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Acute lymphoblastic leukemia (ALL) is effective in children with systemic radiotherapy (TBI) before hematopoietic stem cell transplantation (HSCT), but long-term side effects are worrying.
FORUM study assessed whether preparatory combination chemotherapy could replace TBI in such patients.
The study was an international multi-center, open-label, randomized Phase III non-inefficient trial that recruited patients aged 18 and under who had HSCT between the ages of 4 and 21 who had received complete remission before HSCT, and who were randomly treated with TBI (12 Gy) plus etoposides vs. fluoridalabin, sulfonipan, and sulphate.
the non-poor efficiency threshold is 8 per cent.
the patient is randomly assigned once the non-inefficient boundary value is reached.
2013-December 2018, a total of 543 patients were screened, of whom 417 participated in random groupings, 212 received TBI, and 201 received chemotherapy conditioning.
will reach the non-inefficient threshold by March 31, 2019.
2.1 years of mid-level follow-up.
, the overall survival rate (OS) after TBI was significantly higher (0.91 vs. 0.75) after chemotherapy.
2-year cumulative recurrence rate was 0.12 vs. 0.33 in the TBI group and the chemotherapy conditioning group, and the treatment-related mortality rate was 0.02 vs. 0.09, respectively.
secondary endpoint showed that TBI combined etoposides were better and had a lower risk of recurrence than chemotherapy-conditioned OS.
, it is advisable to use TBI combined etoposide for pre-transplant preparation for high-risk ALL patients over 4 years of age who intend to have the allogeneic HSCT.
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