Department of Surgical Oncology, VU University Medical Center, Amsterdam, Netherlands.
Lancet Oncol. 2013 Jan;14(1):48-54. doi: 10.1016/S1470-2045(12)70527-2. Epub 2012 Dec 4.
Breast-conserving surgery for palpable breast cancer is associated with tumour-involved margins in up to 41% of cases and excessively large excision volumes. Ultrasound-guided surgery has the potential to resolve both of these problems, thereby improving surgical accuracy for palpable breast cancer. We aimed to compare ultrasound-guided surgery with the standard for palpable breast cancer-palpation-guided surgery-with respect to margin status and extent of healthy breast tissue resection.
In this randomised controlled trial, patients with palpable T1-T2 invasive breast cancer were recruited from six medical centres in the Netherlands between October, 2010, and March, 2012. Eligible participants were randomly assigned to either ultrasound-guided surgery or palpation-guided surgery in a 1:1 ratio via a computer-generated random sequence and were stratified by study centre. Patients and investigators were aware of treatment assignments. Primary outcomes were surgical margin involvement, need for additional treatment, and excess healthy tissue resection (defined with a calculated resection ratio derived from excision volume and tumour diameter). Data were analysed by intention to treat. This trial is registered at http://www.TrialRegister.nl, number NTR2579.
134 patients were eligible for random allocation. Two (3%) of 65 patients allocated ultrasound-guided surgery had tumour-involved margins compared with 12 (17%) of 69 who were assigned palpation-guided surgery (difference 14%, 95% CI 4-25; p=0·0093). Seven (11%) patients who received ultrasound-guided surgery and 19 (28%) of those who received palpation-guided surgery required additional treatment (17%, 3-30; p=0·015). Ultrasound-guided surgery also resulted in smaller excision volumes (38 [SD 26] vs 57 [41] cm(3); difference 19 cm(3), 95% CI 7-31; p=0·002) and a reduced calculated resection ratio (1·0 [SD 0·5] vs 1·7 [1·2]; difference 0·7, 95% CI 0·4-1·0; p=0·0001) compared with palpation-guided surgery.
Compared with palpation-guided surgery, ultrasound-guided surgery can significantly lower the proportion of tumour-involved resection margins, thus reducing the need for re-excision, mastectomy, and radiotherapy boost. By achieving optimum resection volumes, ultrasound-guided surgery reduces unnecessary resection of healthy breast tissue and could contribute to improved cosmetic results and quality of life.
Dutch Pink Ribbon Foundation, Osinga-Kluis Foundation, Toshiba Medical Systems.
对于可触及的乳腺癌，保乳手术的肿瘤切缘阳性率高达 41%，且切除范围过大。超声引导手术有可能解决这两个问题，从而提高可触及乳腺癌的手术准确性。我们旨在比较超声引导手术与可触及乳腺癌的标准治疗——触诊引导手术——在切缘状态和健康乳腺组织切除范围方面的差异。
在这项随机对照试验中，我们从荷兰的 6 个医疗中心招募了 2010 年 10 月至 2012 年 3 月期间患有 T1-T2 期可触及浸润性乳腺癌的患者。符合条件的参与者通过计算机生成的随机序列以 1:1 的比例被随机分配至超声引导手术组或触诊引导手术组，并按研究中心进行分层。患者和研究人员均知晓治疗分组。主要结局为手术切缘阳性、需要额外治疗和健康组织过度切除（定义为基于切除体积和肿瘤直径计算的切除比）。数据按意向治疗进行分析。本试验在 http://www.TrialRegister.nl 注册，编号为 NTR2579。
共有 134 名患者符合随机分配条件。与接受触诊引导手术的 69 名患者中有 12 名（17%）存在肿瘤切缘阳性相比，接受超声引导手术的 65 名患者中只有 2 名（3%）存在肿瘤切缘阳性（差值为 14%，95%CI 4-25；p=0·0093）。接受超声引导手术的 7 名患者（11%）和接受触诊引导手术的 19 名患者（28%）需要额外治疗（差值为 17%，3-30；p=0·015）。与触诊引导手术相比，超声引导手术还导致切除体积更小（38[标准差 26] vs 57[41]cm3；差值为 19 cm3，95%CI 7-31；p=0·002）和计算的切除比更低（1·0[标准差 0·5] vs 1·7[1·2]；差值为 0·7，95%CI 0·4-1·0；p=0·0001）。
与触诊引导手术相比，超声引导手术可显著降低肿瘤切缘阳性率，从而减少再次切除、乳房切除术和放疗增量的需求。通过实现最佳的切除范围，超声引导手术减少了对健康乳腺组织的不必要切除，有助于改善美容效果和生活质量。
荷兰粉红丝带基金会、Osinga-Kluis 基金会、东芝医疗系统。
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