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
Open accessAbstract
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/m(2) i.v. days 1 and 8 (3-weekly cycle); P 75 mg/m(2) 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).
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First-generation EGFR TKIs gefitinib and erlotinib have shown improved efficacy and tolerability compared with chemotherapy in phase III trials.
“have shown improved efficacy and tolerability compared with chemotherapy in numerous phase III trials”
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- Authors
- Wu, Y.-L., Zhou, C., Liam, C.-K., Wu, G., Liu, X., Zhong, Z., Lu, S., Cheng, Y., Han, B., Chen, L., Huang, C., Qin, S., Zhu, Y., Pan, H., Liang, H., Li, E., Jiang, G., How, S. H., Fernando, M. C. L., Zhang, Y., Xia, F., & Zuo, Y.
- Affiliations
- Guangdong General Hospital (CN)
- Tongji University (CN)
- University of Malaya (MY)
- Huazhong University of Science and Technology (CN)
- Academy of Military Medical Sciences (CN)
- Army Medical University (CN)
- Jilin Province Tumor Hospital (CN)
- Shanghai Chest Hospital (CN)
- Cancer Hospital of Shantou University Medical College (CN)
- Fujian Provincial Cancer Hospital (CN)
- 81th Hospital of PLA (CN)
- Beijing Chest Hospital (CN)
- Sir Run Run Shaw Hospital (CN)
- First Affiliated Hospital of Xi'an Jiaotong University (CN)
- Fudan University (CN)
- International Islamic University Malaysia (MY)
- Manila Doctors Hospital (PH)
- Roche (China) (CN)
- Corresponding author
- Wu, Y.-L.
- ORCID
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2015-09
- Volume
- 26
- Issue
- 9
- Pages
- 1883-1889
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2133149289
- Cited by
- 738
- References
- 4
- Citations by year
- 2026: 16 · 2025: 38 · 2024: 36 · 2023: 50 · 2022: 89 · 2021: 96 · 2020: 109 · 2019: 82 · 2018: 92 · 2017: 71 · 2016: 42 · 2015: 14 · 2014: 2
- FWCI
- 57.65
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- F. Hoffmann-La Roche
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Keywords
- erlotinib, gemcitabine plus cisplatin, EGFR-mutant non-small cell lung cancer, first-line therapy, progression-free survival, overall survival, objective response rate, rash, neutropenia, Asian patients, tyrosine kinase inhibitors, chemotherapy comparison, safety and tolerability, EGFR tyrosine kinase inhibitors, EGFR mutation
- MeSH terms
- Erlotinib Hydrochloride, Gemcitabine, Adult, Aged, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Deoxycytidine, Female, Humans, Lung Neoplasms, Male, Middle Aged, Survival Analysis, Carboplatin, Treatment Outcome, Disease-Free Survival, Asian People, Protein Kinase Inhibitors, Kaplan-Meier Estimate, ErbB Receptors
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