Objective: To investigate the clinical efficacy and safety of Nimotuzumab combined with concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer. Methods: A total of 65 patients with locally advanced cervical cancer treated with Nimotuzumab combined with concurrent chemoradiotherapy in Tianjin Medical University Cancer Institute and Hospital were selected from January 2015 to November 2018. Intensity-modulated radiotherapy and intracavitary post-packaging were used for radiation therapy. Platinum and paclitaxel were used for chemotherapy. Nimotuzumab were 400 mg/week. The clinical efficacy, the changes of serum tumor markers and the occurrence of adverse events were observed for 2 years, and the evaluation was performed once for every 3 months. Results: Sixty-one cases could be evaluated by imaging during the follow-up. The best curative effect evaluation showed that complete remission (CR) was 43 (70.5%), partial remission (PR) was 9 (14.8%), stable disease (SD) was 6 (9.8%) and objective response rate (CR+PR) was 85.3%, disease control rate (CR+PR+SD) was 95.1%. Survival analysis showed that one-year overall survival rate was 93.9% and two-year overall survival rate was 79.6%. After 3 months of treatment, the serum tumor markers SCC, CA125, CEA, and HE4 were significantly lower than those before treatment (P<0.05). Safety assessments showed that the main adverse events were hematochezia, abdominal pain, diarrhea, fever and dizziness, and 37 cases of them were grades Ⅰ-Ⅱ. Conclusion: Nimotuzumab combined with concurrent chemoradiotherapy has a good clinical effect in the treatment of locally advanced cervical cancer, significantly reduces serum tumor marker levels after treatment, and is safe and tolerable in clinical use.
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的临床疗效与安全性。 方法： 选取2015年1月至2018年11月天津医科大学肿瘤医院经尼妥珠单抗联合同步放化疗治疗的局部晚期宫颈癌患者65例（年龄18~75岁），放疗采用调强放疗和腔内后装放射治疗，化疗采用铂类（奈达铂40 mg/m2或顺铂30 mg/m2）和紫杉醇（60 mg/m2）进行治疗，尼妥珠单抗400 mg/周。观察治疗后患者血清肿瘤标志物的变化及不良事件的发生情况，以及随访1、2年的临床疗效（每3个月评价1次）。 结果： 治疗后61例患者可影像学评估，最佳疗效评价显示：肿瘤完全消退为完全缓解（CR）43例（70.5%）、部分缓解（PR）（肿瘤体积缩小≥30%）9例（14.8%）、肿瘤进展（PD）（肿瘤增大≥20%） 6例（9.8%）和肿瘤无进展（SD）3例，客观缓解率（CR+PR）为85.3%（52/61）、疾病控制率（CR+PR+SD）为95.1%（55/61）。生存分析结果显示，1年和2年总生存率分别为93.9%和79.6%。治疗3个月后，患者血清肿瘤标志物：鳞状细胞癌抗原（SCC）、糖链抗原（CA125）、癌胚抗原（CEA）、人附睾上皮分泌蛋白（HE4）较治疗前显著下降，差异有统计学意义（均P<0.05）。安全性评估，主要不良事件为便血、腹痛、腹泻、发热、头晕等，37例是Ⅰ~Ⅱ级。 结论： 尼妥珠单抗联合同步放化疗治疗局部晚期宫颈癌有较好的临床2年生存率，显著降低治疗后血清肿瘤标志物水平，临床使用安全可耐受。.