评估转移性结直肠癌 (mCRC) 维持治疗效果的关键终点是生存和生活质量结果。我们的目的是比较接受氟尿嘧啶和亚叶酸 (FU/FA) 帕尼单抗 (Pmab) 治疗的 RAS 野生型 (wt) mCRC 患者与单独使用 FU/FA 作为亚叶酸维持治疗后的皮肤科相关生活质量 (DRQOL) 、氟尿嘧啶和奥沙利铂 Pmab 诱导。II 期随机 PanaMa（AIO KRK 0212；NCT01991873）试验纳入了德国 70 个社区/学术机构的 387 名患者。对于这个预先指定的二次分析，在每个第二个治疗周期直至疾病发生之前，使用癌症治疗功能评估-表皮生长因子受体抑制剂 (FACT-EGFRI)、皮肤科生活质量指数 (DLQI) 和 Skindex-16 问卷来评估 DRQOL 结果总共 310/377 (82%) 接受诱导治疗的患者和 216/248 (87%) 随机接受维持治疗的患者至少完成了一份 DRQOL 问卷。根据美国国家癌症研究所 (NCI) - 不良事件通用术语标准 (CTCAE) 在诱导治疗期间经历过皮肤毒性的患者，根据所有三项指标，与未经历过皮肤毒性的患者相比，其 DRQOL 显着较差 [即： Skindex-16，第 2 周期的平均差 -12.87； 95% 置信区间 (CI) -20.01 至 -5.73； P<0.001]。在维持治疗期间，与接受额外 Pmab 的患者相比，接受 FU/FA 的患者的所有 DRQOL 测量均观察到恢复显着改善（即 Skindex-16，第 6 个周期的平均差 -16.53；95% CI -22.68 至 -10.38；P < 0.001)。在这项 II 期随机临床试验的二次分析中，根据 NCI-CTCAE 在诱导治疗期间患者报告的 DRQOL 结果与皮肤毒性相关。与单独使用 FU/FA 治疗 RAS wt mCRC 患者相比，使用 FU/FA Pmab 维持治疗与 DRQOL 恶化相关。版权所有 © 2024 作者。由爱思唯尔有限公司出版。保留所有权利。

The key endpoints for the assessment of the effect of maintenance therapy for metastatic colorectal cancer (mCRC) are survival and quality-of-life outcomes. We aimed to compare dermatology-related quality of life (DRQOL) in patients with RAS wild-type (wt) mCRC treated with fluorouracil and folinic acid (FU/FA) + panitumumab (Pmab) versus FU/FA alone as maintenance therapy after folinic acid, fluorouracil and oxaliplatin + Pmab induction.The phase II randomized PanaMa (AIO KRK 0212; NCT01991873) trial included 387 patients at 70 community/academic sites in Germany. For this prespecified secondary analysis, DRQOL outcomes were assessed using the Functional Assessment of Cancer Therapy-epidermal growth factor receptor inhibitor (FACT-EGFRI), Dermatology Life Quality Index (DLQI), and Skindex-16 questionnaires at every second cycle of therapy until disease progression/death.At least one DRQOL questionnaire was completed by a total of 310/377 (82%) patients who received induction therapy, and by 216/248 (87%) patients who were randomized and received maintenance therapy. Patients who experienced skin toxicity according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) during induction therapy had significantly worse DRQOL according to all three measures, compared to those who did not [i.e. Skindex-16, mean difference at cycle 2 -12.87; 95% confidence interval (CI) -20.01 to -5.73; P < 0.001]. During maintenance therapy, significantly improved recovery was observed in all DRQOL measures for patients receiving FU/FA, compared to those receiving additional Pmab (i.e. Skindex-16, mean difference at cycle 6 -16.53; 95% CI -22.68 to -10.38; P < 0.001).In this secondary analysis of a phase II randomized clinical trial, patient-reported DRQOL outcomes correlated with skin toxicity according to NCI-CTCAE during induction therapy. Maintenance therapy with FU/FA + Pmab was associated with deteriorated DRQOL versus FU/FA alone in patients with RAS wt mCRC.Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.