First salvage treatment with bendamustine and brentuximab vedotin in Hodgkin lymphoma: a phase 2 study of the Fondazione Italiana Linfomi

• Published in: Blood cancer journal (New York) Vol. 9; no. 12; pp. 100 - 8
• Main Authors: Broccoli, A., Argnani, L., Botto, B., Corradini, P., Pinto, A., Re, A., Vitolo, U., Fanti, S., Stefoni, V., Zinzani, P. L.
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 11.12.2019; Springer Nature B.V
• Subjects: 692/308/2779; 692/699/1541; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Bendamustine Hydrochloride; Biomedical and Life Sciences; Biomedicine; Brentuximab Vedotin; Cancer Research; Combined Modality Therapy; Female; Hematology; Hodgkin Disease - diagnosis; Hodgkin Disease - drug therapy; Hodgkin Disease - mortality; Humans; Immunotherapy; Magnetic Resonance Imaging; Male; Middle Aged; Monoclonal antibodies; Neoplasm Grading; Oncology; Salvage Therapy; Targeted cancer therapy; Tomography, X-Ray Computed; Treatment Outcome; Young Adult
• ISSN: 2044-5385; 2044-5385
• DOI: 10.1038/s41408-019-0265-x

Effective salvage options inducing high complete metabolic response (CMR) rates without significant toxicity are needed for Hodgkin lymphoma (HL) patients failing induction treatment and who are candidate to autologous stem cell transplantation (ASCT). Brentuximab vedotin (BV) and bendamustine are active monotherapies in the relapsed/refractory setting and their combination (the BBV regimen) possibly enhances their activity. This single-arm multicenter phase 2 study investigated the efficacy and safety of BBV as first salvage therapy in 40 patients with relapsed/refractory HL. Thirty-eight patients were evaluable for efficacy: 30 (78.9%) had a CMR and 2 (5.3%) a partial response, leading to an overall response rate (ORR) of 84.2%. The ORR in the primary refractory subset was 75.0%, among relapsed patients it was 94.4%. Thirty-five patients could mobilize peripheral blood stem cells and 33 underwent ASCT. At a median follow-up of 23 months, the estimated 3-year overall survival and progression-free survival are 88.1% and 67.3%. During therapy, only 3 grade IV cases of neutropenia occurred and resolved within a week. No grade 4 extrahematologic toxicities were reported; skin reactions were however rather frequent (65%). These results suggest that the BBV regimen exhibits promising efficacy and a manageable toxicity in a challenging subpopulation of HL patients.