Evolving role of toremifene in the adjuvant setting.

The Finnish Breast Cancer Group (FBCG) started the first multicenter trial of toremifene (Fareston) in the adjuvant setting in 1992. The primary aim of the trial is to compare the efficacy and side effects of toremifene and tamoxifen (Nolvadex) as adjuvant therapies for postmenopausal node-positive breast cancer patients. About 830 patients have been enrolled in the trial to date. An interim analysis of the first 500 patients, performed after a mean follow-up of 18 months, showed no significant difference between toremifene and tamoxifen with regard to efficacy or side effects. The study includes additional protocols aimed at examining some side effects, including ocular problems and the formation of DNA adducts in the endometrium and leukocytes, as well as possible additional benefits, such as effects on lipid levels and bone density. Toremifene also is being studied in two other trials in Europe. These studies, which are being coordinated by the International Breast Cancer Study Group (IBCSG), have enrolled approximately 600 patients to date.