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尼妥珠单抗联合放化疗治疗老年食管鳞癌的疗效和安全性:一项前瞻性真实世界实用研究。

Efficacy and Safety of Concurrent Chemoradiotherapy Combined with Nimotuzumab in Elderly Patients with Esophageal Squamous Cell Carcinoma: A Prospective Real-world Pragmatic Study.

机构信息

Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.

Department of Radiation Oncology, Cancer Hospital of HuanXing, Beijing, China.

出版信息

Curr Cancer Drug Targets. 2023;23(8):653-662. doi: 10.2174/1568009623666230315145937.

DOI:10.2174/1568009623666230315145937
PMID:36924100
Abstract

BACKGROUND

Concurrent or definitive chemoradiotherapy is the standard treatment of locally advanced esophageal squamous cell carcinoma (ESCC). Elderly patients could not tolerate the standard concurrent chemotherapy and were treated with radiotherapy because of weak physical status and multiple comorbidities.

OBJECTIVE

The efficacy and safety profile of concurrent (chemo) radiotherapy combined with nimotuzumab in elderly patients with ESCC were investigated.

METHODS

Eligible elderly (≥70 years) patients with locally advanced ESCC were enrolled in this prospective, real-world pragmatic study and received concurrent chemoradiotherapy or radiotherapy combined with nimotuzumab. The primary endpoint was overall survival (OS). Secondary endpoints were objective response rate, disease control rate, progression-free survival (PFS), and adverse drug reactions.

RESULTS

Fifty-three elderly patients were enrolled. Thirty-two (60.4%) were treated with radiotherapy combined with nimotuzumab (RT+N), and 21 (39.6%) with concurrent chemoradiotherapy combined with nimotuzumab (CRT+N). The median age was 75.8 years. Fourteen (56.0%) patients achieved a partial response, and 11 (44.0%) patients achieved stable disease at 3 months. The median follow-up duration was 24.4 (95%CI, 21.6-26.7) months. Median OS (mOS) was 27.0 (95%CI, 14.8-48.4) months. Median PFS (mPFS) was 22.6 (95%CI, 12.4-not reached) months. Higher mPFS (not reached vs. 12.0 months; p=0.022) and mOS (48.4 vs. 15.3 months; p=0.009) were observed in the CRT+N group compared with the RT+N group. Most adverse reactions were grade 1-2 (46, 86.8%).

CONCLUSIONS

Concurrent chemoradiotherapy or radiotherapy combined with nimotuzumab was safe and well-tolerated in elderly patients with locally advanced ESCC. ESCC patients treated with CRT+N could live longer.

摘要

背景

同期或根治性放化疗是局部晚期食管鳞癌(ESCC)的标准治疗方法。由于身体状况较弱和合并多种疾病,老年患者不能耐受标准的同期化疗,只能接受放疗。

目的

探讨同期(放)化疗联合尼妥珠单抗治疗老年 ESCC 患者的疗效和安全性。

方法

本前瞻性、真实世界实用研究纳入了符合条件的老年(≥70 岁)局部晚期 ESCC 患者,接受同期放化疗或放疗联合尼妥珠单抗治疗。主要终点为总生存期(OS)。次要终点为客观缓解率、疾病控制率、无进展生存期(PFS)和药物不良反应。

结果

共纳入 53 例老年患者。32 例(60.4%)接受放疗联合尼妥珠单抗(RT+N)治疗,21 例(39.6%)接受同期放化疗联合尼妥珠单抗(CRT+N)治疗。中位年龄为 75.8 岁。4 例(16.0%)患者达到完全缓解,11 例(44.0%)患者在 3 个月时达到疾病稳定。中位随访时间为 24.4 个月(95%CI,21.6-26.7)。中位 OS(mOS)为 27.0 个月(95%CI,14.8-48.4)。中位 PFS(mPFS)为 22.6 个月(95%CI,12.4-未达到)。与 RT+N 组相比,CRT+N 组 mPFS(未达到比 12.0 个月;p=0.022)和 mOS(48.4 比 15.3 个月;p=0.009)更高。大多数不良反应为 1-2 级(46 例,86.8%)。

结论

同期放化疗或放疗联合尼妥珠单抗治疗老年局部晚期 ESCC 患者安全且耐受良好。接受 CRT+N 治疗的 ESCC 患者生存期更长。

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