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)

Koji Takeda, Toyoaki Hida, Tosiya Sato, Masahiko Ando, Takashi Seto, Miyako Satouchi, Yukito Ichinose, Nobuyuki Katakami, Nobuyuki Yamamoto, Shinzoh Kudoh, Jiichiro Sasaki, Kaoru Matsui, Koichi Takayama, Tatsuhiko Kashii, Yasuo Iwamoto, Toshiyuki Sawa, Isamu Okamoto, Takayasu Kurata, Kazuhiko Nakagawa, Masahiro Fukuoka

    Research output: Contribution to journalArticle

    150 Scopus citations

    Abstract

    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.

    Original languageEnglish (US)
    Pages (from-to)753-760
    Number of pages8
    JournalJournal of Clinical Oncology
    Volume28
    Issue number5
    DOIs
    StatePublished - Feb 10 2010

      Fingerprint

    ASJC Scopus subject areas

    • Oncology
    • Cancer Research

    Cite this

    Takeda, K., Hida, T., Sato, T., Ando, M., Seto, T., Satouchi, M., Ichinose, Y., Katakami, N., Yamamoto, N., Kudoh, S., Sasaki, J., Matsui, K., Takayama, K., Kashii, T., Iwamoto, Y., Sawa, T., Okamoto, I., Kurata, T., Nakagawa, K., & Fukuoka, M. (2010). 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). Journal of Clinical Oncology, 28(5), 753-760. https://doi.org/10.1200/JCO.2009.23.3445