Brentuximab Vedotin and ESHAP is Highly Effective as Second-Line Therapy for Hodgkin Lymphoma Patients (Long-Term Results of a Trial by the Spanish GELTAMO Group)

Abstract

Purpose

In this work, we assessed the efficacy and safety of Brentuximab Vedotin (BV) plus ESHAP [BRESHAP] as second-line therapy for Relapsed/Refractory Hodgkin lymphoma RRHL to improve the results before autologous stem cell transplantation (ASCT).

Patients and Methods

This was a multicenter, open-label, phase I-II trial of patients with RRHL after first-line chemotherapy. Treatment had three 21-day cycles of etoposide, solumedrol, high-dose AraC, and cisplatin. BV was administered at three dose levels (0.9, 1.2 and 1.8 mg/kg) IV on day-1 to 3 + 3 cohorts of patients. Final BV dose was 1.8 mg/kg. Responding patients proceeded to ASCT, followed by three BV courses (1.8 mg/kg, every 21 days). Main endpoints for evaluation were maximum tolerable dose and overall and complete response before ASCT.

Results

66 patients were recruited (median age, 36yr; range, 18-66): 40 were primary refractory, 16 early relapse, and 10 late relapse. There were 39 severe adverse events were reported in 22 patients, most frequently fever (n = 25, 35% neutropenic), including three deaths. Grade 3-4 hematological toxicity presented in 28 cases: neutropenia (n = 21), thrombocytopenia (n = 14), and anemia (n = 7). Grade ≥3-4 extrahematological adverse events (≥5%) were: non-neutropenic fever (n = 13) and hypomagnesaemia (n = 3). 64 patients underwent stem cell mobilization; all collected >2·10e6/Kg CD34+ cells (median, 5.75; range, 2.12-33.4). Overall response before transplant was 91% (CI 84-98%), including 70% complete responses (CR, 95% CI 59-81%). 60 patients were transplanted with no failure engraftments. Post-transplant response was CR in 49 patients (82%, CI 73-91%) and partial responses in six (10%, CI 5-15%). After a mean follow-up of 27 months, the 30-month time to treatment to failure was 74% (95% CI, 68-80%), progression-free survival 71% (95% CI, 65-77%), and overall survival 91% (CI, 84-98%).

Conclusion

BRESHAP looks a safe and effective pre-transplant induction regimen, does not jeopardize transplant and allows long-term remissions and survival.

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