PMID- 32340810 OWN - NLM STAT- MEDLINE DCOM- 20210217 LR - 20210217 IS - 1097-685X (Electronic) IS - 0022-5223 (Linking) VI - 161 IP - 2 DP - 2021 Feb TI - Gefitinib as neoadjuvant therapy for resectable stage II-IIIA non-small cell lung cancer: A phase II study. PG - 434-442.e2 LID - S0022-5223(20)30625-5 [pii] LID - 10.1016/j.jtcvs.2020.02.131 [doi] AB - INTRODUCTION: Currently, limited data on tyrosine kinase inhibitors as neoadjuvant therapy exist. This prospective study aimed to investigate the efficacy and safety of preoperative gefitinib in patients with stage II-IIIA operable non-small cell lung cancer (NSCLC). METHODS: This was a single-arm, phase II trial performed in the Shanghai Cancer Center. Between August 2013 and October 2015, patients with operable stage II-IIIA NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R mutation were enrolled. Patients were treated with preoperative gefitinib (250 mg once daily for 42 days), followed by surgical resection. The primary endpoint was objective response rate (ORR); secondary endpoints were the rate of major pathologic response (MPR), disease-free survival (DFS), overall survival, and adverse events (AEs). ORR was defined as the proportion of patients achieving complete response or partial response radiologically. MPR was defined as no more than 10% viable tumor. RESULTS: Of the 35 eligible patients, 33 were considered as intention-to-treat population. ORR, the primary endpoint, was 54.5% (95% confidence interval [CI], 37.7-70.7), and the rate of MPR was 24.2% (95% CI, 11.9-40.4). Median DFS was 33.5 months (95% CI, 19.7-47.3); median overall survival was not reached. Skin toxicity (24/35,68.6%) and gastrointestinal symptoms (17/35,48.6%) were the most common AEs; no patients reported grade 3 or 4 AEs. After surgery, 4 patients experienced chylothorax (4/33,12.1%). Patients with MPR had a prolonged survival compared with those without (DFS, P = .019). CONCLUSIONS: Neoadjuvant therapy with gefitinib in patients with stage II-IIIA NSCLC is safe and may be a viable treatment for patients whose tumors have EGFR mutations. Patients with MPR were associated with improved survival. CI - Copyright (c) 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved. FAU - Zhang, Yang AU - Zhang Y AD - Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Institute of Thoracic Oncology, Fudan University, Shanghai, China; State Key Laboratory of Genetic Engineering, School of Life Sciences, Fudan University, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Fu, Fangqiu AU - Fu F AD - Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Institute of Thoracic Oncology, Fudan University, Shanghai, China; State Key Laboratory of Genetic Engineering, School of Life Sciences, Fudan University, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Hu, Haichuan AU - Hu H AD - Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Institute of Thoracic Oncology, Fudan University, Shanghai, China; State Key Laboratory of Genetic Engineering, School of Life Sciences, Fudan University, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Wang, Shengping AU - Wang S AD - Institute of Thoracic Oncology, Fudan University, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Department of Radiology, Fudan University Shanghai Cancer Center, Shanghai, China. FAU - Li, Yuan AU - Li Y AD - Institute of Thoracic Oncology, Fudan University, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Department of Pathology, Fudan University Shanghai Cancer Center, Shanghai, China. FAU - Hu, Hong AU - Hu H AD - Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Institute of Thoracic Oncology, Fudan University, Shanghai, China; State Key Laboratory of Genetic Engineering, School of Life Sciences, Fudan University, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Chen, Haiquan AU - Chen H AD - Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Institute of Thoracic Oncology, Fudan University, Shanghai, China; State Key Laboratory of Genetic Engineering, School of Life Sciences, Fudan University, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. Electronic address: hqchen1@yahoo.com. LA - eng PT - Clinical Trial, Phase II PT - Journal Article DEP - 20200319 PL - United States TA - J Thorac Cardiovasc Surg JT - The Journal of thoracic and cardiovascular surgery JID - 0376343 RN - 0 (Antineoplastic Agents) RN - S65743JHBS (Gefitinib) SB - IM CIN - J Thorac Cardiovasc Surg. 2021 Feb;161(2):443-444. PMID: 32359791 CIN - J Thorac Cardiovasc Surg. 2021 Feb;161(2):444-446. PMID: 32444180 CIN - J Thorac Cardiovasc Surg. 2021 Feb;161(2):446-447. PMID: 32505452 MH - Adult MH - Aged MH - Antineoplastic Agents/*therapeutic use MH - Carcinoma, Non-Small-Cell Lung/mortality/pathology/*therapy MH - Combined Modality Therapy MH - Disease-Free Survival MH - Female MH - Gefitinib/*therapeutic use MH - Humans MH - Kaplan-Meier Estimate MH - Lung Neoplasms/mortality/pathology/*therapy MH - Male MH - Middle Aged MH - *Neoadjuvant Therapy/methods MH - Pneumonectomy MH - Survival Analysis OTO - NOTNLM OT - epidermal growth factor receptor OT - gefitinib OT - neoadjuvant therapy OT - non-small cell lung carcinoma EDAT- 2020/04/29 06:00 MHDA- 2021/02/18 06:00 CRDT- 2020/04/29 06:00 PHST- 2019/10/21 00:00 [received] PHST- 2020/02/23 00:00 [revised] PHST- 2020/02/26 00:00 [accepted] PHST- 2020/04/29 06:00 [pubmed] PHST- 2021/02/18 06:00 [medline] PHST- 2020/04/29 06:00 [entrez] AID - S0022-5223(20)30625-5 [pii] AID - 10.1016/j.jtcvs.2020.02.131 [doi] PST - ppublish SO - J Thorac Cardiovasc Surg. 2021 Feb;161(2):434-442.e2. doi: 10.1016/j.jtcvs.2020.02.131. Epub 2020 Mar 19.