A phase Ib/II trial combining brentuximab vedotin with cyclophosphamide, procarbazine, prednisone, etoposide and mitoxantrone (BrEPEM) for older patients with untreated classical Hodgkin lymphoma: A multicentre GELTAMO trial.

Classical Hodgkin lymphoma (cHL) has high curability following initial standard treatments. A less favourable outcome is observed in patients aged ≥60 (poorer tolerability and efficacy). Low-intensity chemotherapies are currently employed for this group of patients, although there is still a need for improvement. This phase Ib/II multicentre, single-arm study evaluated the safety and efficacy of the combination of brentuximab vedotin with cyclophosphamide, prednisolone, procarbazine, etoposide, mitoxantrone (BrEPEM) in older untreated patients with cHL. Forty patients were enrolled (6 phase Ib; 34 phase II). Median age was 73 years (range: 67-88), 93% stage III/IV and median Cumulative Illness Rating Scale-Geriatric (CIRS-G) was 5 (range: 1-28). The median follow-up was 43.2 months. The most common adverse events were haematological toxicities (neutropenia G ≥3: 32%). During treatment, five patients died from infections. Per protocol/intention-to-treat analysis showed an overall response of 93%/63% and a complete response of 89%/60% respectively. Median progression-free survival (PFS) and overall survival (OS) were 14.3 months (95% confidence interval [CI] = 11.5-not reached [NR]) and NR (95% CI = 29.5-NR) respectively. Estimated 2-year PFS and OS were 44% (95% CI = 31-62) and 69% (95% CI = 56-85) respectively. BrEPEM is an alternative option for older untreated cHL patients, albeit not exempt from toxicity. Studies directed to better patient selection are needed to improve survival and mitigate toxicities.