Zhang Kuan, Wang Huiping, Wang Zhenqing, Li Fuqing, Cui Ying, Ma Shengchun, Chen Rui, Wang Yuhui, Guo Shul, Wei Ying
Department of Radiation Oncology, Qinghai Red Cross Hospital.
Ultrasonic Medicine, Xining Maternal and Child Health Planning Branch Family Planning Service Centre, Qinghai, China.
Medicine (Baltimore). 2020 Dec 4;99(49):e21966. doi: 10.1097/MD.0000000000021966.
The treatment of recurrent cervical cancer, especially pelvic locoregional recurrence, is very challenging for gynecologic oncologists. This study investigated the efficacy and safety of intensity-modulated radiation therapy (IMRT)-based concurrent chemoradiotherapy (CCRT) with Endostar, a novel modified recombinant human endostatin, in patients with pelvic locoregional recurrence of cervical cancer following surgical treatment.This phase 2 study was conducted between May 2018 and May 2019 at a single center in the Qinghai-Tibet Plateau and enrolled 31 patients with pelvic locoregional recurrence of cervical cancer following surgical treatment. All patients were treated with IMRT-based CCRT for 6 weeks and intravenous infusions of Endostar (15 mg/m), which were administered on days 1 to 7 of CCRT, followed by rest for 4 weeks. After resting, chemotherapy with cisplatin (70 mg/m) plus paclitaxel (135-175 mg/m) was given every 3 weeks for a total of 4 treatments.Thirty-one patients were evaluable for the primary endpoint. The mean age was 50.03 years (SD 7.72). The objective response rate was 67.74% and the disease control rate was 83.87% (48.39% achieved a complete response, 19.35% a partial response, 16.13% had disease stabilization, and 16.13% had progressive disease). The most common adverse events were nausea, vomiting, alopecia, neutropenia, and leukopenia; most events were grade 1 or 2 in intensity. Grade 3 toxicities included thrombocytopenia and neutropenia in 2 patients each, and leukopenia in 4 patients. No cases of grade 4 acute toxicity were observed.IMRT-based CCRT with Endostar infusions is effective and safe. Our results support the use of this treatment for patients with pelvic locoregional recurrence of cervical cancer following surgical treatment.
复发性宫颈癌的治疗，尤其是盆腔局部复发的治疗，对妇科肿瘤学家来说极具挑战性。本研究调查了基于调强放射治疗（IMRT）的同步放化疗（CCRT）联合恩度（一种新型修饰重组人血管内皮抑素）治疗手术治疗后盆腔局部复发宫颈癌患者的疗效和安全性。这项2期研究于2018年5月至2019年5月在青藏高原的一个单一中心进行，纳入了31例手术治疗后盆腔局部复发的宫颈癌患者。所有患者接受基于IMRT的CCRT治疗6周，并静脉输注恩度（15mg/m²），在CCRT的第1至7天给药，随后休息4周。休息后，每3周给予顺铂（70mg/m²）加紫杉醇（135 - 175mg/m²）化疗，共进行4次治疗。31例患者可评估主要终点。平均年龄为50.03岁（标准差7.72）。客观缓解率为67.74%，疾病控制率为83.87%（48.39%达到完全缓解，19.35%部分缓解，16.13%疾病稳定，16.13%疾病进展）。最常见的不良事件是恶心、呕吐、脱发、中性粒细胞减少和白细胞减少；大多数事件为1级或2级强度。3级毒性包括血小板减少和中性粒细胞减少各2例，白细胞减少4例。未观察到4级急性毒性病例。基于IMRT的CCRT联合恩度输注是有效且安全的。我们的结果支持将这种治疗方法用于手术治疗后盆腔局部复发的宫颈癌患者。
