| 郝晓慧,赵明娟,田龙,等.信迪利单抗联合常规化疗在复发转移宫颈癌治疗中疗效和安全性研究[J].安徽医药,2024,28(6):1246-1250. |
| 信迪利单抗联合常规化疗在复发转移宫颈癌治疗中疗效和安全性研究 |
| Efficacy and safety of sintilimab combined with conventional chemotherapy in the treatment of recurrent metastatic cervical cancer |
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| DOI：10.3969/j.issn.1009-6469.2024.06.040 |
| 中文关键词: 宫颈肿瘤 化疗 免疫治疗 信迪利单抗 短期疗效 长期疗效 |
| 英文关键词: Uterine cervical neoplasms Chemotherapy Immunotherapy Sintilimab Short-term efficacy Long-term efficacy |
| 基金项目:张家口市重点研发计划项目( 2121170D) |
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| 中文摘要: |
| 目的探究程序性死亡受体 1(PD-1)抑制剂信迪利单抗(达伯舒)联合常规化疗在复发转移宫颈癌治疗中短期疗效、长期疗效和安全性。方法筛选 2019年 3月至 2020年 8月河北北方学院附属第一医院符合纳入、排除标准的复发转移宫颈癌病人 88例，采用中央随机系统分配法分为试验组( n=44)和对照组(n=44)。对照组执行常规化疗方案，试验组执行信迪利单抗联合常规化疗方案。参考实体肿瘤疗效评估标准( RECIST)1.1来评价并比较两组病人短期疗效。通过随访和记录无进展生存期( PFS)来评价并比较两组病人长期疗效。参考常见不良事件评价标准( CTCAE)5.0版来评价两组病人不良事件和安全性。结果短期疗效:试验组客观缓解率为 47.73%，显著高于对照组 18.18%(P=0.035)；试验组持久临床受益率为 86.36%，显著高于对照组的 43.18%(P=0.048)。长期疗效:试验组中位 PFS为 7.22个月［ 95%CI:(4.38，14.04)］显著长于对照组的 4.31个月［95%CI:(3.43，9.25)］(P=0.032)。试验组中位总生存期( OS)为 17.30个月［ 95%CI:(14.33，17.58)，］死亡风险显著低于对照组的 6.93个月［ 95%CI:(4.89，13.25)］(P=0.039)。 Cox回归分析结果显示肿瘤突变负荷( P=0.036)、化疗，疗程( P=0.022)、组织学类型( P=0.018)和转移灶位点( P=0.035)是试验组治疗效果的独立预后因素。结论信迪利单抗联合常规化疗方案显著提高 |
| 英文摘要: |
| Objective To investigate the short-term efficacy, long-term efficacy and safety of the programmed death receptor 1 (PD-1) inhibitor sintilimab combined with conventional chemotherapy in the treatment of recurrent metastatic cervical cancer.Methods A to tal of 88 patients who met the inclusion and exclusion criteria and who had recurrent metastatic cervical cancer at The First AffiliatedHospital of Hebei North University from March 2019 to August 2020 were selected and divided into an experimental group (n=44) and a control group (n=44) using the central randomized system allocation method. The control group was treated with a conventional chemotherapy regimen, and the experimental group was treated with sintilimab combined with a conventional chemotherapy regimen. Thecriteria for evaluating the efficacy of solid tumors (RECIST) 1.1 were used to evaluate and compare the short-term efficacy of the two groups of patients. The long-term efficacy of the two treatments will be evaluated and compared by monitoring progression-free survival (PFS). The adverse events and safety of the two groups were evaluated with reference to the Common Terminology Criteria for AdverseEvents (CTCAE) version 5.0.Results Short-term efficacy: The objective remission rate in the experimental group was 47.73%, whichwas significantly greater than that (18.18%) in the control group (P=0.035). The durable clinical benefit rate of 86.36% in the experimental group was significantly greater than that of 43.18% in the control group (P=0.048). Long-term efficacy: The median PFS in the experimental group was 7.22 months [95% CI: (4.38, 14.04)], which was significantly greater than the 4.31 months [95% CI: (3.43, 9.25)] in the control group (P=0.032). The median overall survival (OS) in the experimental group was 17.30 months [95% CI: (14.33, 17.58)], and the risk of death was significantly lower than that of 6.93 months [95% CI: (4.89, 13.25)] in the control group (P=0.039). Cox regression analysis revealed that tumor mutational burden (P=0.036), chemotherapy course (P=0.022), histological type (P=0.018) and metastasis site (P=0.035) were independent prognostic factors for the curative effect in the experimental group.Conclusion Sintilimab combined with conventional chemotherapy significantly improved the short-and long-term treatment efficacy in patients with re current metastatic cervical cancer, with no significant increase in adverse reactions. |
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