Abstract
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.
Highlights
The standard treatment for patients with classicalHodgkin lymphoma who are unresponsive to upfront therapy or relapse after primary treatment consists of salvage chemotherapy, followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT)
Ideally, a first salvage regimen should allow: (i) an effective disease control, which needs to translate into the chance of reinduce high complete response (CR) rates; (ii) a proper mobilization of peripheral blood stem cell (PBSC) without the use of further chemotherapy in patients for whom ASCT is an option; (iii) a long duration of response in those who are not candidate for a high-dose consolidation, after having obtained an adequate response; and (iv) a good toxicity profile, most of all without myelotoxic events and hopefully avoiding prolonged peripheral cytopenias
The effective combination of bendamustine and Brentuximab vedotin (BV) in the first salvage setting is supported by a relevant rate of objective responses observed in patients with relapsed or refractory classicalHodgkin lymphoma (cHL), along with a significant proportion of complete metabolic response (CMR) (84.2% and 78.9%, respectively), stringently confirmed by the application of the Deauville score (Deauville 1–3)
Summary
Hodgkin lymphoma (cHL) who are unresponsive to upfront therapy or relapse after primary treatment consists of salvage chemotherapy (aimed at harvesting autologous stem cells from peripheral blood), followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT). This latter phase has to be reserved only to those patients who are able to tolerate a highly toxic conditioning and a fairly prolonged myelosuppression. Disease recurrence still remains the principal cause of ASCT failure, and early disease progression after transplant, i.e., within 6 months from high-dose conditioning, emerges as a clear predictor of unfavorable outcome[4]. Any strategy aimed at achieving a minimal disease status, and at obtaining a positron emission tomography (PET)-negative status before ASCT without severe toxicity, would represent a major advance in the overall management of these patients[6,7,8,9]
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