Liu Yuan, Qi Manli, Hou Shuping, Shao Lili, Zhang Junyan, Li Yan, Liu Quanzhong
Department of Dermatovenereology, Tianjin Medical University General Hospital, Tianjin, China.
Medicine (Baltimore). 2017 Oct;96(43):e8345. doi: 10.1097/MD.0000000000008345.
Vandetanib is a promising anticancer target agent for treating advanced carcinomas, such as non-small-cell lung cancer (NSCLC) and breast cancer. Rash is a frequently reported adverse event of vandetanib. We conducted this meta-analysis to determine the incidence rate and overall risks of all-grade and high-grade rash with vandetanib in NSCLC patients.
PubMed, Embase, Web of Science, American Society of Clinical Oncology, and Cochrane Library were systematically searched to identify studies with vandetanib and rash in NSCLC patients. Data were extracted to calculate the pooled incidence of all-grade and high-grade (grade ≥3) rash caused by vandetanib treatment.
Nine randomized controlled trials involving 4893 patients met the inclusion criteria and were included in this meta-analysis. The overall incidence of all-grade and high-grade rash caused by vandetanib treatment was 46% (95% CI: 37.1%, 54.8%), and 3.2% (95% CI: 1.4%, 5.1%), respectively. The risk ratios (RR) of all-grade and high-grade rash for vandetanib treatment versus control treatment were 2.35 (95% CI: 1.20, 4.61; P < .001) and 4.68 (95% CI 1.42, 15.37; P < .001), respectively. Subgroup analysis suggested that the increased risk of all-grade rash was clear across all subgroups, including first-line/second-line therapy, phase 2/phase 3 trial, sample size </>200, a dosage of 100 or 300 mg, and monotherapy/combination therapy. However, for the high-grade rash, vandetanib did not increase the risk of rash when it was used in first-line therapy, or in a phase II trial, or in a trial with sample size <200.
This study suggests that vandetanib was associated with a significantly increased risk of rash. Therefore, early recognition and appropriate monitoring should be taken when NSCLC patients were treated with vandetanib.
凡德他尼是一种有前景的抗癌靶向药物,用于治疗晚期癌症,如非小细胞肺癌(NSCLC)和乳腺癌。皮疹是凡德他尼常见的不良事件。我们进行了这项荟萃分析,以确定NSCLC患者使用凡德他尼时全级别和高级别皮疹的发生率及总体风险。
系统检索PubMed、Embase、科学引文索引、美国临床肿瘤学会和考克兰图书馆,以确定有关NSCLC患者使用凡德他尼和皮疹的研究。提取数据以计算凡德他尼治疗引起的全级别和高级别(≥3级)皮疹的合并发生率。
9项涉及4893例患者的随机对照试验符合纳入标准并纳入本荟萃分析。凡德他尼治疗引起的全级别和高级别皮疹的总体发生率分别为46%(95%CI:37.1%,54.8%)和3.2%(95%CI:1.4%,5.1%)。凡德他尼治疗与对照治疗相比,全级别和高级别皮疹的风险比(RR)分别为2.35(95%CI:1.20,4.61;P<0.001)和4.68(95%CI 1.42,15.37;P<0.001)。亚组分析表明,在所有亚组中,包括一线/二线治疗、2期/3期试验、样本量<>200、剂量为100或300mg以及单药治疗/联合治疗,全级别皮疹风险增加均明显。然而,对于高级别皮疹,凡德他尼在一线治疗、II期试验或样本量<200的试验中使用时,并未增加皮疹风险。
本研究表明凡德他尼与皮疹风险显著增加相关。因此,NSCLC患者接受凡德他尼治疗时应尽早识别并进行适当监测。