Noninferiority of Gefitinib vs Erlotinib Not Established in Japanese Trial in Advanced Lung Adenocarcinoma


Key Points

  • Noninferiority of gefitinib vs erlotinib for progression-free survival was not established in previously treated patients with advanced non–small cell lung cancer.
  • Median progression-free survival was 6.5 vs 7.5 months among all patients and 8.3 vs 10.0 months in patients with an EGFR mutation, respectively.

In a Japanese phase III trial (WJOG 5108L) reported in the Journal of Clinical Oncology, Urata et al found that noninferiority of gefitinib vs erlotinib was not established in previously treated patients with advanced non–small cell lung cancer.

Study Details

In the open-label trial, 559 patients with advanced previously treated adenocarcinoma were randomized to receive erlotinib at 150 mg/d (n = 280) or gefitinib at 250 mg/d (n = 279). A total of 401 patients (72%) had an EGFR mutation. The primary endpoint was progression-free survival, with noninferiority of gefitinib established by an upper limit of the 95% confidence interval (CI) of the adjusted hazard ratio (HR) of < 1.30.


Median progression-free survival was 6.5 months in the gefitinib group vs 7.5 months in the erlotinib group (HR = 1.125, 95% CI = 0.940–1.347, P = .257), including 8.3 vs 10.0 months (HR = 1.093, 95% CI = 0.879–1.358, P = .424) among patients with an EGFR mutation. Median overall survival was 22.8 vs 24.5 months (HR = 1.038, 95% CI = 0.833–1.294, P = .768). Objective response rates were 46% vs 44%.

The major grade 3 or 4 adverse events were rash (2.2% in the gefitinib group vs 18.1% in the erlotinib group, elevated alanine transaminase (6.1% vs 2.2%), and elevated aspartate transaminase (13.0% vs 3.3%).

The investigators concluded: “The study did not demonstrate noninferiority of gefitinib compared with erlotinib in terms of [progression-free survival] in patients with lung adenocarcinoma according to the predefined criteria.”

The study was supported by the West Japan Oncology Group.

Yoshiko Urata, MD, of Hyogo Cancer Center, Akashi, is the corresponding author of the Journal of Clinical Oncology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.