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).

Autor:	Garcia-Sanz R; Servicio de Hematología, Hospital Universitario de Salamanca; Instituto de Investigación Biomédica de Salamanca (IBSAL); Centro de Investigación del Cáncer de Salamanca, Salamanca; Servicio de Hematología, Hospital Duran i Reynals, Instituto Catalá d'Oncologia, L'Hospitalet de Llobregat, Barcelona. Electronic address: rgarcias@usal.es., Sureda A; Servicio de Hematología, Hospital Virgen del Rocio de Sevilla, Seville., de la Cruz F; Servicio de Hematología, Hospital La Paz de Madrid, Madrid., Canales M; Servicio de Hematología, Hospital Central de Asturias, Oviedo, Asturias., Gonzalez AP; Servicio de Hematología, Hospital Clínico de Valencia, Valencia., Pinana JL; Servicio de Hematología, Hospital 12 de Octubre de Madrid, Madrid., Rodriguez A; Servicio de Hematología, Hospital Son Espases de Palma de Mallorca, Palma de Mallorca., Gutierrez A; Servicio de Hematología, Hospital del Mar de Barcelona, Barcelona., Domingo-Domenech E; Servicio de Hematología, Hospital Virgen del Rocio de Sevilla, Seville., Sanchez-Gonzalez B; Servicio de Hematología, Hospital Gregorio Marañón, Madrid., Rodriguez G; Servicio de Hematología, Hospital Ramón y Cajal, Madrid., Lopez J; Servicio de Hematología, Hospital Germans Trias y Pujol de Badalona, Barcelona., Moreno M; Servicio de Hematología, Hospital Universitario de Canarias, Tenerife., Rodriguez-Salazar MJ; Servicio de Farmacia, Hospital Universitario de Salamanca., Jimenez-Cabrera S; Pharmacy Department of Salamanca, Salamanca., Caballero MD; Servicio de Hematología, Hospital Universitario de Salamanca; Instituto de Investigación Biomédica de Salamanca (IBSAL); Centro de Investigación del Cáncer de Salamanca, Salamanca; Servicio de Hematología, Hospital Duran i Reynals, Instituto Catalá d'Oncologia, L'Hospitalet de Llobregat, Barcelona., Martinez C; Hospital Clinic de Barcelona, Barcelona, Spain.
Jazyk:	angličtina
Zdroj:	Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2019 Apr 01; Vol. 30 (4), pp. 612-620.
DOI:	10.1093/annonc/mdz009
Abstrakt:	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 >2×10e6/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. (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
Databáze:	MEDLINE
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