RESUMEN
BACKGROUND: The objective was to demonstrate feasibility and therapeutic efficacy of routine clinical use of the bendamustine/rituximab combination in lymphoproliferative diseases. PATIENTS AND METHODS: Data were collected retrospectively from 71 patients treated with bendamustine/rituximab combination in Tyrol/Austria. Toxicities, therapeutic response, and survival outcome in the various lymphoma entities were analyzed. RESULTS: There was considerable hematotoxicity, with neutropenia and thrombocytopenia of grade 3 or 4 in 33% and 18%, respectively. Interestingly, severe infection of grade 3 or 4 was observed in a remarkable percentage of patients with aggressive lymphoma and CLL (21% and 28%, respectively) but not in indolent lymphoma (p = 0.027). Overall, the therapeutic efficacy of bendamustine/rituximab was encouraging. In CLL, an overall response rate (ORR) of 65% was achieved. Notably, in the seven previously untreated CLL patients, ORR was 86%. The therapy was effective across all FISH-cytogenetic subgroups, except for the five patients harboring 17p deletion with unfavorable prognosis (PFS 2.7 months, OS 9.3 months). In indolent lymphoma (n = 25), the bendamustine-rituximab combination induced a remarkable therapeutic effect (ORR 96%, median PFS and OS not reached). In aggressive lymphoma (n = 20), ORR was 50%; in International Prognostic Index high-risk patients (4 or 5 risk factors, n = 10), ORR was only 20%, significantly inferior than in low/intermediate risk patients (ORR 70%; p = 0.025). CONCLUSIONS: In the routine setting aside clinical studies, bendamustine/rituximab therapy resulted in marked clinical responses, especially in CLL and indolent lymphoma. In aggressive lymphoma, the combination of bendamustine and rituximab was effective in favorable risk patients.