Nivo-BeGEV as Preparation for Autologous Hematopoietic Stem Cell Transplantation in Relapsed/Refractory Classical Hodgkin Lymphoma: Results of a Multi-Center Prospective Clinical Study

YaK Mangasarova1, TN Moiseeva1, OV Margolin1, LG Gorenkova1, ES Nesterova1, FE Babaeva1, MO Bagova1, EA Fastova1, RR Abdurashidova1, LS Al-Radi1, EI Dorokhina1, EM Volodicheva2, VA Lapin3, OS Samoilova4, SK Kravchenko1, AU Magomedova1, EE Zvonkov1

1 National Research Center for Hematology, 4 Novyi Zykovskii pr-d, Moscow, Russian Federation, 125167

2 Tula Regional Clinical Hospital, 1A korp. 1 Yablochkova ul., Tula, Russian Federation, 300053

3 Regional Clinical Hospital, 7 Yakovlevskaya ul., Yaroslavl, Russian Federation, 150062

4 NA Semashko Nizhny Novgorod Regional Clinical Hospital, 190 Rodionova ul., Nizhny Novgorod, Russian Federation, 603126

For correspondence: Yana Konstantinovna Mangasarova, MD, PhD, 4 Novyi Zykovskii pr-d, Moscow, Russian Federation, 125167; Tel.: +7(926)395-82-52; e-mail: v.k.jana@mail.ru

For citation: Mangasarova YaK, Moiseeva TN, Margolin OV, et al. Nivo-BeGEV as Preparation for Autologous Hematopoietic Stem Cell Transplantation in Relapsed/Refractory Classical Hodgkin Lymphoma: Results of a Multi-Center Prospective Clinical Study. Clinical oncohematology. 2023;16(3):280–6. (In Russ).

DOI: 10.21320/2500-2139-2023-16-3-280-286


ABSTRACT

Aim. To assess efficacy and safety of the Nivo-BeGEV (nivolumab combined with bendamustine, gemcitabine, and vinorelbine) immunochemotherapy in patients with relapsed/refractory (r/r) classical Hodgkin lymphoma (cHL) selected as candidates for autologous hematopoietic stem cell transplantation (auto-HSCT).

Materials & Methods. During 2018–2022, the study enrolled 51 r/r cHL patients treated with the Nivo-BeGEV immunochemotherapy. The median age was 38 years (range 19–57 years). There were 30 men and 21 women. PET-CT was performed to assess the response according to the LYRIC criteria. Safety and tolerability were analyzed by registering adverse events in line with the NCI CTCAE criteria, version 5.

Results. The median follow-up was 12 months (range 3–54 months). Complete remissions were reported in 100 % of cases. An early relapse was observed in 1 (2 %) patient. The 2-year overall and progression-free survivals were 100 % and 93 %, respectively. During Nivo-BeGEV administration, severe adverse events of grade 3/4 developed in 6 (13 %) out of 51 patients.

Conclusion. The results of this multi-center prospective clinical study of the Nivo-BeGEV immunochemotherapy used as preparation for auto-HSCT in r/r cHL patients showed high efficacy irrespective of prior drug chemotherapy and its duration with an acceptable toxicity profile.

Keywords: classical Hodgkin lymphoma, Nivo-BeGEV immunochemotherapy, autologous hematopoietic stem cell transplantation, immune checkpoint inhibitors, relapse, refractory course.

Received: March 13, 2023

Accepted: June 9, 2023

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