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Objectives: Inotuzumab ozogamicin (InO), a CD22-directed antibody-drug conjugate indicated for relapsed/refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL), is associated with hepatotoxicity and hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), particularly after post-hematopoietic stem cell transplantation (HSCT). In this sttudy, we evaluate HSCT outcomes in patients (pts) who received InO before HSCT. Materials and methods: This observational, post-authorization safety study included pts (>=18y) in the US with B-cell precursor ALL and R/R ALL who received InO and proceeded to first allogeneic HSCT. Post-HSCT outcomes included overall survival (OS), non-relapse mortality (NRM), relapse, and adverse events (AEs). Multivariate analysis examined prognostic factors for NRM and VOD. This final analysis is based om 5-y data. Results: 261 pts (median age 39y, 58% male) were evaluated: 36% in first complete remission (CR1), 46% in CR2, 11% in CR>=3, 4% in first relapse, 1% in >= third relapse, and 2% with primary induction failure. Prior to HSCT, 32%, 47%, 14%, 5% and Median time from last InO dose to HSCT was 2.5 mo. Post-HSCT 18-mo OS was 54% and 50% and 18-mo NRM was 22% and 25% for pts with ALL and R/R ALL respectively; most common causes of NRM were VOD (26%, 24%) and graft-versus-host disease (GVHD: 22%, 19%). AEs=30% of pts with ALL and R/R ALL respectively were bacterial infection (51%, 56%), viral infection (44%, 44%) and acute GVHD (grades II-IV; 43%, 41%). 35 pts with ALL developed VOD: 15 cases were mild, 20 were severe and 22 died = 3.3 mg/m2; and 15%, 2%, 17% and 14% in pts with time from las InO dose to HSCT of 1, 1.1-1.6, 1.7-4, and >=3 mo. 204 pts with ALL were included in multivariate analyses; Karnofsky score |
