Marnitz Simone, Martus Peter, Köhler Christhardt, Stromberger Carmen, Asse Elke, Mallmann Peter, Schmidberger Heinz, Affonso Júnior Renato José, Nunes João Soares, Sehouli Jalid, Budach Volker
Department of Radiation Oncology, University of Cologne Medical Faculty, Cologne, Germany.
Institute for Clinical Epidemiology and Applied Biostatistics, Eberhard-Karls-Universität Tübingen, Tübingen, Germany.
Int J Radiat Oncol Biol Phys. 2016 Feb 1;94(2):243-53. doi: 10.1016/j.ijrobp.2015.10.027. Epub 2015 Oct 20.
The Uterus-11 trial was designed to evaluate the role of surgical staging in patients with cervical cancer before primary chemoradiation therapy (CRT). The present report provides the toxicity data stratified by the treatment arm and technique.
A total of 255 patients with carcinoma of the uterine cervix (International Federation of Gynecology and Obstetrics stage IIB-IVA) were randomized to either surgical staging followed by CRT (arm A) or clinical staging followed by CRT (arm B). Patients with para-aortic metastases underwent extended field radiation therapy (RT). Brachytherapy was mandatory. The present report presents the acute therapy-related toxicities stratified by treatment arm and radiation technique.
A total of 240 patients were eligible (n=121 in arm A; n=119 in arm B). Of the 240 patients, 236 (98.3%) underwent external beam RT with a median total dose of 50.4 Gy. The mean treatment duration was 53 days. Of the patients, 60% underwent intensity modulated RT (IMRT). A total of 234 patients (97.5%) underwent chemotherapy, and 231 (96.3%) underwent brachytherapy, with a median single dose of 6 Gy covering the tumor to a median nominal total dose of 28 Gy. Treatment was well tolerated, with 0% grade ≥3 genitourinary and gastrointestinal toxicity, 6% grade 3 nausea, 3% grade 3 vomiting, and <2% grade 3 diarrhea. More patients after surgical staging experienced grade 2 anemia (54.3% in arm A vs 45.3% in arm B; P=.074) and grade 2 leukocytopenia (41.4% vs 31.6%; P=.56). Of the patients who received IMRT versus a 3-dimensional technique, 65.3% versus 33.7% presented with grade 2 anemia. Grade 3 gastrointestinal and grade 2 bladder toxicity were significantly reduced with the use of IMRT.
The incidence and severity of acute therapy-related toxicity compared favorably with those from other randomized trials. Excellent adherence to treatment and treatment quality was achieved compared with patterns of care analyses. Surgical staging led to a doubled number of patients treated with extended field RT. The question of whether surgical staging is beneficial in the context of primary CRT requires further study.
子宫-11试验旨在评估手术分期在宫颈癌患者接受初始放化疗（CRT）前的作用。本报告提供了按治疗组和技术分层的毒性数据。
共有255例子宫颈癌患者（国际妇产科联盟IIB-IVA期）被随机分为两组，一组先进行手术分期再接受CRT（A组），另一组先进行临床分期再接受CRT（B组）。有腹主动脉旁转移的患者接受扩大野放射治疗（RT）。近距离放射治疗是必需的。本报告呈现了按治疗组和放射技术分层的急性治疗相关毒性。
共有240例患者符合条件（A组121例；B组119例）。在这240例患者中，236例（98.3%）接受了外照射RT，中位总剂量为50.4 Gy。平均治疗持续时间为53天。其中60%的患者接受了调强放疗（IMRT）。共有234例患者（97.5%）接受了化疗，231例（96.3%）接受了近距离放射治疗，中位单次剂量为6 Gy，肿瘤覆盖的中位名义总剂量为28 Gy。治疗耐受性良好，≥3级泌尿生殖系统和胃肠道毒性发生率为0%，3级恶心发生率为6%，3级呕吐发生率为3%，3级腹泻发生率<2%。手术分期后的患者中，2级贫血（A组为54.3%，B组为45.3%；P = 0.074）和2级白细胞减少症（41.4%对31.6%；P = 0.56）的发生率更高。在接受IMRT与三维技术的患者中，2级贫血的发生率分别为65.3%和33.7%。使用IMRT可显著降低3级胃肠道毒性和2级膀胱毒性。
与其他随机试验相比，急性治疗相关毒性的发生率和严重程度更优。与照护模式分析相比，实现了对治疗的良好依从性和治疗质量。手术分期导致接受扩大野RT治疗的患者数量增加了一倍。手术分期在初始CRT背景下是否有益的问题仍需进一步研究。
