Denitrification pathways and rates in the sandy sediments of the Georgia continental shelf, USA

A prospective randomised multicentre clinical study was undertaken for 2 years and 3 months from November 1982, with the aim of examining the significance of using a combination of ftorafur (FT) and tamoxifen (TAM) for post-operative adjuvant therapy of breast cancer. Patients had either stage II or stage Illa disease, were age 75 or below and had undergone radical mastectomy. Patients were divided into two groups and received one of the following treatment protocols: treatment A, intravenous administration of doxorubicin (DOX), 20mg on the day of surgery and 10mg the next day, followed by oral FT 50mg day-' for 2 years from the 14th day; treatment B, the same pattern of DOX administration for the first 2 days, followed by a combined therapy of FT and TAM 20 mg day-' for 2 years. The number of patients was 546 (treatment A 274 and treatment B 272), of whom 34 (6%) were ineligible. The remaining 512 patients (treatment A 254 and treatment B 258) were followed up for 5 years for analysis. Significantly higher 5 year disease-free rate and 5 year survival rates were observed with treatment B compared with treatment A. When seen in terms of background factors, node-positive patients appeared to derive more benefit from tamoxifen than node-negative patients, but the oestrogen receptor-negative and premenopausal subgroups appeared to derive about the same benefit as those who were oestrogen receptor positive and post-menopausal. Indeed, survival in the premenopausal group was significantly better with tamoxifen (P = 0.04). No increase in side-effects was seen by combining TAM with FT. The study results demonstrate that concomitant administration of FT and TAM is better than FT alone for post-operative adjuvant therapy for breast cancer. Tamoxifen (TAM), when used as an adjuvant therapy in primary breast cancer, has been shown to improve survival and disease-free survival (DFS). Compared with no treatment tamoxifen 20 mg day-' for 2 years (Nolvadex Adjuvant Trial Organization, 1988) and compared with no post-operative treatment tamoxifen 20 mg day-' for 5 years (starting at the time of first relapse) (MRC Scottish Cancer Trials Office, 1987) is beneficial. More recently, the Early Breast Cancer Trialists' Collaborative Group (1992) Overview has confirmed the benefit of adjuvant TAM therapy. Ftorafur (FT) is an analogue of 5-fluorouracil (5-FU) widely used in Japan for treatment of stomach and colon cancers. The positive effects of adding TAM to FT in recurrent breast cancer (in which response …