title: Risk of sinusoidal obstruction syndrome in allogeneic stem cell transplantation after prior gemtuzumab ozogamicin treatment: a retrospective study from the Acute Leukemia Working Party of the EBMT.
abstract: Gemtuzumab ozogamicin (GO) may increase the risk of sinusoidal obstruction syndrome (SOS) when used prior to allogeneic stem cell transplantation (HSCT). We assessed SOS incidence and outcomes after HSCT of 146 adults, with a median age of 50 years, previously receiving GO. SOS prophylaxis was used in 69 patients (heparin n=57, ursodeoxycholic acid n=8, defibrotide n=4). Cumulative incidence (CI) of SOS was 8% (n=11), with death in 3 patients. Median interval between last GO dose and HSCT was 130 days. Overall survival (OS) and SOS incidence did not differ for patients receiving GO ⩽3.5 months before HSCT and the others. CI of acute and chronic GVHD was 31% and 25%, respectively. Probability of OS and leukemia-free survival (LFS) at 5 years was 40% and 37%, respectively. Relapse incidence and non-relapse mortality were 42% and 21%, respectively. In multivariate analysis, active disease at HSCT was associated with relapse and worse LFS and OS (P<0.03). Liver abnormalities before HSCT correlated with worse OS (P<0.03). Use of low-dose GO prior to HSCT is associated with an acceptable SOS incidence. Prospective studies investigating the role and the utility of SOS prophylaxis are warranted.
authors.affiliation: Hematology Department, Hôpital Saint Antoine, Service d'Hématologie et Thérapie Cellulaire, Paris, France.|Hematology Department, Federico II University, Naples, Italy.
authors.forename: G
authors.identifier: http://orcid.org/0000-0002-5201-1786
authors.initials: G
authors.lastname: Battipaglia
authors.affiliation: Hematology Department, Hôpital Saint Antoine, Service d'Hématologie et Thérapie Cellulaire, Paris, France.|Hospital Saint-Antoine, Paris University UPMC, Paris, France.
authors.forename: M
authors.initials: M
authors.lastname: Labopin
authors.affiliation: Hematology Department, Azienda Ospedaliero Universitaria S Maria della Misericordia di Udine, Udine, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Candoni
authors.affiliation: Hematology Department, Azienda Ospedaliero Universitaria S Maria della Misericordia di Udine, Udine, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Fanin
authors.affiliation: Hematology Department, Institut Paoli-Calmettes, Marseille, France.
authors.forename: J
authors.initials: J
authors.lastname: El Cheikh
authors.affiliation: Hematology Department, Institut Paoli-Calmettes, Marseille, France.
authors.forename: D
authors.initials: D
authors.lastname: Blaise
authors.affiliation: Hematology Department 1G, Centre Hospitalier Lyon Sud, Pierre Benite, France.
authors.forename: M
authors.initials: M
authors.lastname: Michallet
authors.affiliation: Hematology Department, Hôpital Saint Antoine, Service d'Hématologie et Thérapie Cellulaire, Paris, France.
authors.forename: A
authors.initials: A
authors.lastname: Ruggeri
authors.affiliation: Hematology Department, Centre Becquerel, Rouen, France.
authors.forename: N
authors.initials: N
authors.lastname: Contentin
authors.affiliation: Department of Hematology, ICO Badalona-Germans Trias i Pujol Hospital, Josep Carreras Leukemia Research Institute, Universitat Autonoma de Barcelona, Badalona, Spain.
authors.forename: J M
authors.initials: JM
authors.lastname: Ribera
authors.affiliation: Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Stadler
authors.affiliation: Hematology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Sierra
authors.affiliation: Hematology Department, Leiden University Medical Center, The Netherlands.
authors.forename: P A
authors.initials: PA
authors.lastname: von dem Borne
authors.affiliation: The Christie Clinic, Manchester, UK.
authors.forename: A
authors.initials: A
authors.lastname: Bloor
authors.affiliation: Haematology Department, Hopital Saint-Louis, Paris, France.
authors.forename: G
authors.initials: G
authors.lastname: Socié
authors.affiliation: Acute Leukemia Working Party of EBMT, Paris, France.|Hematology Division, Chaim Sheba Medical Center, Tel Hashomer, Israel.
authors.forename: A
authors.initials: A
authors.lastname: Nagler
authors.affiliation: Hematology Department, Hôpital Saint Antoine, Service d'Hématologie et Thérapie Cellulaire, Paris, France.|Hospital Saint-Antoine, Paris University UPMC, Paris, France.|Acute Leukemia Working Party of EBMT, Paris, France.
authors.forename: M
authors.initials: M
authors.lastname: Mohty
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000617:Aminoglycosides / Q000627:therapeutic use / Q000633:toxicity*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use / Q000633:toxicity*; D005260:Female; D000079982:Gemtuzumab; D006086:Graft vs Host Disease; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006504:Hepatic Veno-Occlusive Disease / Q000209:etiology* / Q000401:mortality / Q000517:prevention & control; D006801:Humans; D007938:Leukemia / Q000150:complications* / Q000401:mortality / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011292:Premedication / Q000379:methods* / Q000401:mortality; D012189:Retrospective Studies; D016019:Survival Analysis; D014184:Transplantation, Homologous; D055815:Young Adult
chemical_list: D000617:Aminoglycosides; D061067:Antibodies, Monoclonal, Humanized; D000079982:Gemtuzumab