乳腺癌的治疗无需手术

Many oncologists have long suspected that surgery may be redundant in some breast cancer patients who have a pathological complete response (pCR) to neoadjuvant systemic treatment. However, early attempts to avoid surgery in such patients were thwarted by high rates of locoregional recurrence, which were likely due to weakly effective agents and insufficient tools for accurately assessing treatment response. But now, armed with advances in early detection, systemic agents, and image-guided biopsy, researchers are revisiting whether surgery can be safely avoided in some breast cancer patients.

“We’ve come to a point where, because of all these improvements, we can consider eliminating surgery for invasive breast cancer in a select group of patients,” said Henry Kuerer, M.D., Ph.D., a professor in the Department of Breast Surgical Oncology at The University of Texas MD Anderson Cancer Center.

Dr. Kuerer is the principal investigator of a clinical trial to determine the feasibility of avoiding surgery in patients who have a pCR to systemic therapy. “If this approach is proven to be safe, it could change the paradigm for the local treatment of breast cancer,” he said.

评估响应的新方法

一些HER2（人表皮生长因子受体2）阳性和三阴性（即，阴性雌激素受体，孕酮受体和HER2）乳腺癌是全身性治疗特别敏感。的谁具有这些类型的肿瘤和接收新辅助全身疗法的患者的至少50％具有PCR，其通常被定义为在乳房和腋窝淋巴结没有侵袭性疾病。

“我们已经知道了一段时间，患者的HER2阳性和三阴病在他身上全身治疗是最有可能消灭癌症的人，” Kuerer博士解释说。“谁拥有这种反应的患者也可能有长期的整体存活率，并明显不太可能有复发。”

但是，这些有利的结果留下一个老生常谈的问题，Kuerer博士说。“如果患者没有任何残留病，为什么他们需要手术吗？”

问题是，直到最近，手术标本病理评估是确定病人谁了PCR技术全身治疗的唯一途径。乳房和腋下，确定临床反应的体检是出了名的不准确;虽然乳房成像方法已经显着改善，但仍不够敏感或特定确认全身治疗后没有残留疾病。

因此，Kuerer博士和他的同事们转向了图像引导下细针穿刺活检，其中针通过乳房插入肿瘤区下超或乳腺X线摄影指导和旋转，收集来自不同的网站有十几个样本。研究人员乐动体育LDsports中国新辅助全身治疗后进行的40例患者术前影像引导活检三阴性或HER2阳性乳腺癌患者，并与那些从患者的手术切除标本的传统的考试结果。

“The bottom line in that study was that image-guided biopsy had an accuracy in identifying residual disease of about 98%,” Dr. Kuerer said. “And for the other 2%, there was just a tiny amount of residual disease that we felt radiation could easily eradicate.” The team published their findings last year in the外科年鉴。

避免腋窝手术

一旦他们发现，影像引导下穿刺活检能准确识别患者进行PCR检测乳腺癌，可能从乳腺外科不遗余力他们，Kuerer博士和他的同事们想知道，如果他们能走得更远了一步。

“对我们来说，问题就变成了，如果有在化疗后乳房没有疾病，如何我们经常会发现癌症在淋巴结，当我们做标准腋窝手术？”Kuerer博士说。

The idea of avoiding axillary surgery to assess lymph nodes for disease has been met with some skepticism. Axillary surgery is generally performed in tandem with surgery to remove the primary breast cancer; skip the surgery, the thinking goes, and disease in the lymph nodes could be missed.

有时学习腋窝手术是否会be avoidable, Dr. Kuerer and his colleagues reviewed the records of 527 patients who received systemic therapy followed by surgery for HER2-positive or triple-negative breast cancer. None of the 116 patients whose initial ultrasonography examination revealed node-negative disease and whose breast tumors had a pCR to systemic therapy had residual disease in their lymph nodes after surgery. Of the 237 patients who did have lymph node disease at presentation and whose breast tumors had a pCR, about 90% had node-negative disease on final pathological examination.

这一发现，Kuerer博士说，有理由避免一些患者的乳腺肿瘤有PCR技术全身治疗腋窝手术。无论是手术在受影响的乳房和腋下都遗漏是在这样的病人建议目前正在临床试验研究。

临床试验可以铺平道路

The trial (No. 2016-0046) is enrolling women 40 years or older who have a pathologically confirmed stage I or II HER2-positive or triple-negative breast tumor that is 5 cm or smaller and for whom initial ultrasonography reveals four or fewer abnormal axillary lymph nodes. The patients receive standard neoadjuvant systemic therapy as directed by their oncologists. After the neoadjuvant treatment, patients who have a pCR as assessed by image-guided biopsy forgo surgery and receive whole-breast radiation therapy; those whose biopsy shows evidence of disease undergo standard breast and nodal surgery before receiving radiation therapy.

在他们的新辅助疗法，其通常持续5-6个月，患者用乳腺成像监控，因为是标准的。对于患者有资格获得图像引导的活检，并在跳过手术的机会，对最终成像的乳腺病变必须在2厘米以下。

“我们选择的是大小，因为在异常收缩下来这么多，我们可以得到该地区的一个很好的取样与穿刺活检，几乎一样好与手术本身，” Kuerer博士说。

此外，患者在其中初始超声揭示放弃腋窝手术淋巴结阴性。这些谁在全身治疗前一至四个腋窝淋巴结活检证实的疾病将进行有针对性的腋窝淋巴结清扫，其中涉及的节点通过很小的切口取出。

The trial is enrolling patients at MD Anderson and other centers, including MD Anderson’s partner institutions MD Anderson Cancer Center at Cooper in Camden, New Jersey, and Banner MD Anderson Cancer Center in Gilbert, Arizona. Thus far, seven patients have been enrolled; ultimately the trial will enroll 50. All patients will be followed up with breast imaging and physical examinations every 6 months for 5 years.

该试验可以是路径上的第一个步骤中提供微创治疗方案更乳腺癌患者。

“We’re constantly identifying new drugs and agents that are getting better and better at killing breast cancer,” Dr. Kuerer said. “So I can imagine that, very far on the horizon, surgery won’t be necessary for the vast majority of patients with breast cancers or other solid tumors.”

For more information, contact Dr. Henry Kuerer at 713-745-5043 orhkuerer@mdanderson.org。有关在MD安德森，请访问临床试验的详细信息www.clinicaltrials.org。

Further Reading

Kuerer HM，劳赫GM，克里希纳穆尔蒂S，等人。临床可行性试验为特殊反应在其中乳腺癌手术可以按照新辅助全身治疗被淘汰的鉴定。安外科杂志。2017; 267：945-931。

Kuerer HM，Vrancken佩特斯MTFD，雷阿DW，等人。非手术治疗新辅助全身治疗后浸润性乳腺癌：概念基础和基本的国际可行性临床试验。安外科杂志ONCOL。2017; 24：2855至2862年。

Tadros AB，杨WT，克里希纳穆尔蒂S等人。患者在乳房腋窝手术的不作为新辅助化疗后记录的病理完全缓解识别。JAMA外科杂志。2017年;152：665-670。

OncoLog, May-June 2018, Volume 63, Issue 5-6