Tamoxifen alone versus tamoxifen plus 1-(2-tetrahydrofuryl)-5-fluorouracil in the treatment of advanced breast cancer: a sequential trial.

During the past 4 years, a sequential study was conducted to compare the effect of tamoxifen (TAM) alone and TAM plus 1-(2-tetrahydrofuryl)-5-fluorouracil (FT) in the treatment of advanced breast cancer. The overall response rates were 28.9% in 45 patients treated with TAM, and 43.2% in 37 treated with TAM + FT. In regard to dominant site of lesions, 4 out of 9 patients (44.4%) with visceral involvement responded to TAM + FT, whereas none out of 10 responded to TAM alone. In a crossover study, 4 out of 5 failures to TAM responded favorably to TAM + FT. The median value of survival was 24 months in patients treated with TAM alone and 36 months with TAM + FT. Side effects such as gastrointestinal disorders and bone marrow suppression slightly increased in incidence when cytotoxic chemotherapy was combined with TAM. The present chemo-endocrine regimen with TAM + FT showed some advantages over TAM alone.

RCT Entities:   Population Interventions Outcomes