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系统评价和荟萃分析维莫非尼治疗黑色素瘤患者相关皮肤毒性的流行率。

Systematic review and meta-analysis of prevalence of dermatological toxicities associated with vemurafenib treatment in patients with melanoma.

机构信息

Department of Pharmacy, Renmin Hospital of Wuhan University, Wuhan, China.

Department of Pharmacy, Dongfeng Hospital, Hubei University of Medicine, Shiyan, China.

出版信息

Clin Exp Dermatol. 2019 Apr;44(3):243-251. doi: 10.1111/ced.13751. Epub 2018 Oct 2.

Abstract

BACKGROUND

Vemurafenib has been linked to dermatological adverse events in patients with melanoma, including an increased risk of rash, cutaneous squamous cell carcinoma, photosensitivity reaction and keratoacanthoma. However, there has been no systematic attempt to assess the dermatological toxicity data of vemurafenib associated with melanoma treatment.

AIM

To evaluate the point prevalence of dermatological toxicities associated with vemurafenib treatment in patients with melanoma.

METHODS

Searches were conducted of the electronic databases PubMed and EMBASE and of conference abstracts published by the American Society of Clinical Oncology. Eligible studies included prospective clinical trials and expanded-access programmes (i.e. outside a clinical trial) of patients with melanoma assigned to vemurafenib treatment. Outcomes included prevalence of dermatological toxicities treated with vemurafenib. Statistical analyses were performed using the R2.8.1 meta package.

RESULTS

In total, 11 studies comprising 4197 patients were included in the meta-analysis. For patients assigned to vemurafenib, the overall prevalence of all-grade cutaneous squamous cell carcinoma (cSCC) was 18.00% (95% CI 12.00-26.00%), rash 45.00% (95% CI 34.00-57.00%), photosensitivity reaction (PR) 30.00% (95% CI 23.00-38.00%), keratoacanthoma (KA) 10.00% (95% CI 6.00-15.00%) and hand-foot skin reaction (HFSR) 9.00% (95% CI 4.00-20.00%), while the prevalence of high-grade events was: cSCC 16.00% (95% CI 11.00-23.00%), rash 12.00% (95% CI 3.00-38.00%), PR 4% (95% CI 2.00-8.00%) and KA 6.00% (95% CI 5.00-7.00%).

CONCLUSION

The most frequent dermatological toxicities associated with vemurafenib treatment in patients with melanoma were cSCC, rash, PR and KA. These data may be useful for estimation of the efficacy and safety of the drug during clinical treatment and for reducing the prevalence of adverse reactions to vemurafenib treatment in patients with melanoma.

摘要

背景

维莫非尼与黑色素瘤患者的皮肤不良事件相关,包括皮疹、皮肤鳞状细胞癌、光敏反应和角化棘皮瘤风险增加。然而,尚未有系统的尝试来评估与黑色素瘤治疗相关的维莫非尼的皮肤毒性数据。

目的

评估黑色素瘤患者接受维莫非尼治疗相关皮肤毒性的时点患病率。

方法

检索电子数据库 PubMed 和 EMBASE,以及美国临床肿瘤学会发表的会议摘要。纳入的研究包括接受维莫非尼治疗的黑色素瘤患者的前瞻性临床试验和扩展使用计划(即临床试验之外)。结果包括接受维莫非尼治疗的皮肤毒性的患病率。使用 R2.8.1 meta 包进行统计分析。

结果

共有 11 项研究,包括 4197 例患者,被纳入荟萃分析。对于接受维莫非尼治疗的患者,所有级别皮肤鳞状细胞癌(cSCC)的总体患病率为 18.00%(95%CI 12.00-26.00%),皮疹为 45.00%(95%CI 34.00-57.00%),光敏反应(PR)为 30.00%(95%CI 23.00-38.00%),角化棘皮瘤(KA)为 10.00%(95%CI 6.00-15.00%),手足皮肤反应(HFSR)为 9.00%(95%CI 4.00-20.00%),而高级别事件的患病率为:cSCC 为 16.00%(95%CI 11.00-23.00%),皮疹为 12.00%(95%CI 3.00-38.00%),PR 为 4%(95%CI 2.00-8.00%),KA 为 6.00%(95%CI 5.00-7.00%)。

结论

黑色素瘤患者接受维莫非尼治疗最常见的皮肤毒性为 cSCC、皮疹、PR 和 KA。这些数据可能有助于在临床治疗期间评估该药物的疗效和安全性,并降低黑色素瘤患者对维莫非尼治疗不良反应的发生率。

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