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Impact of dexamethasone-sparing regimens on delayed nausea caused by moderately or highly emetogenic chemotherapy: a meta-analysis of randomised evidence.
BMC Cancer ( IF 3.4 ) Pub Date : 2019-12-30 , DOI: 10.1186/s12885-019-6454-y
Luigi Celio 1 , Erminio Bonizzoni 2 , Emma Zattarin 1 , Paolo Codega 3 , Filippo de Braud 1 , Matti Aapro 4
Affiliation  

BACKGROUND Nausea can be particularly prominent during the delayed period. Therefore, we performed a meta-analysis of the available randomised evidence to assess the average effect of palonosetron plus one-day dexamethasone (DEX; also called the DEX-sparing strategy) compared with palonosetron plus 3-day DEX for control of chemotherapy-induced nausea and vomiting (CINV), focusing on delayed nausea. METHODS Eligible studies were identified through MEDLINE, Embase, and CENTRAL. Data on acute and delayed CINV were collected. Efficacy end points were complete response (CR; no vomiting, and no use of rescue medication), complete protection (CP; CR plus no clinically significant nausea), and total control (TC; CR plus no nausea) during the delayed period (days 2-5 after chemotherapy initiation). All randomised studies comparing palonosetron plus single-dose DEX (with or without another active agent) on day 1 followed by either no further DEX or additional DEX doses (both alone or in combination with another active agent) qualified. RESULTS Of 864 citations screened, 8 studies with 1970 patients were included in the meta-analysis. During the delayed period, the combined odds ratio (OR) for all comparisons was 0.92 (95% confidence interval [CI], 0.76-1.12) for CR, 0.85 (95% CI, 0.71-1.03) for CP, and 0.92 (95% CI, 0.77-1.11) for TC in patients undergoing moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide-containing chemotherapy (AC). The absolute risk difference (RD) computations for all end points in the delayed period did not exceed the threshold of - 4% (range, - 1% to - 4%). The effect was similar in subgroups defined by various study design parameters. The absolute RD computations in the acute period did not exceed the threshold of 1% (range, 0 to 1%). For one-day vs. 3-day DEX, numbers needed to be treated in order for one additional patient to not experience CR, CP and TC over the delayed period were 100, 25 and 50, respectively. CONCLUSIONS This meta-analysis demonstrates that DEX-sparing regimens do not cause any significant loss in protection against not only vomiting but also nausea induced by single-day MEC or AC during the delayed period. These data should lead clinicians to optimise use of prophylactic DEX in clinical practice.

中文翻译:


地塞米松保留方案对中度或高度致吐化疗引起的迟发性恶心的影响:随机证据的荟萃分析。



背景技术在延迟期间恶心可能特别明显。因此,我们对现有的随机证据进行了荟萃分析,以评估帕洛诺司琼加一日地塞米松(DEX;也称为 DEX 节约策略)与帕洛诺司琼加 3 天 DEX 相比对于控制化疗引起的癌症的平均效果。恶心和呕吐(CINV),重点是迟发性恶心。方法 通过 MEDLINE、Embase 和 CENTRAL 确定合格研究。收集了急性和迟发性 CINV 的数据。疗效终点包括延迟期间(天)内的完全缓解(CR;无呕吐,且未使用救援药物)、完全保护(CP;CR 加无临床意义的恶心)和完全控制(TC;CR 加无恶心)化疗开始后2-5)。所有在第 1 天比较帕洛诺司琼加单剂量 DEX(有或没有另一种活性药物),随后不再使用 DEX 或额外 DEX 剂量(单独或与另一种活性药物联合)的随机研究均合格。结果 在筛选的 864 条引文中,荟萃分析中纳入了 8 项涉及 1970 名患者的研究。在延迟期间,所有比较的综合比值比 (OR) 对于 CR 为 0.92(95% 置信区间 [CI],0.76-1.12),对于 CP 为 0.85(95% CI,0.71-1.03),对于 CP 为 0.92(95% 置信区间 [CI],0.76-1.12)。对于接受中度致吐化疗 (MEC) 或含蒽环类和环磷酰胺化疗 (AC) 的患者的 TC,% CI,0.77-1.11)。延迟期内所有终点的绝对风险差 (RD) 计算未超过 - 4% 的阈值(范围 - 1% 至 - 4%)。在由各种研究设计参数定义的亚组中,效果相似。 急性期的绝对RD计算不超过1%的阈值(范围,0至1%)。对于 1 天和 3 天的 DEX,为了使一名额外患者在延迟期间不出现 CR、CP 和 TC,需要治疗的人数分别为 100、25 和 50。结论 这项荟萃分析表明,保留 DEX 的方案不会导致延迟期间单日 MEC 或 AC 引起的呕吐和恶心的保护作用显着下降。这些数据应引导临床医生在临床实践中优化预防性 DEX 的使用。
更新日期:2019-12-31
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