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

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.

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.

© 2020 by The American Society of Hematology.

Figures

Graphical abstract

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.

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.