Mirsky D, O'Brien S E, McCready D R, Newman T E, Whelan T J, Levine M N
McMaster University, Hamilton, Ont.
Cancer Prev Control. 1997;1(1):10-7.
What is the optimal surgical management of early stage invasive breast cancer (stage I and II)? More specifically, what is the relative efficacy (and safety) of breast conservation therapy (lumpectomy with axillary dissection) compared with modified radical mastectomy?
To make recommendations about surgical management and techniques in the treatment of early stage invasive breast disease (stage I and II).
Survival, local recurrence (for lumpectomy patients) and quality of life are the primary outcomes of interest.
PERSPECTIVE (VALUES): Evidence was selected and reviewed by 6 members of the Ontario Cancer Treatment Practice Guidelines Initiative, Disease Site Group for Breast Cancer (Breast DSG). Earlier drafts of this evidence-based recommendation have been reviewed, discussed and approved by the Breast DSG, which comprises surgeons, medical oncologists, radiation oncologists, epidemiologists, a pathologist and a medical sociologist. There was no consumer participation in the development of this guideline.
There are 7 randomized controlled trials (RCTs) comparing breast conservation therapy with mastectomy in women with early stage breast cancer.
In 6 RCTs, no statistically significant differences were detected in survival rate between the mastectomy and conservative therapy (lumpectomy) groups. In 1 RCT, a statistically significant differences was detected in favour of the mastectomy arm; however, this was an early trial with substantial methodologic weaknesses.
None.
Women with early stage invasive breast cancer (stage I and II) who are candidates for breast conservation therapy (see discussion of technical factors) should be offered the choice of either breast conservation therapy (excision of tumour with clear margins and axillary dissection) or modified radical mastectomy. The choice is an individual one for the patient, and thus she should be fully informed of the options, including the risks and benefits of each procedure. She should be informed that breast irradiation is part of the procedure for breast conservation therapy. In addition, she should be aware of the potential need for further surgery if the margins are positive. For further information about the use of radiotherapy in the management of early stage breast cancer, please refer to the Ontario Cancer Treatment Practice Guidelines Initiative's practice guideline Breast Irradiation in Women with Early Stage Invasive Breast Cancer Following Breast Conserving Surgery.
早期浸润性乳腺癌（I期和II期）的最佳手术治疗方案是什么？更具体地说，与改良根治性乳房切除术相比，保乳治疗（肿块切除术加腋窝清扫术）的相对疗效（和安全性）如何？
对早期浸润性乳腺疾病（I期和II期）的手术治疗和技术提出建议。
生存、局部复发（针对接受肿块切除术的患者）和生活质量是主要关注的结果。
观点（价值观）：安大略癌症治疗实践指南倡议乳腺癌疾病部位小组（乳腺癌DSG）的6名成员对证据进行了筛选和审查。该循证推荐的早期草案已由乳腺癌DSG进行了审查、讨论和批准，乳腺癌DSG成员包括外科医生、医学肿瘤学家、放射肿瘤学家、流行病学家、一名病理学家和一名医学社会学家。在本指南的制定过程中没有消费者参与。
有7项随机对照试验（RCT）比较了早期乳腺癌女性的保乳治疗和乳房切除术。
在6项RCT中，乳房切除术组和保乳治疗（肿块切除术）组的生存率未发现统计学上的显著差异。在1项RCT中，发现有利于乳房切除术组的统计学显著差异；然而，这是一项存在大量方法学缺陷的早期试验。
无。
对于适合保乳治疗（见技术因素讨论）的早期浸润性乳腺癌（I期和II期）女性，应提供保乳治疗（切除切缘阴性的肿瘤并进行腋窝清扫）或改良根治性乳房切除术的选择。这一选择由患者个人决定，因此应让她充分了解各种选择，包括每种手术的风险和益处。应告知她乳房放疗是保乳治疗过程的一部分。此外，她应了解如果切缘阳性可能需要进一步手术。有关早期乳腺癌治疗中放疗使用的更多信息，请参考安大略癌症治疗实践指南倡议的实践指南《保乳手术后早期浸润性乳腺癌女性的乳房放疗》。
