title: Nonmyeloablative allogeneic stem cell transplantation in elderly patients with hematological malignancies: results from the GITMO (Gruppo Italiano Trapianto Midollo Osseo) multicenter prospective clinical trial.
abstract: This study aimed to evaluate the efficacy of a nonmyeloablative conditioning consisting of fludarabine and TBI in patients aged > or =60 years.A total of 32 patients (median age 62 years; range 60-70) with hematological malignancies were treated with fludarabine (30 mg/m(2) x 3-5 days) and 200 cCy TBI followed by allogeneic hematopoietic stem cell transplantation (HSCT) from a matched-sibling donor. GVHD prophylaxis consisted of cyclosporine and mycophenolate. Neutrophil recovery occurred in all patients at a median time of 16 days (range 9-34). Six patients did not become granulocytopenic. On day +30, 10 patients had >95% donor chimerism and 19 patients had mixed chimerism. The cumulative probabilities of Grade II-IV acute GVHD and chronic GVHD were 48 and 83%, respectively. Transplant-related mortality at 100 days and 1 year was 6 and 10%, respectively. The probabilities of 2-year overall (OS) and progression-free survival (PFS) were 39 and 35%, respectively. The estimated 2-year probability of OS and PFS for patients in early disease stages were 77 and 64%, respectively, which were significantly higher than the survival and PFS estimates of 0% obtained in patients with advanced disease stages at the time of transplant. Our analysis would suggest that for patients older than 60, this regimen is well tolerated and associated with a low incidence of transplant-related mortality. The leukemic burden at time of transplant has proven to be the most important risk factor for the outcome.
authors.affiliation: Division of Hematology, San Giovanni Battista Hospital, Turin, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Falda
authors.forename: Alessandro
authors.initials: A
authors.lastname: Busca
authors.forename: Ileana
authors.initials: I
authors.lastname: Baldi
authors.forename: Nicola
authors.initials: N
authors.lastname: Mordini
authors.forename: Benedetto
authors.initials: B
authors.lastname: Bruno
authors.forename: Bernardino
authors.initials: B
authors.lastname: Allione
authors.forename: Alessandro
authors.initials: A
authors.lastname: Rambaldi
authors.forename: Enrico
authors.initials: E
authors.lastname: Morello
authors.forename: Franco
authors.initials: F
authors.lastname: Narni
authors.forename: Stella
authors.initials: S
authors.lastname: Santarone
authors.forename: Franco
authors.initials: F
authors.lastname: Locatelli
authors.forename: Andrea
authors.initials: A
authors.lastname: Bacigalupo
mesh_terms: D000368:Aged; D000380:Agranulocytosis / Q000209:etiology; D018572:Disease-Free Survival; D005260:Female; D006085:Graft Survival; D006086:Graft vs Host Disease / Q000209:etiology; D019337:Hematologic Neoplasms / Q000401:mortality / Q000601:surgery*; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality; D011446:Prospective Studies; D012086:Reoperation; D035781:Siblings; D015996:Survival Rate; D014019:Tissue Donors; D019172:Transplantation Conditioning / Q000009:adverse effects; D014184:Transplantation, Homologous; D014740:Vidarabine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014916:Whole-Body Irradiation / Q000009:adverse effects
chemical_list: D014740:Vidarabine; C024352:fludarabine