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单剂量帕洛诺司琼和地塞米松预防乳腺癌和结直肠癌患者中度致吐性化疗引起的恶心和呕吐

Single-dose palonosetron and dexamethasone in preventing nausea and vomiting induced by moderately emetogenic chemotherapy in breast and colorectal cancer patients.

作者信息

Brugnatelli Silvia, Gattoni Elisabetta, Grasso Donatella, Rossetti Franca, Perrone Tania, Danova Marco

机构信息

Medical Oncology, Fondazione Foliclinico San Matteo, Pavia, Italy.

出版信息

Tumori. 2011 May-Jun;97(3):362-6. doi: 10.1177/030089161109700318.

Abstract

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.

摘要

目的与背景

帕洛诺司琼是一种独特的第二代5-羟色胺3(5-HT3)受体拮抗剂,已被证明可控制与化疗引起的恶心和呕吐(CINV)相关的呕吐。本研究的目的是评估在接受中度致吐性化疗(MEC)的乳腺癌(BC)或结直肠癌(CRC)患者中,先使用帕洛诺司琼再单剂量使用地塞米松的疗效和耐受性。

方法与研究设计

未接受过化疗的BC和CRC患者接受MEC作为辅助或一线治疗。在第1天化疗前静脉注射帕洛诺司琼(0.25mg)和地塞米松(8mg)。主要终点是整个研究期间(第1 - 5天)的完全缓解(CR;无呕吐且未使用救援药物)。在急性期(第1天)和延迟期(第2 - 5天)评估止吐反应。

结果

共纳入68例患者(中位年龄61岁,56例女性;BC = 40例,CRC = 28例)。68例患者中有46例(67.6%)观察到CR,而每个癌症组在急性期和延迟期的CR均为75.0%。该止吐方案耐受性良好。

结论

在BC和CRC患者中于第1天单次给予帕洛诺司琼和地塞米松可在整个呕吐风险期充分控制CINV。

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