General Surgery Unit, Santarcangelo di Romagna Hospital, Rimini, AUSL Romagna, Italy.
General Surgery Unit, Santarcangelo di Romagna Hospital, Rimini, AUSL Romagna, Italy.
Eur J Surg Oncol. 2015 Jan;41(1):64-70. doi: 10.1016/j.ejso.2014.10.047. Epub 2014 Nov 4.
Although Indocyanine green (ICG) is used to find sentinel nodes (SN) in patients with breast cancer (BC), its role in clinical practice is still debated, and needs a definitive validation to be included in the standard approach to finding sentinel nodes in breast cancer.
To validate the ICG methods of detecting the SN in BC we have recently concluded a prospective validation trial. Patients with clinically node-negative, invasive early BC scheduled for breast surgery and SN biopsy were included in the trial. All the patients underwent SN detection using both the standard-of-care procedure using radioisotope technetium (99mTc) and the ICG, using the Photodynamic Eye camera. A comparison of the detection rate and the diagnostic accuracy of the two methods was performed to detect the equivalency of the two approaches.
At the end of the enrollment, 301 patients were considered eligible and included in the trial, and 589 nodes were removed. Five hundred and eighty-three nodes (99%) were identified with ICG (median 2 nodes per patient) and 452 (76.7%) were identified with 99mTc (median 2 nodes per patient). A concordance index of 98.75% (CI, 95% = 97.1%-99.5%) was detected. The dosage given ranged from 0.3 to 1.4 ml. ICG was used in all patients eligible for SN biopsy without any significant acute side effects.
The index of concordance between 99mTc and ICG seems to be extremely high, suggesting that ICG could be validated as an alternative method to 99mTc in the detection of SN in BC.
虽然吲哚菁绿（ICG）用于在乳腺癌（BC）患者中寻找前哨淋巴结（SN），但其在临床实践中的作用仍存在争议，需要进行明确验证才能纳入 BC 中寻找前哨淋巴结的标准方法。
为了验证 ICG 检测 BC 中 SN 的方法，我们最近完成了一项前瞻性验证试验。将计划接受乳房手术和 SN 活检的临床淋巴结阴性、侵袭性早期 BC 患者纳入试验。所有患者均接受放射性同位素锝（99mTc）和 ICG 标准护理程序以及光动力眼相机进行 SN 检测。对两种方法的检测率和诊断准确性进行比较，以检测两种方法的等效性。
在入组结束时，301 名患者被认为符合条件并纳入试验，共切除 589 个淋巴结。用 ICG 识别出 583 个淋巴结（99%）（中位数为每个患者 2 个淋巴结），用 99mTc 识别出 452 个淋巴结（76.7%）（中位数为每个患者 2 个淋巴结）。检测到的一致性指数为 98.75%（CI，95%=97.1%-99.5%）。所给剂量范围为 0.3 至 1.4 毫升。所有有 SN 活检适应证的患者均使用 ICG，无明显急性副作用。
99mTc 和 ICG 之间的一致性指数似乎非常高，表明 ICG 可作为替代 99mTc 检测 BC 中 SN 的方法进行验证。
