Originally published as JCO Early Release 10.1200/JCO.2009.23.3445 on December 28 2009

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Randomized Phase III Trial of Platinum-Doublet Chemotherapy Followed by Gefitinib Compared With Continued Platinum-Doublet Chemotherapy in Japanese Patients With Advanced Non–Small-Cell Lung Cancer: Results of a West Japan Thoracic Oncology Group Trial (WJTOG0203)

From the Department of Clinical Oncology, Osaka City General Hospital; Department of Respiratory Medicine, Osaka City University Medical School, Osaka; Department of Thoracic Oncology, Aichi Cancer Center, Nagoya; Departments of Biostatistics and Preventive Services, Kyoto University School of Public Health, Kyoto; Department of Thoracic Oncology, National Kyushu Cancer Center; Department of Clinical Medicine, Faculty of Medical Science, Research Institute for Diseases of the Chest, Kyushu University, Fukuoka; Department of Thoracic Oncology, Hyogo Cancer Center, Akashi; Division of Respiratory Medicine, Kobe City General Hospital, Kobe; Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi; Department of Respiratory Medicine, Kumamoto University, Kumamoto; Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino; Department Medical Oncology, Toyama University Hospital, Toyama; Department of Medical Oncology, Hiroshima City Hospital, Hiroshima; Department of Respiratory Medicine and Oncology, Gifu Municipal Hospital, Gifu; Department of Medical Oncology, Kinki University School of Medicine, Osaka-Sayama; Department of Cancer Chemotherapy Center, Osaka Medical College, Takatsuki; and the Kinki University School of Medicine, Sakai Hospital, Sakai, Japan.

Corresponding author: Koji Takeda, MD, 2-13-22 Miyakojimahondohri, Miyakojima-ku, Osaka 534-0021, Japan; e-mail: kkk-take{at}ga2.so-net.ne.jp.

Purpose Gefitinib is a small molecule inhibitor of the epidermal growth factor receptor tyrosine kinase. We conducted a phase III trial to evaluate whether gefitinib improves survival as sequential therapy after platinum-doublet chemotherapy in patients with advanced non–small-cell lung cancer (NSCLC).

Patients and Methods Chemotherapy-naïve patients with advanced stage (IIIB/IV) NSCLC, Eastern Cooperative Oncology Group performance status of 0 to 1, and adequate organ function were randomly assigned to either platinum-doublet chemotherapy up to six cycles (arm A) or platinum-doublet chemotherapy for three cycles followed by gefitinib 250 mg orally once daily, until disease progression (arm B). Patients were stratified by disease stage, sex, histology, and chemotherapy regimens. The primary end point was overall survival; secondary end points included progression-free survival, tumor response, safety, and quality of life.

Results Between March 2003 and May 2005, 604 patients were randomly assigned. There was a statistically significant improvement in progression-free survival in arm B (hazard ratio [HR], 0.68; 95% CI, 0.57 to 0.80; P < .001); however, overall survival results did not reach statistical significance (HR, 0.86; 95% CI, 0.72 to 1.03; P = .11). In an exploratory subset analysis of overall survival by histologic group, patients in arm B with adenocarcinoma did significantly better than patients in arm A with adenocarcinoma (n = 467; HR, 0.79; 95% CI, 0.65 to 0.98; P = .03).

Conclusion This trial failed to meet the primary end point of OS in patients with NSCLC. The exploratory subset analyses demonstrate a possible survival prolongation for sequential therapy of gefitinib, especially for patients with adenocarcinoma.

See accompanying editorial on page 713 and article on page 744

This study is registered with UMIN-CTR [http://www.umin.ac.jp/ctr/index.htm, identification number C000000035].

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

Clinical trial information can be found for the following: C000000035.

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