuk Chung-
dc.contributor.googleauthorIn-Jae Oh-
dc.contributor.googleauthorYoung-Chul Kim-
dc.identifier.doi10.21037/tlcr-22-183-
dc.contributor.localIdA00811-
dc.contributor.localIdA02836-
dc.relation.journalcodeJ03382-
dc.identifier.eissn2226-4477-
dc.identifier.pmid36090637-
dc.subject.keywordAdjuvant chemotherapy-
dc.subject.keywordcisplatin-
dc.subject.keywordnon-small-cell carcinoma-
dc.subject.keywordpemetrexed-
dc.contributor.alternativeNameKim, Eun Young-
dc.contributor.affiliatedAuthor김은영-
dc.contributor.affiliatedAuthor이상훈-
dc.citation.volume11-
dc.citation.number8-
dc.citation.startPage1606-
dc.citation.endPage1618-
dc.identifier.bibliographicCitationTRANSLATIONAL LUNG CANCER RESEARCH, Vol.11(8) : 1606-1618, 2022-08-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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