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Value of autologous stem cell transplantation in first line therapy of follicular lymphoma with high tumor burden Final results of the randomized GOELAMS 064 Trial



Value of autologous stem cell transplantation in first line therapy of follicular lymphoma with high tumor burden Final results of the randomized GOELAMS 064 Trial



Blood 102(11): 246a



The role of high dose chemotherapy with stem cell transplantation in first line therapy of follicular lymphoma with high tumor burden remains to be defined. Since 1994, we conducted a randomized multicenter phase III study comparing high dose chemotherapy (HDT) with purged stem cell transplantation versus standard conventional chemotherapy (CHVP)+interferon (GELF protocol) in patients gtoreq60 years old. In the HDT arm, patients received three courses of VCAP (vindesine, 3 mg/m2 day 1; cyclophosphamide, 1 500 mg/m2 day 2; doxorubicin, 80 mg/m2 day 2; prednisolone, 50 mg/m2 day 1 to day 5); in patients in complete remission or very good partial remission, harvest (PBSC or BM) was performed before negative or positive selection; patients in partial remission or in failure received DHAP regimen (dexamethasone, cytarabine, CDDP) before harvest 173 patients have been included and 169 patients are finally analyzed. The median age was 50 years; 72% of the patients had stage IV disease, 35% had a tumor mass >10 cms, 35% had elevated LDH levels. According to the International Prognostic Index, 63% were in the low intermediate, 32% in the high intermediate and 5% in the high risk category. If response rate is comparable in the two groups (88% versus 84%), the response intensity was more important in the high-dose chemotherapy arm (CR+VGPR=76% versus 46%). The median follow-up was 56 (6-108) months. The 5 year-event free survival was significantly better in the HDT than in the chemotherapy arm, 59% (95% CI: 47% to 71%) versus 37% (95% CI: 25.5% to 48.5%); p<0.017. Seven secondary cancers were observed in the HDT arm and the overall survival at 5 and 7 years did not differ significantly (83 and 70% in the standard arm versus 77.5 and 70% in the HDT arm). In conclusion, these results question the role of HDT in first line for follicular lymphoma specially with regard to the high rate of secondary cancers and to the current alternative therapeutic options like monoclonal antibodies. Updated results will be presented during the meeting.

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