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Blood, 15 July 2002, Vol. 100, No. 2, pp. 397-405
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Donor lymphocyte infusion for relapsed chronic myelogenous
leukemia: prognostic relevance of the initial cell dose
Cesare Guglielmi,
William Arcese,
Francesco Dazzi,
Ronald Brand,
Donald Bunjes,
Leo F. Verdonck,
Anton Schattenberg,
Hans-Jochem Kolb,
Per Ljungman,
Agnes Devergie,
Andrea Bacigalupo,
Marta Gomez,
Mauricette Michallet,
Ahmet Elmaagacli,
Alois Gratwohl,
Jane Apperley, and
Dietger Niederwieser on behalf of the
Chronic Leukemia Working Party of the European Group for
Blood and Marrow Transplantation
From the Università "La Sapienza,"
Dipartimento di Biotecnologie Cellulari ed Ematologia, Unità TMO
Allogenico "Giuseppe Papa," Rome, Italy; Imperial College School of
Medicine at the Hammersmith Hospital, Department of Hematology, London,
United Kingdom; Department of Medical Statistics, Leiden University
Medical Center, Leiden, The Netherlands; Abt Innere Medizin III,
Universitat Ulm, Ulm, Germany; University Medical Center, Department of
Haematology, Utrecht, The Netherlands; Department of Hematology,
University Medical Center St Radboud, Nijmegen, The Netherlands;
Klinikum Grosshadern, Medical Klinik III, Munchen, Germany; Huddinge
University Hospital, Stockholm, Sweden; Department of Hematology, Bone
Marrow Transplantation, Hopital St Louis, Paris Cedex 10, France;
Ospedale S Martino, Department of Hematology, Genoa, Italy; Bone Marrow
Transplantation Section, Department of Hematology, Hospital
Clinic, IDIBAPS, Barcelona, Spain; Bone Marrow Transplantation Unit
Pavilion E, Hospital E. Herriot, Lyon Cedex 03, France; Department of
Bone Marrow Transplantation, University Hospital, Essen, Germany;
Kantonsspital, Department of Internal Medicine, Division of Hematology,
Basel, Switzerland; and University of Leipzig, Center of Internal
Medicine, Department. Hematology/Oncology, Leipzig, Germany.
Donor lymphocyte infusion (DLI) can produce durable remissions in
patients with chronic myelogenous leukemia (CML) who have a relapse
after an allogeneic stem cell transplantation. However, the best
modality to administer DLI is still unclear. The effect of the initial
cell dose (ICD; ie, mononuclear cells × 108/kg received
in the first instance) on outcome was retrospectively analyzed in 298 of 344 patients treated with DLI at 51 centers. Patients were
classified into 3 groups according to the ICD: 98 in group A
( 0.20), 107 in group B (0.21-2.0), and 93 in group C (> 2.0).
Additional infusions were given to 62%, 20%, and 5% of patients in
groups A, B, and C, respectively. A lower ICD was associated with less
graft-versus-host disease (GVHD; A, 26%; B, 53%; C, 62%;
P < .001), less myelosuppression (A, 10%; B, 23%; C,
24%; P = .01), and similar response rate (A, 78%; B,
73%; C, 70%; P = .48). Nonadjusted estimates of 3-year
survival, failure-free survival, and DLI-related mortality were 84%,
66%, and 5% respectively, in group A; 63%, 57%, and 20% in group
B; and 58%, 45%, and 22% in group C. Outcome analysis was adjusted
for patient age, donor type, sex of donor, sex mismatch, disease phase
at transplantation, T-cell depletion, interval from transplantation to
DLI, GVHD prior to relapse, relapse type, and date of DLI. After
adjustment, lower ICD was associated with less GVHD, less
myelosuppression, same response rate, better survival, better
failure-free survival, and less DLI-related mortality. Our results
suggest that the first DLI dose should not exceed
0.2 × 108 mononuclear cells/kg.
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