紫杉类化疗前：地塞米松该用多少

　　紫杉醇和多西他赛等紫杉类化疗药物被广泛用于各种癌症，由于众所周知的过敏反应，用药前需要给予地塞米松等类固醇预防过敏。不过，说明书规定的地塞米松用量用法各有不同，例如紫杉醇说明书规定治疗之前12及6小时左右给予地塞米松20毫克口服或治疗之前30～60分钟左右静脉滴注地塞米松20毫克，多西他赛说明书规定治疗前1天开始服用地塞米松每天16毫克持续3天或治疗前12小时、3小时、1小时口服地塞米松各8毫克。而且，反复或大剂量给予地塞米松可能导致多种不良反应。

　　2021年8月6日，美国临床肿瘤学会《临床肿瘤学杂志》在线发表斯坦福大学医学院的研究报告，对近10年来紫杉类化疗前类固醇用法用量与过敏反应进行了回顾分析。

　　该单中心回顾研究对2010年1月～2020年6月在斯坦福癌症研究所接受紫杉醇或多西他赛治疗前的地塞米松用法用量与过敏反应发生率或严重程度进行回顾分析。通过多因素比例风险回归模型对各种影响因素进行校正后，分析地塞米松用量和用法、紫杉类剂量和类型、临床癌症类型、性别和种族对过敏反应发生率和严重程度的影响。

