Department of Medical Oncology, The First Hospital Affiliated to Medical School of Zhejiang University, 79 Qingchun Road, 310003 Hangzhou, Zhejiang, China.
Med Oncol. 2012 Jun;29(2):595-9. doi: 10.1007/s12032-011-9891-2. Epub 2011 Mar 12.
A phase II clinical trial was performed to evaluate the efficacy and safety of gefitinib on pretreated Chinese female non-small-cell lung cancer (NSCLC) patients. Chinese female patients with locally advanced or metastatic NSCLC who failed at least one platinum-based chemotherapy received gefitinib monotherapy (250 mg/day) between April 2002 and January 2010. The primary endpoint was overall response rate (ORR), and secondary endpoints were overall survival (OS) and progression-free survival (PFS). Of the 40 evaluable female patients, the ORR was 62.5%. All patients have responded with one (2.5%) complete response, 24 (60%) partial response, 12 (30%) stable disease, and 3 (7.5%) progressive disease. The OS and PFS were 20 months (95% CI: 11.9-28 months) and 13 months (95% CI: 8.0-17.9 months), respectively. Survival (OS and PFS) were longer in patients with good performance status and in patients older than 65 years (P < 0.05). The most frequently observed toxicities were rash/dry skin (80%), diarrhea (42.5%), and vomiting/anorexia (32.5%). Four patients developed grade 3 toxicities (rash and diarrhea) but did not require either dose reduction or discontinuation. Gefitinib is a highly effective and well-tolerated agent for Chinese women with pretreated advanced NSCLC.
一项评估吉非替尼治疗既往接受过治疗的中国女性非小细胞肺癌（NSCLC）患者的疗效和安全性的 II 期临床试验。2002 年 4 月至 2010 年 1 月，局部晚期或转移性 NSCLC 中国女性患者在至少一次铂类化疗失败后接受吉非替尼单药治疗（250mg/天）。主要终点是总缓解率（ORR），次要终点是总生存期（OS）和无进展生存期（PFS）。在 40 名可评估的女性患者中，ORR 为 62.5%。所有患者均有反应，1 例（2.5%）完全缓解，24 例（60%）部分缓解，12 例（30%）稳定疾病，3 例（7.5%）进展性疾病。OS 和 PFS 分别为 20 个月（95%CI：11.9-28 个月）和 13 个月（95%CI：8.0-17.9 个月）。生存（OS 和 PFS）在表现状态良好和年龄大于 65 岁的患者中更长（P<0.05）。最常见的毒性反应是皮疹/皮肤干燥（80%）、腹泻（42.5%）和呕吐/厌食（32.5%）。4 名患者出现 3 级毒性（皮疹和腹泻），但无需减少剂量或停药。吉非替尼是一种对既往接受过治疗的中国女性晚期 NSCLC 患者具有高度有效性和良好耐受性的药物。
