Best salvage treatment for relapsed/refractory Hodgkin’s lymphoma (RRHL) is still unknown; the superiority of brentuximab vedotin (BV) + chemotherapy (CT) vs CT alone has never been tested in randomized clinical trials. Consolidation with autologous transplant (auto-HCT) is the standard of care for patient (pts) with RRHL but it is unknown if consolidation with BV could spare it in a good risk group. We have conducted a phase IIb prospective clinical trial (BRESELIBET, ClinicalTrials.gov ID: NCT04378647) that evaluates the efficacy of BRESHAP vs ESHAP in RRHL, followed by BV consolidation in those who attained a mCR. 150 adult pts with RRHL were to be included and randomized 1:1 to receive either BRESHAP (x3) or ESHAP (x3). Primary efficacy endpoint was mCR [Deauville Score (DS) of 1-2, DS of 1-3 after the recent amendment of the trial]. Those pts in mCR went on to receive up to 16 doses of BV (1.8 mg/kg iv every 3 weeks). Herein we are reporting preliminary results of the first 92 pts (6 of them, screening failure). Amongst the remaining 86 pts [52 males, median age of 39 (18-64) yrs], 29 were primary refractory, 24 had had an early relapse and 33 a late relapse. 42 pts were randomized into BRESHAP and 44 into ESHAP. 58 pts completed salvage therapy and had their disease status evaluated, 3 pts were discontinued because of an adverse event (AE), 1 pt withdraw consent, 5 pts progressed under therapy and 19 pts are still under treatment. 15 out of 30 (50%) achieved a mCR in the BRESHAP group vs 15 out of 33 (45.5%) in the ESHAP group (NS) (mCR rates were 70% vs 60.6% respectively, when considering DS 1-3). Nine severe AEs were reported in 7 pts [fever (n=3), sepsis (n=2), pneumonia (n=1), pericardial effusion (n=1), diarrhea (n=1), vomiting (n=1)]. 32 pts (15 BRESHAP vs 17 ESHAP) started consolidation with BV; median number of cycles of 9 (1-16). Six pts have finished consolidation with a median follow up after treatment of 3.3 (0.1 – 8) months. Four pts have relapsed after 3, 3, 5 and 9 cycles of BV and two pts stopped BV after 4 and 9 cycles due to grade 2 neurological toxicity. The results of this interim analysis indicate that the mCR rate of BRESHAP is in line to what our GELTAMO group has published before (García-Sanz R, Ann Oncol 2019) and that consolidation strategies with non-HCT approaches appear to be feasible in patients achieving stringent CR assessed by PET-CT. The trial will continue until the recruitment is completed.
Anna Sureda-Balari, M. José Terol, Eva Domingo-Domènech, Ana Pilar González Rodriguez, Francisca Hernández Mohedo, Javier Núñez Céspedes, Fátima de la Cruz Vicente, Carmen Martínez Muñoz, M. Elena Amutio Díaz, Raul Córdoba, Antonia Rodríguez Izquierdo, Samuel Romero Domínguez, Javier Briones Meijide, Richard Greil, Miriam Moreno Velázquez, Araceli Rubio, Mariana Bastos Oteiro, Pilar Gómez, Irit Avivi, María Casanova, Raquel Del Campo García, Victor Noriega, José Javier Sánchez Blanco, Ra