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

Armando Santoro, Rita Mazza, Alessandro Pulsoni, Alessandro Re, Maurizio Bonfichi, Vittorio Ruggero Zilioli, Flavia Salvi, Francesco Merli, Antonella Anastasia, Stefano Luminari, Giorgia Annechini, Manuel Gotti, Annalisa Peli, Anna Marina Liberati, Nicola Di Renzo, Luca Castagna, Laura Giordano, Carmelo Carlo-Stella

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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.

Original languageEnglish
Pages (from-to)3293-3299
Number of pages7
JournalJournal of Clinical Oncology
Volume34
Issue number27
DOIs
Publication statusPublished - Sep 20 2016

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gemcitabine
Induction Chemotherapy
Stem Cell Transplantation
Hodgkin Disease
Disease-Free Survival
Bendamustine Hydrochloride
vinorelbine
Hematopoietic Stem Cell Mobilization
Febrile Neutropenia
Autografts

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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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. / Santoro, Armando; Mazza, Rita; Pulsoni, Alessandro; Re, Alessandro; Bonfichi, Maurizio; Zilioli, Vittorio Ruggero; Salvi, Flavia; Merli, Francesco; Anastasia, Antonella; Luminari, Stefano; Annechini, Giorgia; Gotti, Manuel; Peli, Annalisa; Liberati, Anna Marina; Di Renzo, Nicola; Castagna, Luca; Giordano, Laura; Carlo-Stella, Carmelo.

In: Journal of Clinical Oncology, Vol. 34, No. 27, 20.09.2016, p. 3293-3299.

Research output: Contribution to journalArticle

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title = "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",
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.",
author = "Armando Santoro and Rita Mazza and Alessandro Pulsoni and Alessandro Re and Maurizio Bonfichi and Zilioli, {Vittorio Ruggero} and Flavia Salvi and Francesco Merli and Antonella Anastasia and Stefano Luminari and Giorgia Annechini and Manuel Gotti and Annalisa Peli and Liberati, {Anna Marina} and {Di Renzo}, Nicola and Luca Castagna and Laura Giordano and Carmelo Carlo-Stella",
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T1 - 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

T2 - Final results of a multicenter phase II study

AU - Santoro, Armando

AU - Mazza, Rita

AU - Pulsoni, Alessandro

AU - Re, Alessandro

AU - Bonfichi, Maurizio

AU - Zilioli, Vittorio Ruggero

AU - Salvi, Flavia

AU - Merli, Francesco

AU - Anastasia, Antonella

AU - Luminari, Stefano

AU - Annechini, Giorgia

AU - Gotti, Manuel

AU - Peli, Annalisa

AU - Liberati, Anna Marina

AU - Di Renzo, Nicola

AU - Castagna, Luca

AU - Giordano, Laura

AU - Carlo-Stella, Carmelo

PY - 2016/9/20

Y1 - 2016/9/20

N2 - 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.

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