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

Wu, Y-L and Zhou, C.. and Liam, Chong-Kin and Wu, G. and Liu, X. and Zhong, Z. and Lu, S. and Cheng, Y. and How, Soon Hin and ., et al. (2015) First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Annals on Oncology Advanced, 19 (4). pp. 85-88. ISSN 0923-7534

	PDF - Published Version Restricted to Repository staff only Download (230kB) | Request a copy
	PDF (SCOPUS) - Published Version Restricted to Repository staff only Download (544kB) | Request a copy

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 (Journal)
Additional Information:	2987/44211
Uncontrolled Keywords:	: NSCLC, erlotinib, first-line, EGFR mutation-positive, Asian
Subjects:	R Medicine > RC Internal medicine
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button):	Kulliyyah of Medicine > Department of Internal Medicine
Depositing User:	Mrs Noor Azlin Asnam
Date Deposited:	13 Aug 2015 10:01
Last Modified:	24 Nov 2017 11:05
URI:	http://irep.iium.edu.my/id/eprint/44211

Actions (login required)

View Item