A phase II study of single-agent gefitinib as first-line therapy in patients with stage IV non-small-cell lung cancer

R. Suzuki, Y. Hasegawa, K. Baba, H. Saka, H. Saito, H. Taniguchi, M. Yamamoto, S. Matsumoto, K. Kato, T. Oishi, K. Imaizumi, K. Shimokata

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Abstract

The aim of this study was to evaluate the efficacy and tolerability of gefitinib ('IRESSA') in Japanese patients with previously untreated stage IV non-small-cell lung cancer (NSCLC). This was a multi-institutional phase II study. Thirty-four patients with previously untreated stage IV NSCLC were enrolled between May 2003 and September 2004. Gefitinib was administered orally 250mg once a day and was continued until there was either disease progression or severe toxicity. Objective tumour response rate was 26.5% (95% confidence interval, 11.7-41.3%). Adverse events were generally mild (National Cancer Institute-Common Toxicity Criteria grade 1 or 2) and consisted mainly of skin rash, fatigue and liver dysfunction. No pulmonary toxicity was observed. The global health status revealed that there was no change in quality of life during the study. This study found that single-agent gefitinib is active and well tolerated in chemonaive Japanese patients with advanced NSCLC.

Original languageEnglish
Pages (from-to)1599-1603
Number of pages5
JournalBritish Journal of Cancer
Volume94
Issue number11
DOIs
Publication statusPublished - 05-06-2006

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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    Suzuki, R., Hasegawa, Y., Baba, K., Saka, H., Saito, H., Taniguchi, H., Yamamoto, M., Matsumoto, S., Kato, K., Oishi, T., Imaizumi, K., & Shimokata, K. (2006). A phase II study of single-agent gefitinib as first-line therapy in patients with stage IV non-small-cell lung cancer. British Journal of Cancer, 94(11), 1599-1603. https://doi.org/10.1038/sj.bjc.6603159