Introduction: Given the wide range of effectiveness of various high-dose chemotherapy regimens in patients with r/r HL, the lack of a unified treatment protocol, an active search is currently underway for the place and sequence of using new classes of drugs and their combination with classical chemotherapy. Objective. Analysis of treatment effectiveness and toxicity in patients with r/r cHL according to the BeGEV regimen in combination with nivolumab at a fixed dose of 40 mg.
Materials and methods: Since 2019 we conducted a pilot multicenter prospective study for r/r cHL patients - candidates for auto-HSCT. By 2022, 35 patients were included. The treatment protocol consisted of 2 cycles of chemotherapy according to Nivo40-BeGEV scheme (vinorelbine 20 mg/m2 on day 1, dexamethasone 20 mg/m2 on days 1–5, gemcitabine 800 mg/m2 on days 1 and 4, bendamustine 90 mg/m2 on days days 2 and 3, nivolumab 40 mg IV on day 0) with further assessment of response by PET/CT. When a complete metabolic response was achieved, an additional one course of chemotherapy Nivo40-BeGEV was performed and then auto-HSCT (BeEAM) was held. If a partial remission after 2 cycles of chemotherapy and a complete remission after 4 cycles has not been achieved, the patient was excluded from the treatment protocol.
Results: Treatment according to the Nivo40-BeGEV regimen was completed in 35 patients. All patients achieved complete remission, most after 2 cycles - 34/35 (97.1%). Effective mobilization of HSC and auto-HSCT was performed in 30/34 (85.7%) patients. Complete remission of r/r cHL is maintained in 33/35 (94.2%) patients with a follow-up of 1-34 months, and 2/35 (5.7%) patients had an early relapse of the disease. EFS and OS were 95% and 100%, respectively, with a median follow-up of 13 months. Infectious, immune complications grade III-IV were not detected. Hematological toxicity grade III-IV has been observed in 3/35 (8.5%) patients.
Conclusion: The combination of nivolumab at a fixed dose of 40 mg with chemotherapy BeGEV has demonstrated high efficacy and the absence of severe adverse eventes in patients with r/r cHL.