First-line erlotinib versus gemcitabine/cisplatin in patients with advancedEGFRmutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study

Wu, Y.L. and Zhou, C. and Liam, C.K. and Wu, G. and Liu, X. and Zhong, Z. and Lu, S. and Cheng, Y. and Han, B. and Chen, L. and Huang, C. and Qin, S. and Zhu, Y. and Pan, H. and Liang, H. and Li, E. and Jiang, G. and How, S.H. and Fernando, M.C.L. and Zhang, Y. and Xia, F. and Zuo, Y. (2015) First-line erlotinib versus gemcitabine/cisplatin in patients with advancedEGFRmutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Annals of Oncology, 26 (9). pp. 1883-1889. ISSN 0923-7534

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Official URL: http://dx.doi.org/10.1093/annonc/mdv270

Abstract

Background: The phase III, randomized, open-label ENSURE study (NCT01342965) evaluated first-line erlotinib versus gemcitabine/cisplatin (GP) in patients from China, Malaysia and the Philippines with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). Patients and methods: Patients ≥18 years old with histologically/cytologically confirmed stage IIIB/IV EGFR mutation-positive NSCLC and Eastern Cooperative Oncology Group performance status 0-2 were randomized 1:1 to receive erlotinib (oral; 150 mg once daily until progression/unacceptable toxicity) or GP [G 1250 mg/m2 i.v. days 1 and 8 (3-weekly cycle); P 75 mg/m2 i.v. day 1, (3-weekly cycle) for up to four cycles]. Primary end point: investigator-assessed progression-free survival (PFS). Other end points include objective response rate (ORR), overall survival (OS), and safety. Results: A total of 217 patients were randomized: 110 to erlotinib and 107 to GP. Investigator-assessed median PFS was 11.0 months versus 5.5 months, erlotinib versus GP, respectively [hazard ratio (HR), 0.34, 95% confidence interval (CI) 0.22-0.51; log-rank P < 0.0001]. Independent Review Committee-assessed median PFS was consistent (HR, 0.42). Median OS was 26.3 versus 25.5 months, erlotinib versus GP, respectively (HR, 0.91, 95% CI 0.63-1.31; log-rank P = .607). ORR was 62.7% for erlotinib and 33.6% for GP. Treatment-related serious adverse events (AEs) occurred in 2.7% versus 10.6% of erlotinib and GP patients, respectively. The most common grade ≥3 AEs were rash (6.4%) with erlotinib, and neutropenia (25.0%), leukopenia (14.4%), and anemia (12.5%) with GP. Conclusion: These analyses demonstrate that first-line erlotinib provides a statistically significant improvement in PFS versus GP in Asian patients with EGFR mutation-positive NSCLC (NCT01342965).

Item Type: Article
Uncontrolled Keywords: NSCLC; Erlotinib; First-line; EGFR mutation-positive; Asian
Subjects: R Medicine
Divisions: Faculty of Medicine
Depositing User: Ms. Juhaida Abd Rahim
Date Deposited: 26 Sep 2018 04:38
Last Modified: 26 Sep 2018 04:38
URI: http://eprints.um.edu.my/id/eprint/19426

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