Phase II trial of a single weekly intravenous dose of ranpirnase in patients with unresectable malignant mesothelioma
Phase II trial of a single weekly intravenous dose of ranpirnase in patients with unresectable malignant mesothelioma
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DOI：
10.1200/jco.20.1.274
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发表时间：
2002-01-01
影响因子：
45.3
通讯作者：
Shogen, K
中科院分区：
文献类型：
--
作者：
Mikulski, SM;Costanzi, JJ;Shogen, K
目的：进行雷尼普酶(Onconase；Alfacell Corp，Bloomfield，NJ)作为单一药物的多中心II期试验，以进一步评估这种新型抗肿瘤核糖核酸酶的安全性和临床疗效。不能切除并经组织学证实的恶性间皮瘤(MM)的患者符合条件。患者和方法：105名东方合作肿瘤组评分为0到2的患者纳入研究。37%的患者对之前的化疗没有反应。这项研究的主要终点是生存。肿瘤反应和进展时间也被评估。采用癌症和白血病B组(CALEB)预后分组标准定义治疗靶组(TTG)。结果：意向治疗(ITT)组和TTG组的中位生存期分别为6个月和8.3个月。ITT组1、2年生存率分别为34.3%和21.6%，TTG组分别为42%和26.8%。在81例可评估为肿瘤反应的患者中，4例有部分反应，2例有轻微退化，35例经历了先前进展的疾病的稳定。有反应且病情稳定的患者的生存时间明显延长。大多数患者对兰皮那酶的耐受性良好，没有药物相关的死亡。结论：兰皮那酶在不能切除的MM患者中表现出活性和耐受性，Caleb组的预后价值得到了证实。(C)2001年美国临床肿瘤学会。
Purpose: A multicenter phase II trial of ranpirnase (Onconase; Alfacell Corp, Bloomfield, NJ) as a single agent was conducted to further assess the safety and clinical efficacy of this novel antitumor ribonuclease. Patients with unresectable and histologically confirmed malignant mesothelioma (MM) were eligible.Patients and Methods: One hundred five patients with Eastern Cooperative Oncology Group performance status 0 to 2 were enrolled onto the study. Thirty-seven percent of patients had not responded to prior chemotherapy. The primary end point of the study was survival. Tumor responses and time to progression were also assessed. The Cancer and Leukemia Group B (CALEB) prognostic group criteria were used to define a treatment target group (TTG). Both the intent-to-treat (ITT) and the TTG populations were analyzed for survival.Results: Median survival times of 6 months for the ITT and 8.3 months for the TTG populations were observed. The 1- and 2-year survival rates were 34.3% and 21.6% for ITT, respectively, and 42% and 26.8% for TTG, respectively. Among the 81 patients assessable for tumor response, four had partial responses, two had minor regressions, and thirty-five experienced stabilization of previously progressive disease. Patients with responses and stable disease demonstrated markedly prolonged survival. Ranpirnase was well tolerated in the majority of patients, and there were no drug-related deaths.Conclusion: Ranpirnase demonstrated activity and a tolerable toxicity profile in patients with unresectable MM. The prognostic value of the CALEB groups was confirmed.(C) 2001 by American Society of Clinical Oncology.