Suzuki R, Hasegawa Y, Baba K, Saka H, Saito H, Taniguchi H, Yamamoto M, Matsumoto S, Kato K, Oishi T, Imaizumi K, Shimokata K
Toyohashi Municipal Hospital, 50 Hachiken-nishi, Aotake, Toyohashi, Aichi 441-8570, Japan.
Br J Cancer. 2006 Jun 5;94(11):1599-603. doi: 10.1038/sj.bjc.6603159.
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.
本研究旨在评估吉非替尼（“易瑞沙”）对既往未经治疗的IV期非小细胞肺癌（NSCLC）日本患者的疗效和耐受性。这是一项多机构的II期研究。2003年5月至2004年9月期间，34例既往未经治疗的IV期NSCLC患者入组。吉非替尼口服给药，每日一次，每次250 mg，持续给药直至出现疾病进展或严重毒性。客观肿瘤缓解率为26.5%（95%置信区间，11.7 - 41.3%）。不良事件一般较轻（美国国立癌症研究所通用毒性标准1级或2级），主要包括皮疹、乏力和肝功能障碍。未观察到肺部毒性。整体健康状况显示，研究期间生活质量无变化。本研究发现，单药吉非替尼对未经化疗的晚期NSCLC日本患者有效且耐受性良好。
