Efficacy of two different ProMACE-CytaBOM derived regimens in advanced aggressive non-Hodgkin's lymphoma. Final report of a multicenter trial conducted by GISL

Background and Objective. To compare the efficacy of ProME(Epidoxorubicin)CE-CytaBOM (PE-C) and ProMI(Idarubicin)CE-CytaBOM (PIG) in the treatment of adult patients with aggressive non Hodgkin's lymphoma in a multicenter randomized controlled trial performed by 18 centers of the Italian Lymphoma Study Group (GISL). Design and Methods. One hundred and twenty-eight and 122 patients were randomly assigned to receive either 6 courses of PE-C or PI-C, respectively. Some patients achieving complete remission with induction therapy participated in another randomized study comparing no further therapy versus maintenance therapy consisting of four blocks of two drugs. Results. The rate of CRs was 62% and 64% for patients treated with PE-C and PI-C, respectively (p=0.51). The 5-year relapse-free survival was 60% for PE-C and 53% for PI-C (p=0.29). The estimated relapse-free disease survival rates at 4 years were 75% for patients in the consolidation group and 57% for those in the observation group (p=0.11). Patients alive In first complete remission 4 years after study entry were estimated to be 39% in the PE-C arm and 38% in the PI-C arm (p=0.90). The 3-year and 5-year estimated survival rates were 61% and 55% for the PE-C group and 56% and 47% for the PI-C group (p=0.26). Fatal toxicities occurred in 7 patients (2.9%) with active disease and in 4 patients (1.7%) in complete remission. Stage (p=0.04), bulky disease (p=0.02), serum LDH (p=0.0006), serum albumin (p=0.0051), hemoglobin (p=0.0011), performance status (p=0.0001), International prognostic index (p<0.0001) and the index proposed by the French group G.E.L.A. (p