HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

Individual patient data meta-analysis of randomized trials evaluating IL-2 monotherapy as remission maintenance therapy in acute myeloid leukemia.

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.
AuthorsMarc Buyse, Pierre Squifflet, Beverly J Lange, Todd A Alonzo, Richard A Larson, Jonathan E Kolitz, Stephen L George, Clara D Bloomfield, Sylvie Castaigne, Sylvie Chevret, Didier Blaise, Dominique Maraninchi, Kathryn J Lucchesi, Tomasz Burzykowski
JournalBlood (Blood) Vol. 117 Issue 26 Pg. 7007-13 (Jun 30 2011) ISSN: 1528-0020 [Electronic] United States
PMID21518931 (Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)
Chemical References
  • IL2 protein, human
  • Interleukin-2
  • Recombinant Proteins
Topics
  • Adult
  • Child
  • Female
  • Humans
  • Immunotherapy
  • Interleukin-2 (therapeutic use)
  • Leukemia, Myeloid, Acute (prevention & control, therapy)
  • Male
  • Randomized Controlled Trials as Topic
  • Recombinant Proteins (therapeutic use)
  • Secondary Prevention
  • Survival Analysis

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: