Phase III Comparative Trial Uisng CHOP vs CIOP in the Treatment of Advanced Intermediate-Grade Non-Hodgkin's Lymphoma

Until now, literature data support the fact that the CHOP regimen represents the standard first line treatment for patients with advanced intermediate-grade non-Hcdgkin's lymphoma. Recently, idarubicin has been introduced in clinical trials because of its favourable preclinical profile: it is more active than daunorubicin and doxorubicin against a number of experimental tumour systems and is significantly less cardiotoxic in animal models. From March 1991 to June 1993, 115 previously untreated patients with stage II to IV intermediate-grade non-Hodgkin's lymphoma, according to the Kiel classification, were enrolled in a phase III comparative trial. The objectives of the study were to compare the efficacy and safety of using idarubicin instead of doxorubicin in the polychemother-apeutic regimen CHOP (cyclophosphamide, doxorubicin, vincristine, and dexamethasone). Of the 115 patients registered for the trial, 103 were cvaluable: 52 received CH(doxorubicin)OP and 51 received CI(Idaruhicin)OP. Known prognostic factors were equally distributed among the two groups. There were no significant differences between the 2 groups in the rates of partial and complete response. The overall response rate was 87%. with complete response in 62%: 638 in the CHOP group, and 59% in the CIOP group. At 30 months (median 20 months), 868 of all CR patients were alive without disease in the CHOP group and 85% in the CIOP group. Patients treated with CHOP experienced Severe alopecia more frequently (P =. 004). Only three patients in the CIOP group showed cardiac adverse event (I moderate and 2 mild), while in the CHOP group 4 mild, 2 moderate and I severe were recorded. LVEF monitoring was carried out in 31 patients of the CHOP group and in 27 of the CIOP group. A median drop of 8.3% of the LVEF was observed in patients treated with CHOP regimen as compared to 4.8% in patients with CIOP regimen (P =. OOO1). In this trial, the “idarubicin arm” (CIOP regimen) was found to have an equivalent therapeutic efficacy and, slightly, reduccd clinical toxicity in comparison to the standarddoxorubicin-containing CHOP rcgimen in patients with intcrmediate-grade non-Hodgkin's lymphoma.