Evidence map›Paper›PMID 39168989›Full record

Trial reportBlood cancer journal2024

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

Gianluca Cavallaro, Anna Grassi, Chiara Pavoni, Maria Caterina Micò, Alessandro Busca, Irene Maria Cavattoni, Stella Santarone, Carlo Borghero, Attilio Olivieri, Giuseppe Milone and 22 more

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Blood cancer journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors.

Gianluca CavallaroDepartment of Oncology and Hematology, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Anna GrassiDepartment of Oncology and Hematology, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Chiara PavoniDepartment of Oncology and Hematology, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Maria Caterina MicòDepartment of Oncology and Hematology, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Alessandro BuscaSSD Trapianto Cellule Staminali, AOU Città della Salute e della Scienza, Torino, Italy.
Irene Maria CavattoniEmatologia e TMO, Ospedale di Bolzano, Azienda Sanitaria Alto Adige, Bolzano, Italy.
Stella SantaroneOspedale Civile, Pescara, Italy.ORCID 0000-0002-5037-0515
Carlo BorgheroDipartimento di Ematologia, Ospedale San Bortolo, Vicenza, Italy.
Attilio OlivieriUniversità Politecnica Delle Marche, Ancona, Italy.
Giuseppe MiloneHematology and BMT Unit, Azienda Ospedaliero Universitaria Policlinico "G. Rodolico-San Marco", Catania, Italy.ORCID 0000-0002-7840-4414
Patrizia ChiusoloDipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.ORCID 0000-0002-1355-1587
Pellegrino MustoDepartment 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.ORCID 0000-0003-3277-6594
Riccardo SaccardiAzienda Ospedaliero Universitaria Careggi, Firenze, Italy.
Francesca PatriarcaDivision of Hematology and Transplant Unit, Azienda Sanitaria Universitaria Friuli Centrale, Department of Medicine, Udine University, Udine, Italy.
Fabrizio PaneDipartimento di Medicina Clinica e Chirurgia, UOC Ematologia e Trapianti di Midollo, Azienda Ospedaliera Università Federico II, Napoli, Italy.
Giorgia SaporitiFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Milan, Italy.
Paolo RivelaDivision of Hematology, A.O. SS Antonio e Biagio and Cesare Arrigo, Alessandria, Italy.ORCID 0000-0003-1035-4972
Elisabetta TerruzziHematology Division, San Gerardo Hospital, Monza, Italy.
Raffaella CerrettiHematology Division-Stem Cell Transplant Unit, Policlinico Tor Vergata, Rome, Italy.ORCID 0000-0003-3638-0650
Giuseppe MarottaAzienda Ospedaliera Universitaria Senese, Siena, Italy.
Angelo Michele CarellaEmatologia e Centro Trapianto CSE, Fondazione Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
Arnon NaglerDivision of Hematology and Bone Marrow Transplantation, Chaim Sheba Medical Center, Tel-Hashomer, Israel.
Domenico RussoUnit of Blood Diseases and Stem Cell Transplantation, University of Brescia, ASST Spedali Civili, Brescia, Italy.
Paolo CorradiniUniversità degli Studi di Milano and Fondazione Istituti di Ricovero e Cura a Carattere Scientifico (IRCSS) Istituto Nazionale dei Tumori, Milan, Italy.ORCID 0000-0002-9186-1353
Paolo BernasconiHSCT Unit, UOC Ematologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Anna Paola IoriDivision of Hematology, AOU Policlinico Umberto I, University "Sapienza", Rome, Italy.
Luca CastagnaUOSD Trapianto di Midollo, Ospedale Villa Sofia Cervello, Palermo, Italy.
Nicola MordiniSanta Croce e Carle Hospital, Division of Haematology, Cuneo, Italy.
Elena OldaniDepartment of Oncology and Hematology, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Carmen Di GraziaUO Ematologia e Terapie Cellulari, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
Andrea BacigalupoEmatologia, Fondazione Universitaria Policlinico Gemelli IRCCS, Rome, Italy.
Alessandro RambaldiDepartment of Oncology and Hematology, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy. alessandro.rambaldi@unimi.it.ORCID 0000-0002-3739-7502

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

BusulfanCyclophosphamideHematopoietic Stem Cell TransplantationImmunosuppressive AgentsLeukemia, Myeloid, AcuteTransplantation ConditioningVidarabineAdultAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleFollow-Up StudiesHumansMaleMiddle AgedTransplantation, HomologousBusulfanCyclophosphamidefludarabineImmunosuppressive AgentsVidarabine

Identifiers

PMID39168989
PMCPMC11339290

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.