Long-term results of brentuximab vedotin and bendamustine for first-line treatment of Hodgkin lymphoma in the elderly (HALO trial).

The Hodgkin lymphoma treatment in the elderly (eHL) is a challenge due to a narrow therapeutic window between therapy effectiveness and toxicity. Both bendamustine (Be) and brentuximab vedotin (BV) are well-tolerated, effective drugs in relapsing HL, but no data exist on Be-BV frontline treatment in eHL. The prospective, open-label, phase I/II Hodgkin lymphoma combining Adcetris® and Levact® in Old patients (HALO) study was launched (Clinical Trial.Gov Id. 02467946) to test safety and efficacy of Be-BV in untreated eHL. The mean age was 70.75 (62-79), stage IIB in 12, III in 14 and IV in 31 patients. Most had B-symptoms and an International Prognostic Score (IPS) ≥3 (39). Despite a good performance status and both a high activity of daily living (ADL) (≥6 in 85%) and instrumental activities of daily living (IADL) scores (≥8 in 77%), 68% of patients had ≥5 comorbidities, with a Cumulative Illness Rating Scale-Geriatric (CIRS)-G score >3 in 75%. A complete metabolic response (CMR) was achieved in 44/57 of patients. The 6-year overall survival (OS) and progression-free survival (PFS) in per-protocol (PP) analysis were 67% (95% confidence intertvals [CI] 53-84) and 45% (95% CI 32-65) respectively. A PFS event was observed in 35: 13 progressions (10 deaths), 13 relapses (6 deaths) and 9 deaths. Be-BV, when given in a full dose schedule, is an effective regimen for unselected, poor-risk elderly Hodgkin lymphoma (HL) patients.