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Clinical Trials |
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210 [S. S. F., B. B., T. F., C. D. B., M. A. C.]; Cancer and Leukemia B Statistical Center, Durham, North Carolina 27708 [S. L. G., R. K. D.]; University of Maryland, Baltimore, Maryland 21215 [E. J. L.]; Roswell Park Cancer Institute, Buffalo, New York 14263 [M. B.]; Mount Sinai Hospital, New York, New York 10029 [L. R. S.]; Duke University Comprehensive Cancer Center, Durham, North Carolina 27710 [J. C.]; University of Chicago, Chicago, Illinois 60637 [R. A. L.]; and Wayne State University School of Medicine, Detroit, Michigan 48201 [C. A. S.]
Purpose: The purpose of the study is to investigate the tolerability of interleukin 2 (IL-2) after intensive chemotherapy in elderly acute myeloid leukemia (AML) patients in first complete remission (CR).
Experimental Design: AML patients 
60 years in CR after induction and consolidation chemotherapy on Cancer and Leukemia Group B study 9420 were eligible if they had neutrophils 1 x 109/liters and platelets 75 x 109/liters. Patients received low-dose IL-2 (1 x 106 IU/m2/day s.c. for 90 days) or low-dose IL-2 with intermediate pulse doses (6–12 x 106 IU/m2/day s.c. for 3 days) every 14 days (maximum five pulses). In a subset of patients, we investigated the expression of NKG2D ligands by leukemic cells because they are likely important mediators of natural killer cytotoxicity.
Results: Of 35 CR patients receiving IL-2, 34 were evaluable for toxicity. Median age was 67 (range, 60–76) years. Thirteen of 16 patients receiving low-dose IL-2 completed the planned therapy, and 11 of 18 who also received intermediate pulse dose IL-2 therapy completed all five pulses. The spectrum of toxicity in both groups was similar, with predominantly grade 1–2 fatigue, fever, injection site reactions, nausea, anemia, and thrombocytopenia. Grade 3–4 hematological and nonhematological toxicity were more frequent in patients also receiving intermediate pulse dose IL-2 therapy. Grade 3–4 fatigue and hematological toxicity, although uncommon, were the major causes for discontinuing or attenuating therapy. In 8 cases, mRNA for one or more NKG2D ligands was detected in leukemic cells obtained at diagnosis before treatment.
Conclusions: Low-dose IL-2, with or without intermediate pulse dose therapy, given immediately after chemotherapy in first CR to elderly AML patients is well tolerated. Expression of NKG2D ligands by leukemic cells was detected in the majority of cases tested and should be assessed for correlation with response to IL-2 in future studies.
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