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背景与目的厄洛替尼是一种小分子EGFR酪氨酸激酶抑制剂,国外研究证实该药可延长晚期非小细胞肺癌患者的中位无进展生存期,提高1年生存率。本研究观察厄洛替尼治疗国人晚期复治非小细胞肺癌的疗效及毒副反应。方法本研究为罗氏公司的扩大记名供应研究的一部分。自2005年12月开始,对既往接受过1个-2个标准含铂方案化疗的45例晚期非小细胞肺癌患者采用口服厄洛替尼治疗,每日服药1次,每次150mg。服药4周后进行客观疗效及毒副反应评价,以后每8周评价一次。结果45例患者中可评价疗效者43例,PR19例,RR44.2%,SD13例,DCR74.4%,PD11例(25.6%)。中位无进展生存期为4.8个月,中位生存期为15.0个月,1年生存率为68.8%(31/45)。其中腺癌患者中位无进展生存期为7.6个月,非腺癌患者为2.6个月(P=0.018)。与药物相关的毒副反应依次为:痤疮样皮疹41例(91.1%),胆红素升高15例(33.3%),转氨酶升高9例(20%),腹泻4例(8.9%)。其中出现皮疹的患者中位无进展生存期和中位生存期分别为7.5个月和15.6个月,未出现皮疹患者中位无进展生存期和中位生存期分别为1.1个月和5.2个月(P值分别为0.001和0.002)。结论厄洛替尼治疗晚期复治非小细胞肺癌有效,腺癌患者及治疗中出现皮疹的患者疗效更佳,无进展生存期在腺癌患者更有优势,毒副反应轻微、可耐受。
Background and objective Erlotinib is a small molecule inhibitor of EGFR tyrosine kinase, foreign studies have confirmed that the drug can extend the median progression-free survival of patients with advanced non-small cell lung cancer and improve 1-year survival rate. This study was to observe the curative effect and side effects of erlotinib in treating refractory non-small cell lung cancer in our country. Methodology This study is part of Roche’s expanded naming supply research. Since December 2005, 45 patients with advanced non-small cell lung cancer who had previously received 1 -2 standard platinum regimens were treated with oral erlotinib once daily for 150 mg each. Four weeks after taking the objective efficacy and toxicity evaluation, evaluation every 8 weeks later. Results Of the 45 patients, 43 were evaluable, PR19, RR44.2%, SD13, DCR74.4% and PD11 (25.6%). Median progression-free survival was 4.8 months, median survival was 15.0 months, and 1-year survival was 68.8% (31/45). The median progression-free survival was 7.6 months in patients with adenocarcinoma and 2.6 months in patients with non-adenocarcinoma (P = 0.018). Drug-related side effects were: acne-like rash in 41 cases (91.1%), bilirubin in 15 cases (33.3%), elevated transaminase in 9 cases (20%) and diarrhea in 4 cases (8.9%). The median progression-free survival and median survival of patients with rash were 7.5 months and 15.6 months, respectively. The median progression-free survival and median survival in patients without rash were 1.1 months and 5.2 months, respectively (P values were 0.001 and 0.002, respectively). Conclusions Erlotinib is effective in the treatment of advanced non-small cell lung cancer (NSCLC). Patients with adenocarcinoma and rashes during treatment are more effective. Progression-free survival is more advantageous in patients with adenocarcinoma. Toxicity and side effects are slight and tolerable.