title: B-IGEV (bortezomib plus IGEV) versus IGEV before high-dose chemotherapy followed by autologous stem cell transplantation in relapsed or refractory Hodgkin lymphoma: a randomized, phase II trial of the Fondazione Italiana Linfomi (FIL).
abstract: This randomized, multicenter study evaluates the addition of bortezomib (13 mg/m(2)) to IGEV (B-IGEV) in patients with relapsed/refractory Hodgkin Lymphoma (HL). Patients received either four courses of IGEV alone (n = 40) or B-IGEV (n = 40). The primary endpoint was the complete response (CR) proportion, evaluated by FDG-PET, after induction chemotherapy. CR proportion was 39% with B-IGEV and 53% with IGEV. PFS and OS were similar between the two groups (two-year PFS: 58% vs 56%; two-year OS: 93% vs 81%). The PET-negative status after treatment was the only variable favorably influencing both PFS (two-year PFS: 77% vs 40%; p = 0.002) and OS (two-year OS: 100% vs 76%; p < 0.001). Toxicity was overall similar with the two regimens. The addition of bortezomib to IGEV does not improve response in relapsed/refractory HL patients. However, its favorable therapeutic and safety profile, and the prognostic role of pre-transplant PET negativity in patients receiving IGEV-based regimens are confirmed.
authors.affiliation: a Humanitas Cancer Center , Rozzano , Milan , Italy ;
authors.forename: Monica
authors.initials: M
authors.lastname: Balzarotti
authors.affiliation: a Humanitas Cancer Center , Rozzano , Milan , Italy ;|b San Matteo Hospital , Pavia , Italy ;
authors.forename: Ercole
authors.initials: E
authors.lastname: Brusamolino
authors.affiliation: c U.O. Ematologia E Centro Trapianti Midollo Osseo. "Armando Businco" Hospital , Cagliari , Italy ;
authors.forename: Emanuele
authors.initials: E
authors.lastname: Angelucci
authors.affiliation: d IRCCS AOU San Martino-IST , Genoa , Italy ;
authors.forename: Angelo Michele
authors.initials: AM
authors.lastname: Carella
authors.affiliation: e AO Città Della Salute E Della Scienza , Turin , Italy ;
authors.forename: Umberto
authors.initials: U
authors.lastname: Vitolo
authors.affiliation: f Department of Biotechnology and Hematology, University La Sapienza , Rome , Italy ;
authors.forename: Eleonora
authors.initials: E
authors.lastname: Russo
authors.affiliation: d IRCCS AOU San Martino-IST , Genoa , Italy ;
authors.forename: Angelagiovanna
authors.initials: A
authors.lastname: Congiu
authors.affiliation: b San Matteo Hospital , Pavia , Italy ;
authors.forename: Manuel
authors.initials: M
authors.lastname: Gotti
authors.affiliation: c U.O. Ematologia E Centro Trapianti Midollo Osseo. "Armando Businco" Hospital , Cagliari , Italy ;
authors.forename: Stefania
authors.initials: S
authors.lastname: Massidda
authors.affiliation: e AO Città Della Salute E Della Scienza , Turin , Italy ;
authors.forename: Barbara
authors.initials: B
authors.lastname: Botto
authors.affiliation: f Department of Biotechnology and Hematology, University La Sapienza , Rome , Italy ;
authors.forename: Giorgia
authors.initials: G
authors.lastname: Annechini
authors.affiliation: g National Cancer Institute , Aviano , PN , Italy ;
authors.forename: Michele
authors.initials: M
authors.lastname: Spina
authors.affiliation: h Spedali Civili , Brescia , Italy ;
authors.forename: Alessandro
authors.initials: A
authors.lastname: Re
authors.affiliation: i Niguarda Ca' Granda Hospital , Milan , Italy ;
authors.forename: Vittorio Ruggero
authors.initials: VR
authors.lastname: Zilioli
authors.affiliation: j Arcispedale S. Maria Nuova Hospital , Reggio Emilia , Italy ;
authors.forename: Francesco
authors.initials: F
authors.lastname: Merli
authors.affiliation: k SS Antonio E Biagio E Cesare Arrigo Hospital , Alessandria , Italy ;
authors.forename: Flavia
authors.initials: F
authors.lastname: Salvi
authors.affiliation: l Bianchi, Melacrino, Morelli Hospital , Reggio Calabria , Italy ;
authors.forename: Caterina
authors.initials: C
authors.lastname: Stelitano
authors.affiliation: b San Matteo Hospital , Pavia , Italy ;
authors.forename: Maurizio
authors.initials: M
authors.lastname: Bonfichi
authors.affiliation: a Humanitas Cancer Center , Rozzano , Milan , Italy ;
authors.forename: Marcello
authors.initials: M
authors.lastname: Rodari
authors.affiliation: c U.O. Ematologia E Centro Trapianti Midollo Osseo. "Armando Businco" Hospital , Cagliari , Italy ;
authors.forename: Roberta
authors.initials: R
authors.lastname: Murru
authors.affiliation: a Humanitas Cancer Center , Rozzano , Milan , Italy ;
authors.forename: Massimo
authors.initials: M
authors.lastname: Magagnoli
authors.affiliation: a Humanitas Cancer Center , Rozzano , Milan , Italy ;|h Spedali Civili , Brescia , Italy ;
authors.forename: Antonella
authors.initials: A
authors.lastname: Anastasia
authors.affiliation: a Humanitas Cancer Center , Rozzano , Milan , Italy ;
authors.forename: Rita
authors.initials: R
authors.lastname: Mazza
authors.affiliation: a Humanitas Cancer Center , Rozzano , Milan , Italy ;
authors.forename: Laura
authors.initials: L
authors.lastname: Giordano
authors.affiliation: a Humanitas Cancer Center , Rozzano , Milan , Italy ;|m Humanitas University , Rozzano , Milan , Italy.
authors.forename: Armando
authors.initials: A
authors.lastname: Santoro
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069286:Bortezomib / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D019008:Drug Resistance, Neoplasm; D005260:Female; D019650:Hematopoietic Stem Cell Mobilization; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods; D006689:Hodgkin Disease / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D012008:Recurrence; D012074:Remission Induction; D016019:Survival Analysis; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D014747:Vinblastine; D000069286:Bortezomib; D000077235:Vinorelbine; D007069:Ifosfamide; D000093542:Gemcitabine
keywords: Chemotherapeutic approaches; clinical results; lymphoma and Hodgkin lymphoma