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预防肺癌患者化疗引起的恶心和呕吐:新型止吐组合药物 NEPA(奈妥吡坦帕洛诺司琼)的疗效。

Preventing chemotherapy-induced nausea and vomiting in patients with lung cancer: efficacy of NEPA (netupitant-palonosetron), the first combination antiemetic.

机构信息

Lahey Health Cancer Institute, Lahey Hospital & Medical Center, 41 Mall Road, Burlington, MA, 01805, USA.

Corporate Clinical Development, Helsinn Healthcare SA, Lugano, Switzerland.

出版信息

Support Care Cancer. 2018 Apr;26(4):1151-1159. doi: 10.1007/s00520-017-3936-9. Epub 2017 Oct 28.

Abstract

PURPOSE

Patients receiving platinum-based chemotherapy are at high risk of chemotherapy-induced nausea and vomiting (CINV), a distressing side effect of treatment. This post-hoc subgroup analysis of two pivotal trials evaluated the efficacy of NEPA in preventing CINV in subsets of patients with lung cancer who received cisplatin or carboplatin.

METHODS

In each study, the efficacy endpoints complete response (CR; defined as no emetic episodes and no rescue medication) and no significant nausea (NSN; defined as a score of < 25 mm on a visual analog scale of 0-100 mm) during the acute (0-24 h), delayed (25-120 h), and overall (0-120 h) phases post-chemotherapy in cycle 1 (study 1) and cycles 1-4 (study 2) were assessed. Safety was evaluated by recording treatment-emergent adverse events (AEs) and treatment-related AEs.

RESULTS

NEPA treatment resulted in high CR rates across the acute, delayed, and overall phases (cisplatin: > 88% overall CR; carboplatin: > 75% overall CR), with higher CR rates for NEPA-treated patients than those receiving palonosetron; moreover, CR rates were sustained over multiple chemotherapy cycles (> 75%). High rates of NSN observed during cycle 1 (> 79%) were also maintained over multiple chemotherapy cycles. NEPA was well tolerated in all patients.

CONCLUSIONS

NEPA appears to be effective and well tolerated in patients with lung cancer receiving platinum-based chemotherapy, across the acute, delayed, and overall phases and throughout multiple cycles. As a highly effective oral combination antiemetic agent administered as a single dose once per cycle, NEPA may offer a convenient, simplified prophylactic antiemetic.

摘要

目的

接受铂类化疗的患者有发生化疗引起的恶心和呕吐(CINV)的高风险,这是治疗的一种令人痛苦的副作用。两项关键试验的事后亚组分析评估了 NEPA 预防接受顺铂或卡铂化疗的肺癌患者 CINV 的疗效。

方法

在每项研究中,评估了疗效终点完全缓解(CR;定义为无呕吐发作且无解救药物)和无明显恶心(NSN;定义为 0-100mm 视觉模拟量表上的评分<25mm)在化疗后第 1 周期(研究 1)和第 1-4 周期(研究 2)的急性期(0-24 小时)、延迟期(25-120 小时)和总期(0-120 小时)。通过记录治疗中出现的不良事件(AE)和与治疗相关的 AE 来评估安全性。

结果

NEPA 治疗在急性期、延迟期和总期均产生了高 CR 率(顺铂:总体 CR 率>88%;卡铂:总体 CR 率>75%),NEPA 治疗患者的 CR 率高于帕洛诺司琼;此外,CR 率在多个化疗周期中持续(>75%)。第 1 周期观察到的高 NSN 率(>79%)也在多个化疗周期中得到维持。所有患者均耐受良好。

结论

在接受铂类化疗的肺癌患者中,NEPA 似乎在急性期、延迟期和总期以及多个周期中均有效且耐受良好。作为一种高效的口服联合止吐药,每周期仅给药 1 次,NEPA 可能提供一种方便、简化的预防性止吐方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed8a/5847067/92fda67fd09b/520_2017_3936_Fig1_HTML.jpg

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