Gefitinib Versus Vinorelbine Plus Cisplatin as Adjuvant Treatment for Stage II-IIIA (N1-N2) EGFR-Mutant NSCLC: Final Overall Survival Analysis of CTONG1104 Phase III Trial

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PURPOSE

ADJUVANT-CTONG1104 (ClinicalTrials.gov identifier: NCT01405079), a randomized phase III trial, showed that adjuvant gefitinib treatment significantly improved disease-free survival (DFS) versus vinorelbine plus cisplatin (VP) in patients with epidermal growth factor receptor ( EGFR) mutation-positive resected stage II-IIIA (N1-N2) non–small-cell lung cancer (NSCLC). Here, we report the final overall survival (OS) results.

METHODS

From September 2011 to April 2014, 222 patients from 27 sites were randomly assigned 1:1 to adjuvant gefitinib (n = 111) or VP (n = 111). Patients with resected stage II-IIIA (N1-N2) NSCLC and EGFR-activating mutation were enrolled, receiving gefitinib for 24 months or VP every 3 weeks for four cycles. The primary end point was DFS (intention-to-treat [ITT] population). Secondary end points included OS, 3-, 5-year (y) DFS rates, and 5-year OS rate. Post hoc analysis was conducted for subsequent therapy data.

RESULTS

Median follow-up was 80.0 months. Median OS (ITT) was 75.5 and 62.8 months with gefitinib and VP, respectively (hazard ratio [HR], 0.92; 95% CI, 0.62 to 1.36; P = .674); respective 5-year OS rates were 53.2% and 51.2% ( P = .784). Subsequent therapy was administered upon progression in 68.4% and 73.6% of patients receiving gefitinib and VP, respectively. Subsequent targeted therapy contributed most to OS (HR, 0.23; 95% CI, 0.14 to 0.38) compared with no subsequent therapy. Updated 3y DFS rates were 39.6% and 32. 5% with gefitinib and VP ( P = .316) and 5y DFS rates were 22. 6% and 23.2% ( P = .928), respectively.

CONCLUSION

Adjuvant therapy with gefitinib in patients with early-stage NSCLC and EGFR mutation demonstrated improved DFS over standard of care chemotherapy. Although this DFS advantage did not translate to a significant OS difference, OS with adjuvant gefitinib was one of the longest observed in this patient group compared with historic data.

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Most cited references 27

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The IASLC Lung Cancer Staging Project: Proposals for Revision of the TNM Stage Groupings in the Forthcoming (Eighth) Edition of the TNM Classification for Lung Cancer.

Peter Goldstraw, Kari Chansky, John Crowley … (2016)

The IASLC Staging and Prognostic Factors Committee has collected a new database of 94,708 cases donated from 35 sources in 16 countries around the globe. This has now been analysed by our statistical partners at Cancer Research And Biostatistics and, in close collaboration with the members of the committee proposals have been developed for the T, N, and M categories of the 8th edition of the TNM Classification for lung cancer due to be published late 2016. In this publication we describe the methods used to evaluate the resultant Stage groupings and the proposals put forward for the 8th edition.

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Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma.

Tony Mok, Yi-Long Wu, Sumitra Thongprasert … (2009)

