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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观察研究

[Clinical observational study of Nimotuzumab combined with concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer].

作者信息

Chen J, Cao Y J, Zhu L, Zhang B L, Liu Z Y, Hou H L, Chai Y L, Wang P

机构信息

National Clinical Research Center for Cancer, Tianjin Key Laboratory of Cancer Prevention and Treatment, Department of Radiotherapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China.

出版信息

Zhonghua Yi Xue Za Zhi. 2021 Mar 2;101(8):597-601. doi: 10.3760/cma.j.cn112137-20201104-03011.

DOI:10.3760/cma.j.cn112137-20201104-03011
PMID:33663192
Abstract

To investigate the clinical efficacy and safety of Nimotuzumab combined with concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer. 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. 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 (<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. 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.

摘要

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及安全性。选取2015年1月至2018年11月在天津医科大学肿瘤医院接受尼妥珠单抗联合同步放化疗治疗的65例局部晚期宫颈癌患者。放疗采用调强放疗及腔内后装治疗。化疗采用铂类和紫杉醇。尼妥珠单抗用量为400mg/周。观察2年的临床疗效、血清肿瘤标志物变化及不良事件发生情况,每3个月进行1次评估。随访期间61例患者可进行影像学评估。最佳疗效评估显示,完全缓解(CR)43例(70.5%),部分缓解(PR)9例(14.8%),疾病稳定(SD)6例(9.8%),客观缓解率(CR+PR)为85.3%,疾病控制率(CR+PR+SD)为95.1%。生存分析显示,1年总生存率为93.9%,2年总生存率为79.6%。治疗3个月后,血清肿瘤标志物SCC、CA125、CEA及HE4均显著低于治疗前(<0.05)。安全性评估显示,主要不良事件为便血、腹痛、腹泻、发热及头晕,其中37例为Ⅰ-Ⅱ级。尼妥珠单抗联合同步放化疗治疗局部晚期宫颈癌临床疗效良好,治疗后血清肿瘤标志物水平显著降低,临床使用安全、可耐受。

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