Abstract
BV + AVD is increasingly used for frontline treatment of stage III/IV cHL. Young adults and adults (Ya&A) were the most common patients treated with BV + AVD in clinical trials but have not been studied in non-trial settings. We conducted a real-life study in secondary and tertiary cancer centers to evaluate the PFS in 18-59 years aged patients who were scheduled to receive six BV + AVD for newly diagnosed advanced stage cHL. This is the largest cohort of Ya&A reported to date including 150 patients from four clinical institutions in Southern Italy, all of which employed structured supportive care programs for HL. Fifty patients (30%) had at least one ECHELON-1 ineligibility criterion, including comorbidities and/or adverse performance status. All 150 patients underwent BV + AVD with a median relative dose intensity of 100% (dose reduction and/or discontinuation ≥ 15%, in 11% of them). At end-of-treatment (EoT) FDG-PET, 93% (140/147) of patients (three did not undergo EoT FDG-PET due to early grade 5 toxicity) achieved a complete response (95% CI, 88.1-96.8). Altogether, four patients (2.7%) received consolidation radiotherapy of residual nodal masses with a Deauville score of 4. Grade ≥ 2 peripheral neuropathy, cardiotoxicity, and febrile neutropenia were reported by 13%, 7%, and 3% of patients, respectively. With a 24 month median follow-up, PFS in the entire analyzed population was 91% (95% CI, 0.864-0.958). In Ya&A with high-risk cHL, our data suggest that a BV-driven strategy (without bleomycin and consolidation radiotherapy) is an effective up-front option in oncologic centers specialized in HL care, improving the rate of durable complete remission in routine clinical practice. Trial Registration: ClinicalTrials.gov identifier: NCT06857500.