51. Gemtuzumab ozogamicin (Mylotarg) as single-agent treatment for frail patients 61 years of age and older with acute myeloid leukemia: final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto Leukemia Groups
- Author
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Jean-Pierre Marie, Roberto Stasi, Petra Muus, Stefan Suciu, D Selleslag, Liliana Baila, Francesco Nobile, Sergio Amadori, Roelof Willemze, Zwi N. Berneman, C. Denzlinger, V. Cassibba, Franco Mandelli, F. Beeldens, T. de Witte, J.F.M. Pruijt, Marco Vignetti, and Reinhard Stauder
- Subjects
blood toxicity ,Myeloid ,Male ,hypotension ,medicine.medical_treatment ,CD33 ,diarrhea ,liver venoocclusive disease ,80 and over ,cancer survival ,statistical significance ,Aged, 80 and over ,clinical article ,health care organization ,drug dose regimen ,liver dysfunction ,adult ,Remission Induction ,Antibodies, Monoclonal ,clinical trial ,acute granulocytic leukemia ,Gemtuzumab ,Survival Rate ,Italy ,priority journal ,Oncology ,monotherapy ,Acute Disease ,Aged ,Aminoglycosides ,therapeutic use ,Antibodies ,Monoclonal ,Female ,Frail Elderly ,Humans ,Immunotoxins ,Leukemia ,classification/drug therapy ,Middle Aged ,medicine.medical_specialty ,bone marrow suppression ,infusion site reaction ,neutropenia ,Iron metabolism [IGMD 7] ,human ,survival time ,human cell ,CD33 antigen ,medicine.disease ,infection ,phase 2 clinical trial ,chemistry ,Settore MED/15 - Malattie del Sangue ,drug hypersensitivity ,Cancer Research ,paracetamol ,groups by age ,leukemia remission ,Phases of clinical research ,health status ,antihistaminic agent ,gemtuzumab ozogamicin ,immunotoxin ,aged ,allergic reaction ,antineoplastic activity ,article ,bacterial infection ,bleeding disorder ,cancer chemotherapy ,cancer research ,controlled clinical trial ,controlled study ,drug fatality ,drug infusion ,Europe ,febrile neutropenia ,female ,geriatric care ,heart arrhythmia ,heart disease ,liver failure ,liver toxicity ,male ,mucosa inflammation ,mycosis ,side effect ,Leukemia, Myeloid ,chemistry.chemical_compound ,Immune Regulation [NCMLS 2] ,Myeloid leukemia ,Hematology ,medicine.drug ,Gemtuzumab ozogamicin ,Antibodies, Monoclonal, Humanized ,Translational research [ONCOL 3] ,Internal medicine ,Calicheamicin ,medicine ,Survival rate ,Chemotherapy ,business.industry ,Immunotherapy, gene therapy and transplantation [UMCN 1.4] ,Surgery ,business - Abstract
Contains fulltext : 47837.pdf (Publisher’s version ) (Closed access) The therapeutic activity and toxicity profile of gemtuzumab ozogamicin were assessed in 40 patients >60 years of age with acute myeloid leukemia (AML) who were not considered eligible for conventional chemotherapy because of advanced age or poor performance status. The drug was administered at the dose of 9 mg/m2 as a single 2-h i.v. infusion on days 1 and 15. Patients who achieved a complete remission (CR/CRp) were to receive a consolidation with two additional injections of the immunotoxin at the same dose. The overall CR/CRp rate was 17% (95% CI, 8-32%). The CR/CRp rate in patients 61-75 years old was 33% (6/18), and 5% (1/22) in patients older than 75 years. Induction death occurred in seven patients (17%), all aged above 75 years. Overall survival was significantly longer in patients aged 61-75 years than in older individuals (P=0.05), and in CD33+ cases than in CD33- cases (P=0.05). We conclude that the dose/schedule of gemtuzumab ozogamicin used in this trial is too toxic in the age group over 75 years. For these patients, additional studies with reduced doses of the immunotoxin are warranted.
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- 2005