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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| Format: | Article |
| Language: | English English |
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Oxford University Press on behalf of the European Society for Medical Oncology
2015
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| Online Access: | 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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| 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 |
| building | IIUM Repository |
| collection | Online Access |
| 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). |
| first_indexed | 2025-11-14T16:07:35Z |
| format | Article |
| id | iium-44211 |
| institution | International Islamic University Malaysia |
| institution_category | Local University |
| language | English English |
| last_indexed | 2025-11-14T16:07:35Z |
| publishDate | 2015 |
| publisher | Oxford University Press on behalf of the European Society for Medical Oncology |
| recordtype | eprints |
| repository_type | Digital Repository |
| 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 |
| 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 |
| 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_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_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_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 |
| topic | RC Internal medicine |
| 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 |