Folber F, Sálek C, Doubek M, Soukupová Maaloufová J, Valová T, Trka J, Gökbuget N, Vydra J, Kozák T, Horácek J M, Zák P, Cetkovský P, Hoelzer D, Mayer J
Internl hematoonkologická kIinika Lékarské fakulty MU a FN Brno.
Vnitr Lek. 2010 Mar;56(3):176-82.
We present two years' experience in the treatment of adult acute lymphoblastic leukemia (ALL) according to the German GMALL 07/2003 study protocol at CELL (Czech leukemia study group--for life) hematological centers in the Czech Republic.
A total number of 37 patients were included in this analysis. We evaluated complete remission and molecular remission rate, incidence of relapse, patients' status at the end of the follow-up period, incidence of chemotherapy-related adverse events and causes of death. A statistical analysis of risk factors affecting survival was carried out.
Complete remission was achieved in 36 (97%) patients and molecular remission in 16 (62%) of 26 evaluable patients. Disease relapse occurred in 5 (14%) patients. At the end of the follow-up period with a median of 261 days, 28 (76%) patients were alive in complete remission, one (3%) with relapsed disease and 8 (22%) dead. Treatment toxicity resulted in death in 5 cases, relapse or progression of ALL in 3 patients. Adverse events most often followed consolidation I, induction phase I, consolidation II and induction phase II. Infectious complications in the context of febrile neutropenia, GIT mucositis and side effects of PEG-asparaginase were the most common adverse events observed. The toxicity of allogeneic transplantation was not unexpected, four (25%) patients died after transplantation. Two-year progression-free and overall survival were 66% and 70%, respectively. High risk ALL, age over 35 years, CNS infiltration, disease relapse and permanent minimal residual disease were identified as the major adverse prognostic risk factors. Practical experiences and possible pitfalls of the protocol are described in the discussion.
Our initial impression is promising. The treatment is feasible, the results very good and the toxicity acceptable. Patients at high risk should be headed to allogeneic transplantation, since the results ofconsolidation chemotherapy alone are very poor in this group. We believe that this study protocol could become a standard adult acute lymphoblastic leukemia treatment in the Czech Republic.
我们介绍了在捷克共和国CELL（捷克白血病研究组——为了生命）血液学中心，依据德国GMALL 07/2003研究方案治疗成人急性淋巴细胞白血病（ALL）的两年经验。
本分析共纳入37例患者。我们评估了完全缓解率和分子缓解率、复发率、随访期末患者状态、化疗相关不良事件发生率及死亡原因。对影响生存的危险因素进行了统计分析。
36例（97%）患者实现完全缓解，26例可评估患者中有16例（62%）实现分子缓解。5例（14%）患者疾病复发。随访期中位数为261天时，28例（76%）患者处于完全缓解存活状态，1例（3%）疾病复发，8例（22%）死亡。治疗毒性导致5例死亡，3例患者ALL复发或进展。不良事件最常出现在巩固治疗I期、诱导治疗I期、巩固治疗II期和诱导治疗II期。发热性中性粒细胞减少症背景下的感染并发症、胃肠道黏膜炎和聚乙二醇天冬酰胺酶的副作用是观察到的最常见不良事件。异基因移植的毒性在意料之中，4例（25%）患者移植后死亡。两年无进展生存率和总生存率分别为66%和70%。高危ALL、年龄超过35岁、中枢神经系统浸润、疾病复发和持续性微小残留病被确定为主要不良预后危险因素。讨论中描述了该方案的实际经验和可能存在的问题。
我们的初步印象是有前景的。该治疗可行，结果良好，毒性可接受。高危患者应进行异基因移植，因为仅巩固化疗在该组患者中的效果非常差。我们认为该研究方案可能会成为捷克共和国成人急性淋巴细胞白血病的标准治疗方案。
