Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study
Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study
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DOI：
10.1007/s00520-009-0680-9
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发表时间：
2010-04-01
影响因子：
3.1
通讯作者：
Schmoll, Hans-Joachim
中科院分区：
文献类型：
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作者：
Rapoport, Bernardo L.;Jordan, Karin;Schmoll, Hans-Joachim
此前研究表明，对于接受基于蒽环类药物和环磷酰胺 (AC) 方案的乳腺癌患者，阿瑞匹坦可有效预防中度致吐化疗 (MEC) 化疗引起的恶心和呕吐 (CINV)。这项研究评估了阿瑞匹坦在接受多种 MEC 治疗方案的多种肿瘤类型患者中的作用。这项 III 期、随机、性别分层、双盲试验纳入了确诊为恶性肿瘤、未曾接受过 MEC 或高度致吐化疗的患者，这些患者计划接受单剂量的至少一种 MEC 药物。患者接受口服阿瑞匹坦三联疗法（阿瑞匹坦、昂丹司琼和地塞米松）或对照方案（昂丹司琼和地塞米松）。主要和关键次要疗效终点分别是化疗后 120 小时内无呕吐和完全缓解（无呕吐和无救援药物）的患者比例。 在 848 名随机患者中，77% 为女性，52% 接受非基于 AC 的抗肿瘤方案。值得注意的是，无论接受 AC 方案还是非 AC 方案，阿瑞吡坦组中有更多患者在化疗后 120 小时内没有呕吐并达到完全缓解。总体而言，阿瑞匹坦组 (62.8%) 和对照组 (67.2%) 的不良事件发生率大致相似。阿瑞匹坦方案在接受 MEC（非 AC 或 AC）的广泛患者的 CINV 治疗中，在无呕吐和完全缓解终点方面均具有优异的疗效。阿瑞吡坦总体耐受性良好。这些结果表明，将阿瑞匹坦纳入接受 MEC 的癌症患者标准止吐方案的一部分是有益的。
Aprepitant was shown previously to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC) in breast cancer patients receiving an anthracycline and cyclophosphamide (AC)-based regimen. This study assessed aprepitant in patients receiving a broad range of MEC regimens with a variety of tumor types.This phase III, randomized, gender-stratified, double-blind trial enrolled patients with confirmed malignancies, na < ve to MEC or highly emetogenic chemotherapy, who were scheduled to receive a single dose of at least one MEC agent. Patients received an aprepitant triple-therapy regimen (aprepitant, ondansetron, and dexamethasone) or a control regimen (ondansetron and dexamethasone) administered orally. Primary and key secondary efficacy endpoints were proportions of patients with no vomiting and complete response (no vomiting and no rescue medication), respectively, during the 120 h post-chemotherapy.Of 848 randomized patients, 77% were female, and 52% received non-AC-based antineoplastic regimens. Significantly, more patients in the aprepitant group achieved no vomiting and complete response, regardless of whether they received AC or non-AC regimens, in the 120 h after chemotherapy. Overall, the incidences of adverse events were generally similar in the aprepitant (62.8%) and control groups (67.2%).The aprepitant regimen provided superior efficacy in the treatment of CINV in a broad range of patients receiving MEC (non-AC or AC) in both no vomiting and complete response endpoints. Aprepitant was generally well tolerated. These results show the benefit of including aprepitant as part of the standard antiemetic regimen for cancer patients receiving MEC.