• 1 Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou. Electronic address:
  • 2 Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China
  • 3 Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
  • 4 Cancer Center of Union Hospital, Tongji Medical College, Huzhong University of Science and Technology, Wuhan
  • 5 Department of Internal Medicine Tumor, Academy of Military Medical Sciences Affiliated Hospital (307 Hospital of PLA), Beijing
  • 6 Cancer Centre, Research Institute of Surgery, Daping Hospital, Third Military Medical University, Chongqing
  • 7 Department of Lung Cancer, Shanghai Chest Hospital, Shanghai
  • 8 Jilin Cancer Hospital, Changchun
  • 9 Department of Medical Oncology, Cancer Hospital of Shantou University Medical College, Shantou
  • 10 Fujian Provincial Tumor Hospital, Fujian
  • 11 Nanjing Bayi Hospital, Nanjing
  • 12 Department of Lung Cancer, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing
  • 13 Department of Oncology, Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou
  • 14 Affiliated Xinan Hospital of Third Military Medical University, Chongqing
  • 15 First Affiliated Hospital, Medical School Xi'an Jiaotong University, Xi'an
  • 16 Cancer Hospital, Fudan University, Shanghai, China
  • 17 Department of Medicine, International Islamic University Malaysia, Kuala Lumpur, Malaysia
  • 18 Manila Doctors Hospital, Manila, The Philippines
  • 19 Roche (China) Holding Ltd, Shanghai, China
Ann Oncol, 2015 Sep;26(9):1883-1889.
PMID: 26105600 DOI: 10.1093/annonc/mdv270


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).

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.