EurekaMag.com logo
+ Site Statistics
References:
53,623,987
Abstracts:
29,492,080
+ Search Articles
+ Subscribe to Site Feeds
EurekaMag Most Shared ContentMost Shared
EurekaMag PDF Full Text ContentPDF Full Text
+ PDF Full Text
Request PDF Full TextRequest PDF Full Text
+ Follow Us
Follow on FacebookFollow on Facebook
Follow on TwitterFollow on Twitter
Follow on LinkedInFollow on LinkedIn

+ Translate

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.

(PDF 0-2 workdays service: $29.90)

Accession: 035349725

Download citation: RISBibTeXText



Related references

Rituximab-supplemented high-dose sequential chemotherapy (R-HDS) has better EFS and PFS than R-CHOP in poor risk follicular lymphoma (FL) at diagnosis: A multicenter randomized GITMO/IIL trial. Journal of Clinical Oncology 24(18_suppl): 7525-7525, 2016

Long-term follow-up of the Randomized GITMO/IIL trial, comparing CHOP-rituximab vs. high-dose therapy with rituximab (R-HDS) in high risk follicular lymphoma (Fl): Updated results suggest the use-of R-HDS as salvage treatment. 2007

High rate of clinical and molecular remissions in follicular lymphoma patients receiving high-dose sequential chemotherapy and autografting at diagnosis: a multicenter, prospective study by the Gruppo Italiano Trapianto Midollo Osseo (GITMO). Blood 100(5): 1559-1565, 2002

Prospective, multicenter randomized GITMO/IIL trial comparing intensive (R-HDS) versus conventional (CHOP-R) chemoimmunotherapy in high-risk follicular lymphoma at diagnosis: the superior disease control of R-HDS does not translate into an overall survival advantage. Blood 111(8): 4004-4013, 2008

Rituximab-Supplemented High-Dose Chemotherapy with Autografting in High-Risk B-Diffuse Large Cell Lymphoma A Multicenter, Prospective Study of GITIL. Blood 100(11): Abstract No 2546, November 16, 2002

Randomized Trial Comparing R-CHOP Versus High-Dose Sequential Chemotherapy in High-Risk Patients With Diffuse Large B-Cell Lymphomas. Journal of Clinical Oncology 34(33): 4015-4022, 2017

Frontline high-dose chemotherapy with autologous stem cell transplantation compared to standard CHOP regimen A randomized trial for adult patients with non IPI high-risk intermediate or high grade lymphomas. Blood 94(10 SUPPL 1 PART 1): 610a, Nov 15, 1999

Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood 106(12): 3725-3732, 2005

Frontline High-Dose Chemotherapy with Autologous Stem Cell Transplantation vs Standard CHOP Regimen for Patients with Non IPI High-Risk Intermediate or High-Grade Lymphomas Final Results of a Randomized Trial by the GOELAMS. Blood 100(11): Abstract No 675, November 16, 2002

Rituximab-CHOP-ESHAP vs CHOP-ESHAP-high-dose therapy vs conventional CHOP chemotherapy in high-intermediate and high-risk aggressive non-Hodgkin's lymphoma. Leukemia & Lymphoma 47(7): 1306-1314, 2006

The GITMO experience with high-dose chemotherapy and autografting in advanced follicle centre lymphoma A multicenter trial showing good feasibility and frequent achievement of clinical and molecular remissions. Blood 98(11 Part 1): 678a-679a, November 16, 2001

A phase II multicenter trial of high-dose sequential chemotherapy and peripheral blood stem cell transplantation as initial therapy for patients with high-risk non-Hodgkin's lymphoma. Biology of Blood and Marrow Transplantation 3(4): 210-216, 1997

Bortezomib plus rituximab versus rituximab in patients with high-risk, relapsed, rituximab-naïve or rituximab-sensitive follicular lymphoma: subgroup analysis of a randomized phase 3 trial. Journal of Hematology & Oncology 5(): 67-67, 2013

A multicenter randomized trial by Italian Lymphoma Intergroup comparing high dose chemotherapy with autologous stem cell transplantation vs intensified chemotherapy MegaCEOP in high risk diffuse large cell lymphoma No difference in outcome and toxicity. Blood 98(11 Part 1): 725a-726a, November 16, 2001

Rituximab given after high dose therapy and autologous stem cell transplantation induces durable clearance of minimal residual disease in about half of the patients with follicular non hodgkins lymphoma Interim 24 months results of a multicenter open label phase II Trial. Blood 102(11): 410a, November 16, 2003