Background The prevention of delayed nausea and vomiting causedby moderately emetogenic chemotherapy for cancer has not beenstudied systematically.
Methods We enrolled patients who were scheduled to receive chemotherapyfor the first time in a double-blind, randomized, multicenterstudy. All the patients received ondansetron combined with dexamethasonefor prophylaxis against emesis that might occur within 24 hoursafter the start of chemotherapy (acute emesis). They were thendivided into two groups: patients who did not have either vomitingor moderate-to-severe nausea (the low-risk group) and patientswho had one or both (the high-risk group). Patients in the low-riskgroup were then randomly assigned to one of the following regimens,given on days 2 through 5 after the start of chemotherapy: oralplacebo, 4 mg of dexamethasone given orally twice daily, or8 mg of ondansetron in combination with 4 mg of dexamethasone,given orally twice daily. Patients in the high-risk group wererandomly assigned to receive oral dexamethasone alone or incombination with ondansetron at the same doses as those usedin the low-risk group.
Results Among the 618 patients in the low-risk group, therewas a complete absence of both delayed vomiting and moderate-to-severenausea in 91.8 percent of those who received ondansetron combinedwith dexamethasone, 87.4 percent of those who received dexamethasonealone, and 76.8 percent of those who received placebo. The proportionsof patients who were protected by dexamethasone combined withondansetron or by dexamethasone alone were significantly greaterthan the proportion protected by placebo (P<0.001 and P<0.02,respectively). Of the 87 patients in the high-risk group, completeprotection was achieved in 40.9 percent of those treated withondansetron and dexamethasone and in 23.3 percent treated withdexamethasone alone (P not significant).
Conclusions The best way to prevent delayed nausea and vomitingin patients receiving moderately emetogenic chemotherapy isto control these complications within the first 24 hours afterthe start of chemotherapy. Dexamethasone alone provides adequateprotection against delayed emesis in patients at low risk (thosewho have not had acute emesis).
Source Information
Address reprint requests to Dr. Fausto Roila at the Medical Oncology Division, Policlinico Hospital, 06122 Perugia, Italy, or at faroila{at}unipg.it.
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