Department of Radiation Oncology, Shandong Cancer Hospital Affiliated to Shandong UniversityJinanP.R. China.
Department of Gynecology, Peoples Hospital of Guangxi Zhuang Autonomous RegionNanningP.R. China.
Oncol Res. 2022 Jan 31;28(9):929-944. doi: 10.3727/096504021X16318716607908. Epub 2021 Sep 20.
This phase II randomized clinical trial aimed to assess the efficacy and toxicity of Endostar, an antiangiogenesis inhibitor, combined with concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer (LACC). Patients with LACC were randomly assigned to either CCRT plus Endostar (CCRT+E arm) or CCRT alone (CCRT arm). All patients received pelvic intensity-modulated radiation therapy (IMRT) and brachytherapy. Weekly cisplatin was administered concurrently with IMRT. Patients in the CCRT+E arm also received concurrent Endostar every 3 weeks for two cycles. The primary endpoint was progression-free survival (PFS) and acute toxicities. The exploratory endpoint was the impact of vascular endothelial growth factor receptor-2 (VEGFR2) expression on long-term survival. A total of 116 patients were enrolled. Patients in the CCRT+E arm and in the CCRT arm had similar acute and late toxicity profile. The 1- and 2-year PFS were 91.4% versus 82.1% and 80.8% versus 63.5% (=0.091), respectively. The 1- and 2-year distance metastasis-free survival (DMFS) were 92.7% versus 81.1% and 86.0% versus 65.1% (=0.031), respectively. Patients with positive VEGFR2 expression had significant longer PFS and overall survival (OS) compared with those with negative VEGFR2 expression. Patients in the CCRT+E arm had significantly longer PFS, OS, and DMFS than those in the CCRT arm when VEGFR2 expression was positive. In conclusion, CCRT plus Endostar significantly improved DMFS but not PFS over CCRT alone. The addition of Endostar could significantly improve survival for patients with positive VEGFR2 expression.
这项 II 期随机临床试验旨在评估抗血管生成抑制剂恩度联合同步放化疗（CCRT）治疗局部晚期宫颈癌（LACC）的疗效和毒性。将 LACC 患者随机分为 CCRT 加恩度（CCRT+E 组）或 CCRT 单独治疗（CCRT 组）。所有患者均接受盆腔调强放疗（IMRT）和近距离放疗。每周给予顺铂与 IMRT 同步进行。CCRT+E 组患者还接受恩度联合治疗，每 3 周一次，共两个周期。主要终点是无进展生存期（PFS）和急性毒性。探索性终点是血管内皮生长因子受体-2（VEGFR2）表达对长期生存的影响。共纳入 116 例患者。CCRT+E 组和 CCRT 组患者的急性和晚期毒性谱相似。CCRT+E 组和 CCRT 组的 1 年和 2 年 PFS 分别为 91.4%和 82.1%（=0.091）和 80.8%和 63.5%（=0.091）。1 年和 2 年无远处转移生存率（DMFS）分别为 92.7%和 81.1%（=0.031）和 86.0%和 65.1%（=0.031）。VEGFR2 表达阳性患者的 PFS 和总生存期（OS）明显长于 VEGFR2 表达阴性患者。VEGFR2 表达阳性时，CCRT+E 组的 PFS、OS 和 DMFS 明显长于 CCRT 组。结论：与 CCRT 单独治疗相比，CCRT 加恩度可显著提高 DMFS，但不能提高 PFS。对于 VEGFR2 表达阳性的患者，添加恩度可显著提高生存率。
