Prednimustine v cyclophosphamide-vincristine-prednisolone in the treatment of non-Hodgkin's lymphoma with favorable histopathology: results of a national cancer care program in Sweden.

In a nationwide multicenter study, single-agent treatment with prednimustine (PM) was compared with combination chemotherapy with CVP (cyclophosphamide, vincristine, and prednisolone) in patients with stage III-IV non-Hodgkin's lymphoma (NHL) with favorable histology (Rappaport groups nodular lymphocytic poorly differentiated, nodular mixed, and diffuse lymphocytic poorly and well-differentiated). From January 1979 to May 1982, 217 evaluable patients were randomized, and at present analysis, the median follow-up time is 42 months. Overall response rate in the PM group was 63% (complete, 40%; partial, 23%) compared with 66% in the CVP group (complete, 32%; partial, 34%). There was no significant difference in relapse-free survival (RFS) or survival between the two groups, median RFS being 30 months and median survival being 42 months, respectively. Reclassification of the lymphomas according to the Kiel system (possible in 80%) revealed high-grade malignant NHL in 22 patients (12 in PM group, 10 in CVP group). Within this small group, there was a marked difference in survival in favor of CVP-treated patients. However, treatment with PM was less toxic and better tolerated than the CVP regimen. It was concluded that for patients with low-grade malignant NHL treatment with PM is equally effective and less toxic than the CVP regimen.

RCT Entities:   Population Interventions Outcomes