Antiemetic treatment with two different doses of methylprednisolone in breast cancer patients: a double-blind randomized cross-over study with evaluation of efficacy parameters.
This randomized double-blind cross-over study followed a previous one which showed an antiemetic efficacy from methylprednisolone (MP) 250 mg superior to placebo. The present study compared MP 40 mg with 250 mg in breast cancer patients treated with non-cisplatin chemotherapy. Preference after course II was the determining parameter. Participation in two courses was compulsory for evaluation, participation in four courses was optional. Interim analyses were performed after each 12 patients to a maximum of 60 patients. As there was no significant difference in preference in 60 patients the study was closed. Patients treated with the CEF regimen, patients who requested rescue antiemetics and patients completing four study courses had a better effect from high-dose MP reflected in preference and other parameters. Global assessments, measurement of emetic volumes and the visual analog scale for nausea gave a fair coherence with patients' preference. The numbers of emetic episodes and observer registered nausea were of no value. The stability of preference and other parameters after course II and IV, respectively, was low. The present study did not prove superiority from high-dose MP. This hypothesis must be tested in patients more severely bothered by emesis after chemotherapy. These results show the complexity of evaluation of antiemetic effect and demonstrate the dependency of a given result on the parameter used.
Havsteen
H
H
Department of Oncology, Finsen Institute Rigshospitalet, Copenhagen, Denmark.
Kjaer
M
M
D000328:Adult; D000932:Antiemetics / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008775:Methylprednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
D000932:Antiemetics; D008775:Methylprednisolone