Journal of Clinical Oncology, Vol 11, 2396-2404, Copyright © 1993 by American Society of Clinical Oncology
Difference in persistence of efficacy of two antiemetic regimens on acute emesis during cisplatin chemotherapy. The Italian Group for Antiemetic Research
PURPOSE AND METHODS: We conducted a prospective, double-blind, multicenter
study of 287 cancer patients treated for the first time with high-dose
cisplatin chemotherapy who were randomly assigned to receive three
consecutive cycles of the same antiemetic treatment consisting of
ondansetron plus dexamethasone, or metoclopramide plus dexamethasone and
diphenhydramine. RESULTS: Patients who received the ondansetron combination
achieved significantly greater complete protection from vomiting, but not
from nausea, in all three cycles of chemotherapy than did patients treated
with metoclopramide (78.7% v 59.6%, P < .002 during the first cycle;
73.4% v 51.0%, P < .002 during the second cycle; 73.7% v 47.5%, P <
.001 during the third cycle). The ability of ondansetron treatment to
protect patients from vomiting during the first cycle did not change in
subsequent cycles, but decreased significantly as far as complete
protection from nausea and from both nausea and vomiting are concerned.
With the metoclopramide combination, a significantly greater reduction of
complete protection from vomiting, nausea, and both nausea and vomiting was
detected. Protection obtained in previous cycles of chemotherapy was the
most important prognostic factor. Adverse events were significantly less
frequent with ondansetron treatment during the three cycles of chemotherapy
and no cumulative toxic effects were found with either treatment.
CONCLUSION: Ondansetron plus dexamethasone was significantly more
efficacious and better tolerated than metoclopramide plus dexamethasone and
diphenhydramine during three cycles of chemotherapy and, in contrast to the
metoclopramide regimen, the efficacy of ondansetron plus dexamethasone, at
least for vomiting, is maintained in subsequent cycles.
