Department of Ultrasound, The First Medical Center of Chinese People's Liberation Army General Hospital, Beijing, China.
School of Medicine, Nankai University, Tianjin, China.
JAMA Surg. 2024 Jan 1;159(1):51-58. doi: 10.1001/jamasurg.2023.5202.
Radiofrequency ablation (RFA) has gained increasing interest as a minimally invasive procedure to treat low-risk papillary thyroid carcinoma (PTC). Considering the indolent nature of this disease, studies in large populations with long follow-up would be invaluable to further substantiate the effectiveness of RFA.
To evaluate the long-term (58.5 months) outcomes of patients with T1N0M0 PTC who underwent RFA and investigate risk factors for local tumor progression (LTP).
DESIGN, SETTING, AND PARTICIPANTS: This cohort study included 1613 patients aged 18 years or older with T1N0M0 PTC who underwent ultrasonography-guided RFA between January 2014 and December 2020 at the Chinese People's Liberation Army General Hospital in Beijing, China. Included in the analysis were patients with PTC (confirmed by biopsy) with a maximum diameter of 20 mm or less; no evidence of extrathyroidal extension (capsular disruption or involvement of perithyroidal tissue), lymph node metastasis, or distant metastasis on ultrasonography or computed tomography; and no evidence of an aggressive subtype of PTC on biopsy. Patients with PTC larger than 2 cm, less than 12 months of follow-up, or inadequate follow-up information were excluded. Data were analyzed in April 2023.
Long-term progression rate, disease-free survival, and complete tumor disappearance and their associations with patient and tumor characteristics. Disease-free survival was calculated using Kaplan-Meier analysis. Cox proportional hazards regression analyses were performed to assess risk factors for LTP and complete tumor disappearance.
The study comprised 1613 patients (mean [SD] age, 43.3 [10.2] years; 1256 women [77.9%]) with 1834 T1N0M0 PTC tumors. During a mean follow-up of 58.5 months (range, 27 to 111 months), LTP was observed in 69 patients (4.3%), including 42 (2.6%) with tumor recurrence and 27 (1.7%) with tumor persistence. Cumulative disease-free survival rates at 1, 3, 5, and 8 years were 98.0%, 96.7%, 96.0%, and 95.7%, respectively. The overall complication rate was 2.0% (32 patients), with 6 (0.4%) major complications. Independent risk factors for LTP included subcapsular tumor location 2 mm or less from the capsule or trachea (hazard ratio [HR], 3.36; 95% CI, 2.02-5.59; P < .001) and multifocal tumors (HR, 2.27; 95% CI, 1.30-3.96; P = .004). Furthermore, 1376 patients (85.3%) showed complete tumor disappearance at follow-up ultrasonographic examination. Factors associated with complete tumor disappearance included age 40 years or less (HR, 0.78; 95% CI, 0.70-0.87; P < .001), stage T1a tumors (HR, 0.37; 95% CI, 0.31-0.45; P < .001), and unifocal tumors (HR, 0.50; 95% CI, 0.42-0.60; P < .001).
In this cohort study, ultrasonography-guided RFA for T1N0M0 PTC had excellent long-term outcomes. Patients with unifocal T1N0M0 PTC and subcapsular tumor location more than 2 mm from the capsule or trachea may be the best candidates for RFA.
射频消融(RFA)作为一种治疗低危甲状腺乳头状癌(PTC)的微创方法,越来越受到关注。鉴于这种疾病的惰性,在大人群中进行长期随访的研究对于进一步证实 RFA 的有效性将是非常宝贵的。
评估 T1N0M0 PTC 患者接受超声引导下 RFA 治疗的长期(58.5 个月)结果,并研究局部肿瘤进展(LTP)的危险因素。
设计、设置和参与者:这项队列研究纳入了 1613 名年龄在 18 岁或以上的 T1N0M0 PTC 患者,他们于 2014 年 1 月至 2020 年 12 月期间在中国北京的中国人民解放军总医院接受了超声引导下 RFA。纳入分析的患者是经活检证实的最大直径不超过 20 毫米的 PTC 患者;超声或计算机断层扫描未见甲状腺外延伸(包膜破裂或累及甲状腺周围组织)、淋巴结转移或远处转移;活检未见侵袭性 PTC 亚型。排除 PTC 大于 2 厘米、随访时间不足 12 个月或随访信息不足的患者。数据于 2023 年 4 月进行分析。
长期进展率、无病生存率和完全肿瘤消失及其与患者和肿瘤特征的关系。无病生存率采用 Kaplan-Meier 分析计算。采用 Cox 比例风险回归分析评估 LTP 和完全肿瘤消失的危险因素。
这项研究包括 1613 名患者(平均[标准差]年龄,43.3[10.2]岁;1256 名女性[77.9%]),共 1834 个 T1N0M0 PTC 肿瘤。在平均 58.5 个月(范围,27 至 111 个月)的随访中,观察到 69 例(4.3%)LTP,包括 42 例(2.6%)肿瘤复发和 27 例(1.7%)肿瘤持续存在。1、3、5 和 8 年的累积无病生存率分别为 98.0%、96.7%、96.0%和 95.7%。总的并发症发生率为 2.0%(32 例),其中 6 例(0.4%)为严重并发症。LTP 的独立危险因素包括距包膜或气管 2 毫米以内的包膜下肿瘤位置(危险比[HR],3.36;95%置信区间[CI],2.02-5.59;P<0.001)和多灶性肿瘤(HR,2.27;95%CI,1.30-3.96;P=0.004)。此外,1376 名患者(85.3%)在随访超声检查中显示完全肿瘤消失。与完全肿瘤消失相关的因素包括年龄 40 岁或以下(HR,0.78;95%CI,0.70-0.87;P<0.001)、T1a 期肿瘤(HR,0.37;95%CI,0.31-0.45;P<0.001)和单灶性肿瘤(HR,0.50;95%CI,0.42-0.60;P<0.001)。
在这项队列研究中,超声引导下 RFA 治疗 T1N0M0 PTC 具有优异的长期结果。对于 T1N0M0 PTC 患者,具有单灶性和距包膜或气管 2 毫米以上的肿瘤位置的患者可能是 RFA 的最佳候选者。