急性淋巴细胞白血病治疗方案ALL IC-BFM 2002的毒性评价

T. Valiev, M. Shervashidze, T. Belysheva
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引用次数: 3

摘要

背景。由领先的研究小组BFM(柏林-法兰克福-明斯特)开发的方案治疗儿童急性淋巴细胞白血病的结果令人印象深刻-长期总生存率为93.4%。成功的基础是基于预后因素的差异化方法。在一些局部问题上,BFM方案因其高毒性而受到批评,但试图在局部文献中找到现代尺度的复杂方案毒性评价结果,却缺乏。目的研究ALL - IC-BFM 2002方案治疗急性淋巴细胞白血病的毒性。材料和方法。该研究纳入了119例原发性急性淋巴细胞白血病患者。所有患者均按All IC-BFM 2002方案进行治疗。毒性评价采用美国国家癌症研究所(NCI)第2版标准。根据ALL IC-BFM 2002方案,治疗期间最常见的毒性变异是骨髓抑制、感染和严重程度为I-IV级的肝毒性。临床显著毒性(IV级)为骨髓抑制,需要输血的比例为768 - 100%(取决于预后风险组和方案组)。在89.5%的患者中,高剂量甲氨蝶呤(2000 mg/m2或5000 mg/m2)的肾和肝毒性为I-II级。标准和中等危险组中93.7%的患者出现I-II级口炎,而高危组中大多数(90%)患者出现更高级别的III-IV级口炎。根据ALL - IC-BFM 2002方案,感染并发症的死亡率为1.6%。值得注意的是,ALL IC-BFM 2002方案中规定的支持治疗有助于有效预防和纠正严重毒性。在采用全支持性治疗方法的情况下,通过毒性等级为III-IV级的频率分析,ALL IC-BFM 2002方案的毒性概况是可以接受的。注意到的毒性变异完全消除,对患者没有不可逆转的后果。
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Toxicity assessment of acute lymphoblastic leukemia treatment protocol ALL IC-BFM 2002
Background. Treatment results of acute lymphoblastic leukemia in children on protocol, developed by one of the leading research study group BFM (Berlin-Frankfurt-Munster) are impressive - longstanding overall survival rate comprise 93.4 %. The basis of success is a differential approach based on prognostic factors. In some local issues BFM protocols receive criticism because of high toxicity, but trying to find results of complex protocol toxicity assessment by modern scales in local literature, it was absent.Aim. To study a toxicity of acute lymphoblastic leukemia treatment by ALL IC-BFM 2002 protocol.Materials and methods. 119 patients with primary diagnosed acute lymphoblastic leukemia were enrolled the study. All the patients were treated by ALL IC-BFM 2002 protocol. Toxicity assessment was performed by the scale of National Cancer Institute (NCI) USA, 2nd version.Results. The most often variants of toxicity during treatment according to the ALL IC-BFM 2002 protocol were myelo-suppression, infections and hepatotoxicity of I-IV degrees of severity. Clinically significant toxicity (grade IV) was myelosuppression and necessity for transfusions in 76.8-100 % (depending on prognostic risk group and as such protocol arm). Nephro- and hepatotoxicity described on high-dosed methotrexate (2000 mg/m2 or 5000 mg/m2) were I-II grade in 89.5 % patients. Stomatitis grade I-II was in 93.7 % patients of standard and intermediate risk groups, but in the most (90 %) patients from high risk group it was higher - grade III-IV. Mortality on protocol ALL IC-BFM 2002 caused by infection complications was 1.6 %. It should be noted, that supportive care, prescribed in ALL IC-BFM 2002 protocol help to prevent and correct severe toxicity effectively.Conclusion. The toxicity profile of ALL IC-BFM 2002 protocol, analyzed by frequency of toxicity grade III-IV with whole supportive care approaches, is acceptable. The noted variants of toxicity were fully resolved without irreversible consequences for the patients.
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发文量
20
审稿时长
12 weeks
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