Combination of raltitrexed and oxaliplatin is an active regimen in malignant mesothelioma:: Results of a phase II study
Combination of raltitrexed and oxaliplatin is an active regimen in malignant mesothelioma:: Results of a phase II study
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DOI：
10.1200/jco.2003.05.123
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发表时间：
2003-01-15
影响因子：
45.3
通讯作者：
Ruffié, P
中科院分区：
文献类型：
--
作者：
Fizazi, K;Doubre, H;Ruffié, P
目的：这项开放标签的11期研究的目的是评价活性的雷替曲塞（Tomudex;阿斯利康，Cergy，法国）和奥沙利铂联合治疗弥漫性恶性胸膜间皮瘤患者和方法：15个预处理和55化疗初治患者（中位年龄，60岁;世界卫生组织的性能状态小于或等于2）被招募。大多数患者（66%）患有晚期疾病。患者接受雷替曲塞3 mg/m2，随后奥沙利铂130 mg/m2，每3 week.Results：24例（34%）被归类为预后不良。在整个研究人群中，14例患者（20%）部分缓解，32例患者（46%）病情稳定。症状反应率如下：呼吸急促，36%;疼痛，30%;活动，23%;食欲，21%;和虚弱，20%。至疾病进展的中位时间为18周（95%置信区间[CI]，13 - 22周）。在化疗初治患者中，从治疗开始的中位生存期为31周（95% CI，23 - 40周），从间皮瘤诊断开始的中位生存期为49周（95% CI，40 - 52周）。在预治疗患者中，从治疗开始的中位生存期为44周（95%CI，24至40周），从间皮瘤诊断开始的中位生存期为226周（95%CI，63至292周）。总体1年生存率为26%（95% CI，15.5%-36.4%），化疗初治患者的生存率为22%（95% CI，10.9%-33.2%），预治疗患者为40%（95% CI，15.2%-64.8%）。血液学毒性轻微，无脱发。最常见的不良事件是虚弱，恶心/呕吐，感觉异常，并没有治疗相关的死亡reported.Conclusion：雷替曲塞和奥沙利铂组合是一个积极的门诊方案，恶性间皮瘤，并具有可接受的耐受性。(C)2003年，美国临床肿瘤学会。
Purpose : The aim of this open-label phase 11 study was to evaluate the activity of raltitrexed (Tomudex; AstraZeneca, Cergy, France) and oxaliplatin combination therapy in patients with diffuse malignant pleural mesothelioma.Patients and Methods: Fifteen pretreated and 55 chemotherapy-naive patients (median age, 60 years; World Health Organization performance status of less than or equal to 2) were enrolled. Most patients (66%) had advanced disease. Patients received raltitrexed 3 mg/m(2) followed by oxaliplatin 130 mg/m(2) every 3 weeks.Results: Twenty-four patients (34%) were classified as having a poor prognosis. In the overall study population, 14 patients (20%) had a partial response, and 32 patients (46%) had stable disease. The symptomatic response rates were as follows: shortness of breath, 36%; pain, 30%; activity, 23%; appetite, 21%; and asthenia, 20%. Median time to disease progression was 18 weeks (95% confidence interval [CI], 13 to 22 weeks). In chemotherapy-naive patients, median survival was 31 weeks (95% Cl, 23 to 40 weeks) from the start of treatment and 49 weeks (95% CI, 40 to 52 weeks) from diagnosis of mesothelioma. In pretreated patients, median survival was 44 weeks (95% Cl, 24 to 40 weeks) from the start of treatment and 226 weeks (95% Cl, 63 to 292 weeks) from the diagnosis of mesothelioma. Overall 1-year survival was 26% (95% Cl, 15.5% to 36.4%), survival was 22% (95% CI, 10.9% to 33.2%) in chemotherapy-naive patients and 40% (95% Cl, 15.2% to 64.8%) in pretreated patients. Hematologic toxicity was mild, and there was no alopecia. The most common adverse events were asthenia, nausea/vomiting, and paraesthesia, and no treatment-related deaths were reported.Conclusion: The raltitrexed and oxaliplatin combination is an active outpatient regimen in malignant mesothelioma and has an acceptable tolerability profile. (C) 2003 by American Society of Clinical Oncology.