Department of Oncology, Second Xiangya Hospital, Central South University, Changsha 410011, China.
Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2020 Dec 28;45(12):1412-1418. doi: 10.11817/j.issn.1672-7347.2020.190321.
To observe the efficacy and adverse reactions of the combination of endostar with chemotherapy in the treatment of advanced (IVb) and recurrent metastatic cervical cancer.
Forty-four patients with recurrent and metastatic cervical cancer, who were admitted to the Second Xiangya Hospital, Central South University from December 2016 to December 2018 were randomly divided into an experimental group and a control group (22 cases in each group). The control group was given gemcitabine plus cisplatin (GP) or docetaxel plus cisplatin (DP) treatment, the experimental group was treated with endostar on the basis of the control group.
The objective response rate (ORR) was 42.9% in the experimental group and 22.7% in the control group. There was no significant difference between the 2 groups (=0.371). The disease control rate (DCR) was 76.2% in the experimental group and 68.2% in the control group. There was no significant difference between the 2 groups (=0.558). The effect of combined endostar was doubled compared with the effect of non-combination (50.0% vs 27.3% and 36.4% vs 18.2%), but there was no significant difference (>0.05). Subgroup analysis found no significant difference in DP/GP with or without endostar on DCR (80.0% vs 72.7%, 72.7% vs 63.6%, >0.05, respectively). The median progression-free survival of the experimental group and the control group were 7.2 months and 5.1 months, respectively, and the difference was statistically significant (=0.036). The 2 groups mainly showed that the 3-4 adverse reaction was myelosuppression. The incidence of neutropenia of grade III-IV in the experimental group and the control group were 54.5% and 50.0%, respectively, and there was no statistical difference (>0.05). The incidence of cardiovascular toxicity was higher in the experimental group than that in the control group (13.6% vs 0), but there was no significant difference between the 2 groups (=0.233).
Compared with chemotherapy alone, endostar combined with chemotherapy can prolong the median progression-free survival, with higher ORR and similar adverse reactions.
观察恩度联合化疗治疗晚期(IVb 期)及复发性转移性宫颈癌的疗效及不良反应。
选取 2016 年 12 月至 2018 年 12 月中南大学湘雅二医院收治的 44 例复发性转移性宫颈癌患者,随机分为实验组和对照组,每组 22 例。对照组给予吉西他滨加顺铂(GP)或多西他赛加顺铂(DP)治疗,实验组在对照组的基础上加用恩度。
实验组客观缓解率(ORR)为 42.9%,对照组为 22.7%,两组比较差异无统计学意义(=0.371)。实验组疾病控制率(DCR)为 76.2%,对照组为 68.2%,两组比较差异无统计学意义(=0.558)。与非联合组相比,联合恩度组的疗效加倍(50.0% vs 27.3%,36.4% vs 18.2%),但差异无统计学意义(>0.05)。亚组分析发现,DP/GP 联合或不联合恩度对 DCR 无显著差异(80.0% vs 72.7%,72.7% vs 63.6%,>0.05)。实验组和对照组的中位无进展生存期分别为 7.2 个月和 5.1 个月,差异有统计学意义(=0.036)。两组主要表现为 34 级骨髓抑制。实验组和对照组的 IIIIV 级中性粒细胞减少发生率分别为 54.5%和 50.0%,差异无统计学意义(>0.05)。实验组心血管毒性发生率高于对照组(13.6% vs 0),但差异无统计学意义(=0.233)。
与单纯化疗相比,恩度联合化疗可延长中位无进展生存期,提高客观缓解率,不良反应相似。