2026-08-30T13:04:28Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/227812024-11-28T17:20:33Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16960col_20.500.12105_16967

00925njm 22002777a 4500 dc Garcia-Sanz, R author Sureda Gomila, Antoni author de la Cruz, Fatima author Canales, M author Gonzalez, AP author Pinana, JL author Rodriguez, A author Gutierrez, Antonio author Domingo Domenech, Eva author Sanchez-Gonzalez, B author Rodriguez, G author Lopez, J author Moreno, M author Rodriguez-Salazar, MJ author Jimenez-Cabrera, S author Caballero, Maria Dolores author Martinez, C author 2019-04 Background: In this work, we assessed the efficacy and safety of brentuximab vedotin (BV) plus ESHAP (BRESHAP) as second-line therapy for Relapsed/Refractory Hodgkin lymphoma (RRHL) to improve the results before autologous stem-cell transplantation (ASCT). Patients and methods: This was a multicenter, open-label, phase I-II trial of patients with RRHL after first-line chemotherapy. Treatment had three 21-day cycles of etoposide, solumedrol, high-dose AraC, and cisplatin. BV was administered at three dose levels (0.9, 1.2, and 1.8 mg/kg) intravenous on day -1 to 3 + 3 cohorts of patients. Final BV dose was 1.8 mg/kg. Responding patients proceeded to ASCT, followed by three BV courses (1.8 mg/kg, every 21 days). Main end points for evaluation were maximum tolerable dose and overall and complete response (CR) before ASCT. Results: A total of 66 patients were recruited (median age 36 years; range 18-66): 40 were primary refractory, 16 early relapse and 10 late relapse. There were 39 severe adverse events were reported in 22 patients, most frequently fever (n = 25, 35% neutropenic), including 3 deaths. Grade 3-4 hematological toxicity presented in 28 cases: neutropenia (n = 21), thrombocytopenia (n = 14), and anemia (n = 7). Grade >= 3-4 extrahematological adverse events (>= 5%) were non-neutropenic fever (n = 13) and hypomagnesaemia (n = 3). Sixty-four patients underwent stem-cell mobilization; all collected >2x10e6/kg CD34+ cells (median 5.75; range 2.12-33.4). Overall response before transplant was 91% (CI 84% to 98%), including 70% (CRs 95% CI 59% to 81%). 60 patients were transplanted with no failure engraftments. Post-transplant response was CR in 49 patients (82% CI 73% to 91%) and partial responses in six (10% CI 5% to 15%). After a mean follow-up of 27 months, the 30-month time to treatment to failure was 74% (95% CI 68% to 80%), progression-free survival 71% (95% CI 65% to 77%), and overall survival 91% (CI 84% to 98%). Conclusion: BRESHAP looks a safe and effective pre-transplant induction regimen, does not jeopardize transplant and allows long-term remissions and survival. Garcia-Sanz R, Sureda Gomila A, De La Cruz F, Canales M, Gonzalez AP, Pinana JL, et al. Brentuximab vedotin and ESHAP is highly effective as second-line therapy for Hodgkin lymphoma patients (long-term results of a trial by the Spanish GELTAMO Group). Ann Oncol. 2019 Apr;30(4):612-20. 10.1093/annonc/mdz009 1569-8041 0923-7534 Annals of Oncology http://hdl.handle.net/20.500.13003/17265 30657848 L630735406 2-s2.0-85066842094 https://hdl.handle.net/20.500.12105/22781 468283900018 Hodgkin lymphoma Refractory Polychemotherapy Brentuximab vedotin Transplant Brentuximab vedotin and ESHAP is highly effective as second-line therapy for Hodgkin lymphoma patients (long-term results of a trial by the Spanish GELTAMO Group)