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Interleukin-2 After Autologous Stem-Cell Transplantation for Adult Patients With Acute Myeloid Leukemia in First Complete Remission

Anthony S. Stein, Margaret R. O’Donnell, Marilyn L. Slovak, David S. Snyder, Auayporn P. Nademanee, Pablo Parker, Arturo Molina, George Somlo, Henry C. Fung, Amrita Krishnan, Roberto Rodriguez, Ricardo T. Spielberger, Shirong Wang, Andrew Dagis, Nayana Vora, Daniel A. Arber, Joyce C. Niland, Stephen J. Forman

From the City of Hope National Medical Center, Duarte, CA.

Address reprint requests to Anthony S. Stein, MD, Division of Hematology and Bone Marrow Transplantation, City of Hope National Medical Center, 1500 East Duarte Rd, Duarte, CA 91010; email: astein{at}coh.org

Purpose: To determine the disease-free survival (DFS) and toxicity of administering interleukin-2 (IL-2) immunotherapy early after autologous stem-cell transplantation (ASCT) to simulate a graft versus leukemia effect observed in allogeneic transplantation.

Patients and Methods: Fifty-six patients with acute myeloid leukemia in first remission received a single consolidation of high-dose cytarabine-idarubicin at a median of 1.1 month postremission with the intent to proceed to ASCT and IL-2 9 x 10⁶ U/m²/24 h for 4 days, followed by 10 days of IL-2 1.6 x 10⁶ U/m²/24 h on hematologic recovery.

Results: Eighty-four percent of patients received the intended ASCT, and 68% of patients received IL-2 treatment. With a median follow-up of 39.4 months (range, 1.2 to 76.3 months), the 2-year cumulative probability of DFS for all 56 patients is 68% (95% confidence interval [CI], 55% to 80%) and 74% (95% CI, 57% to 85%) for the 39 patients undergoing IL-2 treatment after ASCT. The 2-year cumulative probability of DFS for favorable, intermediate, and unfavorable cytogenetics is 88% (95% CI, 59% to 97%), 48% (95% CI, 26% to 67%), and 70% (95% CI, 23% to 93%), respectively. Toxicities from IL-2 were mainly thrombocytopenia, leukopenia, fever, and fluid retention. Two septic deaths occurred during neutropenia, which includes one during consolidation and one during transplant, for an overall 4% mortality rate.

Conclusion: These results suggest that a moderate dose of IL-2 after high-dose cytarabine-idarubicin–mobilized ASCT is associated with a low regimen-related toxicity and may improve DFS. A phase III study of IL-2 is now warranted.

Supported by grant nos. CA 30206 and CA 33572 from the National Cancer Institute.

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