A. Czyz1, A. Lojko-Dankowska2, M. Joks2, M. Komarnicki2, M. Dlugosz-Danecka3, W. Jurczak3, J. Rybka1, T. Wrobel1, E. Paszkiewicz4, J. Walewski4, D. Hawrylecka5, J. Drozd-Sokolowska6, E. Subocz7, A. Szymanska8, M. Witkowska9, P. Smolewski9, S. Giebel10, J. M. Zaucha8
1 Department of Hematology, Blood Neoplasms and Bone Marrow Transplantation, Wroclaw Medical University, Wroclaw, Poland, 2 Department of Hematology and Bone Marrow Transplantation, Poznan University of Medical Sciences, Poznan, Poland, 3 Department of Hematology, Jagiellonian University, Kraków, Poland, 4 Department of Lymphoid Malignancies, Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland, 5 Podkarpacie Oncological Centre, Brzozow, Poland, 6 Department of Haematology, Oncology and Internal Diseasese, Warsaw Medical University, Warsaw, Poland, 7 Hematology Department, Military Institute of Medicine, Warszawa, Poland, 8 Hematology and Transplantology, Medical University of Gdansk, Gdansk, Poland, 9 Department of Experimental Hematology, Medical University of Lodz, Lodz, Poland, 10 Department of Bone Marrow Transplantation and Onco-Hematology, Maria Sklodowska-Curie Institute - Oncology Center, Gliwice Branch, Gliwice, Poland
An optimal treatment for patients with primary refractory or relapsed (R/R) Hodgkin lymphoma (HL) who did not respond to standard salvage therapy has not been established. Brentuximab vedotin (BV) and bendamustine (B) used in monotherapy both have shown to be active in R/R HL and both are included in therapy options. However, the combination of BV with B (BVB) has been investigated in only few clinical trials. The goal of this study was to retrospectively compare the efficacy and safety of BV and BVB regimen in R/R HL patients.
Methods: Since March 2014 all patients with R/R HL were considered to receive BV in standard doses every 21 days or BV in combination with B (B 90 mg/m2 on days 1 and 2 of a treatment cycle).
Results: BV or BVB therapy was administered to 93 patients (median age 33 years, range 18–68) with primary refractory (n = 53) or relapsed HL (n = 40), including 34 patients after autologous stem cell transplant (ASCT), who were treated with a median of 3 (range 2–12) prior chemotherapy lines. Fifty six patients received BV and 37 patients BVB regimen. In 16 of them, BVB was de-escalated to BV after the median of 2 cycles (range, 2–7). In the whole study group, the patients received the median of 4 BV/BVB cycles (range, 2–16). Dose-limiting toxicities were observed in 8% of patients. No difference was found between BV and BBV group, with similar rate of grade 3–4 neutropenia (16% vs 13%) and thrombocytopenia (4% vs 3%). Lung infection occurred in 1 patient treated with BV (2%) and 3 treated with BVB (2% vs 8%, p ns), with 2 treatment-related deaths in BVB group. The response rate after 2 cycles of BV and BVB treatment defined as complete (CMR) or partial metabolic response (PMR) assessed by positron emission tomography was 69% (26% of CMR and 43% of PMR) and 91% (41% of CMR and 50% of PMR), respectively (p = 0.029). After 4–6 cycles of treatment, CMR, PMR and stable metabolic disease was achieved in 62%, 18% and 10% of all patients, respectively, with no significant differences between BV and BVB group. Finally, 36 patients proceeded to ASCT, and 16 to allogeneic SCT. The overall and progression-free survival at 24 months were 80% and 51%, and did not differ between two study groups. In conclusion, our experience suggests that BVB is a feasible regimen that provides higher response rate after 2 cycles compared to BV monotherapy. Our results also indicate that BVB may be considered as a bridge to early SCT in R/R HL.