Previous, uncontrolled studies have suggested that first-line treatment with gefitinib would be efficacious in selected patients with non-small-cell lung cancer. In this phase 3, open-label study, we randomly assigned previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers to receive gefitinib (250 mg per day) (609 patients) or carboplatin (at a dose calculated to produce an area under the curve of 5 or 6 mg per milliliter per minute) plus paclitaxel (200 mg per square meter of body-surface area) (608 patients). The primary end point was progression-free survival. The 12-month rates of progression-free survival were 24.9% with gefitinib and 6.7% with carboplatin-paclitaxel. The study met its primary objective of showing the noninferiority of gefitinib and also showed its superiority, as compared with carboplatin-paclitaxel, with respect to progression-free survival in the intention-to-treat population (hazard ratio for progression or death, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001). In the subgroup of 261 patients who were positive for the epidermal growth factor receptor gene (EGFR) mutation, progression-free survival was significantly longer among those who received gefitinib than among those who received carboplatin-paclitaxel (hazard ratio for progression or death, 0.48; 95% CI, 0.36 to 0.64; P<0.001), whereas in the subgroup of 176 patients who were negative for the mutation, progression-free survival was significantly longer among those who received carboplatin-paclitaxel (hazard ratio for progression or death with gefitinib, 2.85; 95% CI, 2.05 to 3.98; P<0.001). The most common adverse events were rash or acne (in 66.2% of patients) and diarrhea (46.6%) in the gefitinib group and neurotoxic effects (69.9%), neutropenia (67.1%), and alopecia (58.4%) in the carboplatin-paclitaxel group. Gefitinib is superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia. The presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib. (ClinicalTrials.gov number, NCT00322452.) 2009 Massachusetts Medical Society

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Osimertinib in Resected EGFR-Mutated Non–Small-Cell Lung Cancer

Yi-Long Wu, Masahiro Tsuboi, Jie He … (2020)

Osimertinib is standard-of-care therapy for previously untreated epidermal growth factor receptor (EGFR) mutation-positive advanced non-small-cell lung cancer (NSCLC). The efficacy and safety of osimertinib as adjuvant therapy are unknown.

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Author and article information

Journal

Journal ID (nlm-ta): J Clin Oncol

Journal ID (iso-abbrev): J Clin Oncol

Journal ID (hwp): jco

Journal ID (pmc): jco

Journal ID (publisher-id): JCO

Title: Journal of Clinical Oncology

Publisher: American Society of Clinical Oncology

ISSN (Print): 0732-183X

ISSN (Electronic): 1527-7755

Publication date (Print): 1 March 2021

Publication date (Electronic): 17 December 2020

Volume: 39

Issue: 7

Pages: 713-722

Affiliations

[ ¹ ]Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, China

[ ² ]Fudan University Affiliated Zhongshan Hospital, Shanghai, China

[ ³ ]Zhejiang Cancer Hospital, Hangzhou, China

[ ⁴ ]Hunan Cancer Hospital, Changsha, China

[ ⁵ ]The Affiliated Hospital of Medical College Qingdao University, Qingdao, China

[ ⁶ ]Shenyang Chest Hospital, Shenyang, China

[ ⁷ ]Fujian Medical University Union Hospital, Fuzhou, China

[ ⁸ ]Jilin Provincial Tumor Hospital, Changchun, China

[ ⁹ ]Jiangsu Cancer Hospital, Nanjing, China

[ ¹⁰ ]The People's Hospital of Peking University, Beijing, China

[ ¹¹ ]Shanghai Pulmonary Hospital, Shanghai, China

[ ¹² ]Tangdu Hospital, Xi'an, China

[ ¹³ ]Peking University First Hospital, Beijing, China

[ ¹⁴ ]Fujian Cancer Hospital, Fuzhou, China

[ ¹⁵ ]Beijing Chest Hospital, Beijing, China

[ ¹⁶ ]The First Hospital of China Medical University, Shenyang, China

[ ¹⁷ ]Beijing Cancer Hospital, Beijing, China

[ ¹⁸ ]Harbin Medical University Cancer Hospital, Harbin, China

[ ¹⁹ ]West China Hospital of Sichuan University, Chengdu, China

[ ²⁰ ]Sichuan Cancer Hospital, Chengdu, China

[ ²¹ ]The Northern Jiangsu People's Hospital, Yangzhou, China

[ ²² ]The First Affiliated Hospital of Suzhou University, Suzhou, China

Author notes

Yi-Long Wu, MD, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Yuexiu Qu, Guangzhou 510080, China; e-mail: syylwu@ 123456live.cn .