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)
Open Access
- 12 April 2010
- journal article
- research article
- Published by Wiley in British Journal of Haematology
- Vol. 149 (3), 376-382
- https://doi.org/10.1111/j.1365-2141.2010.08095.x
Abstract
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/m2 on days 1, 3 and 5 (arm A), or GO 6 mg/m2 on day 1 and 3 mg/m2 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.Keywords
This publication has 18 references indexed in Scilit:
- Treatment of acute myeloid leukemiaHaematologica, 2009
- Gemtuzumab ozogamicin in the treatment of acute myeloid leukemiaCancer Treatment Reviews, 2008
- Composite and surrogate outcomes in randomised controlled trialsBMJ, 2007
- A comparison of low‐dose cytarabine and hydroxyurea with or without all‐trans retinoic acid for acute myeloid leukemia and high‐risk myelodysplastic syndrome in patients not considered fit for intensive treatmentCancer, 2007
- High efficacy and safety profile of fractionated doses of Mylotarg as induction therapy in patients with relapsed acute myeloblastic leukemia: a prospective study of the alfa groupLeukemia, 2006
- Age and acute myeloid leukemiaBlood, 2006
- Acute myelogenous leukemia in elderly patients not eligible for intensive chemotherapy: the dark side of the moonAnnals of Oncology, 2005
- Final report of the efficacy and safety of gemtuzumab ozogamicin (Mylotarg) in patients with CD33‐positive acute myeloid leukemia in first recurrenceCancer, 2005
- 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 GroupsLeukemia, 2005
- The World Health Organization (WHO) classification of the myeloid neoplasmsBlood, 2002