CTONG1103: Final overall survival analysis of the randomized phase 2 trial of erlotinib versus gemcitabine plus cisplatin as neoadjuvant treatment of stage IIIA-N2 EGFR-mutant non–small cell lung cancer.

Authors

Yi-Long Wu

Yi-Long Wu

Guangdong Lung Cancer Institute, Guangdong Provincial Peoples Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China

Yi-Long Wu , Wenzhao Zhong , Ke-Neng Chen , Chun Chen , Fan Yang , Xue-Ning Yang , Chundong Gu , Weimin Mao , Qun Wang , Gui-Bin Qiao , Ying Cheng , Lin Xu , Changli Wang , Mingwei Chen , Hong-Hong Yan , Ri-qiang Liao , Xuchao Zhang , Jinji Yang , Si-yang Liu , Qing Zhou

Organizations

Guangdong Lung Cancer Institute, Guangdong Provincial Peoples Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, Guangzhou, China, Peking University Cancer Hospital and Institute, Beijing, China, Fujian Uion Hospital, Fuzhou, China, Peking University People's Hospital, Beijing, China, Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China, The First Affiliated Hospital of Dalian Medical University, Dalian, China, Zhejiang Cancer Hospital, Hangzhou, China, Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China, Jilin Cancer Hospital, Changchun, China, Cancer Institute of Jiangsu Province, Nanjing, China, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China, First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi’an, China, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China, Guangdong Provincial People's Hospital, Guangzhou, China, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China, Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China

Research Funding

Other
Chinese Thoracic Oncology Group (CTONG)

Background: Median Overall survival (mOS) of stage IIIA resected NSCLC was 59.4 months (m) in CTONG 1104 adj gefitinib and 26.2m in SAKK neoadjuvant chemo trial. EMERGING-CTONG1103 showed neo-adjuvant/adjuvant erlotinib treatment significantly improved progression-free survival (PFS) vs standard doublet chemotherapy in patients (pts) with epidermal growth factor receptor (EGFR) mutation-positive resectable stage IIIA (N2) non-small-cell lung cancer (NSCLC). Here, we present the final overall survival (OS) results from the study. Methods: This was a multicenter (17 centers in China) phase II randomized controlled trial of erlotinib(E)versus gemcitabine plus cisplatin (GC) as neoadjuvant/adjuvant therapy in pts with stage IIIA-N2 NSCLC with EGFR mutations in exon 19 or 21. From Dec 2011 to Dec. 2017, 386 pts sites were screened and 72 pts were randomly assigned to neoadjuvant/adjuvant E arm (N = 37) or GC arm(N = 35). Patients received erlotinib 150 mg/d (neoadjuvant therapy, 42 days; adjuvant therapy, up to 12 months) or gemcitabine 1,250 mg/m2 plus cisplatin 75 mg/m2 (neoadjuvant therapy, two cycles; adjuvant therapy, up to two cycles). Assessments were performed at 6 weeks and every 3 months postoperative. The primary end point was objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; secondary end points were pathologic complete response, downstaging rates of pathological lymph nodes, PFS, OS, safety, and tolerability. Data cut-off date was January, 29 2021. Results: With a median follow-up of 62.5 months, the median OS was 42.2months based on 47 (65.3%) events in ITT whole population. The mOS was 42.2m in E and 36.9m in GC (HR 0.83, 95%CI 0.47-1.47, p = 0.513). The 3-,5-year OS rate were 58.6%, 40.8% in E and 55.9%, 27.6% in GC respectively (p3-y = 0.819, p5-y = 0.252). All predefined subgroups including age, gender, EGFR mutation type had no significant difference in statistics between two arms. Subsequent treatments (ST) especially targeted therapy contributed most to OS (HR = 0.35,95% CI 0.18- 0.70). Median OS of pts receiving ST was 45.8m (n = 38), 34.6m in other treatment (n = 12), 24.6m in without ST (n = 15). For E mOS were 46.4 (n = 15; target therapy), 42.2m (n = 8; other) and 24.6m (n = 9; without, p = 0.021), for GC 42.6 (n = 23; target therapy), 30.1m (n = 4;other) and 24.6m(n = 6; without, p = 0.130). The RR was 53.3%, DCR 93.3%, mPFS 10.9m and mPPS 21.9m for patients with rechallenged EGFR TKI in E arm (n = 15). No novel unexpected SAE was observed during follow up. Conclusion: Erlotinib as neoadjuvant/adjuvant therapy for resected N2 NSCLC was feasibility and had a promising OS. The PFS survival advantage of E did not translate to OS difference in EMERGING trial (NCT01407822). Clinical trial information: NCT01407822

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Oral Abstract Session

Session Title

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Track

Lung Cancer

Sub Track

Adjuvant Therapy

Clinical Trial Registration Number

NCT01407822

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 8502)

DOI

10.1200/JCO.2021.39.15_suppl.8502

Abstract #

8502

Abstract Disclosures