A double-blind randomized crossover study to compare the antiemetic efficacy of 250 mg with 500 mg methylprednisolone succinate (Solu-Medrol) as a single intravenous dose in patients treated with noncisplatin chemotherapy.
A double-blind randomized crossover study was performed in 56 chemotherapy-naive patients, all receiving non-cisplatin-based chemotherapy, to compare the antiemetic effects of 2 doses of a single administration of methylprednisolone succinate (Solu-Medrol): 250 versus 500 mg. Among the 39 patients who satisfactorily completed both parts of the study, complete and major protection from emesis (0 and 1 emetic episode or only retching) was observed in 79% during the first course and in 69% during the second course. Treatment failure (> or = 6 episodes of vomiting) was observed in 18% during the first course and 21% during the second course. There was no significant difference between the two dose levels neither in terms of antiemetic protection nor in terms of the occurrence of side effects nor in patient preference. Most important side effects were facial flushing (45%), headache (22%) and facial edema (18%). It is concluded that, although a comparison with lower dosages cannot be made, within the dose range studied no clear dose-response relationship could be found.
Pieters
R C
RC
Department of Medical Oncology, Free University Hospital, Amsterdam, The Netherlands.
Vermorken
J B
JB
Gall
H E
HE
Nauta
J J
JJ
van Loenen
A C
AC
van Groeningen
C J
CJ
van Rijswijk
R E
RE
Brenninkmeijer
J H
JH
Pinedo
H M
HM
D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008776:Methylprednisolone Hemisuccinate / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*
D000932:Antiemetics; D008776:Methylprednisolone Hemisuccinate