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
Rc. Pieters et al., 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, Oncology, 50(4), 1993, pp. 316-322
A double-blind randomized crossover study was performed in 56 chemothe
rapy-naive patients, all receiving non-cisplatin-based chemotherapy, t
o compare the antiemetic effects of 2 doses of a single administration
of methylprednisolone succinate (Solu-Medrol): 250 versus 500 mg. Amo
ng the 39 patients who satisfactorily completed both parts of the stud
y, complete and major protection from emesis (0 and 1 emetic episode o
r only retching) was observed in 79% during the first course and in 69
% during the second course. Treatment failure (greater-than-or-equal-t
o 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 prefere
nce. Most important side effects were facial flushing (45%), headache
(22%) and facial edema (18%). It is concluded that. although a compari
son with lower dosages cannot be made, within the dose range studied n
o clear dose-reponse relationship could be found.