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Clinical Trial
. 2020 Jan 14;4(1):136-140.
doi: 10.1182/bloodadvances.2019000984.

Five-year results of the BEGEV salvage regimen in relapsed/refractory classical Hodgkin lymphoma

Armando Santoro  1   2 , Rita Mazza  1 , Alessandro Pulsoni  3 , Alessandro Re  4 , Maurizio Bonfichi  5 , Vittorio Ruggero Zilioli  6 , Manuela Zanni  7 , Francesco Merli  8 , Antonella Anastasia  4 , Stefano Luminari  9 , Giorgia Annechini  3 , Manuel Gotti  5 , Annalisa Peli  4 , Anna Marina Liberati  10 , Nicola Di Renzo  11 , Luca Castagna  1 , Laura Giordano  12 , Francesca Ricci  1 , Carmelo Carlo-Stella  1   2
Affiliations
Clinical Trial

Five-year results of the BEGEV salvage regimen in relapsed/refractory classical Hodgkin lymphoma

Armando Santoro et al. Blood Adv. .

Abstract

The complete remission (CR) rate achieved with induction chemotherapy prior to autologous stem cell transplantation (ASCT) represents the strongest prognostic factor in relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL). By inducing a CR rate of 75%, the bendamustine, gemcitabine, vinorelbine (BEGEV) regimen represents an optimal chemotherapy regimen prior to ASCT. Presented here are the 5-year results of BEGEV followed by ASCT in R/R cHL. With a median follow-up of 5 years, progression-free survival (PFS) and overall survival (OS) for the whole series (n = 59) were 59% and 78%, respectively. ASCT was performed in 43 of 49 responding patients (73% by intention to treat [ITT]; 88% by response to BEGEV) and resulted in 33 with continuous CR (56% by ITT; 77% of transplanted patients), 7 with disease relapse, and 3 with nonrelapse mortality. For patients who received transplants, the 5-year PFS and OS were 77% and 91%, respectively, with no significant difference between relapsed and refractory patients. No patient experienced secondary leukemia or myelodysplasia. In summary, the long-term efficacy data, the benefits for both relapsed and refractory patients, and the excellent safety profile provide a strong rationale for further development of the BEGEV regimen. This trial was registered at EudraCT as #2010-022169-91 and at www.clinicaltrials.gov as #NCT01884441.

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Conflict of interest statement

Conflict-of-interest disclosure: A.S. reports receiving honoraria for speaker engagements and scientific advisory fees from Bristol-Myers Squibb, Servier, Gilead, Pfizer, Eisai, Bayer, Merck Sharp & Dohme, ArQule, Takeda, Roche, AbbVie, Amgen, Celgene, AstraZeneca, Pfizer, Lilly, Sandoz, and Novartis. A. Pulsoni reports receiving personal fees from Roche, Merck Sharp & Dohme, Pfizer, Sandoz, Takeda, Gilead, and Bristol-Myers Squibb. F.M. reports receiving nonfinancial support from Roche, Takeda, and Celgene and personal fees from Janssen and Gilead. S.L. reports personal fees from Roche, Celgene, Teva Pharmaceuticals, Gilead Sciences, and Takeda Pharmaceuticals. C.C.-S. reports receiving honoraria for speaker engagements from Bristol-Myers Squibb, Merck Sharp & Dohme, Amgen, Janssen Oncology, and AstraZeneca, and scientific advisory fees from Sanofi, ADC Therapeutics, Servier, Boehringer Ingelheim, Novartis, Roche, Genenta Science srl, and Rhizen Pharmaceuticals. The remaining authors declare no competing financial interests.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
CONSORT diagram showing the flow of participants. *One patient considered to be in PR at the time of the initial report was classified as being in CR when disease response was reassessed for the current analysis. CCR, continuous complete remission; NRM, nonrelapse mortality; PD, progressive disease; SD; stable disease.
Figure 2.
Figure 2.
Kaplan-Meier curves. PFS (A) and OS (B) of the overall population. PFS (C) and OS (D) of patients with relapsed (blue line) or refractory (red line) disease prior to BEGEV. PFS (E) and OS (F) of patients who achieved CR or PR and underwent ASCT.
See this image and copyright information in PMC

References

    1. Linch DC, Winfield D, Goldstone AH, et al. . Dose intensification with autologous bone-marrow transplantation in relapsed and resistant Hodgkin’s disease: results of a BNLI randomised trial. Lancet. 1993;341(8852):1051-1054. - PubMed
    1. Schmitz N, Pfistner B, Sextro M, et al. ; Lymphoma Working Party of the European Group for Blood and Marrow Transplantation . Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin’s disease: a randomised trial. Lancet. 2002;359(9323):2065-2071. - PubMed
    1. Moskowitz CH, Matasar MJ, Zelenetz AD, et al. . Normalization of pre-ASCT, FDG-PET imaging with second-line, non-cross-resistant, chemotherapy programs improves event-free survival in patients with Hodgkin lymphoma. Blood. 2012;119(7):1665-1670. - PMC - PubMed
    1. Moskowitz CH, Nimer SD, Zelenetz AD, et al. . A 2-step comprehensive high-dose chemoradiotherapy second-line program for relapsed and refractory Hodgkin disease: analysis by intent to treat and development of a prognostic model. Blood. 2001;97(3):616-623. - PubMed
    1. Josting A, Rudolph C, Reiser M, et al. ; Participating Centers . Time-intensified dexamethasone/cisplatin/cytarabine: an effective salvage therapy with low toxicity in patients with relapsed and refractory Hodgkin’s disease. Ann Oncol. 2002;13(10):1628-1635. - PubMed

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