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

Adult Brentuximab Vedotin Male Salvage Therapy Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bendamustine Hydrochloride; Brentuximab Vedotin; Combined Modality Therapy; Female; Hodgkin Disease; Humans; Magnetic Resonance Imaging; Male; Middle Aged; Neoplasm Grading; Salvage Therapy; Tomography, X-Ray Computed; Treatment Outcome; Young Adult Middle Aged Combined Modality Therapy Hodgkin Disease Magnetic Resonance Imaging Article 3. Good health Young Adult 03 medical and health sciences Treatment Outcome 0302 clinical medicine Antineoplastic Combined Chemotherapy Protocols Bendamustine Hydrochloride Humans Female bendamustine, brentuximab, vedotin, Hodgkin lymphoma Neoplasm Grading Tomography, X-Ray Computed Aged
DOI: 10.1038/s41408-019-0265-x Publication Date: 2019-12-11T15:04:53Z
ABSTRACT
AbstractEffective 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.
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