Lu Heming, Wu Yuying, Liu Xu, Jiang Hailan, Pang Qiang, Peng Luxing, Cheng Jinjian, Deng Shan, Gu Junzhao, Zhao Renfeng, Hu Xiaoxia, Chen Changyi, Yu Jinming
Department of Radiation Oncology, Shandong Cancer Hospital Affiliated to Shandong University, Jinan, China,
Department of Radiation Oncology, People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.
Onco Targets Ther. 2018 Jul 2;11:3785-3792. doi: 10.2147/OTT.S164071. eCollection 2018.
To investigate the efficacy and safety of neoadjuvant chemoradiotherapy plus anti-epidermal growth factor receptor monoclonal antibody followed by surgery for locally advanced cervical cancer (LACC).
Patients with histologically proven LACC were enrolled into this prospective study. All patients received intensity-modulated radiation therapy with conventional fractionation. Weekly cisplatin or nedaplatin was administered concurrently with intensity-modulated radiation therapy. Nimotuzumab, a humanized anti-epidermal growth factor receptor monoclonal antibody, was given at a dose of 200 mg per week for 6 cycles. Approximately 1 month after the completion of neoadjuvant treatment, the patients were assessed for clinical tumor response and operability based on MRI and gynecological examination. For those who were considered to be candidates for surgery, radical hysterectomy, and pelvic lymph node dissection were performed 5-6 weeks after the completion of neoadjuvant therapy.
Twenty-eight patients were enrolled. Clinical complete response and partial response were found in 8 (28.5%) and 20 (71.5%) patients, respectively. Four patients were not eligible for surgery and 2 patients refused surgery although they were assessed as surgical candidates. They were not included in this analysis. Radical hysterectomy and pelvic lymph node dissection were performed for the remaining 22 patients. Among them, 8 (36.4%) had complete pathology response, 9 (40.9%) presented with persistent atypical cells or cervical intraepithelial neoplasia, and 5 (22.7%) presented with macroscopic and/or microscopic residual disease, according to the pathological evaluation. Median follow-up time was 22 months (range, 5-39 months). The 2-year locoregional control rate, progression-free survival rate, distant metastasis-free survival rate, and overall survival rate were 95.0%, 85.2%, 84.0%, and 90.0%, respectively. Acute toxicities were mild in general and easily manageable. Chronic toxicities were mainly limited to grade 1. No severe late toxicities were observed.
Concurrent chemoradiotherapy plus nimotuzumab followed by surgery is highly effective and safe in LACC. Further studies are warranted to confirm the findings.
探讨新辅助放化疗联合抗表皮生长因子受体单克隆抗体序贯手术治疗局部晚期宫颈癌（LACC）的疗效和安全性。
组织学确诊为LACC的患者纳入本前瞻性研究。所有患者均接受常规分割的调强放射治疗。每周顺铂或奈达铂与调强放射治疗同步给药。尼妥珠单抗，一种人源化抗表皮生长因子受体单克隆抗体，每周给药剂量为200mg，共6个周期。新辅助治疗完成后约1个月，根据磁共振成像（MRI）和妇科检查评估患者的临床肿瘤反应和可手术性。对于被认为适合手术的患者，在新辅助治疗完成后5 - 6周进行根治性子宫切除术和盆腔淋巴结清扫术。
28例患者入组。分别有8例（28.5%）和20例（71.5%）患者达到临床完全缓解和部分缓解。4例患者不符合手术条件，2例患者虽被评估为手术候选者但拒绝手术。这6例患者未纳入本分析。其余22例患者接受了根治性子宫切除术和盆腔淋巴结清扫术。根据病理评估，其中8例（36.4%）病理完全缓解，9例（40.9%）存在持续的非典型细胞或宫颈上皮内瘤变，5例（22.7%）存在肉眼和/或镜下残留病灶。中位随访时间为22个月（范围5 - 39个月）。2年局部区域控制率、无进展生存率、无远处转移生存率和总生存率分别为95.0%、85.2%、84.0%和90.0%。急性毒性一般较轻且易于处理。慢性毒性主要局限于1级。未观察到严重的晚期毒性。
同步放化疗联合尼妥珠单抗序贯手术治疗LACC高效且安全。有必要进一步研究以证实这些发现。
