Failure of three novel regimens to improve outcome for patients with relapsed or refractory acute myeloid leukaemia: a report from the Eastern Cooperative Oncology Group |
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| Authors: | Mark R Litzow Megan Othus Larry D Cripe Steven D Gore Hillard M Lazarus Sandra J Lee John M Bennett Elisabeth M Paietta Gordon W Dewald Jacob M Rowe Martin S Tallman for the Eastern Cooperative Oncology Group Leukemia Committee |
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| Institution: | Division of Hematology, Mayo Clinic, Rochester, MN;, Department of Biostatistical Science, Dana-Farber Cancer Institute, Boston, MA;, University of Indiana, Indianapolis, IN;, Sidney Kimmel Cancer Center, Johns Hopkins University, Baltimore, MD;, University Hospitals Case Medical Center, Ireland Cancer Center, Cleveland, OH;, University of Rochester Cancer Center, University of Rochester, Rochester, NY;, Our Lady of Mercy Cancer Center, Bronx, NY;, Department of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine, Rochester, MN;, Department of Hematology and BMT, Rambam Medical Center, Haifa, Israel;, and Northwestern University Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center, Chicago, IL, USA |
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| Abstract: | The treatment of relapsed acute myeloid leukaemia (AML) remains unsatisfactory. We conducted a phase II randomized trial where patients received intermediate-dose cytarabine for 4 d followed by gemtuzumab ozogamicin on day 5 (Arm A), or combined with liposomal daunorubicin for 3 d (Arm B), or cytarabine given for 5 d combined with cyclophosphamide for 3 d and topotecan by continuous infusion for 5 d (Arm C). Eligible patients had primary refractory AML, a first relapse after a remission of <1 year, or a second or greater relapse. The primary objective of this trial was attainment of a conventional complete remission (CR) or a CR without platelet recovery (CRp) in at least 40% of patients. The CR/CRp rates for the 82 eligible patients were 3/26 (12%) in Arm A, 2/29 (7%) in Arm B, and 1/27 (4%) in Arm C. No patients who had relapsed within 6 months of initial CR or who had suffered multiple relapses responded. More than 95% of patients subsequently died of AML. No unexpected toxicities were encountered. We conclude that none of these three regimens were effective enough in the treatment of high-risk relapsed or refractory AML to warrant further study. This trial was registered at http://www.clinicaltrials.gov as #NCT00005962. |
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| Keywords: | acute myeloid leukaemia relapse gemtuzumab ozogamicin liposomal daunorubicin topotecan |
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