Vittorio Stefoni, Stefano Pileri, Francesco Scopinaro, Stefano Fanti, Alessandro Broccoli, Giancarlo Montini, Monica Tani, Fabio Torelli, Enrico Derenzini, Letizia Gandolfi, Alessandro Pulsoni, A De Renzo, Michele Baccarani, Lisa Argnani, Federica Quirini, Mariapaola Fina, Pier Luigi Zinzani, Cinzia Pellegrini, Martina Rossi, Elena Cavalieri, Zinzani P.L., Tani M., Pulsoni A., De Renzo A., Stefoni V., Broccoli A., Montini G.C., Fina M., Pellegrini C., Gandolfi L., Cavalieri E., Torelli F., Scopinaro F., Argnani L., Quirini F., Derenzini E., Rossi M., Pileri S., Fanti S., and Baccarani M.
Background A prospective, single-arm, open-label, multicenter, nonrandomised phase II trial to evaluate efficacy and safety of short fludarabine, mitoxantrone, and rituximab (FMR) induction followed by radioimmunotherapy, in untreated, intermediate/high-risk follicular non-Hodgkin’s lymphoma (NHL) patients. Patients and methods Fifty-five patients were treated using a sequential treatment schedule of four induction cycles of FMR chemoimmunotherapy, and a subsequent consolidating single administration of 90Y-ibritumomab tiuxetan (90Y-IT), 8–14 weeks later. Patients were eligible for radioimmunotherapy if at least in partial response (PR) after induction, with normal platelet and granulocyte counts and a bone marrow infiltration ≤25%. Primary study end points were response rate and hematologic toxic effects; secondary end points were overall survival (OS) and progression-free survival (PFS). Results All the 55 patients received four induction cycles with an overall response rate of 96% (38 complete responses [CR] and 15 PR). Fifty-one patients (38 in CR and 13 in PR) received 90Y-IT. By the end of the treatment, 49/55 patients achieved a CR. With a median follow-up of 21 months, the estimated 3-year PFS was 81% and the 3-year OS 100%. Conclusions This study has established feasibility, tolerability, and efficacy of a regimen composed by short FMR induction with 90Y-IT consolidation in untreated intermediate/high-risk follicular NHL patients.