NEPA (Netupitant/Palonosetron) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients Receiving Highly or Moderately Emetogenic Chemotherapy Who Experienced Breakthrough CINV in Cycle 1 of Chemotherapy: A Phase II Clinical Trial

IF 3.1 2区医学 Q2 ONCOLOGY Cancer Medicine Pub Date : 2025-03-27 DOI:10.1002/cam4.70549

Rudolph M. Navari, Erminio Bonizzoni

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Abstract

Background

Although control of chemotherapy-induced nausea and vomiting (CINV) is substantially improved with guideline-directed antiemetic prophylaxis, breakthrough CINV remains a significant clinical patient problem. In subsequent cycles after breakthrough occurs, antiemetic guidelines recommend adding agents not used in the initial cycle. This study was designed to evaluate the use of NEPA (netupitant/palonosetron) plus dexamethasone with or without olanzapine for the prevention of CINV in the second cycle of chemotherapy for patients receiving highly (HEC) or moderately emetogenic chemotherapy (MEC) who developed breakthrough CINV in their first cycle despite guideline-directed prophylactic antiemetics.

Methods

This was a Phase 2, single center, open-label study. Patients received guideline-recommended prophylactic antiemetics in Cycle 1 based on the chemotherapy emetogenicity. Patients who experienced breakthrough CINV in Cycle 1 received intravenous (IV) NEPA (Day 1) plus dexamethasone (Days 1–4) and olanzapine (Days 1–4) for HEC or IV NEPA (Day 1) plus dexamethasone (Days 1–4) for MEC in Cycle 2.

Results

Of the 227 patients enrolled in Cycle 1, 100 patients (n = 37 HEC, 63 MEC) experienced breakthrough CINV and received the NEPA-based treatments in Cycle 2. The complete response (no emesis/no rescue use) rates [95% confidence intervals] during the overall (0–120 h) phase were 76% [59%, 88%] and 79% [67%, 89%] in the HEC and MEC groups, respectively.

Conclusion

These results show that NEPA with or without olanzapine is an effective approach for CINV prevention for patients receiving HEC or MEC who develop breakthrough CINV after their first course of chemotherapy. The results support the antiemetic guideline recommendations.

Trial Registration

clinicaltrials.gov identifier: NCT06065722

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NEPA （Netupitant/Palonosetron）用于预防化疗引起的恶心和呕吐（CINV）在化疗第1周期突破的高度或中度致吐性化疗患者：一项II期临床试验

背景虽然化疗引起的恶心和呕吐（CINV）的控制在指南指导下得到了很大的改善，但突破CINV仍然是一个重要的临床患者问题。在突破后的后续周期中，止吐指南建议添加初始周期中未使用的药物。本研究旨在评估NEPA（奈吡坦/帕洛诺司酮）加地塞米松联合奥氮平或不联合奥氮平在第二周期化疗中预防CINV的使用情况，这些患者接受高度（HEC）或中度致吐性化疗（MEC），尽管指南指导的预防性止吐药物在第一个周期发生突破性CINV。方法这是一项2期、单中心、开放标签研究。根据化疗致吐性，患者在第1周期接受指南推荐的预防性止吐药。在第1周期出现CINV突破的患者接受静脉（IV） NEPA（第1天）加地塞米松（第1 - 4天）和奥氮平（第1 - 4天）治疗HEC或静脉NEPA（第1天）加地塞米松（第1 - 4天）治疗MEC。结果在第1周期纳入的227例患者中，有100例（37例HEC， 63例MEC）在第2周期获得突破性CINV，并接受了基于nepa的治疗。在整个（0-120 h）阶段，HEC组和MEC组的完全缓解（无呕吐/无抢救）率[95%置信区间]分别为76%[59%，88%]和79%[67%，89%]。结论对于HEC或MEC患者首次化疗后出现突破性CINV的患者，NEPA联合或不联合奥氮平是预防CINV的有效方法。结果支持止吐指南的建议。试验注册clinicaltrials.gov识别码：NCT06065722

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来源期刊

Cancer Medicine ONCOLOGY-

CiteScore

5.50

自引率

2.50%

发文量

907

审稿时长

19 weeks

期刊介绍： Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas: Clinical Cancer Research Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations Cancer Biology: Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery. Cancer Prevention: Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach. Bioinformatics: Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers. Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.