Both Cyclophsphamide (C) and Fludarabine (F) have individual anti-lymphoma activity and the combination Rituximab (R) + F has been shown to have a synergistic activity against resistant lymphoma cell lines in vitro. In march 2000, we started a Phase II multicenter clinical trial to test safety and efficacy of FC+R combination in patients with relapsed follicular lymphoma. We have recently completed the enrollment of 48 pts in the trial. Patients received 4 doses of R (375 mg/sqm/d) in combination with 4 cycles of F (30 mg/sqm/d for 3 days) and C (300mg/sqm/d for 3 days) every 28 days. Patients characteristic: 45% males, 55% females; median age: 62 years (range 44-71); stage IV 47% pts; Systemic Symptoms 8,5% pts; elevated LDH 15% pts. Rearrangement of BCL2 gene was evaluated with PCR in 38pts (79%) on bone marrow or peripheral blood mononucleated cells; 22 patients showed BCL2 rearrangement (58%). Medium number of previous chemotherapy regimens was 1,7 (range 1-4); median duration of last remission before registration into the trial was 12 months (range 1-68). Thirty-nine patients were available for evaluation at the time of current analysis. One patient did not complete therapy due to severe cytopenia. The response rate in the intent-to-treat analysis was 97%, with 74%, Complete Responses (CR) and 23% Partial Responses (PR). Out of 18 patients with molecular monitoring of disease before and after chemotherapy, 15 patients (83%) obtained molecular remission in the bone marrow (BM) .After a median follow-up of 12 months (1-25), median duration of remission was 13 months; twenty percent of patients were only recently registered into the trial and had a short follow-up (less than 4 months). Overall, 8 patients relapsed (21%). One patient died due to severe neutropenia occurred during chemoterapy; two patients died due to lymphoma progression. Complete responses are ongoing in 28 patients. As far as toxicity is concerned WHO grade III-IV leukopenia was observed in 10 patients, with 4 patients presentig a WHO grade IV granulocytopenia. WHO grade IV infections were observed in only one patient who had a pulmonary infection after third cycle. Non-ematologic toxicity was minimal. During follow up, one patient had a renal cell tumor and one patient had myelodisplasia, 3 and 6 months after the end of treatment, respectively. In conclusion the combination FC+R is associated with acceptable toxicity and with an excellent response rate in this group of heavily pre-treated patients with relapsed follicular lymphoma. Furhter follow-up is required to evaluate response duration and survival in the whole group of patients.
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|Data di pubblicazione:||2002|
|Titolo:||Phase II Study with Fludarabine and Cyclophosphamide Plus Rituximab (FC+R) in Relapsed Follicular Lymphoma Patients.|
|Autori:||Stefano Sacchi; Alessandra Tucci; Francesco Merli; Loretta Orsucci; Giulia Cervetti; Ubaldo Occhini; Marina Liberati; Giuseppe Tarantini; Vicenzo Callea; Maura Brugiatelli; Vito Michele Lauta; Luca Baldini; Stefano Luminari; Massimo Federico.|
|Nome del convegno:||ASH 2002|
|Luogo del convegno:||nd|
|Data del convegno:||nd|
|Titolo del libro:||nd|
|Appare nelle tipologie:||Abstract in Rivista|
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