超声辅助碳纳米粒子混悬液定位与双示踪剂引导前哨淋巴结活检在早期乳腺癌患者中的比较（ultraCars）：III 期随机临床试验。
Ultrasound-assisted carbon nanoparticle suspension mapping versus dual tracer-guided sentinel lymph node biopsy in patients with early breast cancer (ultraCars): phase III randomized clinical trial.
机构信息
Department of Breast Cancer, Cancer Centre, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.
出版信息
Br J Surg. 2022 Nov 22;109(12):1232-1238. doi: 10.1093/bjs/znac311.
BACKGROUND
Appropriate tracing methods for sentinel lymph node biopsy (SLNB) play a key role in accurate axillary staging. This prospective, non-inferiority, phase III RCT compared the feasibility and diagnostic performance of ultrasound-assisted carbon nanoparticle suspension (CNS) mapping with dual tracer-guided SLNB in patients with early breast cancer.
METHODS
Eligible patients had primary breast cancer without nodal involvement (cN0), or had clinically positive lymph nodes (cN1) that were downstaged to cN0 after neoadjuvant chemotherapy. Patients were randomly assigned (1 : 1) to undergo either ultrasound-assisted CNS sentinel lymph node (SLN) mapping (UC group) or dual tracer-guided mapping with CNS plus indocyanine green (ICG) (GC group). The primary endpoint was the SLN identification rate.
RESULTS
Between 1 December 2019 and 30 April 2021, 330 patients were assigned randomly to the UC (163 patients) or GC (167 patients) group. The SLN identification rate was 94.5 (95 per cent c.i. 90.9 to 98.0) per cent in the UC group and 95.8 (92.7 to 98.9) per cent in the GC group. The observed difference of -1.3 (-5.9 to 3.3) per cent was lower than the prespecified non-inferiority margin of 6 per cent (Pnon-inferiority = 0.024). No significant difference was observed in metastatic node rate (30.5 versus 24.4 per cent; P = 0.222), median number of SLNs harvested (3 (range 1-7) versus 3 (1-8); P = 0.181), or duration of surgery (mean(s.d.) 7.53(2.77) versus 7.63(3.27) min; P = 0.316) between the groups. Among the subgroup of patients who had undergone neoadjuvant treatment, the SLN identification rate was 91.7 (82.2 to 100) per cent in the UC group and 90.7 (81.7 to 99.7) per cent in the GC group.
CONCLUSION
The diagnostic performance of ultrasound-assisted CNS mapping was non-inferior to that of dual tracer-guided SLN mapping with CNS plus ICG in patients with early breast cancer.
REGISTRATION NUMBER
NCT04951245 (http://www.clinicaltrials.gov).
背景
前哨淋巴结活检 (SLNB) 的适当追踪方法对于准确的腋窝分期起着关键作用。这项前瞻性、非劣效性、III 期 RCT 比较了超声辅助碳纳米粒子混悬液 (CNS) 示踪与双示踪剂引导的 SLNB 在早期乳腺癌患者中的可行性和诊断性能。
方法
合格的患者患有无淋巴结受累的原发性乳腺癌 (cN0)，或有临床阳性淋巴结 (cN1)，在新辅助化疗后降期为 cN0。患者被随机分配（1:1）接受超声辅助 CNS 前哨淋巴结 (SLN) 定位（UC 组）或 CNS 加吲哚菁绿 (ICG) 双示踪引导定位（GC 组）。主要终点是 SLN 识别率。
结果
2019 年 12 月 1 日至 2021 年 4 月 30 日，330 名患者被随机分配至 UC（163 名患者）或 GC（167 名患者）组。UC 组的 SLN 识别率为 94.5%（95%可信区间 90.9%至 98.0%），GC 组为 95.8%（92.7%至 98.9%）。观察到的差异-1.3%（-5.9%至 3.3%）低于预设的 6%非劣效性边界（Pnon-inferiority = 0.024）。转移淋巴结率（30.5%比 24.4%；P = 0.222）、中位 SLN 数量（3 个（范围 1-7）比 3 个（1-8）；P = 0.181）或手术时间（均值（标准差）7.53(2.77)比 7.63(3.27)min；P = 0.316）两组之间无显著差异。在接受新辅助治疗的亚组患者中，UC 组的 SLN 识别率为 91.7%（82.2%至 100%），GC 组为 90.7%（81.7%至 99.7%）。
结论
在早期乳腺癌患者中，超声辅助 CNS 定位的诊断性能不劣于 CNS 加 ICG 双示踪剂引导的 SLN 定位。
登记号
NCT04951245（http://www.clinicaltrials.gov）。
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