Antonio Russo1, Alessandro Pulsoni2, Francesca Ricci1, Rita Mazza1, Massimo Magagnoli1, Lucia Morello1, Marcello Rodari3, Alessandra Serrao2, Giorgia Annechini2, Andrea Nervini2, Laura Giordano1, Luca Castagna1, Arturo Chiti3,4, Armando Santoro1,4, Carmelo Carlo-Stella1,4
1 Hematology, Humanitas Cancer Center, Humanitas Research Hospital, Rozzano-Milano, Italy, 2 Department of Cellular Biotechnology and Hematology, La Sapienza University, Rome, Italy, 3 Nuclear Medicine, Humanitas Research Hospital, Rozzano-Milano, Italy, 4 Department of Biomedical Sciences, Humanitas University, Rozzano-Milano, Italy
Introduction: In a multicenter phase II study, The BEGEV regimen has been proved an effective second-line therapy for relapsed/refractory classical Hodgkin Lymphoma (cHL) (Santoro et al., 2016). Here, we report a real-life analysis with BEGEV administered as second- or subsequent line therapy.
Patients and methods: From February 2013 to February 2018, 59 cHL patients (median age, 34 years; range, 19 – 70) received 4 courses of BEGEV as second (n = 38) or subsequent line (n = 21) therapy. Primary refractory patients were 55% in the second-line group and 76% in the group treated beyond second-line. The latter group received a median of 3 (range, 2–6) therapy lines prior to BEGEV; 11 of 21 patients (52%) had previously been treated with Gemcitabine (n = 9) and/or Bendamustine (n = 3) and 15 (71%) with Brentuximab Vedotin (BV). Nine patients (43%) had received autologous stem cell transplantation (auto-SCT).
Results: As reported in the phase 2 study, BEGEV had a good toxicity profile and all patients but 6 received the planned cycles. Reasons for premature therapy discontinuation included progressive disease (n = 5) and sepsis (n = 1). Overall, 39 patients achieved complete remission (CR) and 7 partial remission (PR) with an objective response rate (ORR) of 78%; stable disease and progressive disease (PD) were experienced by 1 and 11 (19%) patients, respectively. The ORR in patients receiving BEGEV beyond second-line was 76%. Interestingly, CR was achieved by all patients who were unresponsive to BV, all but one patient who had previously received auto-SCT, all but two patients pre-treated with Gemcitabine and all patients pre-treated with Bendamustine. All 46 patients that achieved a clinical response after BEGEV were offered SCT: 3 relapsed before SCT could be performed; 31 (67%) received auto-SCT and 8 (17%) allo-SCT; 3 patients are scheduled to perform the procedure, and 1 refused SCT. With a median follow-up of 392 days, the 1-yr overall survival (OS) and progression-free survival (PFS) are 91% and 72%, respectively. No significant OS or PFS difference was detected when comparing patients receiving BEGEV in second-line chemotherapy vs those receiving BEGEV beyond second line.
Conclusion: This real-life analysis shows that: (i) the BEGEV regimen is an effective treatment option for relapsed/refractory cHL treated beyond second-line and (ii) confirms BEGEV efficacy in patients with chemorefractory disease as well as in those failing auto-SCT and BV.