Among patients who received ASCT, the 5-year OS was 91% and PFS was 77%.
Among 16 patients who did not receive transplants, the 5-year OS was 43%, with a median survival of 32 months. When the investigators conducted the last follow-up, 7 patients were alive, and 9 patients died due to disease progression, infection, and unknown cause.
Moreover, 18 of 23 patients who failed the BEGEV/ASCT program were given further treatments. Specifically, 3 patients received radiation therapy, 13 received brentuximab vedotin, 2 received nivolumab, 7 received standard-dose chemotherapy, 4 received autologous transplants, another 4 were given allogeneic transplants, and 2 received tandem autologous/allogeneic transplants. In this group of patients, 9 exhibited CR, 1 showed PR, and 6 experienced progressive disease. In addition, the investigators observed responses in 2 patients who were still receiving therapy at the time of the analysis.
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The researchers noted that other research has looked at brentuximab vedotin or programmed death 1 inhibitors combined with conventional chemotherapy for the condition. Even though therapy with brentuximab vedotin–based regimens yielded ORR and CR rates similar to those shown in the current BEGEV study, the combination of brentuximab vedotin and bendamustine was linked to significant toxicity7, the authors of the new study wrote in their paper. Another study looked at combining brentuximab vedotin with nivolumab, which produced a CR rate of 62% and an ORR rate of 82%.8 Nonetheless, the authors of the new study noted, 20% of the patients required salvage chemotherapy prior to ASCT. More research is also needed to determine how effective the combination of these drugs may be, they stated.
Stephen Ansell, MD, PhD, a professor of medicine at the Mayo Clinic in Rochester, Minnesota, who was not involved in the new research, said that the high response rates found in the BEGEV study were “very encouraging,” but he also called for further research. “I think what [the study] tells us is this is a good regimen that seems to be well tolerated, but to really prove that it is better than other things that we do will take a randomized trial,” he said. “I think also a lot of other active agents in this space are being tested, and that includes treatments like immune checkpoint therapy and antibody-drug conjugates, so we really at this time don’t have clear understanding as to what the very best regimen is for salvage treatment.”
Other experts echoed the comments about the need for further research. “What we really need in this setting is a randomized trial so that we could establish a standard of care,” said Reid Merryman, MD, a medical oncologist at Dana-Farber Cancer institute in Boston, Massachusetts, who was not involved in the study.
“These results are encouraging, but patient numbers are small,” Ruthee-Lu Bayer, MD, director of stem cell transplantation, Northwell Health Cancer Institute, Lake Success, New York, who was not involved in the study, said in an email. “A randomized head-to-head clinical trial is needed. I may consider this regimen for a patient with relapsed HD in the future. One main benefit is that it can be administered as an outpatient.”
References
- 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.
- 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.
- 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.
- Shah GL, Moskowitz CH. Transplant strategies in relapsed/refractory Hodgkin lymphoma. Blood. 2018;131(15):1689-1697.
- Santoro A, Mazza R, Pulsoni A, et al. 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. J Clin Oncol. 2016; 34(27):3293-3299.
- Santoro A, Mazza R, Pulsoni A, et al. Five-year results of the BEGEV salvage regimen in relapsed/refractory classical Hodgkin lymphoma. Blood Adv. 2020;4(1):136-140.
- LaCasce AS, Bociek RG, Sawas A, et al. Brentuximab vedotin plus bendamustine: a highly active first salvage regimen for relapsed or refractory Hodgkin lymphoma. Blood. 2018;132(1):40-48.
- Herrera AF, Moskowitz AJ, Bartlett NL, et al. Interim results of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2018;131(11):1183-1194.