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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|
Lange, Beverly J.
Alonzo, Todd A.
Larson, Richard A.
Kolitz, Jonathan E.
George, Stephen L.
Bloomfield, Clara D.
Lucchesi, Kathryn J.
|Issue Date: ||2011|
|Publisher: ||AMER SOC HEMATOLOGY|
|Citation: ||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|
|ISI #: ||000292244000008|
|Type: ||Journal Contribution|
|Validation: ||ecoom, 2012|
|Appears in Collections: ||Research publications|
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