Department of Oncology, The Affiliated Hospital of Southwest Medical University, Luzhou, China.
Department of Oncology, The First People's Hospital of Neijiang, Neijiang, China.
Cancer Sci. 2018 Dec;109(12):3953-3961. doi: 10.1111/cas.13845. Epub 2018 Nov 28.
The aim of this study was to evaluate whether a patented single-channel applicator, which was modified from the traditional tandem applicator and wrapped with an oval-shield alloy around the source channel, has the same clinical efficacy and safety as the standard Fletcher-type applicator in high dose rate (HDR) brachytherapy for carcinoma of the cervix. Between December 2011 and February 2017, 299 patients with pathologically confirmed International Federation of Gynecology and Obstetrics (2009) stage Ib2-IVa cervical cancer were recruited to the trial and finished the allocated intervention. Of the first 151 patients, 71 were allocated to the Fletcher group and 80 to the single-channel group, satisfying the criteria for a preliminary analysis. All but 3 patients were treated with concurrent cisplatin chemotherapy and external beam radiotherapy followed by HDR brachytherapy. The 2-year overall survival, progression-free survival, and locoregional failure-free survival was 80.3%, 77.5%, and 78.9%, respectively, for the Fletcher group, and 86.3%, 82.5%, and 83.8%, respectively, for the single-channel group. The seriousness of acute treatment-related toxicities was similar in the 2 groups. The cumulative rate of late rectal complications of grade 3-4 in the Fletcher group and the single-channel group was 2.8% and 2.5%, respectively. The cumulative rate of grade 3 bladder complications was 2.8% for the Fletcher group and 1.3% for the single-channel group. The preliminary results of our study show that the patented single-channel intracavitary applicator might be able to provide protection for the rectum and bladder and seems to have the same clinical efficacy as the standard Fletcher-type 3-channel applicator in HDR brachytherapy for carcinoma of the cervix. This trial was registered with the Chinese Clinical Trial Registry (registration no. ChiCTR-TRC-12002321).
本研究旨在评估一种专利单通道施源器（由传统的 tandem 施源器改良而来，并在源通道周围包裹椭圆形屏蔽合金）在宫颈癌高剂量率（HDR）近距离治疗中的临床疗效和安全性是否与标准 Fletcher 三通道施源器相当。2011 年 12 月至 2017 年 2 月，共招募了 299 例经病理证实的国际妇产科联盟（2009 年）Ib2-IVa 期宫颈癌患者参与本试验，并完成了分配的干预措施。在最初的 151 例患者中，71 例分配至 Fletcher 组，80 例分配至单通道组，符合初步分析标准。除 3 例患者外，所有患者均接受顺铂同期化疗和外照射放疗，随后行 HDR 近距离治疗。Fletcher 组的 2 年总生存率、无进展生存率和局部区域无失败生存率分别为 80.3%、77.5%和 78.9%，单通道组分别为 86.3%、82.5%和 83.8%。两组急性治疗相关毒性的严重程度相似。Fletcher 组和单通道组 3-4 级晚期直肠并发症的累积发生率分别为 2.8%和 2.5%。Fletcher 组和单通道组 3 级膀胱并发症的累积发生率分别为 2.8%和 1.3%。本研究的初步结果表明，专利单通道腔内施源器可能能够为直肠和膀胱提供保护，并且在 HDR 近距离治疗宫颈癌方面似乎与标准 Fletcher 三通道施源器具有相同的临床疗效。本试验在中国临床试验注册中心（注册号 ChiCTR-TRC-12002321）注册。
