Methylprednisolone for the control of CMF-induced emesis.

Sixty-eight breast cancer patients for outpatient adjuvant chemotherapy (CT) with cyclophosphamide, methotrexate, and fluorouracil (CMF) on a 1-day schedule entered a randomized trial comparing the antiemetic-efficacy of different doses of methylprednisolone (MPN). Treatment was administered concomitantly with the first course of CT and consisted of MPN in either 375 or 120-mg doses divided into 3 equal parts, the first administered i.v. just prior to CMF and then i.m. 6 and 12 h after CT. Overall, antiemetic protection was appreciable: complete emetic protection (no emetic episodes) was observed in 71 and 66% of patients receiving MPN 375 and 120 mg, respectively. In 43 and 54% of patients receiving MPN 375 and 120 mg, respectively, nausea did not occur. Efficacy of the two treatment arms was not statistically different for either emesis or nausea. Antiemetic protection with MPN was reproducible over time at subsequent courses: 60% of patients in either treatment arm experienced less than 5 emetic episodes at their 12th CMF course. Facial flush was the most frequently observed side effect (36% with MPN 120 mg vs. 68% with MPN 375 mg). Other acute untoward effects consisted of headache, pyrosis, and edema. However, the latter was observed only with the higher dose. In patients receiving CMF, MPN alone provides effective and reproducible emetic protection. No dose-response relationship was observed.

RCT Entities:   Population Interventions Outcomes