白蛋白紫杉醇诱导皮疹的相关处理

克艾力的生物等效性研究数据显示[2]，本品的皮疹发生率为10.3%， 原研为13.2%。胡夕春等的研究中[3]，白蛋白紫杉醇（原研药） 顺铂方案，皮疹发生率为37%。克艾力的生物等效性研究数据表明本品皮疹发生率较低。

白蛋白紫杉醇皮疹多为1-2级，皮疹通常发生在化疗第2天[CI:1-7]，抗组胺用药2天(95%CI:1–10)后，皮疹会逐渐消退。仅1例出现3级，后期用药需降低剂量[3]。

一

白蛋白紫杉醇治疗乳腺癌的流行病学

1、白蛋白紫杉醇治疗乳腺癌转移复发时皮疹的流行病学[4-10]

备注nab-p：白蛋白紫杉醇；qw：每周一次；q3w：每三周一次

2、白蛋白紫杉醇治疗乳腺癌新辅助时皮疹的流行病学[11-16]

备注nab-p：白蛋白紫杉醇；qw：每周一次；q3w：每三周一次

  • 白蛋白紫杉醇在乳腺癌转移复发和新辅助治疗中有一定的皮疹发生率、单用发生率11.7-30.4%，这可能与使用周期和剂量有关。

  • 白蛋白紫杉醇联用方案中皮疹有一定的发生率，可能与联用药物可能有关，其中与拉帕替尼联用时最高。

  • 白蛋白紫杉醇单周或三周方案方案可发生3级皮疹，发生率较低，0-1.8%。

二

临床表现[9]

临床表现：通常发生在化疗第2天[CI:1-7]出现黄斑丘疹和丘疹伴瘙痒

皮疹分布特点

三

评估[17]

  • CTCAE 5.0对斑丘疹的评估

定义： 出现斑疹（扁平）和丘疹（突起）。也称为麻疹，是最常见的皮肤不良事件之一，常常影响上半身，向心性发展，伴有瘙痒。

  • 免疫检查点抑制剂相关的毒性管理指南毒性管理原则

四

预防

1、激素预处理 ：对先前白紫出现皮疹的患者，考虑进行预处理。对白紫有严重超敏反应的病人不要再次挑战。

2、化疗后在药物代谢期间，如果在较热的环境下，患者出汗可导致药物从汗腺的分泌，从而诱使皮肤病（包括皮疹、脱皮等）的不良反应的发生率升高。故临床经验认为化疗过程中及化疗后4天内避免过热出汗、阳光直晒。

五

剂量调整

六

处理[9]

  • 抗组胺药物[9]

    皮疹治疗过程中，约48.14%皮疹部位有残留色素沉着，尤其在脸和颈部。

  • 参考CSCO免疫检查点抑制剂相关的毒性管理指南中皮疹的处理方法

备注：ICIs：免疫检查点抑制剂

参考文献（上下滑动查看）

[1] Sibaud V , Leb Uf N R , Henri Roche Dermatological adverse events with taxane chemotherapy[J]. European Journal of Dermatology Ejd, 2016, 26(5):427-443.

[2] 注射用白蛋白结合型紫杉醇与原研药 Abraxane 用于转移性乳腺癌的生物等效性和延长用药疗效分析

[3] Tang LC, et al. Higher rate of skin rash in a phase II trial with weekly nanoparticle albumin-bound paclitaxel and cisplatin combination in Chinese breast cancer patients. BMC Cancer. 2013 May 9;13:232.

[4] Zhong-Zhen G, et al. Superior efficacy of a Cremophor-free albumin-bound paclitaxel compared with solvent-based paclitaxel in Chinese patients with metastatic breast cancer. Asia–Pacific Journal of Clinical Oncology 2009; 5: 165–174.

[5] Denise A, et al. Phase II study evaluating lapatinib in combination with nab-paclitaxel in HER2-overexpressing metastatic breast cancer patients who have received no more than one prior chemotherapeutic regimen. Breast Cancer Res Treat  2013; 137:457–464.

[6] Andrew D, et al. Randomized Phase II Trial of Weekly vs. Every 2 Weeks vs. Every 3 Weeks Nanoparticle AlbuminBound Paclitaxel With Bevacizumab as First-Line Chemotherapy for Metastatic Breast Cancer. Clinical Breast Cancer,2013; 13: 239-46.

[7] Christopher Lobo, et al. Final results of a phase II study of nab-paclitaxel, bevacizumab, and gemcitabine as first-line therapy for patients with HER2-negative metastatic breast cancer. Breast Cancer Res Treat 2010; 123:427–435.

[8] Lee S. Schwartzberg, et al. Phase II Multicenter Trial of Albumin-Bound Paclitaxel and Capecitabine in First-Line Treatment of Patients With Metastatic Breast Cancer .Clinical Breast Cancer,2012; 12: 87-93

[9] Tang et al. Higher rate of skin rash in a phase II trial with weekly anoparticle albumin-bound paclitaxel and cisplatin combination in Chinese breast cancer patients. BMC Cancer 2013; 13:232.

[10] Alison K,et al. Phase II Trial of Weekly Nanoparticle Albumin-Bound Paclitaxel With Carboplatin and Trastuzumab as First-line Therapy for Women With HER2-Overexpressing Metastatic Breast Cancer Clin Breast Cancer. 2010; 10 (4).

[11] TSUTOMU TAKASHIMA,et al. Safety and Efficacy of Low-dose Nanoparticle Albumin-bound Paclitaxel for HER2-negative Metastatic Breast Cancer. ANTICANCER RESEARCH 38: 379-383 (2018).

[12] Untch M ,et al. Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trial.Lancet Oncol 2016;17:345-356.

[13] Furlanetto J, et al. Efficacy and safety of nab-paclitaxel 125 mg/m2 and nab-paclitaxel 150 mg/m2 compared to paclitaxel in early high-risk breast cancer. Results from the neoadjuvant randomized GeparSepto study (GBG 69). Breast Cancer Res Treat. 2017 Jun;163(3):495-506.

[14] Shigematsu H, et al. The Efficacy and Safety of Preoperative Chemotherapy With Triweekly Abraxane and Cyclophosphamide Followed by 5-Fluorouracil, Epirubicin, and Cyclophosphamide Therapy for Resectable Breast Cancer: A Multicenter Clinical Trial. Clin Breast Cancer. 2015 Apr;15(2):110-6.

[15] Virginia G, et al. Pilot neoadjuvant trial in HER2 positive breast cancer with combination of nab-paclitaxel and lapatinib. Breast Cancer Res Treat (2012) 132:833–842.

[16] Huang L, et al. Phase II trial of weekly nab-paclitaxel and carboplatin treatment with or without trastuzumab as nonanthracycline neoadjuvant chemotherapy for locally advanced breast cancer. Int J Nanomedicine. 2015 Mar 11;10:1969-75.

[17] Common Toxicity Criteria of the National Cancer Institute for Adverse Events(CTCAE) version 5.0.

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