Phase II study of erlotinib in advanced non-small-cell lung cancer after failure of gefitinib

Chul Cho Byoung, Chong Kun Im, Moo Suk Park, Kyu Kim Se, Joon Chang, Pil Park Jong, Jin Choi Hye, Jin Kim Yu, Sang Joon Shin, Hyuk Sohn Joo, Hoguen Kim, Hang Kim Joo

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151 Citations (Scopus)


Purpose: This study was designed to evaluate the efficacy and toxicity of erlotinib in patients with advanced non-small-cell lung cancer (NSCLC) who experienced disease progression after treatment with gefitinib. Patients and Methods: The study included stage IIIB/IV recurrent or metastatic NSCLC patients who received two or three prior chemotherapy regimens and showed progressive disease within 4 months of gefitinib therapy discontinuation. Patients received erlotinib 150 mg/d until disease progression or unacceptable toxicity. Epidermal growth factor receptor (EGFR) mutations and other genetic abnormalities were analyzed from available tumor samples. Results: Patient and disease characteristics (N = 21) included median age 56 years; number of prior chemotherapy regimens (three; n = 11); female sex (n = 11); adenocarcinoma (n = 15); and never-smoker status (n = 11). Among the 17 patients with tumor samples available, EGFR mutations were detected in five. The disease control rate (DCR) and response rate (RR) for all patients were 28.6% and 9.5%, respectively. The median duration of disease control was 125 days. The median time to progression and overall survival were 60 days and 158 days, respectively. Patients who had stable disease (SD) while receiving gefitinib showed significantly higher DCR (75% v 17.6% in non-SD patients; P = .050) and RR (50.0% v 0% in non-SD patients; P = .029). Among 17 patients with biomarker results available, those lacking EGFR mutations who had SD while receiving gefitinib showed significantly higher DCR and RR. Conclusion: Erlotinib seems to be a potential therapeutic option for the treatment of advanced NSCLC patients with wild-type EGFR who had SD while receiving gefitinib.

Original languageEnglish
Pages (from-to)2528-2533
Number of pages6
JournalJournal of Clinical Oncology
Issue number18
Publication statusPublished - 2007 Jun 20

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research


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