In more than 70% of patients undergoing surgery for
breast cancer with histologically positive lymph nodes, precautional
therapy with CMF (
cyclophosphamide,
methotrexate,
5-fluorouracil) causes
nausea and
vomiting. At the present time, the optimal
antiemetic therapy has not been found. From May 1983 to March 1984, 35 patients, of whom 34 were evaluable, were entered in a randomized double blind
antiemetic treatment with either
bromopride (16 patients), a
procainamide derivative structurally similar to
metoclopramide, or placebo (18 patients).
Bromopride (20 mg) and the placebo were administered in a 3-min i.v. injection half an hour before
chemotherapy and at 3 1/2 and 7 1/2 following
chemotherapy. A complete
antiemetic protection was obtained in 9 patients (56.3%) treated with
bromopride compared to 5 patients (27.8%) treated with the placebo. A major
antiemetic (less than or equal to 2
vomiting episodes) was obtained in 3 patients (18.7%) treated with
bromopride compared to 5 patients (27.8%) treated with the placebo. Statistical analysis showed a trend in favor of
bromopride (P = 0.058). The most frequent side effect was sedation reported in 6 patients (37.5%) treated with
bromopride and 2 patients (11.1%) treated with the placebo (P = 0.06). The study was interrupted when several patients presented
vomiting episodes more than 12 h after CMF administration, and thus beyond the foreseeable protective effect of the
antiemetic treatment. It is our opinion that the search for an optimal
antiemetic regimen in the course of i.v. CMF
therapy should consider the administration of
antiemetic drugs at least until 12 h after
chemotherapy.