单管式子宫颈癌后装施源器前瞻性随机对照Ⅱ期临床研究近期疗效

Evaluation of clinical efficacy and safety of single-channel intracavitary applicator for uterine cervical cancer： early results of a prospective randomized phase Ⅱ clinical trial

目的观察自主研发的单管式子宫颈癌后装施源器与标准Fletcher三管施源器的临床疗效以及安全性。方法选取2011-2017年就诊的子宫颈癌初诊患者，随机分为外照射＋单管式后装组（专利单管组）和外照射＋Fletcher三管式后装组。外照射采用6MYX线四野盒式或前后对穿野照射，30Gy后改野挡铅行后装治疗，1次／周，剂量为A点7Gy，共5～6次（A点生物等效剂量：80～90Gv）。外照射时同步使用顺铂（40mg／m2）化疗，1次／周，治疗结束随访其疗效及不良反应并对比。结果符合入组条件并完成治疗，Fletcher三管组150例，专利单管组149例。两组近期疗效以及急性期不良反应相近（P〉0．05）。Fletcher三管组有效率为94．0％，专利单管组为94．7％。≥3级急性期血液学不良反应，Fletcher三管组为76例（50．7％），专利单管组为61例（40．9％）（P=0．195）。结论专利单管式子宫颈癌后装施源器与标准Fletcher三管施源器近期疗效相当，且急性期不良反应相似。临床试验注册中国临床试验注册中心（ChiCTR—TRC-12002321）。

Objective To evaluate whether the self-designed single-channel intracavitary applicator yields equivalent clinical efficacy and safety to the standard Fletcher-type three-channel applicator in the high-dose-rate （HDR） brachytherapy for uterine cervical cancer. Methods From December 2011 to April 2017,patients initially diagnosed with cervical cancer were randomly assigned into the external beam radiotherapy （EBRT）＋ single-channel intracavitary applicator group （the patent single-channel group） and EBRT＋the Fletcher applicator group. Whole pelvis irradiation was delivered with 6-MV photons via a four- field box variant or anterior and posterior parallel fields. Five to six fractions of intracavitary brachytherapy were performed at a dose of 7 Gy at point A once a week after 30 Gy （BED at point A：80-90 Gy）. Chemotherapy was given with intravenous injection of cisplatin at a dose of 40 mg/m2 once weekly during EBRT.Clinical efficacy and safety were evaluated after the treatment. Results In total, 150 eligible cases were assigned into the Fletcher applicator group and 149 cases into the patent single-channel group. The short-term clinical efficacy and acute toxicity did not significantly differ between two groups. The response rate was 94.0% in the Fletcher group, and 94. 7% in the patent single-channel group. In the Fletcher applicator group,76（50. 7%） patients developed ≥ grade 3 hematologic toxicity and 61 （40. 9%） in the patent group （ P= 0. 195 ）. Conclusions The self-designed patent single-channel intracavitary applicator yields equivalent clinical efficacy and safety （acute toxicity） to the standard Fletcher-type three-channel applicator in the HDR brachytherapy for uterine cervical cancer. Clincal Trial Registration Chinese Clinical Trial Registry （ ChiCTR-TRC-12002321 ）.