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J Clin Oncol. 2016 Sep 20;34(27):3293-9. doi: 10.1200/JCO.2016.66.4466. Epub 2016 Jul 5.

Bendamustine in Combination With Gemcitabine and Vinorelbine Is an Effective Regimen As Induction Chemotherapy Before Autologous Stem-Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma: Final Results of a Multicenter Phase II Study.

Author information

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01884441.

PMID:
27382096
DOI:
10.1200/JCO.2016.66.4466
[Indexed for MEDLINE]
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