PHASE-III COMPARATIVE TRIAL USING CHOP VS CIOP IN THE TREATMENT OF ADVANCED INTERMEDIATE-GRADE NON-HODGKINS-LYMPHOMA

Until now, literature data support the fact that the CHOP regimen repr esents the standard first line treatment for patients with advanced in termediate-grade non-Hodgkin's lymphoma. Recently, idarubicin has been introduced in clinical trials because of its favourable preclinical p rofile: it is more active than daunorubicin and doxorubicin against a number of experimental tumour systems and is significantly less cardio toxic in animal models. From March 1991 to June 1993, 115 previously u ntreated patients with stage II to IV intermediate-grade non-Hodgkin's lymphoma, according to the Kiel classification, were enrolled in a ph ase III comparative trial. The objectives of the study were to compare the efficacy and safety of using idarubicin instead of doxorubicin in the polychemotherapeutic regimen CHOP (cyclophosphamide, doxorubicin, vincristine, and dexamethasone). Of the 115 patients registered for t he trial, 103 were evaluable: 52 received CH(doxorubicin)OP and 51 rec eived CI(Idarubicin)OP. Known prognostic factors were equally distribu ted among the two groups. There were no significant differences betwee n the 2 groups in the rates of partial and complete response. The over all response rate was 87%, with complete response in 62%:63% in the CH OP group, and 59% in the CIOP group. At 30 months (median 20 months), 86% of all CR patients were alive without disease in the CHOP group an d 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 events (1 moderate and 2 mild), while in the CHOP group 4 mild, 2 moderate and 1 severe were recorded. LVEF mon itoring 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 pati ents treated with CHOP regimen as compared to 4.8% in patients with CI OP regimen (P = .0001). In this trial, the ''idarubicin arm'' (CIOP re gimen) was found to have an equivalent therapeutic efficacy and, sligh tly, reduced clinical toxicity in comparison to the standard doxorubic in-containing CHOP regimen in patients with intermediate-grade non-Hod gkin's lymphoma.