Premium
Long‐term outcome evaluation of medium/high risk acute lymphoblastic leukaemia children treated with or without cranial radiotherapy in the EORTC 58832 randomized study
Author(s) -
Piette Caroline,
Suciu Stefan,
Bertrand Yves,
Uyttebroeck Anne,
Vandecruys Els,
Plat Geneviève,
Paillard Catherine,
Pluchart Claire,
Sirvent Nicolas,
Maurus Renée,
Poirée Maryline,
Simon Pauline,
Ferster Alina,
Hoyoux Claire,
Mazingue Françoise,
Paulus Robert,
Freycon Claire,
Thomas Caroline,
Philippet Pierre,
Gilotay Caroline,
Werff Ten Bosch Jutte,
Rohrlich Pierre S.,
Benoit Yves
Publication year - 2020
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.16337
Subject(s) - medicine , hazard ratio , incidence (geometry) , confidence interval , radiation therapy , adverse effect , acute lymphocytic leukemia , gastroenterology , surgery , leukemia , lymphoblastic leukemia , physics , optics
Summary We investigated the long‐term outcome, the incidence of second neoplasms (SN) and the rate of late adverse effects (LAE) in children with central nervous system (CNS) negative medium/high‐risk de novo acute lymphoblastic leukaemia (ALL), in first complete remission (CR1) at end of late intensification, randomized to receive no cranial radiotherapy (No CRT, n = 92) versus CRT (standard arm, n = 84) in the non‐inferiority EORTC 58832 study (1983–1989). Median follow‐up was 20 years (range 4–32 years). The 25‐year disease‐free survival rate (± SE ) was 67·4 ± 4·9% without CRT and 70·2 ± 5·0% with CRT. The 25‐year incidence of isolated (6·5 ± 2·6% vs. 4·8 ± 2·3%) and any CNS relapse {8·7 ± 2·9% vs. 11·9 ± 3·5%; hazard ratio (HR) 0·71 [95% confidence interval (CI) 0·28–1·79]; test of non‐inferiority: P = 0·01} was not increased without CRT. The 25‐year SN incidence in CR1 was 7·9 ± 4·6% vs. 11·0 ± 4·2%. The 25‐year event‐free and overall survival rates were quite similar in both arms [59·5 ± 6·3% vs. 60·5 ± 5·9%, HR 0·94 (95% CI 0·57–1·52), and 78·1 ± 4·3% vs. 78·5 ± 4·5%, HR 1·00 (95% CI 0·53–1·88)]. Omission of CRT was associated with dramatic decrease in CNS and endocrine LAE rates. In conclusion, our data suggest that, with proper systemic and intrathecal CNS prophylaxis, CRT could totally be omitted in CR1 without jeopardizing survival, while decreasing LAE in childhood ALL.