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

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

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). Pati...

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Main Authors: Wu, Y-L, Zhou, C.., Liam, Chong-Kin, Wu, G., Liu, X., Zhong, Z., Lu, S., Cheng, Y., How, Soon Hin, ., et al.
Format: Article
Language:English
English
Published: Oxford University Press on behalf of the European Society for Medical Oncology 2015
Subjects:
RC Internal medicine
Online Access:http://irep.iium.edu.my/44211/
http://irep.iium.edu.my/44211/
http://irep.iium.edu.my/44211/
http://irep.iium.edu.my/44211/2/firstline_erlotinib.pdf
http://irep.iium.edu.my/44211/6/44211_First-line%20erlotinib%20versus%20gemcitabine_SCOPUS.pdf
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spelling iium-442112017-11-24T03:05:26Z http://irep.iium.edu.my/44211/ 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 Zhou, C.. Liam, Chong-Kin Wu, G. Liu, X. Zhong, Z. Lu, S. Cheng, Y. How, Soon Hin ., et al. RC Internal medicine 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). Oxford University Press on behalf of the European Society for Medical Oncology 2015-06-23 Article PeerReviewed application/pdf en http://irep.iium.edu.my/44211/2/firstline_erlotinib.pdf application/pdf en http://irep.iium.edu.my/44211/6/44211_First-line%20erlotinib%20versus%20gemcitabine_SCOPUS.pdf 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 http://annonc.oxfordjournals.org/content/early/2015/06/22/annonc.mdv270.abstract 10.1093/annonc/mdv270
repository_type Digital Repository
institution_category Local University
institution International Islamic University Malaysia
building IIUM Repository
collection Online Access
language English
English
topic RC Internal medicine
spellingShingle RC Internal medicine
Wu, Y-L
Zhou, C..
Liam, Chong-Kin
Wu, G.
Liu, X.
Zhong, Z.
Lu, S.
Cheng, Y.
How, Soon Hin
., et al.
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
description 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).
format Article
author Wu, Y-L
Zhou, C..
Liam, Chong-Kin
Wu, G.
Liu, X.
Zhong, Z.
Lu, S.
Cheng, Y.
How, Soon Hin
., et al.
author_facet Wu, Y-L
Zhou, C..
Liam, Chong-Kin
Wu, G.
Liu, X.
Zhong, Z.
Lu, S.
Cheng, Y.
How, Soon Hin
., et al.
author_sort Wu, Y-L
title 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
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
publisher Oxford University Press on behalf of the European Society for Medical Oncology
publishDate 2015
url http://irep.iium.edu.my/44211/
http://irep.iium.edu.my/44211/
http://irep.iium.edu.my/44211/
http://irep.iium.edu.my/44211/2/firstline_erlotinib.pdf
http://irep.iium.edu.my/44211/6/44211_First-line%20erlotinib%20versus%20gemcitabine_SCOPUS.pdf
first_indexed 2023-09-18T21:02:52Z
last_indexed 2023-09-18T21:02:52Z
_version_ 1777410740571865088

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