Tian Hui, Wang Xuan, Lian Bin, Yan Xieqiao, Si Lu, Chi Zhihong, Sheng Xinan, Kong Yan, Mao Lili, Bai Xue, Tang Bixia, Li Siming, Zhou Li, Cui Chuanliang, Guo Jun
Key Laboratory of Carcinogenesis and Translational Research (Ministry Education), Department of Melanoma, Peking University Cancer Hospital and Research Institute, Beijing, China.
Front Pharmacol. 2021 Nov 9;12:747416. doi: 10.3389/fphar.2021.747416. eCollection 2021.
To describe the frequency and spectrum of treatment-related adverse events (TRAEs) of immunotherapy combined with antiangiogenic therapy in patients with melanoma. This retrospective cohort study included three clinical trials on patients with stage III/IV melanoma treated with anti-PD 1 and antiangiogenic therapy. We analyzed data from 72 patients with a median follow-up time of 25.9 months (95% CI, 9.1-42.7 m). The median treatment duration was 7.5 months (range, 0.7-42.8 m), and the median of treatment cycles was 11.0 (range, 1-90). Most patients (70 of 72 or 97.2%) experienced TRAEs (mostly grades 1 or 2). No drug-related deaths were reported. Most TRAEs were hepatic (75%), endocrine (72.2%), skin (65.3%), and gastrointestinal tract (59.7%) manifestations, followed by myelosuppression (55.6%), renal dysfunction (55.6%), and dyslipidaemia (54.2%). The adverse event (AE) spectra were similar between regimens. Using multivariate Cox proportional risk models showed that hypertension was associated with a long PFS. According to our multivariable logistic regression models, TRAEs were not associated with ORR. We found that the prevalence of AEs was higher than that of anti-PD-1 monotherapy. Most of the AEs were mild. The AE spectra were similar to those seen after anti-PD-1 or antiangiogenic therapy monotherapy, without unexpected AEs. Immunotherapy combined with antiangiogenic therapy was well tolerated. : ClinicalTrials.gov, identifier NCT03955354.
描述免疫疗法联合抗血管生成疗法治疗黑色素瘤患者时与治疗相关的不良事件（TRAEs）的频率和谱。这项回顾性队列研究纳入了三项关于接受抗PD-1和抗血管生成疗法治疗的III/IV期黑色素瘤患者的临床试验。我们分析了72例患者的数据，中位随访时间为25.9个月（95%CI，9.1 - 42.7个月）。中位治疗持续时间为7.5个月（范围，0.7 - 42.8个月），治疗周期中位数为11.0（范围，1 - 90）。大多数患者（72例中的70例或97.2%）经历了TRAEs（大多为1级或2级）。未报告与药物相关的死亡。大多数TRAEs为肝脏（75%）、内分泌（72.2%）、皮肤（65.3%）和胃肠道（59.7%）表现，其次是骨髓抑制（55.6%）、肾功能不全（55.6%）和血脂异常（54.2%）。各治疗方案之间的不良事件（AE）谱相似。使用多变量Cox比例风险模型显示高血压与较长的无进展生存期相关。根据我们的多变量逻辑回归模型，TRAEs与客观缓解率无关。我们发现AE的发生率高于抗PD-1单药治疗。大多数AE为轻度。AE谱与抗PD-1或抗血管生成疗法单药治疗后所见相似，无意外AE。免疫疗法联合抗血管生成疗法耐受性良好。：ClinicalTrials.gov标识符NCT03955354
