title: Allogeneic Stem Cell Transplantation for Relapsed/Refractory B Cell Lymphomas: Results of a Multicenter Phase II Prospective Trial including Rituximab in the Reduced-Intensity Conditioning Regimen.
abstract: The treatment of patients with refractory/relapsed B cell non-Hodgkin lymphoma (NHL) is evolving because of the availability of novel drugs. Allogeneic stem cell transplantation (alloSCT) can be curative, but its morbidity and mortality remain a matter of concern. We conducted a multicenter prospective phase II trial to evaluate the benefit of including only 1 dose of rituximab in the conditioning regimen before alloSCT. The primary endpoint was progression-free survival. The study enrolled 121 patients with relapsed/refractory B cell lymphomas. The conditioning regimen consisted of thiotepa, cyclophosphamide, fludarabine, and rituximab (500 mg/m2). Rabbit antithymocyte globulin was administered only in case of unrelated donors. Sixty-seven (55%) and 54 (45%) patients received grafts from related and unrelated donors, respectively. The crude cumulative incidence (CCI) of nonrelapse mortality (NRM) was 21% at 3 years. The CCIs of chronic graft-verus-host disease (GVHD) at 3 years were 54% and 31% in recipients of matched sibling and unrelated grafts, respectively. At a median follow-up of 41 months, the estimated 3-year progression-free and overall survival were 50% and 61%, respectively. Long-term outcome was also evaluated with the composite endpoint of GVHD-free and relapse-free survival (GRFS). This is the first work evaluating the GRFS in a prospective trial of lymphoma patients: the 1-year and 3-year GRFS were 40% and 34%, respectively. AlloSCT can cure a fraction of patients with rather low NRM and an encouraging PFS and GRFS.
authors.affiliation: Division of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy. Electronic address: anna.dodero@istitutotumori.mi.it.
authors.forename: Anna
authors.initials: A
authors.lastname: Dodero
authors.affiliation: Department of Hematology, University of Udine, Udine, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Patriarca
authors.affiliation: Department of Hematology, Azienda Ospedaliera Universitaria, Presidio Ospedaliero Ferrarotto, Catania, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Milone
authors.affiliation: Department of Hematology, Humanitas Cancer Center, Rozzano, Italy.
authors.forename: Barbara
authors.initials: B
authors.lastname: Sarina
authors.affiliation: Department of Medical Statistics, Biometry and Bioinformatics, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
authors.forename: Rosalba
authors.initials: R
authors.lastname: Miceli
authors.affiliation: Department of Hematology, Umberto I, Roma, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Iori
authors.affiliation: Department of Medical Statistics, Biometry and Bioinformatics, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Barretta
authors.affiliation: Department of Hematology, Ospedale San Gerardo Monza, Monza, Italy.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Terruzzi
authors.affiliation: Division of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Mussetti
authors.affiliation: Department of Hematology, Ospedale di Alessandria, Alessandria, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Pini
authors.affiliation: Department of Transplantation, Azienda Ospedaliero-Univerisitaria Carreggi, Firenze, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Bosi
authors.affiliation: Department of Stem Transplantation, Ospedale San Martino, Genova, Italy.
authors.forename: Alida
authors.initials: A
authors.lastname: Dominietto
authors.affiliation: Department of Hematology, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Cascavilla
authors.affiliation: Department of Hematology, Universita' di Modena, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Onida
authors.affiliation: Department of Hematology, Ospedale Policlinico di Modena, Modena, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Narni
authors.affiliation: Division of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Farina
authors.affiliation: University of Milan, Hematology and Bone Marrow Transplant Unit, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Rambaldi
authors.affiliation: Division of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy; Dept of Oncology, University of Milan, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Corradini
mesh_terms: D000328:Adult; D000368:Aged; D000074322:Antineoplastic Agents, Immunological / Q000627:therapeutic use*; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D016393:Lymphoma, B-Cell / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011446:Prospective Studies; D000069283:Rituximab / Q000627:therapeutic use*; D019172:Transplantation Conditioning / Q000379:methods*; D014184:Transplantation, Homologous / Q000379:methods*; D055815:Young Adult
chemical_list: D000074322:Antineoplastic Agents, Immunological; D000069283:Rituximab
keywords: Graft-versus-host disease–free/relapse-free survival; Lymphoma; Rituximab