Armando Santoro1, Rita Mazza2, Alessandro Pulsoni2, Alessandro Re2, Maurizio Bonfichi2, Vittorio Ruggero Zilioli2, Flavia Salvi2, Francesco Merli2, Antonella Anastasia2, Stefano Luminari2, Giorgia Annechini2, Manuel Gotti2, Annalisa Peli2, Anna Marina Liberati2, Nicola Di Renzo2, Luca Castagna2, Laura Giordano2, Carmelo Carlo-Stella2. 1. Armando Santoro, Rita Mazza, Luca Castagna, Laura Giordano, and Carmelo Carlo-Stella, Humanitas Cancer Center; Armando Santoro, Humanitas University, Rozzano; Alessandro Pulsoni and Giorgia Annechini, Sapienza University, Rome; Alessandro Re, Antonella Anastasia, and Annalisa Peli, Spedali Civili, Brescia; Maurizio Bonfichi and Manuel Gotti, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia; Vittorio Ruggero Zilioli, Niguarda Ca' Granda Hospital; Carmelo Carlo-Stella, University of Milano, Milan; Flavia Salvi, SS Antonio e Biagio Hospital, Alessandria; Francesco Merli, Arcispedale S. Maria Nuova/IRCCS, Reggio Emilia; Stefano Luminari, University of Modena and Reggio Emilia, Modena; Anna Marina Liberati, A.O. Santa Maria, Terni; and Nicola Di Renzo, Vito Fazzi Hospital, Lecce, Italy. armando.santoro@cancercenter.humanitas.it. 2. Armando Santoro, Rita Mazza, Luca Castagna, Laura Giordano, and Carmelo Carlo-Stella, Humanitas Cancer Center; Armando Santoro, Humanitas University, Rozzano; Alessandro Pulsoni and Giorgia Annechini, Sapienza University, Rome; Alessandro Re, Antonella Anastasia, and Annalisa Peli, Spedali Civili, Brescia; Maurizio Bonfichi and Manuel Gotti, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia; Vittorio Ruggero Zilioli, Niguarda Ca' Granda Hospital; Carmelo Carlo-Stella, University of Milano, Milan; Flavia Salvi, SS Antonio e Biagio Hospital, Alessandria; Francesco Merli, Arcispedale S. Maria Nuova/IRCCS, Reggio Emilia; Stefano Luminari, University of Modena and Reggio Emilia, Modena; Anna Marina Liberati, A.O. Santa Maria, Terni; and Nicola Di Renzo, Vito Fazzi Hospital, Lecce, Italy.
Abstract
PURPOSE: This multicenter, open-label, phase II study evaluated the combination of bendamustine, gemcitabine, and vinorelbine (BeGEV) as induction therapy before autologous stem-cell transplantation (ASCT) in patients with relapsed or refractory Hodgkin lymphoma (HL). PATIENTS AND METHODS: Patients with HL who were refractory to or had relapsed after one previous chemotherapy line were eligible. The primary end point was complete response (CR) rate after four cycles of therapy. Secondary end points were: overall response rate, stem-cell mobilization activity, and toxicity. Progression-free and overall survival were also evaluated. RESULTS: In total, 59 patients were enrolled. After four cycles of therapy, 43 patients (73%) achieved CR, and six (10%) achieved partial response, for an overall response rate of 83%. The most common grade 3 to 4 nonhematologic toxicities included febrile neutropenia (n = 7) and infection (n = 4). Regarding hematologic toxicities, grade 3 to 4 thrombocytopenia and neutropenia were each experienced by eight patients (13.5%). CD34+ cells were successfully harvested in 55 of 57 evaluable patients, and 43 of 49 responding patients underwent ASCT. With a median follow-up of 29 months, the 2-year progression-free and overall survival rates for the total population were 62.2% and 77.6%, respectively. The same figures for patients undergoing autograft were 80.8% and 89.3%, respectively. CONCLUSION: This phase II study demonstrates that BeGEV is an effective salvage regimen able to induce CR in a high proportion of patients with relapsed or refractory HL before ASCT. These data provide a strong rationale for further development of the BeGEV regimen.
PURPOSE: This multicenter, open-label, phase II study evaluated the combination of bendamustine, gemcitabine, and vinorelbine (BeGEV) as induction therapy before autologous stem-cell transplantation (ASCT) in patients with relapsed or refractory Hodgkin lymphoma (HL). PATIENTS AND METHODS: Patients with HL who were refractory to or had relapsed after one previous chemotherapy line were eligible. The primary end point was complete response (CR) rate after four cycles of therapy. Secondary end points were: overall response rate, stem-cell mobilization activity, and toxicity. Progression-free and overall survival were also evaluated. RESULTS: In total, 59 patients were enrolled. After four cycles of therapy, 43 patients (73%) achieved CR, and six (10%) achieved partial response, for an overall response rate of 83%. The most common grade 3 to 4 nonhematologic toxicities included febrile neutropenia (n = 7) and infection (n = 4). Regarding hematologic toxicities, grade 3 to 4 thrombocytopenia and neutropenia were each experienced by eight patients (13.5%). CD34+ cells were successfully harvested in 55 of 57 evaluable patients, and 43 of 49 responding patients underwent ASCT. With a median follow-up of 29 months, the 2-year progression-free and overall survival rates for the total population were 62.2% and 77.6%, respectively. The same figures for patients undergoing autograft were 80.8% and 89.3%, respectively. CONCLUSION: This phase II study demonstrates that BeGEV is an effective salvage regimen able to induce CR in a high proportion of patients with relapsed or refractory HL before ASCT. These data provide a strong rationale for further development of the BeGEV regimen.
Authors: Ann S LaCasce; R Gregory Bociek; Ahmed Sawas; Paolo Caimi; Edward Agura; Jeffrey Matous; Stephen M Ansell; Howland E Crosswell; Miguel Islas-Ohlmayer; Caroline Behler; Eric Cheung; Andres Forero-Torres; Julie Vose; Owen A O'Connor; Neil Josephson; Yinghui Wang; Ranjana Advani Journal: Blood Date: 2018-04-27 Impact factor: 22.113
Authors: Alison J Moskowitz; Heiko Schöder; Somali Gavane; Katie L Thoren; Martin Fleisher; Joachim Yahalom; Susan J McCall; Briana R Cadzin; Stephanie Y Fox; John Gerecitano; Ravinder Grewal; Paul A Hamlin; Steven M Horwitz; Anita Kumar; Matthew Matasar; Andy Ni; Ariela Noy; M Lia Palomba; Miguel-Angel Perales; Carol S Portlock; Craig Sauter; David Straus; Anas Younes; Andrew D Zelenetz; Craig H Moskowitz Journal: Blood Date: 2017-09-05 Impact factor: 22.113
Authors: Peter D Cole; Kathleen M McCarten; Qinglin Pei; Menachem Spira; Monika L Metzger; Richard A Drachtman; Terzah M Horton; Rizvan Bush; Susan M Blaney; Brenda J Weigel; Kara M Kelly Journal: Lancet Oncol Date: 2018-08-16 Impact factor: 41.316
Authors: M Picardi; R Della Pepa; C Giordano; N Pugliese; C Mortaruolo; F Trastulli; M G Rascato; I Cappuccio; M Raimondo; M Memoli; M Monteverde; M Mascolo; F Pane Journal: Blood Adv Date: 2019-05-14