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首页> 外文期刊>Supportive care in cancer: official journal of the Multinational Association of Supportive Care in Cancer >Safety and tolerability of velafermin (CG53135-05) in patients receiving high-dose chemotherapy and autologous peripheral blood stem cell transplant.
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Safety and tolerability of velafermin (CG53135-05) in patients receiving high-dose chemotherapy and autologous peripheral blood stem cell transplant.

机译：Velafermin（CG53135-05）在接受大剂量化疗和自体外周血干细胞移植的患者中的安全性和耐受性。

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GOALS OF WORK: The objective of this study was to evaluate the safety and tolerability of velafermin in patients at risk of developing severe oral mucositis (OM) from chemotherapy. MATERIALS AND METHODS: This study was a single-center, open-label, single-dose escalation, phase I trial in patients undergoing high-dose chemotherapy (HDCT) and autologous peripheral blood stem cell transplant (PBSCT). Velafermin was administered 24 h after stem cell infusion as a single intravenous dose infused over 15 min. Clinical safety variables were assessed and OM status scored daily for 30 days using the World Health Organization (WHO) grading scale. MAIN RESULTS: Thirty patients were treated with velafermin at doses of 0.03 (n = 10), 0.1 (n = 10), 0.2 (n = 8), or 0.33 mg/kg (n = 2). Patients were diagnosed with multiple myeloma (n = 16), non-Hodgkin's lymphoma (n = 12), acute myelogenous leukemia (n = 1), or desmoplasmic round cell tumor (n = 1). Velafermin was well tolerated at doses up to 0.2 mg/kg. There were nodrug-related serious adverse events. No patient discontinued because of adverse events; however, two patients administered 0.33 mg/kg developed adverse reactions immediately after infusion of the study drug. No other patients were treated at this dose level. The most frequent (>35% of patients) treatment-emergent adverse events were diarrhea, fatigue, pyrexia, vomiting, and nausea. Most adverse events were mild or moderate and resolved the same day without sequelae. Eight (27%) patients developed WHO grade 3 or 4 OM during the study; seven of these patients received high-dose melphalan as a conditioning regimen. CONCLUSION: Velafermin was well tolerated by autologous PBSCT patients at doses up to 0.2 mg/kg.
机译：工作目标：这项研究的目的是评估Velafermin在有可能因化疗而发展为严重口腔粘膜炎（OM）的患者中的安全性和耐受性。材料与方法：本研究是一项单中心，开放标签，单剂量递增的I期试验，用于接受大剂量化疗（HDCT）和自体外周血干细胞移植（PBSCT）的患者。 Velafermin在干细胞输注后24小时以15分钟内的单次静脉注射剂量给药。使用世界卫生组织（WHO）等级量表评估临床安全性变量，并在30天内每天对OM状态进行评分。主要结果：30例患者接受了velafermin的0.03（n = 10），0.1（n = 10），0.2（n = 8）或0.33 mg / kg（n = 2）的剂量治疗。患者被诊断出患有多发性骨髓瘤（n = 16），非霍奇金淋巴瘤（n = 12），急性骨髓性白血病（n = 1）或等质性圆形细胞瘤（n = 1）。 Velafermin的最高耐受剂量为0.2 mg / kg。有与毒品相关的严重不良事件。没有患者因不良事件而停药;但是，有两名患者以0.33 mg / kg的剂量输注研究药物后立即出现不良反应。没有其他患者在此剂量水平接受治疗。最常发生的（> 35％的患者）治疗后不良反应为腹泻，疲劳，发热，呕吐和恶心。大多数不良事件为轻度或中度，并在当天消除，无后遗症。在研究过程中，八（27％）名患者发生了WHO的3级或4级OM;这些患者中有7位接受了大剂量美法仑作为调理方案。结论：自体PBSCT患者以0.2 mg / kg的剂量耐受Velafermin。

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