Recombinant interleukin‐2 in patients aged younger than 60 years with acute myeloid leukemia in first complete remission: Results from Cancer and Leukemia Group B 19808
Year: 2013
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: Recombinant interleukin-2 (rIL-2) induces cellular cytotoxicity against leukemia blasts. Patients with acute myeloid leukemia (AML) in first complete remission (CR) may harbor minimal residual disease that is susceptible to rIL-2-activated effector cells. METHODS: In the Cancer and Leukemia Group B (CALGB) 19808 study, patients with AML in first CR were randomly assigned after all planned chemotherapy to receive a 90-day course of subcutaneously administered rIL-2 or no further therapy. The primary objective was to compare disease-free survival (DFS) between the 2 treatment arms. A total of 534 patients achieved a CR, 214 of whom were randomized. Six courses of low-dose daily rIL-2 were given for the expansion of cytotoxic effector cells, each followed by 3-day high-dose boluses given to trigger cytotoxicity against minimal residual disease. RESULTS: On the protocol-specified intention-to-treat analysis, the hazards ratio for DFS was 0.75 (95% confidence interval, 0.52-1.09; P = .13); the 5-year DFS rate was 42% in the observation arm and 53% in the rIL-2 treatment arm. The hazards ratio for overall survival (OS) was 0.88 (95% confidence interval, 0.54-1.23; P = .34); the 5-year OS rate was 58% for the observation arm and 63% for the rIL-2 treatment arm. Twenty-five of the 107 patients randomized to treatment with rIL-2 either refused or were unable to initiate therapy and 30 patients did not complete their assigned therapy. However, significant toxicities were not commonly observed. The trial design did not anticipate the difficulties patients would encounter with protocol compliance. CONCLUSIONS: The efficacy of immunotherapy with rIL-2 administered after intensive postremission treatment was not assessed as planned because of unexpected refusals by patients and/or their physicians to comply with protocol-directed therapy. Neither DFS nor OS was found to be significantly improved.
Source: Cancer
DOI: 10.1002/cncr.28516
Institutions: Northwell Health, Hofstra University, Mayo Clinic, Duke University, Alliance for Clinical Trials in Oncology, Mayo Clinic Comprehensive Cancer Center (Minnesota), The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Washington University in St. Louis, Wake Forest University, Dana-Farber Cancer Institute, University of North Carolina at Chapel Hill, University of Chicago
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: Bristol-Myers Squibb, Massachusetts General Hospital, Teva Pharmaceutical Industries, Celgene, University of Nebraska Medical Center, Ohio State University, Syracuse University, Wake Forest University, University of Missouri, University of Minnesota, University of Oklahoma, Georgetown University, Dartmouth College, University of Illinois at Urbana-Champaign, University of North Carolina at Chapel Hill, Norris Cotton Cancer Center, State University of New York Upstate Medical University, National Cancer Institute
Awards: G1069145923, G10814802, G1109514914, Northwell Health NCORP, G1391839138, Alliance Statistics and Data Management Center, WUMC Cancer and Leukemia Group B, G1486637521, G1570777714, G1689128559, Illinois Oncology Research Association Community Clinical Oncology Program, G199746015, G20154349, G220937036, G2296793909, G237383067, North Shore CCOP, ITSC for Leukemia: Novel Molecular Strategies for NCTN: "Individualized" Therapie, Experimental Therapeutics of Leukemia, G260759372, Cancer and Leukemia Group B, G2647518335, Minority Based Community Clinical Oncology Program, Cancer and Leukemia Group B Statistical Center, University of Iowa CALGB Institutional Grant, G3255944410, Southeast Cancer Control Consortium, Inc, Cancer and Leukemia Group B CCOP Research Base, Cancer and Leukemia Group B, Cancer and Leukemia Group B - Leukemia Correlative Sciences, Cancer and Leukemia Group B, G3710026009, Cancer and Leukemia Group B: RPCI/SUNYAB, CANCER AND LEUKEMIA GROUP B, G4670716055, Cancer and Leukemia Group B, NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer Care, CANCER AND LEUKEMIA GROUP B, Cancer and Leukemia Group B, GREEN MOUNTAIN ONCOLOGY GROUP, G639492384, Delaware/Christiana Care Community Clinical Oncology Program, Cancer and Leukemia Group B, NCTN Lead Academic Participating Sites Application, NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer Care, G7338240445, G739544170, Cancer and Leukemia Group B, Cancer and Leukemia Group B - The Ohio State University, Nevada Cancer Research foundation-Community Clinical Oncology Program, G877081928, G877907214, Cancer Center Support Grant, G973482110
OpenAlex ID: W1492672626