新辅助化疗后同期放化疗联合或不联合尼妥珠单抗治疗局部晚期鼻咽癌的回顾性研究。

Neoadjuvant chemotherapy followed by concurrent chemoradiotherapy with or without nimotuzumab in the treatment of locally advanced nasopharyngeal carcinoma: a retrospective study.

机构信息

Department of Oncology, People's Hospital of Xiangxi Tujia and Miao Autonomous Prefecture, First Affiliated Hospital of Jishou University, Jishou, 416000, Hunan, China.

Department of Otolaryngology, People's Hospital of Xiangxi Tujia and Miao Autonomous Prefecture, First Affiliated Hospital of Jishou University, Jishou, 416000, Hunan, China.

出版信息

BMC Cancer. 2023 Nov 24;23(1):1140. doi: 10.1186/s12885-023-11608-5.

Abstract

PURPOSE

We aimed to investigate the efficacy and side effects of concurrent chemoradiotherapy, with or without nimotuzumab, for the treatment of locally advanced nasopharyngeal carcinoma after neoadjuvant chemotherapy.

METHODS

This study retrospectively enrolled 109 patients with NPC from our hospital from July 2019 to May 2021.All patients were treated with docetaxel, cisplatin, and fluorouracil(TPF) neoadjuvant chemotherapy for 2 cycles, and concurrent chemoradiotherapy was performed 2 weeks after chemotherapy. According to whether nimotuzumab was added in concurrent chemoradiotherapy, they were divided into the nimotuzumab group and the control group, with 52 cases in the nimotuzumab group and 57 cases in the control group.The efficacy and adverse reactions of the two groups were retrospectively analyzed.

RESULTS

The objective remission and complete remission rates in the nimotuzumab and control groups were 100% vs 98.2% (p = 1.000), and 92.3% vs 78.9% (p = 0.049), respectively. The 3-year distant metastasis-free survival of the nimotuzumab and control groups was 91.6% and 77.3% (p = 0.047), respectively.The 3-year progression-free survival, locoregional relapse-free survival, and overall survival of the nimotuzumab and control groups were 87.6% vs 75.5% (p = 0.110), 90.5% vs 86.9% (p = 0.566), and 94.5% vs 87.1% (p = 0.295), respectively. In the nimotuzumab group, subgroup analysis showed that patients aged < 60 years (hazard ratio [HR] = 0.350, 95% confidence interval [CI]: 0.131-0.934, p = 0.036) and those with a neutrophil-to-lymphocyte ratio (neutrophil/lymphocyte ratio) ≤ 4 (HR = 0.365, 95% CI: 0.144-0.923, p = 0.033) achieved a better result. Additionally, multivariate analysis demonstrated that neutrophil/lymphocyte ratio was an independent risk factor for disease progression (HR = 7.485, p = 0.012) and distant metastasis (HR = 17.540, p = 0.009).No grade 4 adverse reactions were observed in either group. Grade 3 oral mucosal reactions, as well as pharyngeal and esophageal reactions were slightly higher in the nimotuzumab group than in the control group, but the difference was not statistically significant. No significant differences were observed in the incidence of adverse reactions such as leukopenia, HB reduction, thrombocytopenia between the two groups (P > 0.05).

CONCLUSION

The concurrent chemoradiotherapy plus nimotuzumab after neoadjuvant chemotherapy for locally advanced nasopharyngeal carcinoma achieved a higher complete remission rate and significantly improved distant metastasis-free survival compared with concurrent chemoradiotherapy alone. Additionally, an increasing trend was observed in progression-free survival, and the incidence of side effects was similar in both groups.

摘要

目的

本研究旨在探讨新辅助化疗后同期放化疗联合尼妥珠单抗与单纯同期放化疗治疗局部晚期鼻咽癌的疗效和副作用。

方法

本研究回顾性纳入了 2019 年 7 月至 2021 年 5 月期间我院收治的 109 例 NPC 患者。所有患者均接受多西他赛、顺铂和氟尿嘧啶(TPF)新辅助化疗 2 个周期,化疗后 2 周行同期放化疗。根据同期放化疗中是否添加尼妥珠单抗,将患者分为尼妥珠单抗组和对照组,尼妥珠单抗组 52 例,对照组 57 例。回顾性分析两组患者的疗效和不良反应。

结果

尼妥珠单抗组和对照组的客观缓解率和完全缓解率分别为 100%和 98.2%(p=1.000)和 92.3%和 78.9%(p=0.049)。尼妥珠单抗组和对照组的 3 年无远处转移生存率分别为 91.6%和 77.3%(p=0.047)。尼妥珠单抗组和对照组的 3 年无进展生存率、局部区域无复发生存率和总生存率分别为 87.6%和 75.5%(p=0.110)、90.5%和 86.9%(p=0.566)和 94.5%和 87.1%(p=0.295)。在尼妥珠单抗组中,亚组分析显示,年龄<60 岁的患者(风险比 [HR] = 0.350,95%置信区间 [CI]:0.131-0.934,p=0.036)和中性粒细胞与淋巴细胞比值(neutrophil/lymphocyte ratio,NLR)≤4 的患者(HR=0.365,95%CI:0.144-0.923,p=0.033)取得了更好的结果。此外,多变量分析表明,NLR 是疾病进展(HR=7.485,p=0.012)和远处转移(HR=17.540,p=0.009)的独立危险因素。两组均未观察到 4 级不良反应。尼妥珠单抗组 3 级口腔黏膜炎和咽食管反应发生率略高于对照组,但差异无统计学意义。两组白细胞减少、HB 降低、血小板减少等不良反应发生率无显著差异(P>0.05)。

结论

新辅助化疗后同期放化疗联合尼妥珠单抗治疗局部晚期鼻咽癌可获得更高的完全缓解率,并显著提高无远处转移生存率。此外,无进展生存率呈上升趋势,两组不良反应发生率相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5db7/10668510/76deba2d15e5/12885_2023_11608_Fig1_HTML.jpg

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