Jordan Karin, Hinke Axel, Grothey Axel, Schmoll Hans Joachim
Department for Hematology/Oncology, Martin-Luther University Halle/Wittenberg, Ernst-Grube-Str. 40, 06120, Halle, Germany.
Support Care Cancer. 2005 Jan;13(1):26-31. doi: 10.1007/s00520-004-0672-8. Epub 2004 Nov 18.
This analysis compares the antiemetic efficacy of the 5-HT3-receptor antagonists granisetron and tropisetron in acute chemotherapy-induced nausea and vomiting (CINV). All published randomized studies comparing granisetron with tropisetron in conventionally-dosed, emetogenic chemotherapy are included in this pooled analysis. The target criterion for antiemetic success was 'acute complete response' (complete absence of vomiting in the 24 h after the start of chemotherapy) and the rate of successful treatment reported as 'response rate' (acute complete response rate per patient). Twelve studies were used comprising 810 patients. Comparison between granisetron and tropisetron in patients receiving cisplatin-based therapy showed superiority of granisetron (odds ratio above 1.0) in six out of seven studies. However, this difference did not reach statistical significance. In patients receiving noncisplatin-based therapies, four out of five studies showed an advantage of granisetron over tropisetron with one study showing a significant advantage. Pooled analysis of all studies demonstrated a significant overall advantage for granisetron over tropisetron (p=0.042). This is supported by the individual studies: overall, ten out of the 12 studies analyzed showed an advantage for granisetron, with a 6.4% difference in response rate. This advantage was more pronounced in noncisplatin-based therapy (7.3%), whereas in cisplatin-based therapy, the difference was 5.4%. The overall results of this pooled analysis of cisplatin and noncisplatin-based studies suggest that granisetron has a marginal but clinically potentially relevant statistically significant advantage in efficacy over tropisetron for the control of acute CINV.
本分析比较了5-羟色胺3(5-HT3)受体拮抗剂格拉司琼和托烷司琼对急性化疗引起的恶心和呕吐(CINV)的止吐疗效。所有已发表的比较格拉司琼与托烷司琼在常规剂量致吐性化疗中的随机研究均纳入本汇总分析。止吐成功的目标标准为“急性完全缓解”(化疗开始后24小时内完全无呕吐),成功治疗率报告为“缓解率”(每位患者的急性完全缓解率)。共纳入12项研究,涉及810例患者。在接受顺铂为基础治疗的患者中比较格拉司琼和托烷司琼,7项研究中有6项显示格拉司琼具有优势(优势比高于1.0)。然而,这种差异未达到统计学显著性。在接受非顺铂为基础治疗的患者中,5项研究中有4项显示格拉司琼优于托烷司琼,1项研究显示有显著优势。对所有研究的汇总分析表明,格拉司琼总体上比托烷司琼有显著优势(p=0.042)。这得到了各单项研究的支持:总体而言,分析的12项研究中有10项显示格拉司琼具有优势,缓解率相差6.4%。这种优势在非顺铂为基础的治疗中更为明显(7.3%),而在顺铂为基础的治疗中,差异为5.4%。对基于顺铂和非顺铂研究的汇总分析的总体结果表明,在控制急性CINV方面,格拉司琼在疗效上比托烷司琼有微小但临床上可能具有相关性的统计学显著优势。