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

Author:

Buyse Marc12,Squifflet Pierre1,Lange Beverly J.3,Alonzo Todd A.4,Larson Richard A.5,Kolitz Jonathan E.6,George Stephen L.7,Bloomfield Clara D.8,Castaigne Sylvie9,Chevret Sylvie10,Blaise Didier11,Maraninchi Dominique11,Lucchesi Kathryn J.12,Burzykowski Tomasz12

Affiliation:

1. International Drug Development Institute, Louvain-la-Neuve, Belgium;

2. I-BioStat, Hasselt University, Diepenbeek, Belgium;

3. Children's Cancer Group, University of Pennsylvania School of Medicine and Children's Hospital of Philadelphia, Philadelphia, PA;

4. Children's Cancer Group, Department of Preventive Medicine, University of Southern California, Arcadia, CA;

5. Cancer and Leukemia Group B, University of Chicago, Chicago, IL;

6. Cancer and Leukemia Group B, North Shore University Hospital, New York University School of Medicine, Manhasset, NY;

7. Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Durham, NC;

8. Cancer and Leukemia Group B, The Ohio State University, Columbus, OH;

9. Acute Leukemia French Association, Centre Hospitalier de Versailles, Hôpital André Mignot, Service Hématologie et Oncologie, Le Chesnay, France;

10. Département de Biostatistique et Informatique Médicale, Hôpital Saint-Louis, Paris, France;

11. Département d' Hématologie, Institut Paoli Calmettes, Marseille, France; and

12. MedVal Scientific Information Services LLC, Skillman, NJ

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.

Publisher

American Society of Hematology

Subject

Cell Biology,Hematology,Immunology,Biochemistry

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