Postremission therapy with low-dose interleukin 2 with or without intermediate pulse dose interleukin 2 therapy is well tolerated in elderly patients with acute myeloid leukemia

Cancer and Leukemia Group B study 9420

Sherif Farag, Stephen L. George, Edward J. Lee, Maria Baer, Richard K. Dodge, Brian Becknell, Todd Fehniger, Lewis R. Silverman, Jeffrey Crawford, Clara D. Bloomfield, Richard A. Larson, Charles A. Schiffer, Michael A. Caligiuri

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Abstract

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 × 109/liters and platelets >75 × 109/liters. Patients received low-dose IL-2 (1 × 106 IU/m2/day s.c. for 90 days) or low-dose IL-2 with intermediate pulse doses (6-12 × 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.

Original languageEnglish (US)
Pages (from-to)2812-2819
Number of pages8
JournalClinical Cancer Research
Volume8
Issue number9
StatePublished - Sep 2002
Externally publishedYes

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Acute Myeloid Leukemia
Interleukin-2
Leukemia
Neoplasms
Therapeutics
Ligands
Fatigue
Consolidation Chemotherapy
Remission Induction
Drug Therapy
Induction Chemotherapy
Interleukin-1
Thrombocytopenia
Nausea
Anemia
Neutrophils
Research Design
Fever
Blood Platelets
Messenger RNA

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Postremission therapy with low-dose interleukin 2 with or without intermediate pulse dose interleukin 2 therapy is well tolerated in elderly patients with acute myeloid leukemia : Cancer and Leukemia Group B study 9420. / Farag, Sherif; George, Stephen L.; Lee, Edward J.; Baer, Maria; Dodge, Richard K.; Becknell, Brian; Fehniger, Todd; Silverman, Lewis R.; Crawford, Jeffrey; Bloomfield, Clara D.; Larson, Richard A.; Schiffer, Charles A.; Caligiuri, Michael A.

In: Clinical Cancer Research, Vol. 8, No. 9, 09.2002, p. 2812-2819.

Research output: Contribution to journalArticle

Farag, S, George, SL, Lee, EJ, Baer, M, Dodge, RK, Becknell, B, Fehniger, T, Silverman, LR, Crawford, J, Bloomfield, CD, Larson, RA, Schiffer, CA & Caligiuri, MA 2002, 'Postremission therapy with low-dose interleukin 2 with or without intermediate pulse dose interleukin 2 therapy is well tolerated in elderly patients with acute myeloid leukemia: Cancer and Leukemia Group B study 9420', Clinical Cancer Research, vol. 8, no. 9, pp. 2812-2819.
Farag, Sherif ; George, Stephen L. ; Lee, Edward J. ; Baer, Maria ; Dodge, Richard K. ; Becknell, Brian ; Fehniger, Todd ; Silverman, Lewis R. ; Crawford, Jeffrey ; Bloomfield, Clara D. ; Larson, Richard A. ; Schiffer, Charles A. ; Caligiuri, Michael A. / Postremission therapy with low-dose interleukin 2 with or without intermediate pulse dose interleukin 2 therapy is well tolerated in elderly patients with acute myeloid leukemia : Cancer and Leukemia Group B study 9420. In: Clinical Cancer Research. 2002 ; Vol. 8, No. 9. pp. 2812-2819.
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abstract = "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 × 109/liters and platelets >75 × 109/liters. Patients received low-dose IL-2 (1 × 106 IU/m2/day s.c. for 90 days) or low-dose IL-2 with intermediate pulse doses (6-12 × 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.",
author = "Sherif Farag and George, {Stephen L.} and Lee, {Edward J.} and Maria Baer and Dodge, {Richard K.} and Brian Becknell and Todd Fehniger and Silverman, {Lewis R.} and Jeffrey Crawford and Bloomfield, {Clara D.} and Larson, {Richard A.} and Schiffer, {Charles A.} and Caligiuri, {Michael A.}",
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T1 - Postremission therapy with low-dose interleukin 2 with or without intermediate pulse dose interleukin 2 therapy is well tolerated in elderly patients with acute myeloid leukemia

T2 - Cancer and Leukemia Group B study 9420

AU - Farag, Sherif

AU - George, Stephen L.

AU - Lee, Edward J.

AU - Baer, Maria

AU - Dodge, Richard K.

AU - Becknell, Brian

AU - Fehniger, Todd

AU - Silverman, Lewis R.

AU - Crawford, Jeffrey

AU - Bloomfield, Clara D.

AU - Larson, Richard A.

AU - Schiffer, Charles A.

AU - Caligiuri, Michael A.

PY - 2002/9

Y1 - 2002/9

N2 - 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 × 109/liters and platelets >75 × 109/liters. Patients received low-dose IL-2 (1 × 106 IU/m2/day s.c. for 90 days) or low-dose IL-2 with intermediate pulse doses (6-12 × 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.

AB - 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 × 109/liters and platelets >75 × 109/liters. Patients received low-dose IL-2 (1 × 106 IU/m2/day s.c. for 90 days) or low-dose IL-2 with intermediate pulse doses (6-12 × 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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