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Prepublished online as a Blood First Edition Paper on July 12, 2002; DOI 10.1182/blood-2002-03-0701.
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Blood, 1 November 2002, Vol. 100, No. 9, pp. 3121-3127
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Nonmyeloablative transplantation with or without
alemtuzumab: comparison between 2 prospective studies in
patients with lymphoproliferative disorders
José A. Pérez-Simón,
Panagiotis D. Kottaridis,
Rodrigo Martino,
Charles Craddock,
Dolores Caballero,
Raj Chopra,
Javier García-Conde,
Don W. Milligan,
Stephen Schey,
Alvaro Urbano-Ispizua,
Anne Parker,
Angel Leon,
Kwee Yong,
Ana Sureda,
Ann Hunter,
Jordi Sierra,
Anthony H. Goldstone,
David C. Linch,
Jesus F. San Miguel, and
Stephen Mackinnon for the
Spanish and United Kingdom
Collaborative Groups for Nonmyeloablative
Transplantation
From the Department of Hematology, Hospital
Universitairo de Salamanca, Spain; University College London Hospital,
England; Hospital Santa Crev i Sant Pau, Barcelona, Spain; Heartlands
and University Hospitals, Birmingham, England; Hospital Clinico de
Valencia, Spain; Christie Hospital, Mancester, England; Hospital Clinic
i Provincial Barcelona, Spain; Guys Hospital, London, England; Hospital
de Jerez, Spain; Leicester Royal Infirmary, England.
Although nonmyeloablative conditioning regimen
transplantations (NMTs) induce engraftment of allogeneic stem
cells with a low spectrum of toxicity, graft-versus-host disease (GVHD)
remains a significant cause of morbidity and mortality. In vivo T-cell depletion, using alemtuzumab, has been shown to reduce the incidence of
GVHD. However, this type of maneuver, although reducing GVHD, may have
an adverse impact on disease response, because NMTs exhibit their
antitumor activity by relying on a graft-versus-malignancy effect. To
explore the efficacy of alemtuzumab compared with methotrexate (MTX)
for GVHD prophylaxis, we have compared the results in 129 recipients of
a sibling NMT enrolled in 2 prospective studies for chronic
lymphoproliferative disorders. Both NMTs were based on the same
combination of fludarabine and melphalan, but the United Kingdom
regimen (group A) used cyclosporin A plus alemtuzumab, whereas the
Spanish regimen (group B) used cyclosporin A plus MTX for GVHD
prophylaxis. Patients receiving alemtuzumab had a higher incidence of
cytomegalovirus (CMV) reactivation (85% versus 24%,
P < .001) and a significantly lower incidence of acute
GVHD (21.7% versus 45.1%, P = .006) and chronic GVHD
(5% versus 66.7%, P < .001). Twenty-one percent of
patients in group A and 67.5% in group B had complete or partial
responses 3 months after transplantation (P < .001).
Eighteen patients in group A received donor lymphocyte infusions (DLIs)
to achieve disease control. At last follow-up there was no difference
in disease status between the groups with 71% versus 67.5%
(P = .43) of patients showing complete or partial responses in groups A and B, respectively. No significant differences were observed in event-free or overall survival between the 2 groups.
In conclusion, alemtuzumab significantly reduced GVHD but its use was
associated with a higher incidence of CMV reactivation. Patients
receiving alemtuzumab often required DLIs to achieve similar tumor
control but the incidence of GVHD was not significantly increased after DLI.
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