Single-dose palonosetron and dexamethasone in preventing nausea and vomiting induced by moderately emetogenic chemotherapy in breast and colorectal cancer patients
Single-dose palonosetron and dexamethasone in preventing nausea and vomiting induced by moderately emetogenic chemotherapy in breast and colorectal cancer patients
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DOI：
10.1700/912.10035
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发表时间：
2011-05-01
期刊：
影响因子：
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通讯作者：
Danova, Marco
中科院分区：
文献类型：
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作者：
Brugnatelli, Silvia;Gattoni, Elisabetta;Danova, Marco
目标和背景。帕洛诺司琼是一种独特的第二代5-HT 3受体拮抗剂，已被证明可以控制化疗引起的恶心呕吐（CINV）。本研究的目的是评估帕洛诺司琼的疗效和耐受性，其次是单剂量的地塞米松在乳腺癌（BC）或结直肠癌（CRC）接受中度致吐化疗（MEC）的患者。化疗初治的BC和CRC患者给予MEC作为辅助或一线治疗。帕洛诺司琼（0.25毫克IV）和地塞米松（8毫克IV）化疗前的第1天。主要终点为整个研究期间（第1-5天）的完全缓解（CR;无呕吐且未使用补救药物）。在急性期（第1天）和延迟期（第2-5天）评价止吐反应。入组了68例患者（中位年龄61岁，56例女性; BC = 40，CRC = 28）。68例患者中有46例（67.6%）观察到CR，而各组中急性期和延迟期的CR均为75.0%。止吐方案耐受性良好。在BC和CRC患者中，在第1天单次给予帕洛诺司琼和地塞米松足以在整个呕吐风险期间控制CINV。
Aims and background. Palonosetron, a unique second-generation 5-HT3 receptor antagonist, has been demonstrated to control emesis related to chemotherapy-induced nausea and vomiting (CINV). The aim of this study was to evaluate the efficacy and tolerability of palonosetron followed by a single dose of dexamethasone in patients with breast cancer (BC) or colorectal cancer (CRC) receiving moderate emetogenic chemotherapy (MEC).Methods and study design. Chemotherapy-naive BC and CRC patients were given MEC as adjuvant or first-line treatment. Palonosetron (0.25 mg IV) and dexamethasone (8 mg IV) were administered before chemotherapy on day 1. The primary endpoint was complete response (CR; no vomiting and no use of rescue medication) during the overall study period (days 1-5). The antiemetic response was evaluated during the acute (day 1) and delayed (days 2-5) phases.Results. Sixty-eight patients were enrolled (median age 61 years, 56 females; BC = 40, CRC = 28). CR was observed in 46 of 68 patients (67.6%), while CR during the acute and delayed phases was 75.0% in each cancer group. The antiemetic regimen was well tolerated.Conclusions. A single administration of palonosetron and dexamethasone on day 1 in BC and CRC patients adequately controls CINV during the entire period of emetic risk.