| 戴李宸,黄建锋,胡莉钧,吴佳,汪建林,孟庆红,孙菲,段秋华,于静萍.同步放化疗联合尼妥珠单抗治疗非手术食管鳞癌患者的有效性与安全性分析[J].中华放射医学与防护杂志,2023,43(3):182-188 |
| 同步放化疗联合尼妥珠单抗治疗非手术食管鳞癌患者的有效性与安全性分析 |
| The effectiveness and safety of concurrent chemoradiotherapy combined with nimotuzumab for patients with inoperable esophageal squamous cell carcinoma |
| 投稿时间：2022-12-26 |
| DOI：10.3760/cma.j.cn112271-20221226-00499 |
| 中文关键词: 食管鳞癌 尼妥珠单抗 放射治疗 靶向治疗 |
| 英文关键词:Esophageal squamous cell carcinoma Nimotuzumab Radiotherapy Targeted therapy |
| 基金项目:常州市科技计划项目（CZ20210030）；常州市卫生健康委员会重大科技项目（ZD202017） |
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| 中文摘要: |
| 目的 评估同步放化疗联合尼妥珠单抗治疗不可手术食管鳞状细胞癌（ESCC）患者的有效性与安全性。方法 回顾性分析2014年至2020年于南京医科大学附属常州第二人民医院放疗科和江南大学附属医院肿瘤放疗科接受同步放化疗的503例非手术ESCC患者。其中，同步放化疗联合尼妥珠单抗组（联合组）69例，单纯同步放化疗组（同步放化疗组）434例，采用倾向性评分匹配法（PSM）对两组患者进行1 ∶2匹配，最终得到可供临床分析的患者共168例，其中，联合组61例，同步放化疗组107例。比较两组患者的近期疗效和不良反应，采用Kaplan-Meier法绘制总生存曲线和无进展生存曲线，并行Log-rank检验。结果 匹配后两组患者临床基线特征的差异无统计学意义（P>0.05）。联合组的客观缓解率（ORR）显著高于同步放化疗组，差异有统计学意义（85.2%vs. 71.0%，χ2=4.33，P=0.037）；联合组的疾病控制率（DCR）与同步放化疗组差异无统计学意义（98.4%vs.91.6%，P>0.05）。联合组的中位无进展生存（PFS）时间为28.07个月，1、3、5年PFS率分别为78.2%、37.5%和29.1%；同步放化疗组的中位PFS时间为19.54个月，1、3、5年PFS率分别为72.9%、28.3%和21.3%，两组比较差异有统计学意义（χ2=4.49，P=0.034）；联合组的中位总生存（OS）时间为34.93个月，1、3、5年OS率分别为88.5%、46.8%和37.4%；同步放化疗组的中位OS时间为24.30个月，1、3、5年OS率分别为81.3%、35.2%和28.0%，两组患者OS差异有统计学意义（χ2=5.11，P=0.024）。两组患者治疗期间各项不良反应的严重程度差异无统计学意义（P>0.05）。结论 同步放化疗联合尼妥珠单抗相比单纯同步放化疗可提高非手术食管鳞癌患者的客观缓解率，并延长患者的无进展生存期及总生存期，且不会增加不良反应，患者整体可耐受，安全性良好。 |
| 英文摘要: |
| Objective To evaluate the effectiveness and safety of concurrent chemoradiotherapy combined with nimotuzumab in the treatment of patients with inoperable esophageal squamous cell carcinoma (ESCC).Methods A retrospective analysis was conducted on the clinical data of 503 patients with inoperable ESCC who underwent concurrent chemoradiotherapy in the Department of Radiation Oncology, Changzhou No. 2 People's Hospital Affiliated to Nanjing Medical University and Department of Radiation Oncology, Affiliated Hospital of Jiangnan University from 2014 to 2020. Among these patients, 69 received concurrent chemoradiotherapy combined with nimotuzumab (the combined therapy group) and 434 received concurrent chemoradiotherapy alone (the concurrent chemoradiotherapy group). Patients of both groups were matched at a ratio of 1:2 using the propensity score matching (PSM) method. As a result, 168 patients were determined for clinical analysis, including 61 in the combined therapy group and 107 in the concurrent chemoradiotherapy group. The short-term efficacy and adverse reactions of both groups were compared. The overall survival (OS) curves and progression-free survival (PFS) curves were plotted using the Kaplan-Meier method for the Log-rank test.Results The two groups showed no statistical difference (P > 0.05) in clinical baseline characteristics after the PSM. The objective response rate (ORR) of the combined therapy group was significantly higher than that of the concurrent chemoradiotherapy group with statistically significant differences (85.2% vs. 71.0%, χ2=4.33, P=0.037). There was no statistical difference (98.4% vs. 91.6%, P > 0.05) in the disease control rate (DCR) between the two groups. The combined therapy group had median PFS of 28.07 months and 1-, 3-, and 5-year PFS ratios of 78.2%, 37.5% and 29.1%, respectively. The concurrent chemoradiotherapy group had mPFS of 19.54 months and 1-, 3-, and 5-year PFS ratios of 72.9%, 28.3% and 21.3%, respectively. Both groups showed statistically significant differences in PFS (χ2=4.49, P=0.034). The combined group had median OS of 34.93 months and 1-, 3-, and 5-year OS ratios of 88.5%, 46.8% and 37.4%, respectively. The concurrent chemoradiotherapy group had mOS of 24.30 months and 1-, 3-, and 5-year OS ratios of 81.3%, 35.2% and 28.0%, respectively. Both groups showed statistically significant differences in OS (χ2=5.11, P=0.024), but did not show statistical differences (P > 0.05) in the severity degree of each adverse effect during the treatment.Conclusions Concurrent chemoradiotherapy combined with nimotuzumab can improve the ORR and prolong the PFS and OS of patients with inoperable ESCC compared with concurrent chemoradiotherapy alone. Furthermore, combining with nimotuzumab does not increase adverse effects and can be tolerated by patients with high safety. |
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