Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi University Hospital, Bologna, Italy
Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi University Hospital, Bologna, Italy.
In Vivo. 2020 Mar-Apr;34(2):479-488. doi: 10.21873/invivo.11798.
Despite several clinical trials and advances in understanding the genetic basis of biliary tract cancer (BTC), the addition of epidermal growth factor receptor (EGFR) targeted therapy does not seem to enhance the activity of first-line chemotherapy (CHT).
We carried out a meta-analysis of available randomized clinical trials to assess the efficacy and safety of gemcitabine-based first-line CHT plus monoclonal antibodies against EGFR (EGFR-mAbs) in advanced or metastatic BTC.
In the overall population, the pooled hazard ratio for overall (OS) and progression-free (PFS) survival were 0.82 (95% confidence interval=0.64-1.06) and 0.88 (95% confidence intervaI=0.73-1.08), respectively. No differences were detected in objective response rate between the two groups. Patients treated with gemcitabine-based CHT plus EGFR-mAbs showed a statistically significant increased risk of grade 3-4 neutropenia, grade 3-4 thrombocytopenia and especially grade 3-4 skin rash.
The addition of EGFR-mAbs to gemcitabine-based first-line CHT does not significantly improve overall and progression-free survival, nor the objective response rate in patients with advanced BTC and increases the risk of hematological and cutaneous adverse drug events.
尽管进行了多项临床试验并深入了解了胆道癌（BTC）的遗传基础，但表皮生长因子受体（EGFR）靶向治疗的加入似乎并未增强一线化疗（CHT）的活性。
我们对现有随机临床试验进行了荟萃分析，以评估吉西他滨为基础的一线 CHT 联合针对 EGFR 的单克隆抗体（EGFR-mAbs）在晚期或转移性 BTC 中的疗效和安全性。
在总体人群中，总生存期（OS）和无进展生存期（PFS）的合并危险比分别为 0.82（95%置信区间=0.64-1.06）和 0.88（95%置信区间=0.73-1.08）。两组之间的客观缓解率没有差异。接受吉西他滨为基础的 CHT 联合 EGFR-mAbs 治疗的患者出现 3-4 级中性粒细胞减少症、3-4 级血小板减少症，尤其是 3-4 级皮疹的风险显著增加，且具有统计学意义。
在吉西他滨为基础的一线 CHT 中添加 EGFR-mAbs 并不能显著改善晚期 BTC 患者的总生存期和无进展生存期，也不能提高客观缓解率，反而增加了血液学和皮肤不良药物事件的风险。
