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单次 NEPA 联合地塞米松预防肉瘤患者多日化疗。

One shot NEPA plus dexamethasone to prevent multiple-day chemotherapy in sarcoma patients.

机构信息

Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, Palermo, Italy.

Medical Oncology Unit, Santa Chiara Hospital, Trento, Italy.

出版信息

Support Care Cancer. 2019 Sep;27(9):3593-3597. doi: 10.1007/s00520-019-4645-3. Epub 2019 Feb 14.

Abstract

PURPOSE

Chemotherapy-induced nausea and vomiting (CINV) is one of the most feared and disturbing adverse events of cancer treatment associated with decreased adherence to effective chemotherapy regimens. For high-risk soft tissue sarcoma patients, receiving multiple-day chemotherapy (MD-CT), antiemetic guidelines recommend a combination of an NK receptor antagonist (NK-RA), a 5-HT receptor antagonist (5HT-RA), and dexamethasone on each day of the antineoplastic treatment. NEPA is the first oral fixed-dose combination of a highly selective NK-RA, netupitant, and second-generation 5HT-RA, palonosetron. So far, no data has been published in literature about the efficacy of a single dose of NEPA in MD-CT.

METHODS

We performed a prospective, non-comparative study to assess the efficacy of one shot of NEPA plus dexamethasone in sarcoma patients receiving MD-CT. The primary efficacy endpoint was a complete response (CR: no emesis, no rescue medication) during the overall phase (0-120 h) in cycle 1. The main secondary endpoints were CR during the overall phase of cycles 2 and 3.

RESULTS

The primary endpoint was reached in 88.9% of patients. Cycles 2 and 3 overall CR rates were 88.9% and 82.4%, respectively. The antiemetic regimen was well tolerated.

CONCLUSIONS

This pilot study showed the benefit of one shot of NEPA to prevent CINV in sarcoma patients receiving MD-chemotherapy.

摘要

目的

化疗引起的恶心和呕吐(CINV)是癌症治疗中最令人恐惧和困扰的不良反应之一,与有效化疗方案的依从性降低有关。对于接受多日化疗(MD-CT)的高危软组织肉瘤患者,抗恶心指南建议在抗肿瘤治疗的每一天使用神经激肽-1 受体拮抗剂(NK-RA)、5-羟色胺受体拮抗剂(5HT-RA)和地塞米松的组合。NEPA 是首个高选择性 NK-RA 奈妥吡坦和第二代 5HT-RA 帕洛诺司琼的口服固定剂量复方制剂。到目前为止,文献中尚无关于 NEPA 在 MD-CT 中单剂疗效的数据。

方法

我们进行了一项前瞻性、非对照研究,以评估 NEPA 加地塞米松单次给药在接受 MD-CT 的肉瘤患者中的疗效。主要疗效终点是第 1 周期的整个阶段(0-120 小时)完全缓解(CR:无恶心,无解救药物)。主要次要终点是第 2 和第 3 周期的整个阶段的 CR。

结果

主要终点在 88.9%的患者中达到。第 2 和第 3 周期的总体 CR 率分别为 88.9%和 82.4%。抗恶心方案耐受良好。

结论

这项初步研究表明,在接受 MD-化疗的肉瘤患者中,单次使用 NEPA 预防 CINV 是有益的。

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