DP076 | TOLERABILITY AND EFFICACY OF “CARMEN” AND OTHER INTENSIFIED REGIMENS USED IN HIV-NEGATIVE AND HIV-POSITIVE PATIENTS WITH BURKITT LYMPHOMA: REAL-LIFE DATA FROM A MULTICENTER SERIES OF 153 PATIENTS

Introduction: Treatment for sporadic and HIV-associated BL involves resource-heavy regimens, with long delivery times, often dose-limiting toxicity, and increased TRM. Over the last decades, BL pts have been successfully treated with the dose-dense, short-term “CARMEN” therapy in Italian Centres. CARMEN is a 36-day HDMTX-based regimen including single doses of cyclophosphamide, etoposide, and doxorubicin (Ferreri et al. Blood Adv 2022), with potentially better feasibility and tolerability than other used regimens. In a situation where comparative prospective trials are impractical, we analysed toxicity and efficacy of CARMEN and other regimens in BL pts treated at the 6 Italian centres that have developed the CARMEN program. Methods: Consecutive pts ≤70 y with BL treated with curative intent between 2009 and 2024 were included. Pts treated with intensified regimens other than CARMEN served as controls. Toxic deaths, interruptions/dose reductions, G≥3 non-hematol toxicity, and G≥3 infections were used to define feasibility and tolerability. Results: 153 pts (median 48 y, 19-69; 116 males) were considered: 57 received CARMEN and 96 received other regimens (GMALL, R-HyperCVAD, R-daEPOCH, CODOXM-IVAC). Fifty-seven pts had HIV. There were no differences between CARMEN and controls in age (median: 43 vs 48 y), PS 2-4 (41% vs 44%), advanced stage (86% vs 78%), extranodal disease (86% vs 77%), CNS involvement (14% vs 11%), high LDH serum level (74% vs 79%), and bulky disease (44% vs 32%). CARMEN was better tolerated than controls, with significantly lower rates of dose reductions, interruptions, G ≥3 non-hematol toxicities, and severe infections (Table). At a median follow-up of 84 (10-189) months, 7 pts had a second tumor: 2 (3%) after CARMEN and 5 (5%) after others. CARMEN was equally effective than other used regimens, with a 5-yr PFS of 68% (95%CI 66-70) and 66% (95%CI 64-68), respectively, and a 5-yr OS of 74% (95%CI 73-75) and 69% (95%CI 68-70) respectively. HIV status did not alter efficacy of CARMEN; this combination showed better efficacy in pts with CNS involvement. Conclusions: With intrinsic limitations, this real-life study shows that CARMEN achieves comparable outcomes to other standard therapies, with significantly better tolerability in both HIV- and HIV+ BL pts. In addition to its short duration and good tolerability, CARMEN may be associated with reduced risk of chronic toxicity and second tumors due to the use of single doses of cytotoxic agents.