Busulfan-fludarabine versus busulfan-cyclophosphamide for allogeneic transplant in acute myeloid leukemia: long term analysis of GITMO AML-R2 trial.

Autor: Cavallaro G; Department of Oncology and Hematology, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy., Grassi A; Department of Oncology and Hematology, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy., Pavoni C; Department of Oncology and Hematology, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy., Micò MC; Department of Oncology and Hematology, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy., Busca A; SSD Trapianto Cellule Staminali, AOU Città della Salute e della Scienza, Torino, Italy., Cavattoni IM; Ematologia e TMO, Ospedale di Bolzano, Azienda Sanitaria Alto Adige, Bolzano, Italy., Santarone S; Ospedale Civile, Pescara, Italy., Borghero C; Dipartimento di Ematologia, Ospedale San Bortolo, Vicenza, Italy., Olivieri A; Università Politecnica Delle Marche, Ancona, Italy., Milone G; Hematology and BMT Unit, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-San Marco', Catania, Italy., Chiusolo P; Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Musto P; Department of Precision and Regenerative Medicine and Ionian Area, 'Aldo Moro' University School of Medicine, and Unit of Hematology and Stem Cell Transplantation, AOUC Policlinico, Bari, Italy., Saccardi R; Azienda Ospedaliero Universitaria Careggi, Firenze, Italy., Patriarca F; Division of Hematology and Transplant Unit, Azienda Sanitaria Universitaria Friuli Centrale, Department of Medicine, Udine University, Udine, Italy., Pane F; Dipartimento di Medicina Clinica e Chirurgia, UOC Ematologia e Trapianti di Midollo, Azienda Ospedaliera Università Federico II, Napoli, Italy., Saporiti G; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Milan, Italy., Rivela P; Division of Hematology, A.O. SS Antonio e Biagio and Cesare Arrigo, Alessandria, Italy., Terruzzi E; Hematology Division, San Gerardo Hospital, Monza, Italy., Cerretti R; Hematology Division-Stem Cell Transplant Unit, Policlinico Tor Vergata, Rome, Italy., Marotta G; Azienda Ospedaliera Universitaria Senese, Siena, Italy., Carella AM; Ematologia e Centro Trapianto CSE, Fondazione Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy., Nagler A; Division of Hematology and Bone Marrow Transplantation, Chaim Sheba Medical Center, Tel-Hashomer, Israel., Russo D; Unit of Blood Diseases and Stem Cell Transplantation, University of Brescia, ASST Spedali Civili, Brescia, Italy., Corradini P; Università degli Studi di Milano and Fondazione Istituti di Ricovero e Cura a Carattere Scientifico (IRCSS) Istituto Nazionale dei Tumori, Milan, Italy., Bernasconi P; HSCT Unit, UOC Ematologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy., Iori AP; Division of Hematology, AOU Policlinico Umberto I, University 'Sapienza', Rome, Italy., Castagna L; UOSD Trapianto di Midollo, Ospedale Villa Sofia Cervello, Palermo, Italy., Mordini N; Santa Croce e Carle Hospital, Division of Haematology, Cuneo, Italy., Oldani E; Department of Oncology and Hematology, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy., Di Grazia C; UO Ematologia e Terapie Cellulari, IRCCS Ospedale Policlinico San Martino, Genova, Italy., Bacigalupo A; Ematologia, Fondazione Universitaria Policlinico Gemelli IRCCS, Rome, Italy., Rambaldi A; Department of Oncology and Hematology, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy. alessandro.rambaldi@unimi.it.
Jazyk: angličtina
Zdroj: Blood cancer journal [Blood Cancer J] 2024 Aug 21; Vol. 14 (1), pp. 141. Date of Electronic Publication: 2024 Aug 21.
DOI: 10.1038/s41408-024-01116-5
Abstrakt: We report the long-term results of a randomized trial (GITMO, AML-R2), comparing 1:1 the combination of busulfan and cyclophosphamide (BuCy2, n = 125) and the combination of busulfan and fludarabine (BuFlu, n = 127) as conditioning regimen in acute myeloid leukemia patients (median age 51 years, range 40-65) undergoing allogeneic hematopoietic stem cell transplantation. With a median follow-up of 6 years, significantly better non-relapse mortality (NRM) was confirmed in BuFlu recipients, which is sustained up to 4 years after transplant (10% vs. 20%, p = 0.0388). This difference was higher in patients older than 51 years (11% in BuFlu vs. 27% in BuCy2, p = 0.0262). The cumulative incidence of relapse, which was the first cause of death in the entire study population, did not differ between the two randomized arms. Similarly, the leukemia-free survival (LFS) and overall survival (OS) were not different in the two cohorts, even when stratifying patients per median age. Graft-and relapse-free survival (GRFS) in BuFlu arm vs. the BuCy2 arm was 25% vs. 20% at 4 years and 20% vs. 17% at 10 years. Hence, the benefit gained by NRM reduction is not offsets by an increased relapse. Leukemia relapse remains a major concern, urging the development of new therapeutic approaches.
(© 2024. The Author(s).)
Databáze: MEDLINE
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