Brentuximab vedotin consolidation after autologous stem cell transplantation for Hodgkin lymphoma: A Fondazione Italiana Linfomi real‐life experience

Abstract

The standard management for relapsed or refractory classical Hodgkin lymphoma (cHL) is salvage therapy followed by autologous stem cell transplantation (ASCT). This strategy allows almost 50% of patients to be cured. Post‐ASCT maintenance treatment with brentuximab vedotin (BV) confers improved progression‐free survival (PFS) to cHL patients at high risk of relapse. We investigated the outcome of 105 cHL patients receiving post‐ASCT BV maintenance in the real‐life setting of 23 Italian hematology centers. This population included naïve patients and those previously exposed to BV. Median follow‐up was 20 months. Patients presented a median of two lines of treatment pre‐ASCT, with 51% receiving BV. Twenty‐nine percent of patients had at least two high‐risk factors (refractory disease, complete response [CR] less than 12 months, extranodal disease at relapse), while 16% presented none. At PET‐CT, a Deauville score (DS) of 1–3 was reported in 75% and 78% of pre‐ and post‐ASCT evaluations, respectively. Grade 3–4 adverse events (AEs), mainly peripheral neuropathy, were observed in 16% of patients. Three‐year PFS and overall survival (OS) were 62% and 86%, respectively. According to BV exposure, 3‐year PFS and OS were 54% and 71%, respectively, for naïve and 77% and 96%, respectively, for previously exposed patients. Refractory disease (hazard ratio [HR] 4.46; p = 0.003) and post‐ASCT DS 4–5 (HR 3.14; p = 0.005) were the only two factors significantly associated with PFS reduction in multivariable analysis. Post‐ASCT BV maintenance is an effective, safe treatment option for cHL naïve patients and those previously exposed to BV.

Effect of cumulative dose of brentuximab vedotin maintenance in relapsed/refractory classical Hodgkin lymphoma after autologous stem cell transplant: an analysis of real-world outcomes

“…A median number of 12 cycles were delivered to all patients, which is comparable to previously reported studies. 10-12 Despite 44% of patients having prior BV exposure, total mean number of BV cycles during maintenance was similar in the BV-exposed versus BV-naïve patients (10.6 vs . 11 cycles) which highlights that toxicity management and dose reductions were appropriate.…”

“…In a study conducted in Italy, early treatment discontinuations were reported at a rate of 44%, with the most common reason for discontinuation being toxicity. 10 A real-world study assessing patients who received BV maintenance in Europe found that the median cycles of BV maintenance completed was 11. 11 A similar study from Colombia also illustrated that the median number of cycles for BV maintenance was 12 and 18% of patients had grade 3 or higher PN.…”

Current perspectives on the management of refractory or relapsed classic hodgkin lymphoma in brazil: Balancing efficacy, safety, and tolerability

“…In Turkey, 75 patients were analyzed at a median follow-up of 26 months, and 50 patients had an ongoing response (CR in 41 cases), for 2-year PFS and OS rates of 68% and 88%, respectively [ 93 ]. In Italy, 105 patients with CHL (both naïve and previously exposed to BV) were analyzed at a median follow-up of 20 months, and the 3-year PFS and OS rates were 62% and 86%, respectively, once again confirming the real-life activity of BV [ 94 ]. Although most observational studies were not comparative, a retrospective comparison between BV and chemotherapy in 312 patients from the UK and Germany with a relapse after ASCT (196 treated with BV) showed a median PFS of 27 months for BV, versus 13 months for chemotherapy, with longer 1-year OS rate for BV (78% versus 66%) [ 95 ].…”

Anti-CD30 antibody–drug conjugate therapy in lymphoma: current knowledge, remaining controversies, and future perspectives

“…Real-world data on brentuximab vedotin for cHL have demonstrated the utility and feasibility of CD30-targeted ADC therapy beyond the setting of clinical trials and specialized centers (Table 3). Although there was a paucity of data on the real-world use of brentuximab vedotin as consolidation therapy post-ASCT for some time, several recent retrospective studies have assessed the effectiveness of this approach in adults, children, and adolescents, and support the results of the AETHERA trial [50][51][52][53][54]. Real-world data also support the efficacy and acceptable safety profile of brentuximab vedotin in adults with refractory or relapsed cHL [55,56], including as a bridge to ASCT [57], and the use of brentuximab vedotin in combination with bendamustine in children, adolescents, and adults with cHL [58,59].…”