[Efficacy and safety of palonosetron versus tropisetron in the prevention of highly emetogenic chemotherapy-induced acute and delayed vomiting in Chinese cancer patients].
OBJECTIVE
To explore the efficacy and safety of palonosetron in the prevention of acute and delayed chemotherapy-induced nausea and vomiting after moderate to severe emetogenic chemotherapy.


METHODS
From November 2008 to November 2009, a multicenter, randomized, double-blind and self-crossover phase II clinical trial with a total planned enrollment of 160 patients was carried out to compare palonosetron (drug A) with tropisetron (drug B). The subjects were randomized divided into groups AB and BA. The dosing sequence in the group AB was drug A the first cycle and drug B the second cycle while the BA group was administered reversely. The efficacy was evaluated within a period of 5 days after cisplatin or adriamycin-based regimen chemotherapy. Adverse effects were assessed by CTCAE 3.0.


RESULTS
Among 155 enrolled cases, 132 cases were assessable for efficacy. The complete control rate of acute chemotherapy-induced nausea and vomiting was 54.55% vs 51.52% for drug A vs drug B (P > 0.05), but that of delayed reaction was 53.03% vs 38.64% respectively. There were significant differences (P = 0.01). Meanwhile, the rate of adverse effects was 4.90% for investigational agent without severe adverse events. The main adverse reactions were headache and dizziness.


CONCLUSIONS
With a high safety profile, palonosetron is an effective agent for the prevention of acute and delayed chemotherapy-induced nausea and vomiting.
Department of Medical Oncology, Affiliated Cancer Hospital, Tianjin Medical University, Tianjin 300060, China.
Li-Hua
LH
Qiu
Hua-Qing
HQ
Wang
Zhuang
Z
Yu
Li
L
Li
Xiang-Hui
XH
Wang
Shun-Jin
SJ
Wang
Guo-Ping
GP
Sun
Min
M
Liu
Shu-Cai
SC
Zhang
D000932:Antiemetics / Q000627:therapeutic use; D004311:Double-Blind Method; D006801:Humans; D009325:Nausea; D009369:Neoplasms; D014839:Vomiting
D000932:Antiemetics