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- Title
A phase II study of single-agent gefitinib as first-line therapy in patients with stage IV non-small-cell lung cancer.
- Authors
Suzuki, R.; Hasegawa, Y.; Baba, K.; Saka, H.; Saito, H.; Taniguchi, H.; Yamamoto, M.; Matsumoto, S.; Kato, K.; Oishi, T.; Imaizumi, K.; Shimokata, K.
- 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 250 mg 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 chemo-naive Japanese patients with advanced NSCLC.
- Subjects
LUNG cancer diagnosis; LUNG cancer patients; TOXICITY testing; PROTEIN-tyrosine kinases; TUMORS; FATIGUE (Physiology)
- Publication
British Journal of Cancer, 2006, Vol 94, Issue 11, p1599
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/sj.bjc.6603159