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Gemcitabine治疗晚期非小细胞肺癌的临床研究 被引量:177

Gemcitabine in the treatment of advanced nonsmallcell lung cancer
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摘要 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
出处 《癌症》 SCIE CAS CSCD 北大核心 1999年第3期241-245,共5页 Chinese Journal of Cancer
关键词 肺肿瘤 非小细胞肺癌 药物疗法 GEMCITABINE Gemcitabine/Therapeutic Use Non Small Cell Lung Cancer (NSCLC) Clinical Trial
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