表皮生长因子受体靶向抗体尼莫妥珠单抗联合化放疗可提高局部晚期头颈部鳞状细胞癌患者的生存率:一项倾向评分匹配真实世界研究。

IF 10.7 Q1 MEDICINE, RESEARCH & EXPERIMENTAL MedComm Pub Date : 2024-07-02 DOI:10.1002/mco2.608
Peng Zhang, Xinxin Zhang, Jinyi Lang, Shaoxiong Wu, Yan Sun, Peiguo Wang, Sufang Qiu, Xiaodong Huang, Guoxin Ren, Kun Liu, Xiaojing Du, Shaowen Xiao, Zhongqiu Wang, Youliang Weng, Ye Zhang, Hang Zhou, Wenyong Tu, Chenping Zhang, Junlin Yi
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引用次数: 0

摘要

局部晚期头颈部鳞状细胞癌(LA-HNSCC)患者的生存率很低。尼莫妥珠单抗加基于调强放疗(IMRT)的化放疗对LA-HNSCC患者的实际疗效仍不清楚。该研究共筛选了25442名HNSCC患者,并通过倾向评分匹配(PSM)(1:1)对612名患者进行了匹配。倾向得分匹配法用于平衡已知的混杂因素。完成至少五剂尼莫妥珠单抗治疗的患者被确定为研究组。主要终点是3年总生存率(OS)。对数秩检验检验两条生存曲线之间的差异,克洛格转换检验比较固定时间点的生存率。中位随访时间为 54.2 个月(95% 置信区间 [CI]:52.7-55.9)。该研究组的 OS(危险比 [HR] = 0.75,95% CI:0.57-0.99,p = 0.038)和无进展生存期(PFS)(HR = 0.74,95% CI:0.58-0.96,p = 0.021)均有所改善。亚组分析显示,年龄在50-60岁、IV、N2、放疗剂量≥60 Gy、既往未接受过手术、新辅助治疗的患者有获益于尼莫妥珠单抗的趋势。尼莫妥珠单抗具有良好的安全性,仅有0.2%的患者发生了与尼莫妥珠单抗相关的严重不良反应。我们的研究表明,在IMRT时代,尼莫妥珠单抗联合化放疗可为LA-HNSCC患者带来生存获益和安全性。
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Epidermal growth factor receptor‑targeted antibody nimotuzumab combined with chemoradiotherapy improves survival in patients with locally advanced head and neck squamous cell carcinoma: a propensity score matching real-world study

Patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) have poor survival outcomes. The real-world efficacy of nimotuzumab plus intensity modulated radiotherapy (IMRT)-based chemoradiotherapy in patients with LA-HNSCC remains unclear. A total of 25,442 HNSCC patients were screened, and 612 patients were matched by propensity score matching (PSM) (1:1). PSM was utilized to balance known confounding factors. Patients who completed at least five doses of nimotuzumab were identified as study group. The primary end point was 3-year overall survival (OS) rate. Log-rank test examined the difference between two survival curves and Cloglog transformation test was performed to compare survival at a fixed time point. The median follow-up time was 54.2 (95% confidence interval [CI]: 52.7–55.9) months. The study group was associated with improved OS (hazard ratio [HR] = 0.75, 95% CI: 0.57–0.99, p = 0.038) and progression-free survival (PFS) (HR = 0.74, 95% CI: 0.58–0.96, p = 0.021). Subgroup analysis revealed that aged 50–60 year, IV, N2, radiotherapy dose ≥ 60 Gy, without previous surgery, and neoadjuvant therapy have a trend of survival benefit with nimotuzumab. Nimotuzumab showed favorable safety, only 0.2% had nimotuzumab-related severe adverse events. Our study indicated the nimotuzumab plus chemoradiotherapy provides survival benefits and safety for LA-HNSCC patients in an IMRT era.

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