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Clofarabine added to intensive treatment in adult patients with newly diagnosed ALL:the HOVON-100 trial
- Source :
- Rijneveld , A W , van der Holt , B , the Dutch-Belgian HOVON Cooperative group , de Weerdt , O , Biemond , B J , van de Loosdrecht , A A , van der Wagen , L E , Bellido , M , van Gelder , M , van der Velden , W J F M , Selleslag , D , van Lammeren-Venema , D , Halkes , C J M , Fijnheer , R , Havelange , V , van Sluis , G L , Legdeur , M C , Deeren , D , Gadisseur , A , Sinnige , H A M , Breems , D A , Jaspers , A , Legrand , O , Terpstra , W E , Boersma , R S , Mazure , D , Triffet , A , Tick , L W , Beel , K , Maertens , J A , Beverloo , H B , Bakkus , M , Homburg , C H E , de Haas , V , van der Velden , V H J & Cornelissen , J J 2022 , ' Clofarabine added to intensive treatment in adult patients with newly diagnosed ALL : the HOVON-100 trial ' , Blood advances , vol. 6 , no. 4 , pp. 1115-1125 .
- Publication Year :
- 2022
-
Abstract
- Clofarabine (CLO) is a nucleoside analog with efficacy in relapsed/refractory acute lymphoblastic leukemia (ALL). This randomized phase 3 study aimed to evaluate whether CLO added to induction and whether consolidation would improve outcome in adults with newly diagnosed ALL. Treatment of younger (18-40 years) patients consisted of a pediatric-inspired protocol, and for older patients (41-70 years), a semi-intensive protocol was used. Three hundred and forty patients were randomized. After a median follow-up of 70 months, 5-year event-free survival (EFS) was 50% and 53% for arm A and B (CLO arm). For patients #40 years, EFS was 58% vs 65% in arm A vs B, whereas in patients .40 years, EFS was 43% in both arms. Complete remission (CR) rate was 89% in both arms and similar in younger and older patients. Minimal residual disease (MRD) was assessed in 200 patients (60%). Fifty-four of 76 evaluable patients (71%) were MRD2 after consolidation 1 in arm A vs 75/81 (93%) in arm B (P 5 .001). Seventy (42%) patients proceeded to allogeneic hematopoietic stem cell transplantation in both arms. Five-year overall survival (OS) was similar in both arms: 60% vs 61%. Among patients achieving CR, relapse rates were 28% and 24%, and nonrelapse mortality was 16% vs 17% after CR. CLO-treated patients experienced more serious adverse events, more infections, and more often went off protocol. This was most pronounced in older patients. We conclude that, despite a higher rate of MRD negativity, addition of CLO does not improve outcome in adults with ALL, which might be due to increased toxicity.
Details
- Database :
- OAIster
- Journal :
- Rijneveld , A W , van der Holt , B , the Dutch-Belgian HOVON Cooperative group , de Weerdt , O , Biemond , B J , van de Loosdrecht , A A , van der Wagen , L E , Bellido , M , van Gelder , M , van der Velden , W J F M , Selleslag , D , van Lammeren-Venema , D , Halkes , C J M , Fijnheer , R , Havelange , V , van Sluis , G L , Legdeur , M C , Deeren , D , Gadisseur , A , Sinnige , H A M , Breems , D A , Jaspers , A , Legrand , O , Terpstra , W E , Boersma , R S , Mazure , D , Triffet , A , Tick , L W , Beel , K , Maertens , J A , Beverloo , H B , Bakkus , M , Homburg , C H E , de Haas , V , van der Velden , V H J & Cornelissen , J J 2022 , ' Clofarabine added to intensive treatment in adult patients with newly diagnosed ALL : the HOVON-100 trial ' , Blood advances , vol. 6 , no. 4 , pp. 1115-1125 .
- Notes :
- application/pdf, English
- Publication Type :
- Electronic Resource
- Accession number :
- edsoai.on1376785145
- Document Type :
- Electronic Resource