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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
Open accessAbstract
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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Citations
Cites
Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma
Mok, T. S., Wu, Y.-L., Thongprasert, S., Yang, C.-H., Chu, D.-T., Saijo, N., Sunpaweravong, P., Han, B., Margono, B., Ichinose, Y., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0810699 · Cited by 8,261
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Non‐small cell lung cancer in China
Chen, P., Liu, Y., Wen, Y., & Zhou, C. (2022) · Cancer Communications · doi:10.1002/cac2.12359 · Cited by 656
Self-citationRyad, N., Elmaaty, A. A., Selim, S., Almuhayawi, M. S., Al Jaouni, S. K., Abdel-Aziz, M. S., Alqahtani, A. S., Zaki, I., & Abdel Ghany, L. M. A. (2024) · RSC Advances · doi:10.1039/d4ra06712f · Cited by 13
Metadata
- Authors
- Zhong, W.-Z., Wang, Q., Mao, W.-M., Xu, S.-T., Wu, L., Wei, Y.-C., Liu, Y.-Y., Chen, C., Cheng, Y., Yin, R., Yang, F., Ren, S.-X., Li, X.-F., Li, J., Huang, C., Liu, Z.-D., Xu, S., Chen, K.-N., Xu, S.-D., Liu, L.-X., Yu, P., Wang, B.-H., Ma, H.-T., Yang, J.-J., Yan, H.-H., Yang, X.-N., Liu, S.-Y., Zhou, Q., & Wu, Y.-L.
- Venue
- Journal of Clinical Oncology
- Published
- 2021-03-01
- Volume
- 39
- Issue
- 7
- Pages
- 713-722
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W3111438285
- Cited by
- 273
- References
- 1
- FWCI
- 21.30
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- The paper
- Zhong, W.-Z., Wang, Q., Mao, W.-M., Xu, S.-T., Wu, L., Wei, Y.-C., Liu, Y.-Y., Chen, C., Cheng, Y., Yin, R., Yang, F., Ren, S.-X., Li, X.-F., Li, J., Huang, C., Liu, Z.-D., Xu, S., Chen, K.-N., Xu, S.-D., . . . Wu, Y.-L. (2021). 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. Journal of Clinical Oncology. https://doi.org/10.1200/jco.20.01820
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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