Originally published as JCO Early Release 10.1200/JCO.2008.18.7658 on February 17 2009

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First-Line Gefitinib for Patients With Advanced Non–Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations Without Indication for Chemotherapy

From the North East Japan Study Group; Tohoku University, Graduate School of Medicine and School of Medicine; Miyagi Cancer Center; Kesennuma City Hospital, Miyagi; Saitama Medical University, Saitama; Kanto Medical Center NTT EC; Nippon Medical School, Tokyo; Tsuboi Cancer Center Hospital, Fukushima; Hokkaido University, Graduate School of Medicine, Hokkaido; Yokohama City University, Kanagawa, Japan.

Corresponding author: Kunihiko Kobayashi, MD, PhD, Department of Respiratory Medicine, Saitama International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka City, 350-1298 Japan; e-mail: kobakuni{at}saitama-med.ac.jp.

Purpose This multicenter phase II study was undertaken to investigate the efficacy and feasibility of gefitinib for patients with advanced non–small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations without indication for chemotherapy as a result of poor performance status (PS).

Patients and Methods Chemotherapy-naïve patients with poor PS (patients 20 to 74 years of age with Eastern Cooperative Oncology Group PS 3 to 4, 75 to 79 years of age with PS 2 to 4, and 80 years of age with PS 1 to 4) who had EGFR mutations examined by the peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp method were enrolled and received gefitinib (250 mg/d) alone.

Results Between February 2006 and May 2007, 30 patients with NSCLC and poor PS, including 22 patients with PS 3 to 4, were enrolled. The overall response rate was 66% (90% CI, 51% to 80%), and the disease control rate was 90%. PS improvement rate was 79% (P < .00005); in particular, 68% of the 22 patients improved from PS 3 at baseline to PS 1. The median progression-free survival, median survival time, and 1-year survival rate were 6.5 months, 17.8 months, and 63%, respectively. No treatment-related deaths were observed.

Conclusion This is the first report indicating that EGFR mutation-positive patients with extremely poor PS benefit from first-line gefitinib. Because there previously has been no standard treatment for these patients with short life expectancy other than best supportive care, examination of EGFR mutations as a biomarker is recommended in this patient population.

Written on behalf of the North East Japan Gefitinib Study Group.

Supported by grant-in-aids from Japan Society for Promotion of Science and Japanese Foundation for the Multidisciplinary Treatment of Cancer.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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• The "Lazarus Response" in Treatment-Naïve, Poor Performance Status Patients With Non–Small-Cell Lung Cancer and Epidermal Growth Factor Receptor Mutation
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