SNAC1:A randomised trial of sentinel node based management versus axillary clearance for women with small breast cancers

每年有超过13，000名ANZ女性被诊断患有乳腺癌。大多数需要手术切除癌症，并确定它是否扩散到腋窝的腺体（腋窝淋巴结）。了解癌症是否已经扩散到腋窝淋巴结有助于确定预后和计划治疗。手术切除是评估腋窝淋巴结的最可靠方法。SNAC 1比较了两种评估早期乳腺癌女性癌症扩散至淋巴结的手术：1）腋窝清除术和2）前哨淋巴结活检。腋窝淋巴结清扫包括腋窝大部分淋巴结的清除。在前哨淋巴结活检中，只有少数与乳腺癌关系最密切的淋巴结被切除。腋窝间隙是目前的标准操作。然而，它与感染、疼痛、僵硬、麻木和淋巴水肿（手臂肿胀）等风险相关。乳腺水肿可能发生在5-50%接受乳腺癌治疗的女性中，并可能导致严重的痛苦和残疾。在许多妇女中，她们的乳腺癌还没有扩散到淋巴结，腋窝清除是不必要的。最近的研究表明前哨淋巴结活检可以提供尽可能多的信息腋窝清除。扫描和染色用于帮助定位前哨淋巴结。尽量减少腋窝的手术量可以减少副作用。然而，仅移除少数节点的长期安全性和有效性尚不清楚。该试验将确定前哨淋巴结活检是否能减少淋巴水肿，并提供相同的治愈率。如果是这样，那么它应该成为标准做法。该研究通过提供有关手臂症状和生活质量的独特信息，补充了在美国，英国和欧洲进行的可比研究。SNAC 1在4年内招募了1 088名妇女。此应用程序用于报告所有女性随访5年后的结果所需的工作。

Over 13,000 ANZ women are diagnosed with breast cancer each year. Most need surgery to remove the cancer and determine if it has spead to glands in the armpit (axillary lymph nodes). Knowing whether the cancer has spread to the axillary lymph nodes helps determine prognosis and plan treatment. Surgical removal is the most reliable way to assess the axillary lymph nodes. SNAC1 compares two operations for assessing cancer spread to the lymph nodes in women with early breast cancer: 1) axillary clearance and 2) sentinel node biopsy. Axillary clearance involves removal of most lymph nodes in the armpit. In sentinel node biopsy only a few lymph nodes most closely related to the breast cancer are removed. Axillary clearance is the current standard operation. However, it is associated with risks including infection, pain, stiffness, numbness and lymphoedema (arm swelling). Lymphoedema may occur in 5-50% of women treated for breast cancer and can cause major suffering and disability. In many women their breast cancer has not spread to the lymph nodes, and axillary clearance is unnecessary. Recent studies suggest sentinel node biopsy may provide as much information as axillary clearance. Scans and dye are used to help locate the sentinel nodes. Minimising the amount of surgery to the armpit should reduce the side effects. However, the long term safety and effectiveness of removing only a few nodes is unknown. The trial will determine if sentinel node biopsy reduces lymohoedema and gives equivalent cure rates. If it does, then it should become standard practice. The study complements comparable studies being done in US, UK and Europe by providing unique information about arm symptoms and quality of life. SNAC1 recruited 1,088 women in 4 years. This application is for the work needed to report on outcomes after all women have been followed for 5 years.