title: 188Re or 90Y-labelled anti-CD66 antibody as part of a dose-reduced conditioning regimen for patients with acute leukaemia or myelodysplastic syndrome over the age of 55: results of a phase I-II study.
abstract: In a phase I-II study for patients aged 55-65 years, we employed radioimmunotherapy using an anti-CD-66 antibody as part of a dose-reduced conditioning regimen, which was followed by a T-cell-depleted graft. 20 patients with a median age of 63 years suffering from acute leukaemia (n=17) or myelodysplastic syndrome (n=3) received the antibody labelled either with 188Rhenium (n=8) or with 90Yttrium (n=12) during conditioning. Radioimmunotherapy provided a mean dose of 21.9 (+/-8.4) Gy to the bone marrow with a significantly higher dose when 90Yttrium was used. Additional conditioning was fludarabine-based plus anti-thymocyte globulin in matched related donor transplants (n=11), or plus melphalan in matched unrelated donor transplants (n=9). Regimen-related toxicity was low, with two patients developing three episodes of grade III organ toxicity. All patients engrafted, grade II-IV acute graft-versus-host disease (GvHD) was observed in one patient (5%) and chronic GvHD in three patients (15%). The cumulative incidence of non-relapse mortality was 25%, the cumulative incidence of relapse 55%. The probability of survival was estimated to be 70% at 1 year and 52% at 2 years post-transplant, although no plateau was reached afterwards. In conclusion, radioimmunotherapy using the anti-CD66 antibody was feasible and safe in our elderly patient group and provided a high marrow dose.
authors.affiliation: Department of Internal Medicine III, University of Ulm, Ulm, Germany.
authors.forename: Mark
authors.initials: M
authors.lastname: Ringhoffer
authors.forename: Norbert
authors.initials: N
authors.lastname: Blumstein
authors.forename: Bernd
authors.initials: B
authors.lastname: Neumaier
authors.forename: Gerhard
authors.initials: G
authors.lastname: Glatting
authors.forename: Stephanie
authors.initials: S
authors.lastname: von Harsdorf
authors.forename: Inga
authors.initials: I
authors.lastname: Buchmann
authors.forename: Markus
authors.initials: M
authors.lastname: Wiesneth
authors.forename: Jörg
authors.initials: J
authors.lastname: Kotzerke
authors.forename: Thorsten
authors.initials: T
authors.lastname: Zenz
authors.forename: Andreas K
authors.initials: AK
authors.lastname: Buck
authors.forename: Peter
authors.initials: P
authors.lastname: Schauwecker
authors.forename: Stephan
authors.initials: S
authors.lastname: Stilgenbauer
authors.forename: Hartmut
authors.initials: H
authors.lastname: Döhner
authors.forename: Sven N
authors.initials: SN
authors.lastname: Reske
authors.forename: Donald
authors.initials: D
authors.lastname: Bunjes
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D015703:Antigens, CD / Q000276:immunology*; D000943:Antigens, Differentiation / Q000276:immunology*; D000961:Antilymphocyte Serum / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000627:therapeutic use; D015815:Cell Adhesion Molecules; D005260:Female; D005500:Follow-Up Studies; D006402:Hematologic Diseases / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007938:Leukemia / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy; D008212:Lymphocyte Depletion; D008297:Male; D008558:Melphalan / Q000627:therapeutic use; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy; D016499:Radioimmunotherapy / Q000379:methods*; D011868:Radioisotopes / Q000627:therapeutic use*; D011874:Radiometry; D012211:Rhenium / Q000627:therapeutic use; D033581:Stem Cell Transplantation; D015996:Survival Rate; D019172:Transplantation Conditioning / Q000379:methods*; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D014740:Vidarabine / Q000031:analogs & derivatives / Q000627:therapeutic use; D015021:Yttrium Radioisotopes / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D015703:Antigens, CD; D000943:Antigens, Differentiation; D000961:Antilymphocyte Serum; D000970:Antineoplastic Agents; C069847:CD66 antigens; D015815:Cell Adhesion Molecules; D007166:Immunosuppressive Agents; D011868:Radioisotopes; D015021:Yttrium Radioisotopes; D012211:Rhenium; D014740:Vidarabine; C024352:fludarabine; D008558:Melphalan