The Antiemetic Efficacy of Thiethylperazine and Methylprednisolone Versus Thiethylperazine and Placebo in Breast Cancer Patients Treated with Adjuvant Chemotherapy (Fluorouracil, Doxorubicin and Cyclophosphamide): A randomized, double-blind, cross-over tr

Abstract

Forty-six women with breast cancer treated with adjuvant FAC (fiuorouracil, doxorubicin and cyclophosphamide) entered a multicenter, randomized, double-blind, cross-over trial in which thiethylperazine (T) (6.5 mg p.o every 8 h × 3 days) plus methyl-prednisolone (MP) (250 mg i.v. × 2 doses) was compared with thiethylperazine plus placebo. Forty-four patients were evaluable for efficacy. T + MP was significantly better in reducing vomiting (p<0.01) and nausea (p<0.02). the complete protection rate against vomiting was 36% for T + MP compared to 18% for T + placebo, and the percentage of nausea grades 0 + 1 (none or slight) was 59% and 27% respectively. the patient preference after cross-over was strikingly in favor of T + MP (70% versus 13%) (p<0.001). the most important side-effects of T+MP were facial flushing (22%) and euphoria (27%). Other side-effects, such as dryness of the mouth and sedation, were common after both treatments. in conclusion, the study suggested that T + MP is superior to T alone in protecting from nausea and vomiting induced by FAC.