Originally published as JCO Early Release 10.1200/JCO.2008.17.0472 on June 30 2008

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Low-Dose Interleukin-2 Immunotherapy Does Not Improve Outcome of Patients Age 60 Years and Older With Acute Myeloid Leukemia in First Complete Remission: Cancer and Leukemia Group B Study 9720

Maria R. Baer, Stephen L. George, Michael A. Caligiuri, Ben L. Sanford, Sandra M. Bothun, Krzysztof Mrózek, Jonathan E. Kolitz, Bayard L. Powell, Joseph O. Moore, Richard M. Stone, John Anastasi, Clara D. Bloomfield, Richard A. Larson

From the University of Maryland Greenebaum Cancer Center, Baltimore, MD; Roswell Park Cancer Institute, Buffalo; North Shore University Hospital, Manhasset, NY; CALGB Statistical Center, Duke University Medical Center, Durham, NC; The Ohio State University Medical Center, Columbus, OH; Comprehensive Cancer Center of Wake Forest University, Winston-Salem; Duke University Medical Center, Durham, NC; Dana-Farber Cancer Institute, Boston, MA; and University of Chicago, Chicago, IL

Corresponding author: Maria R. Baer, MD, University of Maryland Greenebaum Cancer Center, 22 South Greene St, Baltimore, MD, 21201; e-mail: mbaer{at}umm.edu

Purpose Cancer and Leukemia Group B (CALGB) 9720 evaluated subcutaneous low-dose recombinant interleukin-2 (rIL-2) maintenance immunotherapy as a strategy for prolonging remission in older patients with acute myeloid leukemia (AML).

Patients and Methods AML patients age 60 years and older in first complete remission after induction and consolidation chemotherapy were randomly assigned to no further therapy or a 90-day regimen of 14-day cycles of low-dose rIL-2, aimed at expanding natural killer (NK) cells, followed by 3-day higher doses aimed at activating cytotoxicity of expanded NK cells to lyse residual AML cells. All randomly assigned patients were included in an intention-to-treat analysis.

Results A total of 163 (64%) of 254 patients who completed induction and consolidation chemotherapy on CALGB 9720 were randomly assigned to rIL-2 (n = 81) or no further therapy (n = 82); the most common reasons for lack of random assignment were patient refusal and relapse. Fifteen patients randomly assigned to rIL-2 never initiated it because of refusal, intercurrent medical problems, or relapse, and 24 patients initiated rIL-2 but stopped early because of toxicity or relapse. Grade 4 toxicities during rIL-2 therapy included thrombocytopenia (65%) and neutropenia (64%), and grade 3 toxicities included anemia (33%), infection (24%) and malaise/fatigue (14%). Forty-two patients (52%) randomly assigned to rIL-2 completed the full 90-day course. Patients in both arms had similar distributions of both disease-free (combined median = 6.1 months; P = .47) and overall survival (combined median = 14.7 months; P = .61) after random assignment. Moreover, the 42 patients who completed all planned therapy did not show prolongation of disease-free or overall survival.

Conclusion Low-dose rIL-2 maintenance immunotherapy is not a successful strategy in older AML patients.

published online ahead of print at www.jco.org on June 30, 2008.

Supported in part by grants from the National Cancer Institute (NCI) to the Cancer and Leukemia Group B (NCI CA31946) and to the CALGB Statistical Center (CA33601); and NCI Grants No. CA31983 (M.R.B.), CA02599 (M.R.B.), CA77658 (M.A.C., K.M., C.D.B.), CA35279 (J.E.K.), CA03927 (B.L.P.), CA47577 (J.O.M.), CA32291 (R.M.S.), and CA41287 (J.A., R.A.L.).

Presented at the 48th Annual Meeting of the American Society of Hematology, December 9-12, 2006, Orlando, FL, and the 12th International Symposium on Acute Leukemias, February 16-20, 2008, Munich, Germany.

The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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