V. Gebbia et al., TREATMENT OF CISPLATIN-RELATED NAUSEA AND VOMITING WITH A COMBINATIONOF ONDANSETRON AND METOCLOPRAMIDE - A PILOT-STUDY, Anti-cancer drugs, 7(7), 1996, pp. 734-737
Forty chemotherapy-naive patients receiving high-dose cisplatin were i
ncluded in a pilot study of a combination of ondansetron plus metoclop
ramide as antiemetic therapy. Patients received ondansetron 16 mg plus
metoclopramide 0.5 mg/kg in 250 cm(3) of normal saline i.v. 15 min be
fore cisplatin administration on day 1; then ondansetron 8 mg was give
n orally b.i.d. and metoclopramide 0.5 mg/kg was given intramuscularly
t.i.d. for 4 days. This combination was given to all patients receivi
ng the first cycle of chemotherapy. At the second cycle of chemotherap
y all patients received the same antiemetic treatment as above plus me
thylprednisolone 125 mg i.v. on day 1 and then intramuscularly once a
day for 4 days. There were 20 females and 20 males with a mean perform
ance status of 1 (range 0-2) and a mean age of 58 years (range 36-68).
Ten patients had ovarian carcinoma, eight patients had uterine adenoc
arcinoma and 22 had non-small cell lung carcinoma. The mean cisplatin
dose was 96 mg/m(2). All patients denied significant alcohol consumpti
on. At cycle 1, complete protection against acute emesis was achieved
in 22 patients (55%), major protection in 12 cases (30%), minor protec
tion in four patients (10%) and failure in two cases (5%). On the othe
r hand, the efficacy of this combination on delayed vomiting was not s
triking. For delayed vomiting, complete protection was observed in nin
e patients (23%), major protection in 13 cases (33%), minor protection
in 10 patients (25%) and failure in eight cases (20%). At cycle 2, pa
tients also received methylprednisolone showing complete protection fr
om vomiting in 19 cases (47%) and major protection in 12 cases (30%).
Results achieved with ondansetron plus metoclopramide are in the range
reported for ondansetron alone in the medical literature. Although th
is study was not prospectively carried out in a randomized fashion, th
e results are not suggestive of a possible positive effect of metoclop
ramide addition to ondansetron. On the other hand, these results stres
s the role that corticosteroids may play in the control of delayed eme
sis. Toxicity was predictable and the frequency of side-effects was in
the range reported in other studies with ondansetron.