Abstract
Objectives: To the best of our knowledge, data from Gemtuzumab ozogamicin in Acute Myeloid Leukemia (AML) patients with failure of organ functions and poor performance status are extremely lacking. Moreover, the fast recovery from organ failure, after Gemtuzumab ozogamicin administration, has never been reported. This study aimed to demonstrate the efficacy and rapid response of Gemtuzumab ozogamicin in refractory acute myeloid leukemia (AML) patients with pulmonary and kidney failure and poor performance status. Three refractory AML patients, with organ dysfunction, are described. One patient was pre-treated with intensive chemotherapy, and two other patients progressed during Azacitidine treatment. Two patients had respiratory failure grade 2 and one patient suffered from acute kidney insufficiency. Two patients were highly febrile with an elevated С-Reactive Protein (CRP) level. The WHO performance status of three was measured in all patients. Gemtuzumab ozogamicin administration was performed in three patients, followed by a further switch to Gemtuzumab ozogamicin + Azacitidine or “7+3” treatment. Results: Gemtuzumab ozogamicin administration resulted in abrupt fever cessation in two febrile patients simultaneously with a rapid decrease in CRP level and fast resolution of respiratory failure. Recovery of kidney function was noticed rapidly in patients with renal insufficiency. The WHO performance status was elevated in all three patients. No adverse grade II–III effects were noticed. Further treatment made two patients eligible for intensive chemotherapy, one patient underwent allogeneic stem cell transplantation, and the patient with kidney failure obtained complete remission. Conclusions: Gemtuzumab ozogamicin therapy appeared to be safe and highly efficacious in relapsed/refractory AML patients with organ dysfunction, like pulmonary or renal failure and poor performance status, and may contribute to rapid recovery from organ failures.
Highlights
Patients with acute myeloid leukemia (AML) comprise the cohort of patients at a higher risk of life-threatening complications and intensive care unit (ICU) admission for intensive monitoring and treatment due to the severity of the disease, hospital-acquired infections, and intensive chemotherapy regimens used [1,2].Biology 2020, 9, 28; doi:10.3390/biology9020028 www.mdpi.com/journal/biologyRelapsed and refractory AML (10–40% of AML) represents the most common group of AML patients with organ dysfunction and poor outcomes [3].Low toxicity of Gemtuzumab ozogamicin (GO) seems to provide a new, promising option for the treatment of highly compromised patients
Amadori et al reported the results of the GIMEMA trial of GO versus best supportive care in the treatment of unfit for intensive chemotherapy patients in a front-line setting [4]
GO has been shown to be an efficacious treatment in relapse/refractory AML patients [5,6]
Summary
Patients with acute myeloid leukemia (AML) comprise the cohort of patients at a higher risk of life-threatening complications and intensive care unit (ICU) admission for intensive monitoring and treatment due to the severity of the disease, hospital-acquired infections, and intensive chemotherapy regimens used [1,2].Biology 2020, 9, 28; doi:10.3390/biology9020028 www.mdpi.com/journal/biologyRelapsed and refractory AML (10–40% of AML) represents the most common group of AML patients with organ dysfunction and poor outcomes [3].Low toxicity of Gemtuzumab ozogamicin (GO) seems to provide a new, promising option for the treatment of highly compromised patients. Relapsed and refractory AML (10–40% of AML) represents the most common group of AML patients with organ dysfunction and poor outcomes [3]. Amadori et al reported the results of the GIMEMA trial of GO versus best supportive care in the treatment of unfit for intensive chemotherapy patients in a front-line setting [4]. The toxicity of GO was comparable to best supportive care, whereas a statistically significant increase in overall survival was shown in the GO arm. GO has been shown to be an efficacious treatment in relapse/refractory AML patients [5,6]. Significant organ dysfunction was the exclusion criterion in all these trials. To the best of our knowledge, data of GO in AML patients with organ failure are lacking
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