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
- Authors
- 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
- Issue Date
- Aug-2022
- Publisher
- Society for Translational Medicine (STM)
- Keywords
- Adjuvant chemotherapy; pemetrexed; cisplatin; non-small-cell carcinoma
- Citation
- Translational Lung Cancer Research, v.11, no.8, pp 1606 - 1618
- Pages
- 13
- Indexed
- SCIE
SCOPUS
- Journal Title
- Translational Lung Cancer Research
- Volume
- 11
- Number
- 8
- Start Page
- 1606
- End Page
- 1618
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/61338
- DOI
- 10.21037/tlcr-22-183
- ISSN
- 2218-6751
2226-4477
- 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/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.
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Collections - 2. Clinical Science > Department of Pulmonary, Allergy, and Critical Care Medicine > 1. Journal Articles
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