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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
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 st...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
AME Publishing Company
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9459613/ https://www.ncbi.nlm.nih.gov/pubmed/36090637 http://dx.doi.org/10.21037/tlcr-22-183 |
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author | Park, Cheol-Kyu Oh, Hyung-Joo Yoo, Seung Soo Lee, Shin Yup Lee, Sang Hoon Kim, Eun Young Lee, Sung Yong Choi, Juwhan Lee, Min Ki Kim, Mi-Hyun Jang, Tae Won Chung, Chaeuk Oh, In-Jae Kim, Young-Chul |
author_facet | Park, Cheol-Kyu Oh, Hyung-Joo Yoo, Seung Soo Lee, Shin Yup Lee, Sang Hoon Kim, Eun Young Lee, Sung Yong Choi, Juwhan Lee, Min Ki Kim, Mi-Hyun Jang, Tae Won Chung, Chaeuk Oh, In-Jae Kim, Young-Chul |
author_sort | Park, Cheol-Kyu |
collection | PubMed |
description | 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/m(2)) plus cisplatin (75 mg/m(2)). 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). |
format | Online Article Text |
id | pubmed-9459613 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | AME Publishing Company |
record_format | MEDLINE/PubMed |
spelling | pubmed-94596132022-09-10 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 Park, Cheol-Kyu Oh, Hyung-Joo Yoo, Seung Soo Lee, Shin Yup Lee, Sang Hoon Kim, Eun Young Lee, Sung Yong Choi, Juwhan Lee, Min Ki Kim, Mi-Hyun Jang, Tae Won Chung, Chaeuk Oh, In-Jae Kim, Young-Chul Transl Lung Cancer Res Original Article 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/m(2)) plus cisplatin (75 mg/m(2)). 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). AME Publishing Company 2022-08 /pmc/articles/PMC9459613/ /pubmed/36090637 http://dx.doi.org/10.21037/tlcr-22-183 Text en 2022 Translational Lung Cancer Research. All rights reserved. https://creativecommons.org/licenses/by-nc-nd/4.0/Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/) . |
spellingShingle | Original Article Park, Cheol-Kyu Oh, Hyung-Joo Yoo, Seung Soo Lee, Shin Yup Lee, Sang Hoon Kim, Eun Young Lee, Sung Yong Choi, Juwhan Lee, Min Ki Kim, Mi-Hyun Jang, Tae Won Chung, Chaeuk Oh, In-Jae Kim, Young-Chul 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9459613/ https://www.ncbi.nlm.nih.gov/pubmed/36090637 http://dx.doi.org/10.21037/tlcr-22-183 |
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