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

Vollständiger Abstract

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Summary 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.