Treatment of adult acute lymphoblastic leukemia according to GMALL 07/ 2003 study protocol in the Czech Republic – the first experience

Czech version

Authors: F. Folber ¹; C. Šálek ²; M. Doubek ¹; J. Soukupová Maaloufová ²; T. Valová ³; J. Trka ³; N. Gökbuget ⁴; J. Vydra ⁵; T. Kozák ⁵; J. M. Horáček ⁶; P. Žák ⁶; P. Cetkovský ²; D. Hoelzer ⁴; J. Mayer ¹
Authors‘ workplace: Interní hematoonkologická klinika Lékařské fakulty MU a FN Brno, pracoviště Bohunice, přednosta prof. MU Dr. Jiří Vorlíček, CSc. 2Klinický úsek Ústavu hematologie a krevní transfuze Praha, přednosta doc. MU Dr. Petr Cetkovský, Ph. D. 3Childhood leukaemia ¹
Published in: Vnitř Lék 2010; 56(3): 176-182
Category: Original Contributions

Overview

Introduction:
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.

Methods:
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.

Results:
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.

Conclusion:
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 of consolidation 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.

Key words:
acute lymphoblastic leukemia – adults – chemotherapy – hematopoietic stem cell transplantation – adverse events – risk factors – GMALL 07/ 2003 trial

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