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| 尼妥珠单抗联合同步放化疗治疗局部晚期宫颈癌的临床疗效和安全性 |
| Nimotuzumab combined with concurrent chemoradiotherapy: safety and clinical effectiveness in patients with locally advanced cervical cancer |
| 投稿时间：2024-11-15 |
| DOI：10.3969/j.issn.1000-0399.2025.04.004 |
| 中文关键词: 同步放化疗 尼妥珠单抗 局部晚期宫颈癌 |
| 英文关键词: Concurrent chemoradiotherapy Nimotuzumab Locally advanced cervical cance |
| 基金项目:安徽省高校自然科学基金研究重点项目（编号：2022AH051139） |
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| 中文摘要: |
| 目的 探讨尼妥珠单抗联合同步放化疗治疗局部晚期宫颈癌（LACC）的临床疗效和安全性。方法 选取 2022 年 1月至 2024 年 10 月于安徽医科大学第一附属医院肿瘤放疗科治疗的 89 例 LACC 患者为研究对象，依据治疗方法不同分为观察组（n=43）和对照组（n=46）。观察组采用尼妥珠单抗联合同步放化疗（CCRT）治疗方案，对照组仅采用 CCRT 治疗方案。观察两组患者的肿瘤标志物水平［鳞状细胞癌抗原（SCC）、细胞角蛋白 19 片段抗原 21-1（CYFRA21-1）、癌胚抗原（CEA）］、近期疗效及不良反应（3~4 级血液学不良反应与放射性肠炎、放射性膀胱炎）发生情况。结果 观察组完全缓解（CR）率高于对照组，差异有统计学意义（P<0.05）。两组患者客观缓解率（ORR）、疾病控制率（DCR）比较，差异均无统计学意义（P>0.05）。两组患者肿瘤标志物水平（SCC、CEA、CYFRA21-1）与治疗前比较，治疗后水平降低，差异有统计学意义（P<0.05），两组患者肿瘤标志物下降程度比较，差异无统计学意义（P>0.05）。两组患者不良反应发生率比较，差异均无统计学意义（P>0.05）。结论 尼妥珠单抗联合 CCRT 治疗 LACC 可进一步提高 CR 率，两组不良反应发生率相当。尼妥珠单抗联合 CCRT 有望成为 LACC 有效的新型治疗方案。 |
| 英文摘要: |
| Objective To look into the clinical effectiveness and safety of treating locally advanced cervical cancer (LACC) with nimotuzumab in conjunction with concurrent chemoradiotherapy (CCRT). Methods The study included 89 LACC patients who were treated at Department of Radiation Oncology of the First Affiliated Hospital of Anhui Medical University between January 2022 and October 2024. Based on different treatment methods, they were divided into an observation group (n=43) and a control group (n=46). The observation group received nimotuzumab combined with CCRT, while the control group received CCRT alone. Tumor markers [squamous cell carcinoma antigen (SCC), cytokeratin 19 fragment antigen 21-1 (CYFRA21-1) and carcinoembryonic antigen (CEA)], short-term efficacy and adverse reactions (grade 3~4 hematologic adverse reactions, radiation enteritis, and radiation cystitis) were observed and compared between the two groups. Results The observation group’s complete response (CR) rate was greater than the control group with significant differences (P < 0.05). No statistically significant differences were observed in terms of disease control rate (DCR) or objective response rate (ORR) (P>0.05) between the two groups. Tumor markers (SCC, CEA, and CYFRA21-1) in both groups were significantly reduced compared to pre-treatment levels (P < 0.05), but there was no discernible difference between the two groups’ extents of reduction (P>0.05). Between the two groups, the frequency of adverse responses was similar and did not differ significantly (P>0.05). Conclusion Nimotuzumab combined with CCRT can further improve the CR rate in LACC patients, with comparable adverse reactions between the two groups. Nimotuzumab combined with CCRT may become an effective novel treatment option for LACC. |
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