Medical Oncology Department, Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou 510060, China.
Chin Clin Oncol. 2020 Apr;9(2):17. doi: 10.21037/cco.2019.11.02. Epub 2019 Dec 16.
Review the clinical evidence of tropisetron or palonosetron, an old- and new-generation serotonin (5-hydroxytryptamine) type 3 (5-HT3) receptor antagonist (RA), respectively, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer, and evaluate any difference in efficacy trends. A literature search of the EMBASE and PubMed databases was performed to identify publications of intravenous (IV) tropisetron (generic forms or Navoban®) for the treatment of CINV in patients with various cancers. Data from the pivotal clinical studies evaluating the IV formulation of Aloxi® (palonosetron HCl) were also considered. The effectiveness and safety of each antiemetic was summarized. Sixteen papers for tropisetron fulfilled the inclusion criteria and were extracted for full analysis; publications from six pivotal palonosetron clinical trials were considered. No direct data comparisons could be made between the two drugs, due to the varying definitions of efficacy endpoints between studies. For tropisetron, the rates of no emesis were lower in patients receiving highly emetogenic chemotherapy (HEC) versus moderately emetogenic chemotherapy (MEC). For palonosetron, the rates of complete response (no emesis, no rescue medication) were comparable in the MEC and HEC settings, demonstrating the effectiveness of this agent in patients receiving HEC. Both antiemetics offered some protection against nausea, although lower rates of no nausea were achieved compared with rates of no emesis. Two trials that evaluated the efficacy of palonosetron and tropisetron within the same study reported that palonosetron was more effective than tropisetron in controlling delayed vomiting in the HEC and MEC settings, with significantly higher rates of no emesis observed (P≤0.01). Palonosetron was non-inferior or more efficacious in controlling CINV compared with other older 5-HT3RAs, such as dolasetron, ondansetron, and granisetron. Conversely, tropisetron was no more efficacious than ondansetron or granisetron. Both tropisetron and palonosetron were generally well tolerated, with adverse event profiles consistent with drugs of this class (e.g., headache, constipation, and diarrhea). These data suggest that palonosetron is a highly selective prophylactic agent that may have an improved therapeutic profile compared with tropisetron, and is a feasible treatment option for controlling CINV in patients with cancer.
回顾曲昔派特或帕洛诺司琼的临床证据，分别为新一代和旧一代 5-羟色胺（5-HT3）受体拮抗剂（RA），用于预防癌症患者的化疗引起的恶心和呕吐（CINV），并评估疗效趋势的任何差异。对 EMBASE 和 PubMed 数据库进行了文献检索，以确定静脉注射（IV）曲昔派特（通用形式或 Navoban®）治疗各种癌症患者 CINV 的出版物。还考虑了评价 Aloxi®（盐酸帕洛诺司琼）IV 制剂的关键临床研究的数据。总结了每种止吐药的有效性和安全性。16 篇曲昔派特的论文符合纳入标准，并进行了全面分析；考虑了来自 6 项关键帕洛诺司琼临床试验的出版物。由于研究之间疗效终点的定义不同，无法对这两种药物进行直接数据比较。对于曲昔派特，在接受高致吐性化疗（HEC）的患者中，无呕吐的发生率低于接受中度致吐性化疗（MEC）的患者。对于帕洛诺司琼，在 MEC 和 HEC 环境中，完全缓解（无呕吐，无解救药物）的发生率相当，表明该药物在接受 HEC 的患者中有效。两种止吐药均对恶心有一定的保护作用，尽管无恶心的发生率低于无呕吐的发生率。两项评估帕洛诺司琼和曲昔派特在同一研究中的疗效的试验报告称，帕洛诺司琼在控制 HEC 和 MEC 环境中的延迟性呕吐方面比曲昔派特更有效，无呕吐的发生率显著更高（P≤0.01）。与其他较老的 5-HT3RA 如多拉司琼、昂丹司琼和格拉司琼相比，帕洛诺司琼在控制 CINV 方面具有非劣效性或更高的疗效。相反，曲昔派特与昂丹司琼或格拉司琼一样没有更有效。曲昔派特和帕洛诺司琼通常都具有良好的耐受性，不良反应谱与该类药物一致（例如，头痛、便秘和腹泻）。这些数据表明，帕洛诺司琼是一种高度选择性的预防剂，与曲昔派特相比，可能具有改善的治疗谱，并且是控制癌症患者 CINV 的可行治疗选择。
