Department of Radiation Oncology, University of Colorado Cancer Center, Aurora, CO, United States of America.
Department of Pediatrics, Cancer Center Biostatistics Core, University of Colorado and Children's Hospital Colorado, Aurora, CO, United States of America.
Gynecol Oncol. 2019 Mar;152(3):522-527. doi: 10.1016/j.ygyno.2018.12.010.
Gynecologic oncology group protocol 249 (GOG 249) is the contemporary US study that aimed to define the standard of care adjuvant therapy for patients with high-intermediate risk (HIR) endometrial cancer; patients were randomized to pelvic radiation therapy (RT) or vaginal brachytherapy (VBT) with chemotherapy (VBT-C). The preliminary results of GOG 249 were recently presented, yet the management of patients represented in this trial remains controversial. We set out to review US patterns of care for patients meeting eligibility criteria for GOG 249.
The National Cancer Database (NCDB) was used to identify patients meeting GOG 249 eligibility criteria between 2010 and 2015. The Man-Kendall trend test was used to assess for significant trends over time.
We identified 23,015 patients that met study inclusion criteria. Between 2010 and 2015, there was a decline in the use of pelvic RT from 9.8% to 7.5%, although not meeting statistical significance (p = 0.136), and an increase in the use of VBT-C from 4.6% to 7.7% (p = 0.017). Most patients did not receive treatment per either arm of GOG 249, with observation being the most common approach throughout this era, although the percentage of patients observed decreased from 58.1% to 45.8% between 2010 and 2015 (p = 0.003). Further, 21.5% of patients received VBT alone in 2010, increasing to 30.3% by 2015 (p = 0.003).
National practice trends in HIR endometrial cancer reveal that a large number of patients are observed in lieu of receiving adjuvant therapy. Further, the utilization of pelvic RT has declined below utilization of VBT-C, despite a lack of data supporting either improved disease outcomes or toxicity with this experimental regimen on GOG 249.
妇科肿瘤组方案 249（GOG 249）是当代美国的一项研究，旨在为高-中危（HIR）子宫内膜癌患者确定辅助治疗的标准；患者被随机分配接受盆腔放疗（RT）或阴道近距离放疗（VBT）联合化疗（VBT-C）。GOG 249 的初步结果最近公布，但该试验中代表的患者的管理仍存在争议。我们着手审查符合 GOG 249 入选标准的美国患者的护理模式。
使用国家癌症数据库（NCDB）确定 2010 年至 2015 年期间符合 GOG 249 入选标准的患者。使用曼-肯德尔趋势检验来评估随时间的显著趋势。
我们确定了 23015 名符合研究纳入标准的患者。2010 年至 2015 年，盆腔 RT 的使用率从 9.8%下降到 7.5%，尽管没有达到统计学意义（p=0.136），而 VBT-C 的使用率从 4.6%增加到 7.7%（p=0.017）。大多数患者未接受 GOG 249 任何治疗组的治疗，观察是这一时期最常见的方法，尽管 2010 年至 2015 年期间观察患者的比例从 58.1%下降到 45.8%（p=0.003）。此外，2010 年有 21.5%的患者单独接受 VBT，到 2015 年增加到 30.3%（p=0.003）。
HIR 子宫内膜癌的全国实践趋势表明，大量患者被观察而未接受辅助治疗。此外，尽管 GOG 249 缺乏支持该实验方案改善疾病结局或毒性的数据，但盆腔 RT 的使用率已下降至低于 VBT-C 的使用率。
