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评估止吐指南依从性对预防化疗引起的恶心和呕吐的影响:肿瘤学恶心/呕吐登记研究(NERO)的结果。

Assessing the impact of antiemetic guideline compliance on prevention of chemotherapy-induced nausea and vomiting: Results of the nausea/emesis registry in oncology (NERO).

作者信息

Aapro Matti, Caprariu Zoe, Chilingirov Petio, Chrápavá Marika, Curca Razvan-Ovidiu, Gales Laurentia, Grigorescu Alexandru C, Huszno Joanna, Karlínová Bára, Kellnerová Renata, Malejčíková Miroslava, Marinca Mihai, Petru Edgar, Płużanski Adam, Pokorná Petra, Pribulova Zuzana, Rubach Maryna, Steger Gunther G, Tesařová Petra, Valekova Lubica, Yordanov Nicolay, Walaszkowska-Czyz Anna

机构信息

Oncology Department, Genolier Cancer Center, Clinique de Genolier, Genolier, Switzerland.

Oncomed, Timisoara, Romania.

出版信息

Eur J Cancer. 2022 May;166:126-133. doi: 10.1016/j.ejca.2022.01.028. Epub 2022 Mar 12.

Abstract

BACKGROUND

Evidence-based antiemetic guidelines offer predominantly consistent recommendations for chemotherapy-induced nausea and vomiting (CINV) prophylaxis. However, studies suggest that adherence to these recommendations is suboptimal. We explored inconsistencies between clinical practice and guideline-recommended treatment with a registry evaluating the effect of guideline-consistent CINV prophylaxis (GCCP) on patient outcomes.

PATIENTS AND METHODS

This was a prospective, non-interventional, multicentre study. The primary objective was to assess the overall (Days 1-5) complete response (CR: no emesis/no rescue use) rates in patients who received GCCP or guideline-inconsistent CINV prophylaxis (GICP) using diaries for 5 days following chemotherapy. Cycle 1 results are presented in patients who received either (1) anthracycline/cyclophosphamide (AC) highly emetogenic chemotherapy (HEC), non-AC HEC or carboplatin, with GCCP for all these groups consisting of prophylaxis with an NK receptor antagonist (RA), 5-HTRA and dexamethasone prior to chemotherapy or (2) moderately emetogenic chemotherapy (MEC), with GCCP consisting of a 5-HTRA and dexamethasone prior to chemotherapy as per MASCC/ESMO 2016 guidelines, in place at the time of the study.

RESULTS

1,089 patients were part of the cycle 1 efficacy evaluation. Overall GCCP was 23%. CR rates were significantly higher (P < 0.05) in patients receiving GCCP (62.2%) versus GICP (52.6%) in the overall population, as well as in the subsets of patients receiving AC/non-AC HEC (60.2% versus 47.8%), MEC (73.8% versus 57.8%) and in those non-naïve to the chemotherapy received (65.9% versus 53.8%). No impact on daily living due to CINV (FLIE assessment) was observed in 43.4% patients receiving GCCP versus 28.5% GICP (P < 0.001).

CONCLUSION

Consistent with prior studies, GCCP was very low; a significant benefit of almost 10% improved prevention of CINV was observed with GCCP. As per MASCC/ESMO guidelines, such an absolute difference should be practice changing. Comprehensive multifaceted strategies are needed to achieve better adherence to antiemetic guidelines.

摘要

背景

循证止吐指南对化疗引起的恶心和呕吐(CINV)预防提出了基本一致的建议。然而,研究表明对这些建议的依从性并不理想。我们通过一项评估指南一致的CINV预防(GCCP)对患者结局影响的登记研究,探讨了临床实践与指南推荐治疗之间的不一致性。

患者与方法

这是一项前瞻性、非干预性、多中心研究。主要目的是使用化疗后5天的日记,评估接受GCCP或指南不一致的CINV预防(GICP)的患者的总体(第1 - 5天)完全缓解率(CR:无呕吐/未使用救援药物)。第1周期结果在接受以下治疗的患者中呈现:(1)蒽环类/环磷酰胺(AC)高致吐性化疗(HEC)、非AC HEC或卡铂,所有这些组的GCCP包括在化疗前用NK受体拮抗剂(RA)、5 - HTRA和地塞米松进行预防;或(2)中度致吐性化疗(MEC),根据研究时有效的MASCC/ESMO 2016指南,GCCP包括在化疗前用5 - HTRA和地塞米松进行预防。

结果

1089例患者参与了第1周期疗效评估。总体GCCP为23%。在总体人群中,接受GCCP的患者(62.2%)的CR率显著高于接受GICP的患者(52.6%)(P < 0.05),在接受AC/非AC HEC的患者亚组(60.2%对47.8%)、MEC患者亚组(73.8%对57.8%)以及既往接受过化疗的患者亚组(65.9%对53.8%)中也是如此。接受GCCP的患者中有43.4%未观察到因CINV对日常生活产生影响(FLIE评估),而接受GICP的患者中这一比例为28.5%(P < 0.001)。

结论

与先前研究一致,GCCP非常低;观察到GCCP在预防CINV方面有近10%的显著改善益处。根据MASCC/ESMO指南,这样的绝对差异应该会改变临床实践。需要综合多方面的策略来更好地遵循止吐指南。

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