Randomized phase III evaluation of cisplatin plus fluorouracil versus cisplatin plus paclitaxel in advanced head and neck cancer (E1395): An intergroup trial of the eastern cooperative oncology group
Randomized phase III evaluation of cisplatin plus fluorouracil versus cisplatin plus paclitaxel in advanced head and neck cancer (E1395): An intergroup trial of the eastern cooperative oncology group
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DOI：
10.1200/jco.2005.01.057
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发表时间：
2005-05-20
影响因子：
45.3
通讯作者：
Forastiere, AA
中科院分区：
文献类型：
--
作者：
Gibson, MK;Li, Y;Forastiere, AA
目的确定答复率;在患有不可治愈的头颈部鳞状细胞癌的患者中，输注顺铂加氟尿嘧啶（CF）与顺铂加紫杉醇（CP）的存活率和毒性，假设CP更上级。患者和方法218例局部晚期，复发，或转移性疾病患者随机分配至CF组（顺铂100 mg/m（2）第1天和氟尿嘧啶1，000 mg/m2/24小时，连续静脉输注，第1天至第4天）或CP（顺铂75 mg/m2，第1天，紫杉醇175 mg/m2，第1天，持续3小时）。每3周重复一个周期，直至进展或至少6个周期完全缓解或疾病稳定。主要结局是总生存率。次要结果包括反应率和毒副反应。结果总生存率和反应率无显著差异。CF组的估计中位生存期为8.7个月，CP组为8.1个月。CF组的客观缓解率（完全缓解加部分缓解）为27%，CP组为26%。两组之间的毒性相似，最常见的包括骨髓抑制、血小板减少、贫血、恶心、呕吐和口腔炎。治疗期间共发生12例死亡（CF，7例; CP，5例），8例死于感染，2例死于出血，1例死于心脏原因，1例死于不明原因。胃肠道和血液系统毒性更常见的CF组，而神经毒性是等效的groups.Conclusion 111期，随机，多中心试验显示，CF或CP治疗的患者之间的生存没有差异。(c)2005年，美国临床肿瘤学会。
Purpose To determine the response rate; survival and toxicity of infusional cisplatin plus fluorouracil (CF) versus cisplatin plus paclitaxel (CP) in patients with incurable squamous cell cancer of the head and neck, with the hypothesis that CP is superior.Patients and Methods Two hundred eighteen patients with locally advanced, recurrent, or metastatic disease were randomly assigned to CF (cisplatin 100 mg/m(2) day 1 and fluorouracil 1,000 mg/m(2)/24 hours by continuous intravenous infusion day 1 through 4) or CP (cisplatin 75 mg/m(2) day 1 and paclitaxel 175 mg/m(2) over 3 hours on day 1). Cycles were repeated every 3 weeks until progression or a minimum of 6 cycles with complete response or stable disease. The primary outcome was overall survival. Secondary outcomes included response rate and toxicity.Results No significant difference in overall survival or response rate was seen. Estimated median survival was 8.7 months in the CF group and 8.1 month in the CP group. Objective response rate (complete response plus partial response) was 27% in the CF group and 26% in the CP group. Toxicity was similar between groups, with the most frequent including myelosuppression, thrombocytopenia, anemia, nausea, vomiting, and stomatitis. A total of 12 deaths occurred (CF, seven; CP, five) during treatment,, eight from infection, two from hemorrhage, one from cardiac causes and one from unknown causes. Gastrointestinal and hematologic toxicities were more common in the CF group, whereas neurotoxicity was equivalent between groups.Conclusion This phase 111, randomized, multicenter trial showed no difference in survival between patients treated with CF or CP. (c) 2005 by American Society of Clinical Oncology.