Evidence map›Paper›PMID 38058184›Full record

ArticleHaematologica2024

Impact of inotuzumab ozogamicin on outcome in relapsed or refractory acute B-cell lymphoblastic leukemia patients prior to allogeneic hematopoietic stem cell transplantation and risk of sinusoidal obstruction syndrome/venous occlusive disease.

Sabine Kayser, Chiara Sartor, Fabio Giglio, Alessandro Bruno, Jonathan Webster, Patrizia Chiusolo, Francesco Saraceni, Selene Guerzoni, Lara Pochintesta, Erika Borlenghi and 9 more

Open access · goldAbstract read
In one paragraph

Article in Haematologica, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 10% of its field
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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

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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

19 authors at 14 institutions in 3 countries.

Sabine KayserInstitute of Transfusion Medicine and Immunology, Medical Faculty Mannheim, Heidelberg University, German Red Cross Blood Service Baden-Württemberg-Hessen, Mannheim, Germany; NCT Trial Center, National Center of Tumor Diseases, German Cancer Research Center (DKFZ), Heidelberg. s.kayser@dkfz-heidelberg.de.
Chiara SartorIstituto di Ematologia "Seràgnoli", Bologna.
Fabio GiglioHematology and Bone Marrow Transplantation Unit, IRCCS San Raffaele Scientific Institute, Milano, Italy; Onco-Hematology Division, IEO European Institute of Oncology IRCCS, Milano.
Alessandro BrunoHematology and Bone Marrow Transplantation Unit, IRCCS San Raffaele Scientific Institute, Milano.
Jonathan WebsterSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.
Patrizia ChiusoloSezione di Ematologia, Dipartimento di Scienze Radiologiche ed Ematologiche, Università Cattolica del Sacro Cuore, Roma, Italy; Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico A. Gemelli IRCCS, Roma.
Francesco SaraceniDepartment of Hematology and Bone Marrow Transplantation, Azienda Ospedaliero-Universitaria delle Marche, Ancona.
Selene GuerzoniDepartment of Hematology and Bone Marrow Transplantation, Azienda Ospedaliero-Universitaria delle Marche, Ancona.
Lara PochintestaHematology and Bone Marrow Transplant (BMT) Unit, "Guglielmo da Saliceto" Piacenza Hospital, Piacenza.
Erika BorlenghiDepartment of Hematology, ASST Spedali Civili, Brescia.
Giovanni MarconiHematology Unit, IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori (IRST) "Dino Amadori", Meldola, FC.
Irene ZacheoHematology Unit, IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori (IRST) "Dino Amadori", Meldola, FC.
Marco CerranoDeptartment of Oncology, Division of Hematology, Presidio Molinette, AOU Città della Salute e Della Scienza, Torino.
Prassede SalutariAzienda USL di Pescara, Pescara.
Francesco RestucciaAzienda USL di Pescara, Pescara.
Mariachiara AbbenanteHematology Unit, IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Foggia.
Mark J LevisSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.
Richard F SchlenkNCT Trial Center, National Center of Tumor Diseases, German Cancer Research Center (DKFZ), Heidelberg, Germany; Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg.
Cristina PapayannidisIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna.
Azienda USL di Pescara · ITIstituto di Ematologia di Bologna · ITSidney Kimmel Comprehensive Cancer Center · USAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITCasa Sollievo della Sofferenza · ITGerman Red Cross · DEGuglielmo da Saliceto Hospital · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITIstituto di Ricovero e Cura a Carattere Scientifico San RaffaeleIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITPresidio Ospedaliero · ITUniversità Cattolica del Sacro Cuore · ITUniversity Hospital Heidelberg · DEVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We evaluated 58 patients with relapsed or refractory (r/r) acute B-lymphoblastic leukemia (B-ALL; median age 42.5 years; range, 16-69 years), treated with inotuzumab ozogamicin (INO) between 2016-2022 and who received an allogeneic hematopoietic stem cell transplantation (allo-HCT) consecutively. Forty-seven (81%) of the 58 patients were heavily pretreated receiving intensive chemotherapy +/- tyrosine kinase inhibitor, blinatumomab in 24 (41%) and allo-HCT at first-line in 11 (19%) patients. Complete remission rate prior to allo-HCT was 84%. Median follow-up was 30.5 months and median overall survival (OS) measured from start of INO was 11.2 months. One- and 2-year OS rates were 50% (95% confidence interval [CI]: 38.4-56.1) and 36.7% (95% CI: 25.5-52.9), respectively. Sinusoidal obstruction syndrome/venous occlusive disease (SOS/ VOD) after allo-HCT occurred in 17 (29%) patients. Of those, nine (53%) patients died due to SOS/VOD and multi-organ failure. Two had received >2 INO cycles (3 cycles, 5 cycles, N=1, each), all others ≤2 INO cycles prior to allo-HCT. Logistic regression analysis revealed conditioning with double alkylators (P=0.038) and allo-HCT during first-line therapy (P=0.050) as significant risk factors for SOS/VOD and in trend allo-HCT ≤60 days from last INO application (P=0.07), whereas number of INO cycles before allo-HCT and time between last INO application and allo-HCT were not significant. Relapse/progressive disease occurred in 20 (34%) patients. Of those, five (25%) patients are still alive, whereas 15 succumbed of their disease. Treatment with INO seems to be an effective approach with successful bridge-to-transplant. However, risk of SOS/VOD is high, necessitating continuous monitoring and recognition of SOS/VOD risk factors.

Indexed as

Hematopoietic Stem Cell TransplantationHepatic Veno-Occlusive DiseaseInotuzumab OzogamicinTransplantation, HomologousAdolescentAdultAgedAntineoplastic Agents, ImmunologicalFemaleHumansMaleMiddle AgedPrecursor B-Cell Lymphoblastic Leukemia-LymphomaRecurrenceTransplantation ConditioningTreatment OutcomeAntineoplastic Agents, ImmunologicalInotuzumab Ozogamicin

Identifiers

PMID38058184
PMCPMC11063861
OpenAlexW4389451773

What OpenQuestion holds

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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.