　　结果，5217例患者接受过紫杉醇或多西他赛治疗，其中3181例（乳腺癌1071例，占33.67%）符合分析标准，过敏反应发生率为8.3%。

　　对其他影响因素进行校正后：

  • 地塞米松大于20毫克：过敏反应发生率相似（校正后风险比：0.97，95%置信区间：0.59～1.60，P=0.9079）

  • 地塞米松10～20毫克：过敏反应发生率相似（校正后风险比：1.06，95%置信区间：0.88～1.28，P=0.5313）

  • 地塞米松小于10毫克：过敏反应发生率相似（校正后风险比：0.93，95%置信区间：0.69～1.25，P=0.6325）

  • 地塞米松口服用药：过敏反应发生率相似（校正后风险比：1.12，95%置信区间：0.91～1.38，P=0.2959）

  • 地塞米松静脉用药：过敏反应发生率相似（校正后风险比：0.79，95%置信区间：0.58～1.06，P=0.1154）

  • 多西他赛：过敏反应发生率相似（校正后风险比：0.82，95%置信区间：0.64～1.06，P=0.1345）

  • 紫杉醇：过敏反应发生率相似（校正后风险比：1.16，95%置信区间：0.96～1.41，P=0.1345）

  • 紫杉类剂量较大：过敏反应发生率相似（校正后风险比：1.03，95%置信区间：0.90～1,17，P=0.6897）

  • 紫杉类剂量较小：过敏反应发生率相似（校正后风险比：0.96，95%置信区间：0.79～1.17，P=0.6897）

  • 乳腺癌：过敏反应发生率相似（校正后风险比：0.87，95%置信区间：0.68～1.10，P=0.2381）

  • 胃肠癌：过敏反应发生率相似（校正后风险比：0.77，95%置信区间：0.46～1.29，P=0.3238）

  • 泌尿生殖癌：过敏反应发生率相似（校正后风险比：1.27，95%置信区间：0.70～2.31，P=0.4227）

  • 妇科癌：过敏反应发生率较高（校正后风险比：1.34，95%置信区间：1.01～1.79，P=0.0444）

  • 妇科癌：3～4级过敏反应发生率较高（校正后风险比：2.34，95%置信区间：1.14～4.79，P=0.0200）

  • 头颈癌：过敏反应发生率相似（校正后风险比：0.82，95%置信区间：0.49～1.36，P=0.4398）

  • 肺癌：过敏反应发生率相似（校正后风险比：0.90，95%置信区间：0.57～1.42，P=0.6501）

  • 肉瘤：过敏反应发生率相似（校正后风险比：1.31，95%置信区间：0.62～2.79，P=0.4771）

  • 女性：过敏反应发生率较高（校正后风险比：1.26，95%置信区间：1.09～1.46，P=0.0014）

  • 女性：3～4级过敏反应发生率相似（校正后风险比：0.98，95%置信区间：0.74～1.28，P=0.8682）

  • 男性：过敏反应发生率较低（校正后风险比：0.59，95%置信区间：0.42～0.82，P=0.0014）

  • 亚裔：过敏反应发生率相似（校正后风险比：1.09，95%置信区间：0.87～1.36，P=0.4546）

  • 黑人：过敏反应发生率相似（校正后风险比：0.45，95%置信区间：0.17～1.19，P=0.1071）

  • 白人：过敏反应发生率相似（校正后风险比：1.05，95%置信区间：0.93～1.19，P=0.3973）

　　因此，该单中心回顾研究结果表明，地塞米松剂量和给药途径对随后的过敏反应影响不大。由于反复给予大剂量类固醇可能导致不良事件，故常规给予低剂量地塞米松（例如单次10毫克）预防紫杉类过敏反应与目前说明书推荐剂量相比，可最大程度地减少大多数患者的过敏反应和类固醇副作用。

J Clin Oncol. 2021 Aug 6. Online ahead of print.

Do Steroids Matter? A Retrospective Review of Premedication for Taxane Chemotherapy and Hypersensitivity Reactions.

Lansinger OM, Biedermann S, He Z, Colevas AD.

Stanford University School of Medicine, Stanford, CA.

PURPOSE: Despite the widespread use of the taxanes paclitaxel and docetaxel for a variety of cancers and their well-known association with hypersensitivity reactions (HSRs), there is still significant variation in the prescribing practices of steroids for premedication. Premedication almost always includes dexamethasone, which can be associated with multiple adverse effects if taken for extended periods of time. This study reviews the pattern of steroid premedication in patients who received paclitaxel or docetaxel at Stanford Cancer Institute between January 2010 and June 2020.

METHODS: We used an electronic query of the electronic medical record followed up with a manual review of patient charts to ask whether we could find a correlation between steroid premedication dosing and the incidence or severity of HSRs with the first taxane dose. Variables considered included steroid dose and route, dose and type of taxane, clinical cancer group, sex, and race.

RESULTS: Five thousand two hundred seventeen patients were identified as having received paclitaxel or docetaxel, and 3,181 met criteria for our analysis. There were 264 (8.3%) HSRs. In adjusted multivariate analysis, we found no correlation of HSR rate or severity among any of the variables evaluated except gynecology oncology clinic patients, who had an increased risk (hazard ratio [HR] 1.34) of HSRs overall and high-grade HSRs (HR 2.34), and female patients, who had a higher rate of HSRs overall (HR 1.26), but not high-grade HSRs.

CONCLUSION: Neither dexamethasone dose nor route correlated with subsequent HSRs. Given the potential for adverse events from repeated high-dose steroids, our findings suggest that routine use of lower doses, such as a single 10 mg dose of dexamethasone, as premedication for taxanes to prevent HSRs is preferable to the current prescribing guidelines.

KEY OBJECTIVE: Taxanes are widely used to treat many cancers throughout the world. Despite their well-known association with hypersensitivity reactions (HSRs) and significant clinical variation in dexamethasone premedication, there has not been research into optimizing the dose of dexamethasone. This retrospective cohort study reviews 3,181 patients over 10 years to determine if there is any significant association between dose of dexamethasone and rate of HSR.

KNOWLEDGE GENERATED: In an adjusted multivariate analysis, patients receiving high-dose dexamethasone did not have significantly different rates of HSR than those receiving low-dose dexamethasone. Gynecologic cancer and female sex were significantly associated with higher rates of HSR.

RELEVANCE: Low-dose dexamethasone is just as effective at preventing HSR as high-dose premedication. Given the adverse effects of long-term high-dose steroids, a single low dose (10 mg) of dexamethasone can be used to minimize both HSR and steroid side effects in most patients.

PMID: 34357780

DOI: 10.1200/JCO.21.01200

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