• Zhaocai Yu, Wenchao Liu, Ling Wang, Houjie Liang, Ying Huang, Xiaoming Si, Helong Zhang, Duhu Liu, and Hongmei Zhang.
• Department of Clinical Oncology, Xijing Hospital, The Fourth Military Medical University, No 15, West Changle Road, Xi'an, 710032, China.
• Support Care Cancer. 2009 Jan 1;17(1):99-102.

PurposeThis clinical trial was conducted to evaluate the efficacy and safety of Palonosetron in preventing chemotherapy-induced vomiting (CIV) among the Chinese cancer patients.Patients And MethodsTwo hundred and forty patients were scheduled to be enrolled and randomized to receive a single intravenous dose of palonosetron 0.25 mg, or granisetron 3 mg, 30 min before receiving highly emetogenic chemotherapy. The primary efficacy endpoint was the complete response (CR) rate for acute CIV (during the 0-24-h interval after chemotherapy). Secondary endpoints included the CR rates for delayed CIV (more than 24 h after chemotherapy).ResultsTwo hundred and eight patients were accrued and received study medication. CR rates for acute CIV were 82.69% for palonosetron and 72.12% for granisetron, which demonstrated that palonosetron was not inferior to granisetron in preventing acute CIV. Comparisons of CR rates for delayed CIV yielded no statistical difference between palonosetron and granisetron groups and did not reveal non-inferiority of palonosetron to granisetron. Adverse events were mostly mild to moderate, with quite low rates among the two groups.ConclusionsA single dose (0.25 mg) of palonosetron is not inferior to a single dose (3 mg) of granisetron in preventing CIV and possesses an acceptable safety profile in the Chinese population.

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