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Multicenter Prospective Randomized GITMO Trial Comparing High Dose Sequential Chemotherapy with Autografting and CHOP Both Supplemented with Rituximab as Frontline Therapy for High-Risk Follicular Lymphoma Patients An Interim Analysis

Multicenter Prospective Randomized GITMO Trial Comparing High Dose Sequential Chemotherapy with Autografting and CHOP Both Supplemented with Rituximab as Frontline Therapy for High-Risk Follicular Lymphoma Patients An Interim Analysis

Blood 100(11): Abstract No 4769, November 16

A recently published GITMO trial has shown that an intensified version of the high-dose (hd) sequential chemotherapy regimen (i-HDS) is a feasible and simple purging-free autografting-containing regimen that appears particularly effective for patients with high-risk FL at diagnosis (Ladetto et al, Blood, 2002 100: 1559). The program was characterized by an intensified chemotherapeutic debulkying, followed by a late mobilization course in order to collect progenitor cells with minimal or no tumor contamination. The regimen was then concluded with a TBI-free conditioning regimen consisting of hd-mitoxantrone and hd-melphalan followed by autologous transplantation. Moreover, recent studies have shown that i-HDS can be safely supplemented with four rituximab courses delivered before and during the mobilization phase (R-HDS). Rituximab supplementation proved feasible with an impressive improvement of the in vivo purging effect on stem cell collections and very promising clinical results (Magni et al, Blood, 2000, 96:864; Ladetto ed al, Leukemia, 2001 15:1941-9). Based on these experiences the GITMO has decided to launch at the end of 1999 a multicenter trial comparing R-HDS with a Rituximab supplemented CHOP (R-CHOP). Patients were considered eligible if they had FL at diagnosis with an age-adjusted I.P.I. score gtoreq2 or gtoreq3 adverse parameters according to the Italian Lymphoma Intergroup (I.L.I.) score. Twenty-five Italian Centers and one Brazilian Center have so far actively participated to the study by enrolling at least one patient. So far, 72 patients have been enrolled: 65 were eligible due to the age-adjusted I.P.I. score and 7 were eligible due to the I.L.I. score, despite an I.P.I. score <2 . Centralized molecular analysis has been planned for all patients entering the study using either the Bcl-2 translocation or the immunoglobulin heavy chain rearrangement. The two arms appear so far well balanced in terms of age, sex, histological grade, and entry criteria. A molecular marker has been obtained in 34 of the 51 (67%) patients so far evaluated. Both treatments appeared to be feasible with one toxic death due to septic shock in the R-CHOP arm. One patient enrolled in the R-HDS arm was withdrawn from the study due to toxicity while already in CR (asymptomatic heart failure detected by radionuclide cardiac scan before hd-cyclophosphamide). 45 patients are so far evaluable for response (21 in the R-HDS arm and 24 in the R-CHOP arm). Overall CR rate was 75%, PR rate was 4%, while 20% of patients had stable disease or disease progression. This preliminary analysis demonstrates the feasibility and modest toxicity of rituximab-supplemented chemotherapy in high-risk FL patients at diagnosis. In addition, an overall CR rate of 75% in such a high-risk patient population suggests that rituximab-containing regimens allow improving cytoreduction compared to rituximab-free regimens in FL lymphoma patients at diagnosis.

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Accession: 035349725

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