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

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...

The effectiveness and safety of concurrent chemoradiotherapy combined with nimotuzumab for patients with inoperable esophageal squamous cell carcinoma

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.