Cited 3 times in
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
DC Field | Value | Language |
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dc.contributor.author | 김은영 | - |
dc.contributor.author | 이상훈 | - |
dc.date.accessioned | 2023-03-10T01:35:19Z | - |
dc.date.available | 2023-03-10T01:35:19Z | - |
dc.date.issued | 2022-08 | - |
dc.identifier.issn | 2218-6751 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/193248 | - |
dc.description.abstract | Background: 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.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Pioneer Bioscience Publishing Company | - |
dc.relation.isPartOf | TRANSLATIONAL LUNG CANCER RESEARCH | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Cheol-Kyu Park | - |
dc.contributor.googleauthor | Hyung-Joo Oh | - |
dc.contributor.googleauthor | Seung Soo Yoo | - |
dc.contributor.googleauthor | Shin Yup Lee | - |
dc.contributor.googleauthor | Sang Hoon Lee | - |
dc.contributor.googleauthor | Eun Young Kim | - |
dc.contributor.googleauthor | Sung Yong Lee | - |
dc.contributor.googleauthor | Juwhan Choi | - |
dc.contributor.googleauthor | Min Ki Lee | - |
dc.contributor.googleauthor | Mi-Hyun Kim | - |
dc.contributor.googleauthor | Tae Won Jang | - |
dc.contributor.googleauthor | Chaeuk Chung | - |
dc.contributor.googleauthor | In-Jae Oh | - |
dc.contributor.googleauthor | Young-Chul Kim | - |
dc.identifier.doi | 10.21037/tlcr-22-183 | - |
dc.contributor.localId | A00811 | - |
dc.contributor.localId | A02836 | - |
dc.relation.journalcode | J03382 | - |
dc.identifier.eissn | 2226-4477 | - |
dc.identifier.pmid | 36090637 | - |
dc.subject.keyword | Adjuvant chemotherapy | - |
dc.subject.keyword | cisplatin | - |
dc.subject.keyword | non-small-cell carcinoma | - |
dc.subject.keyword | pemetrexed | - |
dc.contributor.alternativeName | Kim, Eun Young | - |
dc.contributor.affiliatedAuthor | 김은영 | - |
dc.contributor.affiliatedAuthor | 이상훈 | - |
dc.citation.volume | 11 | - |
dc.citation.number | 8 | - |
dc.citation.startPage | 1606 | - |
dc.citation.endPage | 1618 | - |
dc.identifier.bibliographicCitation | TRANSLATIONAL LUNG CANCER RESEARCH, Vol.11(8) : 1606-1618, 2022-08 | - |
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