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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



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



Introduction: CHOP remains the standard therapy for intermediate and high grade NHL. We performed a randomized trial of CHOP vs ASCT in pts age 15 to 60 yo with newly diagnosed non high risk age adjusted IPI intermediate or high grade NHL. Methods: pts were randomized between CHOP (C= 750mg/m2; H = 50mg/m2) for 8 courses every 21 d or HDC consisting of 2 courses of CEEP (C= 1,2g/m2; epirubicin= 100mg/m2; vindesine= 3mg/m2; and PDN) every 15 d supported with GM-CSF, followed by a course of high dose Methotrexate (3g/m2) with cytarabine: 100mg/m2/d 5 d civi. PBSC were harvested after 1st or 2d CEEP in order to support a BEAM regimen (Etoposide: 400mg/m2/d X 4 d; cytarabine 400mg/m2/d civi X 4 d) scheduled on d 66 of 1st CEEP. Results: 207 pts were included, 197 eligible pts (99 CHOP; 98 HDC) are evaluable. The med age was 47 yo, 71% had diffuse large cell histology. At dg AA stage was II with Abdominal bulk, III and IV in 19%, 21% and 60% of pts respectively. According to age adjusted IPI, 6% of the pts were in the low, 41% in the intermediate low, 53% in the high intermediate risk category. Characteristics were matched between the two groups. The program was completed in 72% and 81% of CHOP and HDC groups respectively. In an intent to treat analysis, with a med FU of 46 m the 5 y probability of survival (SV), event free survival (EFS) and freedom from progression (FFP) are as follow: Conclusion: HDC with frontline ASCT is superior to standard CHOP for pts ltoreq60 yo EFS and FFP. There is a trend for better overall survival which is significant (74% vs 43% p=0.005) for pts with intermediate high risk IPI.

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