[A randomized cross-over comparative study of granisetron alone and combination of granisetron, methylprednisolone and droperidol as antiemetic prophilaxis in CDDP-based chemotherapy for gynecologic cancer]

Abstract

A cross-over clinical trial was carried out to compare the efficacy and safety of granisetron alone (40 micrograms/kg) as a "single" group, with that of granisetron, methylprednisolone (250 mg/ body) and droperidol (0.5 ml/body) as a "cocktail" group for control of emesis and vomiting induced by CDDP-based chemotherapy in 68 courses of 34 patients with gynecologic malignancies. At the first course, "single" or "cocktail" drugs were administered at day 1, 2, and 3 of chemotherapy, and at the second course, "cocktail" or "single" drugs in as cross-over fashion. We examined the degree of nausea and frequency of vomiting during the first 7 days of chemotherapy. As for the severity of nausea, the "single" group showed prominent nausea immediately after CDDP and the most severe level at the 3rd or 4th day. The "cocktail" group showed mild symptoms from the next day and it lasted for several days. Vomiting started 12 hours later in the "single" group and the most frequent peak was the 2nd day, whereas the "cocktail" group showed less than one vomiting at the 2nd or 3rd day throughout the treatment. Clinical response (extremely good, good) in the current series of 68 courses of chemotherapy was also evaluated to be 45% and 35% in the "single" group, respectively, against 75% and 20% in the "cocktail" group, respectively. There was no clinical toxicity or side effects in either treatment group. We conclude that the cocktail treatment is very useful for not only acute, but also late emesis in CDDP-based chemotherapy in gynecologic malignancies.