1. Randomized trial of two schedules of low-dose gemtuzumab ozogamicin as induction monotherapy for newly diagnosed acute myeloid leukaemia in older patients not considered candidates for intensive chemotherapy. A phase II study of the EORTC and GIMEMA leukaemia groups (AML-19)
- Author
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Adriano Venditti, Giuliana Alimena, Liliana Baila, Domenico Magro, Emma Cacciola, Dominik Selleslag, Sergio Amadori, Theo de Witte, Petra Muus, Francesco Lauria, Vittorio Rizzoli, Erika Borlenghi, Gianluca Gaidano, Marco Vignetti, Roberto Stasi, Giuseppe Torelli, and Stefan Suciu
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Male ,medicine.medical_specialty ,Randomization ,acute myeloid leukaemia ,acute myeloid leukemia ,elderly ,gemtuzumab ozogamicin ,supportive care ,targeted therapy ,Gemtuzumab ozogamicin ,medicine.medical_treatment ,Phases of clinical research ,Antineoplastic Agents ,Antibodies, Monoclonal, Humanized ,Article ,Drug Administration Schedule ,law.invention ,Randomized controlled trial ,Immune Regulation [NCMLS 2] ,Translational research [ONCOL 3] ,law ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,Adverse effect ,Aged ,Chemotherapy ,business.industry ,Antibodies, Monoclonal ,Hematology ,Middle Aged ,Gemtuzumab ,Surgery ,Leukemia, Myeloid, Acute ,Regimen ,Aminoglycosides ,Treatment Outcome ,Disease Progression ,Feasibility Studies ,Female ,business ,Settore MED/15 - Malattie del Sangue ,medicine.drug - Abstract
Contains fulltext : 89504.pdf (Publisher’s version ) (Closed access) This study compared two schedules of low-dose gemtuzumab ozogamicin (GO) as induction monotherapy for untreated acute myeloid leukaemia in older patients unfit for intensive chemotherapy, to identify the more promising regimen for further study. Patients were randomized to receive either best supportive care or a course of GO according to one of two schedules: 3 mg/m(2) on days 1, 3 and 5 (arm A), or GO 6 mg/m(2) on day 1 and 3 mg/m(2) on day 8 (arm B). Primary endpoint was the rate of disease non-progression (DnP), defined as the proportion of patients either achieving a response or maintaining a stable disease following GO induction in each arm. Fifty-six patients were randomized in the two GO arms (A, n = 29; B, n = 27). The rate of DnP was 38% [90% confidence interval (CI), 23-55] in arm A, and 63% (90% CI, 45-78) in arm B. Peripheral cytopenias were the most common adverse events for both regimens. The all-cause early mortality rate was 14% in arm A and 11% in arm B. The day 1 + 8 schedule, which was associated with the highest rate of DnP, met the statistical criteria to be selected as the preferred regimen for phase III comparison with best supportive care. 01 mei 2010
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- 2010