Department of Internal Medicine, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Department of Biostatistics, University of Washington, Seattle, WA, USA.
Int J Dermatol. 2021 Oct;60(10):1242-1247. doi: 10.1111/ijd.15583. Epub 2021 Apr 19.
Skin toxicity is a common, expected side effect of tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs) used for metastatic renal cell carcinoma (mRCC). We evaluated the association between skin toxicity and clinical efficacy outcomes of these agents in mRCC patients.
Data were obtained from patients with mRCC treated with TKIs and/or ICIs from 2016-2019 at a referral hospital in Mexico City. Clinical outcomes were compared among patients who developed treatment-related cutaneous adverse events (AEs) and those without skin toxicity.
Thirty-five patients with mRCC were identified who were treated with sunitinib (51.4%), nivolumab plus cabozantinib (28.6%), nivolumab monotherapy (17.1%), or ipilimumab plus nivolumab plus cabozantinib (2.9%). Any grade skin toxicity was seen in 65.7% of patients. With a median follow-up of 14 months, radiological responses were as follows: 48.6% stable disease, 25.7% partial response, and 2.8% complete response. Compared to subjects without skin toxicity, patients who developed cutaneous AEs had higher disease control rate 91.3% vs. 50.0% (P = 0.019) and superior 12-month overall survival rate 91% vs. 67% (P = 0.01), respectively. There was a trend toward improved median progression-free survival (16 months vs. 5 months, P = 0.13). Grade 1-2 cutaneous toxicity was found to be predictive for disease control, with HR 2.72 (95% CI 1.1-6.71, P = 0.030), and all grade cutaneous toxicity was prognostic of overall survival, with HR 0.18 (95% CI 0.04-0.91, P = 0.039).
Cutaneous AEs are associated with improved overall survival and response in patients with mRCC treated with immunotherapy and/or TKIs.
皮肤毒性是转移性肾细胞癌（mRCC）患者使用酪氨酸激酶抑制剂（TKIs）和免疫检查点抑制剂（ICIs）的常见预期副作用。我们评估了这些药物在 mRCC 患者中的皮肤毒性与临床疗效结果之间的关系。
数据来自于 2016 年至 2019 年期间在墨西哥城一家转诊医院接受 TKI 和/或 ICI 治疗的 mRCC 患者。比较了发生治疗相关皮肤不良反应（AE）的患者和无皮肤毒性的患者之间的临床结局。
共确定了 35 例接受舒尼替尼（51.4%）、纳武单抗联合卡博替尼（28.6%）、纳武单抗单药治疗（17.1%）或伊匹单抗联合纳武单抗联合卡博替尼（2.9%）治疗的 mRCC 患者。65.7%的患者出现任何级别的皮肤毒性。中位随访 14 个月时，影像学反应如下：48.6%疾病稳定，25.7%部分缓解，2.8%完全缓解。与无皮肤毒性的患者相比，发生皮肤 AE 的患者疾病控制率更高（91.3% vs. 50.0%，P=0.019），12 个月总生存率更高（91% vs. 67%，P=0.01）。中位无进展生存期也有改善的趋势（16 个月 vs. 5 个月，P=0.13）。发现 1-2 级皮肤毒性与疾病控制相关，HR 为 2.72（95%CI 1.1-6.71，P=0.030），所有级别的皮肤毒性与总生存率相关，HR 为 0.18（95%CI 0.04-0.91，P=0.039）。
免疫治疗和/或 TKI 治疗的 mRCC 患者发生皮肤 AE 与总生存和缓解相关。
