[Phase III clinical studies with ondansetron (Qilu) in the prophylaxis of nausea and vomiting induced by cisplatin].
OBJECTIVE
To further evaluate the clinical usefulness of ondensetron(OND, supplied by Qilu Pharmaceutical Company) with modified regime in the prevention of cisplatin (DDP)-induced nausea and vomiting.


METHODS
A total of 773 patients were enrolled in a multicenter cooperative study. Of them, 330 patients were given i.v. OND 8 mg once or twice a day and 443 patients were given i.v. OND 8 mg plus dexamethasone(DXM) 10 mg once a day during the therapeutic period of DDP, followed by OND 4 mg orally twice a day for two days after DDP treatment.


RESULTS
Effective control of acute nausea was achieved in 86.7% and 94.8% of the patients receiving OND alone and OND plus DXM, respectively(P < 0.001). The mean frequency of vomiting was 0.9 times in OND and 0.4 times in OND plus DXM(P < 0.01). Total control of delayed vomiting (day 2-5) was comparable in both groups. Complete inhibition of vomiting (CR rate) was more frequently observed in males than in females. Adverse effects were identical and well tolerated.


CONCLUSIONS
OND with modified regimen is effective in the control of DDP-induced vomiting. It is more effective when OND and DXM are given than OND given alone.
Cancer Institute (Hospital), Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing.
B
B
Xu
J
J
Zhou
A
A
Zhou
D000293:Adolescent; D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy; D002648:Child; D002675:Child, Preschool; D002945:Cisplatin / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D017294:Ondansetron / Q000627:therapeutic use*; D014840:Vomiting, Anticipatory / Q000209:etiology / Q000517:prevention & control*
D000932:Antiemetics; D000970:Antineoplastic Agents; D017294:Ondansetron; D002945:Cisplatin