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Title: Individual patient data meta-analysis of randomized trials evaluating IL-2 monotherapy as remission maintenance therapy in acute myeloid leukemia
Authors: BUYSE, Marc 
Squifflet, Pierre
Lange, Beverly J.
Alonzo, Todd A.
Larson, Richard A.
Kolitz, Jonathan E.
George, Stephen L.
Bloomfield, Clara D.
Castaigne, Sylvie
Chevret, Sylvie
Blaise, Didier
Maraninchi, Dominique
Lucchesi, Kathryn J.
Issue Date: 2011
Source: BLOOD, 117(26). p. 7007-7013
Abstract: IL-2 is a natural, T cell-derived cytokine that stimulates the cytotoxic functions of T and natural killer cells. IL-2 monotherapy has been evaluated in several randomized clinical trials (RCTs) for remission maintenance in patients with acute myeloid leukemia (AML) in first complete remission (CR1), and none demonstrated a significant benefit of IL-2 monotherapy. The objective of this meta-analysis was to reliably determine IL-2 efficacy by combining all available individual patient data (IPD) from 5 RCTs (N = 905) and summary data from a sixth RCT (N = 550). Hazard ratios (HRs) were estimated using Cox regression models stratified by trial, with HR < 1 indicating treatment benefit. Combined IPD showed no benefit of IL-2 over no treatment in terms of leukemia-free survival (HR = 0.97; P = .74) or overall survival (HR = 1.08; P = .39). Analyses including the sixth RCT yielded qualitatively identical results (leukemia-free survival HR = 0.96, P = .52; overall survival HR = 1.06; P = .46). No significant heterogeneity was found between the trials. Prespecified subset analyses showed no interaction between the lack of IL-2 effect and any factor, including age, sex, baseline performance status, karyotype, AML subtype, and time from achievement of CR1 to initiation of maintenance therapy. We conclude that IL-2 alone is not an effective remission maintenance therapy for AML patients in CR1. (Blood. 2011;117(26):7007-7013)
Notes: [Buyse, M; Squifflet, P; Burzykowski, T] Int Drug Dev Inst, B-1340 Louvain, Belgium [Buyse, M; Burzykowski, T] Hasselt Univ, I BioStat, Diepenbeek, Belgium [Lange, BJ] Univ Penn, Sch Med, Childrens Canc Grp, Philadelphia, PA 19104 USA [Lange, BJ] Childrens Hosp Philadelphia, Philadelphia, PA 19104 USA [Alonzo, TA] Univ So Calif, Childrens Canc Grp, Dept Prevent Med, Arcadia, CA USA [Larson, RA] Univ Chicago, Canc & Leukemia Grp B, Chicago, IL 60637 USA [Kolitz, JE] NYU, Sch Med, Canc & Leukemia Grp B, N Shore Univ Hosp, Manhasset, NY USA [George, SL] Duke Univ, Med Ctr, Canc & Leukemia Grp B, Stat Ctr, Durham, NC USA [Bloomfield, CD] Ohio State Univ, Canc & Leukemia Grp B, Columbus, OH 43210 USA [Castaigne, S] Hop Andre Mignot, Serv Hematol & Oncol, Ctr Hosp Versailles, Acute Leukemia French Assoc, Le Chesnay, France [Chevret, S] Hop St Louis, Dept Biostat & Informat Med, Paris, France [Blaise, D; Maraninchi, D] Inst Paoli Calmettes, Dept Hematol, Marseille, France [Lucchesi, KJ] MedVal Sci Informat Serv LLC, Skillman, NJ USA
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ISSN: 0006-4971
e-ISSN: 1528-0020
DOI: 10.1182/blood-2011-02-337725
ISI #: 000292244000008
Category: A1
Type: Journal Contribution
Validations: ecoom 2012
Appears in Collections:Research publications

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