Lyon-University Hospital Experience with Gemtuzumab Ozogamicin Therapy in Acute Myeloid Leukemia: a 'Real-Life' Study

Abstract

Ninety-four adults with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) were treated with fractionated doses of gemtuzumab ozogamicin (GO) at one-single French center over ten years. We attempted to define predictive factors for response and survival. The overall response rate was 70% (86% in newly diagnosed and 65% in relapsed/refractory AML). Mortality during induction was 6%. Disease-free survival (DFS) and overall survival at three years after GO treatment was 36% and 31%, respectively. Median DFS in relapsed/refractory patients was eight months with a 3-year DFS at 34%. Among remitters, allogeneic hematopoietic stem cell transplantation (HSCT) can be performed in 28 cases (42%), including two patients in first-line therapy and 26 in further line. In relapsed/refractory patients undergoing allogeneic HSCT after responding to GO therapy, the median DFS was not reached. Incidences of transplant-related mortality, grade ≥ 3 acute graft-versus-host (GvH) disease, and extensive chronic GvH disease were 11%, 14%, and 25%, respectively. No sinusoidal obstruction syndromes were reported among allografted patients as among the other patients in the studied cohort. GO-based chemotherapy is a viable option for the treatment of relapsed/refractory AML patients and is a feasible schedule as a bridge to allogeneic transplant.

Keywords: Acute myeloid leukemia; Gemtuzumab ozogamicin; Prognosis; Treatment.

Figure 1

Kaplan-Meier analyses for DFS: (A) all remitters; (B) according to leukemia status (group 1: patients who received GO as front-line therapy; group 2: patients who received GO after one or further lines of therapy in the relapsed/refractory setting; group 3: very high-risk refractory patients who received GO 2 weeks prior starting conditioning regimen in the setting of allogeneic HSCT) (p values were given by Wald’s test, a HR value > 1 in the Cox model indicates that the outcome is worse in that category as compared with the baseline); (C) according to consolidation therapy after GO therapy (AlloHSCT or not) in relapsed/refractory patients (group 2 and group 3); (D) according to ELN stratification in relapsed/refractory patients (group 2 and group 3) (p values were given by Wald’s test, a HR value > 1 in the Cox model indicates that the outcome is worse in that category as compared with the baseline); (E) according to leukemia status (de novo AML or secondary AML).