Juravinski Cancer Centre, Department of Obstetrics & Gynecology, McMaster University, Hamilton, Ontario, Canada.
Princess Margaret Cancer Centre, Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada.
JAMA Netw Open. 2018 Sep 7;1(5):e182081. doi: 10.1001/jamanetworkopen.2018.2081.
In women with locally advanced cancer of the cervix (LACC), staging defines disease extent and guides therapy. Currently, undetected disease outside the radiation field can result in undertreatment or, if disease is disseminated, overtreatment.
To determine whether adding fludeoxyglucose F 18 positron emission tomography-computed tomography (PET-CT) to conventional staging with CT of the abdomen and pelvis affects therapy received in women with LACC.
DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial was conducted. Women with newly diagnosed histologically confirmed International Federation of Gynecology and Obstetrics stage IB to IVA carcinoma of the cervix who were candidates for chemotherapy and radiation therapy (CRT) were allocated 2:1 to PET-CT plus CT of the abdomen and pelvis or CT alone. Enrollment occurred between April 2010 and June 2014 at 6 regional cancer centers in Ontario, Canada. The PET-CT scanners were at 6 associated academic institutions. The median follow-up at the time of the analysis was 3 years. The analysis was conducted on March 30, 2017.
Patients received either PET-CT plus CT of the abdomen and pelvis or CT of the abdomen and pelvis.
Treatment delivered, defined as standard pelvic CRT vs more extensive CRT, ie, extended field radiotherapy or therapy with palliative intent.
One hundred seventy-one patients were allocated to PET-CT (n = 113) or CT (n = 58). The trial stopped early before the planned target of 288 was reached because of low recruitment. Mean (SD) age was 48.1 (11.2) years in the PET-CT group vs 48.9 (12.7) years in the CT group. In the 112 patients who received PET-CT, 68 (60.7%) received standard pelvic CRT, 38 (33.9%) more extensive CRT, and 6 (5.4%) palliative treatment. The corresponding data for the 56 patients who received CT alone were 42 (75.0%), 11 (19.6%), and 3 (5.4%). Overall, 44 patients (39.3%) in the PET-CT group received more extensive CRT or palliative treatment compared with 14 patients (25.0%) in the CT group (odds ratio, 2.05; 95% CI, 0.96-4.37; P = .06). Twenty-four patients in the PET-CT group (21.4%) received extended field radiotherapy to para-aortic nodes and 14 (12.5%) to common iliac nodes compared with 8 (14.3%) and 3 (5.4%), respectively, in the CT group (odds ratio, 1.64; 95% CI, 0.68-3.92; P = .27).
There was a trend for more extensive CRT with PET-CT, but the difference was not significant because the trial was underpowered. This trial provides information on the utility of PET-CT for staging in LACC.
ClinicalTrials.gov Identifier: NCT00895349.
对于局部晚期宫颈癌（LACC）患者，分期可确定疾病范围并指导治疗。目前，辐射野外未检测到的疾病可能导致治疗不足，或者如果疾病扩散，则治疗过度。
确定在 LACC 女性中，将氟脱氧葡萄糖 F18 正电子发射断层扫描-计算机断层扫描（PET-CT）与腹部和骨盆 CT 常规分期相结合是否会影响接受治疗的患者。
设计、地点和参与者：这是一项随机临床试验。新诊断为组织学证实的国际妇产科联合会（FIGO）IB 至 IVA 期宫颈癌且有接受化疗和放疗（CRT）适应证的女性患者被随机分配到 2:1 的 PET-CT 加腹部和骨盆 CT 或单独 CT 组。入组于 2010 年 4 月至 2014 年 6 月在加拿大安大略省的 6 个区域癌症中心进行。PET-CT 扫描仪位于 6 个相关学术机构。在分析时的中位随访时间为 3 年。分析于 2017 年 3 月 30 日进行。
患者接受了 PET-CT 加腹部和骨盆 CT 或腹部和骨盆 CT。
接受的治疗，定义为标准盆腔 CRT 与更广泛的 CRT，即扩展野放疗或姑息性治疗。
171 名患者被分配到 PET-CT（n=113）或 CT 组（n=58）。由于招募人数不足，该试验提前在计划的 288 名目标之前停止。PET-CT 组的平均（SD）年龄为 48.1（11.2）岁，CT 组为 48.9（12.7）岁。在 112 名接受 PET-CT 的患者中，68 名（60.7%）接受了标准盆腔 CRT，38 名（33.9%）接受了更广泛的 CRT，6 名（5.4%）接受了姑息性治疗。单独接受 CT 的 56 名患者中，分别有 42 名（75.0%）、11 名（19.6%）和 3 名（5.4%）接受了上述治疗。总的来说，44 名（39.3%）PET-CT 组患者接受了更广泛的 CRT 或姑息性治疗，而 CT 组仅 14 名（25.0%）患者接受了此类治疗（比值比，2.05；95%CI，0.96-4.37；P=0.06）。24 名（21.4%）PET-CT 组患者接受了para-aortic 淋巴结的扩展野放疗，14 名（12.5%）患者接受了 common iliac 淋巴结放疗，而 CT 组分别有 8 名（14.3%）和 3 名（5.4%）患者接受了上述治疗（比值比，1.64；95%CI，0.68-3.92；P=0.27）。
PET-CT 有增加更广泛 CRT 的趋势，但由于试验力量不足，差异无统计学意义。这项试验提供了关于 PET-CT 在 LACC 分期中的应用的信息。
ClinicalTrials.gov 标识符：NCT00895349。
