Journal
BLOOD
Volume 139, Issue 12, Pages 1785-1793Publisher
AMER SOC HEMATOLOGY
DOI: 10.1182/blood.2021012328
Keywords
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Categories
Funding
- Deutsche Krebshilfe grants [108588, 70112517, 70112958]
- French Hospital Program for Clinical Research [PHRC 10-02-05]
- Danish Childhood Cancer Foundation [2019-5934]
- Danish Cancer Society [R257-A14720]
- US National Cancer Institute [CA021765]
- American Lebanese Syrian Associated Charities
- Swedish Childhood Cancer Fund [TJ2017-0076]
- Japan Agency for Medical Research and Development (AMED) [21ck0106612h0002]
- Blood Cancer UK
- NCTN Operations Center [U10CA180886]
- Statistics & Data Center (SDC) [U10CA180899]
- St Baldrick's Foundation
- Italian Association for Cancer Research (AIRC) [IG 2017: 20564, IG 2018: 21724, IG2015:17593]
- Italian Association for Cancer Research (CRUK/AIRC/FC AECC) [22791]
- Italian Association for Cancer Research (AIRC Molecular Clinical Oncology 5 per mille) [21147]
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Comparison of treatment strategies in de novo pediatric acute lymphoblastic leukemia (ALL) requires standardized measures of efficacy. Key parameters defining disease-related events, such as complete remission (CR), treatment failure (TF), and relapse, have significant heterogeneity in their definitions. A consensus definition was established by representatives of major international ALL clinical trial groups, which includes specific criteria for CR, TF, and relapse. These consensus definitions will improve the comparability of outcomes in pediatric ALL trials and promote the development of international collaborative trials.
Comparison of treatment strategies in de novo pediatric acute lymphoblastic leukemia (ALL) requires standardized measures of efficacy. Key parameters that define disease-related events, including complete remission (CR), treatment failure (TF; not achieving CR), and relapse (loss of CR) require an updated consensus incorporating modern diagnostics. We collected the definitions of CR, TF, and relapse from recent and current pediatric clinical trials for the treatment of ALL, including the key components of response evaluation (timing, anatomic sites, detection methods, and thresholds) and found significant heterogeneity, most notably in the definition of TF. Representatives of the major international ALL clinical trial groups convened to establish consensus definitions. CR should be defined at a time point no earlier than at the end of induction and should include the reduction of blasts below a specific threshold in bone marrow and extramedullary sites, incorporating minimal residual disease (MRD) techniques for marrow evaluations. TF should be defined as failure to achieve CR by a prespecified time point in therapy. Relapse can only be defined in patients who have achieved CR and must include a specific threshold of leukemic cells in the bone marrow confirmed by MRD, the detection of central nervous system leukemia, or documentation of extramedullary disease. Definitions of TF and relapse should harmonize with eligibility criteria for clinical trials in relapsed/refractory ALL. These consensus definitions will enhance the ability to compare outcomes across pediatric ALL trials and facilitate development of future international collaborative trials.
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