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Inotuzumab-ozogamicin Hyperbilirubinaemia and veno-occlusive disease: 4 case reports

In a a multi-centre, retrospective study of 84 patients, who were treated for relapsed/refractory (RR) B-cell acute lymphocytic leukaemia (ALL) between July 2013 and May 2019, four patients [ages and sexes not stated] were described, who developed hyperbilirubinaemia (1 patient) and veno-occlusive disease (VOD) (3 patients) secondary to inotuzumab ozogamicin. The patients with RR B-cell ALL started receiving IV inotuzumab ozogamicin at a starting dose of 0.8 mg on day 1 of each cycle, and 0.5mg on days 8 and 15. The duration of cycle 1 was 21 days, and 28 days for subsequent cycles. They had underwent allogeneic haematopoietic stem-cell transplantation (allo-HCT) before inotuzumab ozogamicin therapy. All patients received ursodeoxycholic acid prophylaxis for VOD. Subsequently, one patient developed hyperbilirubinaemia leading to discontinuation of inotuzumab ozogamicin treatment. One patient developed grade 2 VOD. This patient experienced relapse, 6 months following allo-HCT and again received mini hyperfractionated inotuzumab ozogamicin along with cyclophosphamide, vincristine, dexamethasone. Two more patients developed grade 4 VOD and they experienced late relapses following allo-HCT at 27 and 36 months, respectively. One of these two patients received mini hyper-fractionated inotuzumab ozogamicin along with cyclophosphamide, vincristine, dexamethasone while other patient received one cycle of inotuzumab ozogamicin at a cumulative dose of 1.8 mg/m2, followed by a second allo-HCT with myeloablative conditioning [durations of treatments to reactions onsets and outcomes not stated]. Badar T, et al. Real-World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated With Inotuzumab Ozogamicin. Clinical Lymphoma, Myeloma & 803500921 Leukemia 20: 556-560.e2, No. 8, Aug 2020. Available from: URL: http://doi.org/10.1016/j.clml.2020.03.004

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Editorial comment: Details of this case report have previously been published and processed for Adis PV [see Reactions 1787 p296; 803446226].

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Reactions 12 Sep 2020 No. 1821