Researchers from Italy have reported that high-dose sequential therapy with Rituxan results in a higher remission rate when compared to CHOP-R for the
treatment of patients with poor risk follicular lymphoma. The details of this multicenter randomized trial were presented at the 2006 meeting of the American Society of Hematology.
Patients with follicular lymphoma often receive moderate dose chemotherapy until they fail to respond. Then, many receive an autologous transplant as salvage therapy. A previous study by the same Italian researchers showed that high-dose chemotherapy produced complete molecular remissions in 61% of patients and that these patients had an 85% DFS at 54 months (see first item in related news).
The current study was a randomized trial involving 136 poor risk patients with FL. They were randomly allocated to receive 6 cycles of CHOP-R or an intensive induction regimen that included 3 phases: (1) 2 APO and 2 DHAP courses, (2) etoposide cyclophosphamide and Rituxan followed by stem cell harvest and (3) high-dose chemotherapy with mitoxantrone and Alkeran® (melphalan) with stem cell infusion. This was a crossover study and patients who failed R-CHOP could receive Rituxan supplemented high-dose sequential chemotherapy.
There were 4 toxic deaths; 2 in each arm. Disease progression occurred in 28% of the R-CHOP patients and 10% of the high-dose group. Two thirds of the patients failing R-CHOP crossed over to receive high-dose sequential therapy and 73% achieved a CR. Event-free survival at 40 months was approximately 65% for the high-dose group and 20% for the CHOP group. However, 83% of patients survived at 36 months in both arms. A stable molecular remission was achieved in 28% of R-CHOP patients and 78% of the high-dose group.
Ladetto M, de Marco F, Benedetti F, et al. Clinical and molecular results of the multicenter randomized GITMO-IIL trial in poor risk follicular lymphoma (FL) at diagnosis: Rituximab-supplemented high-dose sequential chemotherapy (R-HDS) is superior to CHOP-R in molecular remissions rate, EFS and PFS. Blood 2006;108:101a, abstract 325.
