| 郝晓慧.信迪利单抗联合常规化疗在宫颈癌治疗中效果研究[J].安徽医药,待发表. |
| 信迪利单抗联合常规化疗在宫颈癌治疗中效果研究 |
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| 投稿时间：2022-12-05 录用日期：2023-01-04 |
| DOI： |
| 中文关键词: 晚期宫颈癌 化疗 免疫治疗 信迪利单抗 疗效 安全性 |
| 英文关键词: |
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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 筛选符合纳排标准的复发转移宫颈癌患者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RECIST 1.1来评价并比较两组患者短期疗效。通过随访和记录无进展生存期(PFS)来评价并比较两组患者长期疗效。参考CTCAE 5.0版来评价两组患者不良事件和安全性。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 mon(95%CI：4.38-14.04),显著长于对照组的4.31 mon(95%CI：3.43-9.25)(P=0.022)。试验组中位OS为17.30 mon(95%CI：14.33-17.58),死亡风险显著低于对照组的6.93 mon(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=0.038)、化疗疗程(P=0.022)、组织学类型(P=0.049)和转移灶位点(P=0.012)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了复发转移宫颈癌患者的短、长期疗效,不良反应未明显增加,具有一定临床价值。 |
| 英文摘要: |
| Objective To explore the short-term efficacy, long-term efficacy and safety of programmed cell death 1 (PD-1) inhibitor sintilimab combined with conventional chemotherapy in the treatment of recurrent and metastatic cervical cancer. Methods 88 patients with recurrent and metastatic cervical cervical cancer who met the inclusion-exclusion criteria were selected and divided into experimental group (n = 44) and control group (n = 44) by using central random system allocation method. The control group was treated with conventional chemotherapy, and the experimental group was treated with sintilimab combined with conventional chemotherapy. The short-term curative effect of the two groups was evaluated and compared by referring the RECIST 1.1. The long-term curative effect of the two groups was evaluated and compared by using follow-up and recording progression free survival (PFS). The adverse event and safety of the two groups was evaluated by referring to the CTCAE 5.0. Results Short-term curative effect: the objective response rate in the experimental group was 47.73%, significantly higher than that 18.18% in the control group (P = 0.035); The durable clinical benefit rate of the experimental group was 86.36%, which was significantly higher than that 43.18% of the control group (P = 0.048). Long-term curative effect: the median PFS of the experimental group was 7.22 mon (95% CI: 4.38-14.04), which was significantly longer than that 4.31 mon (95% CI: 3.43-9.25) of the control group (P = 0.022). The median OS in the experimental group was 17.30 mon (14.33-17.58), and the risk of death was significantly lower than that 6.93 mon (4.89-13.25) in the control group (P = 0.039). Cox regression analysis showed that tumor mutational burden (P = 0.038), chemotherapyScycle (P = 0.022), histology (P = 0.049) and metastasis site (P = 0.012) were independent prognostic factors for the curative. effect in the experimental group. Conclusion Sintilimab combined with conventional chemotherapy significantly improves the short-term and long-term curative effect of patients with recurrent and metastatic cervical cervical cancer, with no significant increase in adverse reaction, which has a certain clinical value. |
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