Clinical outcomes of gemtuzumab ozogamicin for relapsed acute myeloid leukemia: single-institution experience
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ORIGINAL ARTICLE
Clinical outcomes of gemtuzumab ozogamicin for relapsed acute myeloid leukemia: single‑institution experience Naoko Hosono1 · Miyuki Ookura1 · Hiroaki Araie1 · Mihoko Morita1 · Kazuhiro Itoh1 · Yasufumi Matsuda1 · Takahiro Yamauchi1 Received: 9 June 2020 / Revised: 17 September 2020 / Accepted: 5 October 2020 © Japanese Society of Hematology 2020
Abstract We retrospectively evaluated the clinical efficacy and toxicity of gemtuzumab ozogamicin (GO) in patients with relapsed acute myeloid leukemia (AML). Nineteen patients (median 70 years) received GO (9 mg/m2, days 1 and 15) as salvage therapy in our institution between 2006 and 2017. The primary endpoint was the response rate. The secondary endpoint was the occurrence of adverse events. Thirteen patients had de novo AML, and 6 patients had secondary AML. Most of the patients had received salvage treatments more than once prior to GO. Six patients responded to the treatment (31.6%) with 3 complete remissions (15.8%). Five patients had stable disease, and 8 patients did not show any response. GO was more efficacious among the patients with fewer numbers of prior salvage treatments. CD33 positivity of leukemic cells was higher in responders than in nonresponders. Peripheral WT1 mRNA levels mostly decreased over time in the responders. The adverse event most commonly seen was febrile neutropenia (84%). No patient presented with veno-occlusive disease. Three patients died by day 30 (mortality rate 15.8%), one due to acute respiratory distress syndrome and the other two due to sepsis. GO remains an effective salvage treatment. Keywords Acute myeloid leukemia (AML) · Relapsed · Gemtuzumab ozogamicin (GO) · Wilms Tumor 1 (WT1)
Introduction Acute myeloid leukemia (AML) is an aggressive malignancy derived from myeloid cells in the bone marrow [1]. The treatment of AML consists mainly of chemotherapy and hematopoietic stem cell transplantation [2]. Conventional induction chemotherapy is a combination of cytarabine with an anthracycline (daunorubicin or idarubicin). Despite the high complete remission rate (70–80%) [3, 4], most patients eventually relapse, strongly suggesting a need for new agents [5]. Gemtuzumab ozogamicin (GO) is a monoclonal antibody against CD33 that is conjugated to the cytotoxic antibiotic calicheamicin [6]. GO was granted for accelerated approval by the Food and Drug Administration in the US in 2000 as a single-agent treatment for elderly patients with relapsed * Naoko Hosono hosono@u‑fukui.ac.jp 1
Department of Hematology and Oncology, University of Fukui, 23‑3, Shimoaizuki, Fukui, Matsuoka 910‑1193, Japan
AML with CD33 positivity. GO was also approved in Japan in 2006. However, the confirmatory, phase 3 randomized comparison between cytarabine/daunorubicin and cytarabine/daunorubicin plus GO failed to show a clinical benefit of the addition of GO to the conventional chemotherapy regimen [7]. There was no difference in CR rates (69% in the GO arm, 70% in the cytarabine/daunorubicin arm) but there was a higher mortality rate
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