title: Reduced intensity VEPEMB regimen compared with standard ABVD in elderly Hodgkin lymphoma patients: results from a randomized trial on behalf of the Fondazione Italiana Linfomi (FIL).
abstract: Survival rates for elderly Hodgkin Lymphoma (HL) have not improved substantially in recent years, mainly because of a lack of prospective randomized studies, due to difficulties in enrolling patients. Between 2002 and 2006, 54 untreated HL patients, aged between 65 and 80 years and considered 'non-frail' according to a comprehensive geriatric evaluation, were enrolled into a phase III randomized trial to compare a reduced-intensity regimen (vinblastine, cyclophosphamide, procarbazine, prednisone, etoposide, mitoxantrone, bleomycin; VEPEMB) with standard ABVD (adriamycin, bleomycin, vinblastine, dacarbazine). Primary endpoint was progression-free survival (PFS). Seventeen patients were in early stage (I-IIA), while 37 were advanced stage. Median age was 72 years and median follow-up was 76 months. Five-year PFS rates were 48% vs. 70% [adjusted Hazard ratio (HR) = 2·19, 95% confidence interval (CI) = 0·94-5·10, P = 0·068] and 5-year overall survival (OS) rates were 63% vs. 77% (adjusted HR = 1·67, 95% CI = 0·69-4·03, P = 0·254) for VEPEMB compared to ABVD. Overall treatment-related mortality was 4%. World Health Organization grade 4 cardiac and lung toxicity occurred in four patients treated with ABVD versus no cases in the VEPEMB arm. Standard ABVD regimen resulted in better PFS and OS than the VEPEMB, although the differences were not statistically significant. The low toxicity of both treatments was probably attributable to stringent selection of patients based on a Comprehensive Geriatric Assessment that excluded frail patients.
authors.affiliation: Haematology Department, SS Antonio & Biagio and C. Arrigo Hospital, Alessandria, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Zallio
authors.affiliation: Haematology Department, SS Antonio & Biagio and C. Arrigo Hospital, Alessandria, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Tamiazzo
authors.affiliation: Unity of Clinical Epidemiology, Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino and CPO Piemonte, Torino, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Monagheddu
authors.affiliation: Haematology, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Merli
authors.affiliation: Haematology, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy.
authors.forename: Fiorella
authors.initials: F
authors.lastname: Ilariucci
authors.affiliation: Haematology, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Stelitano
authors.affiliation: Department of Surgery and Biomedicine, Division of Onco-haematology with Autologous Transplant, University of Perugia, Perugia, Italy.
authors.forename: Anna Marina
authors.initials: AM
authors.lastname: Liberati
authors.affiliation: Division of Haematology, Papardo Hospital, Messina, Italy.
authors.forename: Donato
authors.initials: D
authors.lastname: Mannina
authors.affiliation: Haematology, Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Vitolo
authors.affiliation: Haematology Division, Businco Hospital, Cagliari, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Angelucci
authors.affiliation: Division of Candiolo Cancer Institute, IRCCS University of Torino Medical School, Candiolo, Italy.
authors.forename: Delia
authors.initials: D
authors.lastname: Rota Scalabrini
authors.affiliation: Oncology and Haematology Department, Azienda Unità Sanitaria Locale, Piacenza, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Vallisa
authors.affiliation: Department of Diagnostic Medicine, Clinical and Public Health, University of Modena and Reggio Emilia, Modena, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Bellei
authors.affiliation: Department of Diagnostic Medicine, Clinical and Public Health, University of Modena and Reggio Emilia, Modena, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Bari
authors.affiliation: Unity of Clinical Epidemiology, Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino and CPO Piemonte, Torino, Italy.
authors.forename: Giovannino
authors.initials: G
authors.lastname: Ciccone
authors.affiliation: Haematology Department, SS Antonio & Biagio and C. Arrigo Hospital, Alessandria, Italy.
authors.forename: Flavia
authors.initials: F
authors.lastname: Salvi
authors.affiliation: Haematology Department, SS Antonio & Biagio and C. Arrigo Hospital, Alessandria, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Levis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008942:Mitoxantrone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D009367:Neoplasm Staging; D011344:Procarbazine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D001761:Bleomycin; D011344:Procarbazine; D014747:Vinblastine; D003606:Dacarbazine; D004317:Doxorubicin; D003520:Cyclophosphamide; D008942:Mitoxantrone
keywords: Hodgkin Lymphoma; elderly; randomized study