Emetic control in breast cancer patients receiving iv CMF

Two consecutive antiemetic studies were performed in a homogeneous population of female breast cancer patients receiving i.v. CMF chemotherapy for six courses. Survival analyses (failure-free survival and emesis-free survival) were used as method of assessment of efficacy in these studies. The first of the two studies was a randomized, single-blind, placebo-controlled trial comparing three different dose levels of i.v. methylprednisolone (80 mg i.v., 250 mg i.v. and 500 mg i.v.) and placebo. 104 consecutive female breast cancer patients entered the study. There were no statistically significant differences in failure-free survival or emesis-free survival among the three methylprednisolone dose levels. Both failure-free survival and emesis-free survival were significantly superior in the three methylprednisolone arms than in the placebo group (p<0.05 to p<0.01). Since the results obtained with methylprednisolone alone in the first study were not completely satisfactory, the second study analyzed the interest of adding oral thyethylperazine (6 mg p.o. every 8 h) to i.v. methylprednisolone (80 mg) in 31 consecutive female patients scheduled to receive 6 courses of i.v. CMF. Sixty-eight percent of patients were free of emesis during the 6 courses of i.v. CMF chemotherapy with i.v. methylprednisolone plus oral thyethylperazine. This figure was significantly better than the emesis-free survival observed in methylprednisnolone-treated patients in the first study (p<0.05). Patients who did not achieve a complete response with methylprednisolone plus thyethylperazine in study 2 were treated with methyl-prednisolone (80 mg i.v.) and ondansetron (8 mg i.v. before chemotherapy and 8 mg per os every 8 h for 3 days) in subsequent courses of chemotherapy. Nearly 3/4 of such patient were rendered emesis-free with subsequent ondansetron treatment. Overall, 90% of patients obtained an excellent control of emesis with first-line methylprednisolone plus thyethylperazine or methylprednisolone-ondansetron rescue. The cost per patient of this antiemetic approach compares favorably with that of ondansetron as primary antiemetic therapy.