Real-world, multicenter study of brentuximab vedotin-based regimens in Chinese patients with relapsed/refractory Hodgkin lymphoma

Abstract Background: Brentuximab Vedotin (BV) has demonstrated significant efficacy and favorable safety profile in patients with relapsed or refractory (R/R) classical Hodgkin Lymphoma (cHL). However, real-world clinical data from China remain scarce. This study aims to investigate the clinical characteristics and therapeutic outcomes of BV, either as monotherapy or combination regimens among Chinese patients with R/R cHL. Methods: This multi-center retrospective study was conducted across 11 medical centers in China. Patients diagnosed with R/R cHL who had received BV-containing therapeutic regimens were retrospectively evaluated. Comprehensive clinical data were collected, encompassing therapeutic efficacy, treatment-related toxicity and survival outcomes. The trial was registered on ClincialTrials.gov (NCT06761911). Results: This study enrolled a cohort of 93 patients diagnosed with classical R/R cHL, all aged 18 years or older, who had undergone BV-based therapeutic regimens. The study population comprised 46 females and 47 males, with a demographic distribution of 59 patients aged under 45 years and 34 patients aged 45 years or older. The pathological classification comprised 53 cases of nodular sclerosis, 23 cases of mixed cellularity, 15 cases of lymphocyte-rich, and 2 cases of lymphocyte-depleted HL. The clinical staging distribution included 24 patients in stage I-II and 69 patients in stage III-IV. Additionally, 35 patients manifested with B symptoms. The first-line therapeutic regimen was predominantly ABVD, with 34 cases of complete remissions (CR), 29 cases of partial remissions (PR), 3 cases of stable diseases (SD), and 27 cases of progressive diseases (PD). This resulted in an overall response rate (ORR) of 67.74% (with CR 36.56% and PR 31.18%). Among the 64 patients with relapsed/refractory disease who received BV-based therapeutic interventions, 2 patients received BV as monotherapy and 62 patients received combination therapy. The BV-containing treatment mainly included AVD, ICE, bendamustine and PD-1 monoclonal antibodies. Within this cohort, 44 patients achieved CR, 14 patients of PR, 2 patients of SD, and 4 patients experienced PD, with an ORR of 90.63% (CR 68.75%, PR 21.88%). Notably, among the 18 patients who received BV in combination with PD-1 monoclonal antibodies, the CR rate reached 77.78%. The progression-free survival (PFS) analysis demonstrated a 1-year PFS rate of 75%, and a 2-year PFS rate of 57.5% in the relapsed/refractory patient population.The most frequently observed adverse events included neutropenia (N=24, 37.5%), elevated transaminases (N=24, 37.5%), anemia (N=24, 37.5%), thrombocytopenia (N=9, 14.1%), gastrointestinal disorders (N=7, 10.9%), pneumonia (N=5, 7.8%), cutaneous rash (N=3, 4.7%), peripheral neuropathy (N=1, 1.6%). Conclusion: BV-based therapeutic regimens demonstrated superior efficacy and an acceptable safety profile in Chinese patients with r/r cHL, potentially establishing them as a preferred therapeutic option for this patient population.