Gemcitabine治疗晚期非小细胞肺癌的临床研究

Gemcitabine in the treatment of advanced nonsmallcell lung cancer

目的：评价Ｇｅｍｃｉｔａｂｉｎｅ（中文译名：健择）单药及其与顺氯铵铂联合化疗方案治疗ＩＩ、ＩＶ期非小细胞肺癌（ＮＳＣＬＣ）的临床疗效及其不良反应。材料与方法：１健择单药研究：从１９９７年９月至１９９８年５月入选ＩＩ、ＩＶ期ＮＳＣＬＣ病人２１例，以前未接受过任何化疗、放疗。ＩＩ期病人１１例，ＩＶ期病人１０例。健择１０００ｍｇ／ｍ２，第１，８，１５天各注一次，每２８天为一疗程。２健择与顺氯铵铂联合化疗研究：从１９９７年１０月至１９９８年７月入选ＩＩ、ＩＶ期ＮＳＣＬＣ病人４８例，以前未接受过任何化疗、放疗。ＩＩ期病人１９例，ＩＶ期病人２９例。健择１０００ｍｇ／ｍ２，第１，８，１５天各注一次；顺氯铵铂１００ｍｇ／ｍ２，第一天用，每２８天为一疗程。结果：１健择单药研究：可评价疗效的有１９例，６例获部分缓解（ＰＲ），其中２例（１０５％）经４周以上复查证实。总有效率３１５％［９５％ＣＩ，９４％～４５１５％］。全组均可评价不良反应，少数病人发生轻微胃肠道反应、白细胞下降、血红蛋白下降和血小板下降，只有４８％（各１例）患者发生ＩＩ度的恶心呕吐及白细胞下降，有１例患者发生ＩＩ度感染。全组中位生存期６１３月。２?

Objective: The aim of the study was to evaluate the clinical efficacy and toxicity of Gemcitabine singledrug and gemcitabinecisplatin combination in advanced nonsmallcell lung cancer (NSCLC). Methods: 1 gemcitabine singledrug study:Twentyone previously untreated NSCLC patients entered the trial from September 1997 to May 1998 gemcitabine 1000 mg/m2 was administeredon days 1,8 and 15 in each 28day cycle. 2 GemcitabineCisplatin combination study:Fortyeight previously untreated NSCLC patients entered the trial from October 1997 to July 1998 Gemcitabine 1000 mg/m2 was administered on days 1,8 and 15 and Cisplatin 100 mg/m2, on day 1 in each 28day cycle. Results:TBZ1 Gemcitabine singledrug study:Of 19 assessable patients, 6 achieved a partial response (PR), and among them 2(105%) were confirmed PR. The overall response rate was 316%(95%confidence interval , 94%to 4515%). 21 patients can be evaluated the toxicity. A minor proportion of patients experienced mild GI reaction, leukopenia, thrombocytopenia and decreased hemoglobin levels. Only 48%(1 patient each) of the patients experience grade III leukopenia and nausea/ vomiting. One patient experienced grade III infection. The median survival of the whole group was 613 months. 2 Gemcitabinecisplatin combination study:Of 41 assessable patients, 23 achieved a partial response (PR), and among them 18(439%) were confirmed PR. The overall response rate was 561%(95%confidence interval , 398%to 715%). 48 patients can be evaluated for toxicity. About 1/3 of the patients experienced grade IIIIV nausea/vomiting and leukopenia and decreased hemoglobin. 1875%(9 patients) experienced grade III thrombocytopenia. The other toxicity was mild and tolerable. 39 cycles (2437%) of gemcitabine injections were dosereduced or omitted due to toxicity. The median survival of the whole group was 89 months. Conclusion: The singledrug gemcitabine induced an objective efficacy in advanced NSCLC, with modest side effects. The gemcitabinecisqlatin combination regime was effective and well tolerated in the treatment of advanced NSCLC, it could be considered as one of the recommended standard regime.