Many women with early-stage breast cancer can avoid the more invasive procedure of axillary lymph node dissection (ALND), which removes most of the lymph nodes in the armpit and can cause long-term adverse effects of pain, discomfort, and lymphedema. Instead, they can have the less invasive diagnostic technique of sentinel lymph node biopsy (SLNB), which removes only a few lymph nodes and is associated with fewer complications.
This new clinical guidance comes in an update issued by the American Society of Clinical Oncology (ASCO) and published online March 24 in the Journal of Clinical Oncology.
"We're saying more patients can safely get sentinel node biopsy without axillary lymph node dissection. These guidelines help determine for whom sentinel node biopsy is appropriate," said Armando Giuliano, MD, FACS, cochair of ASCO's expert panel that updated the guideline.
Dr. Giuliano, from the John Wayne Cancer Institute at Saint John's Health Center in Santa Monica, California, is also the principal investigator of the Z0011 trial, which was first presented in 2010 at ASCO's annual meeting and has since been published in JAMA (2011;305:569-575, 606-607).
This trial found that for women who had 1 or 2 positive nodes, there was no difference in overall survival between women who had undergone ALND and SLNB.
At the time, when the results were first presented, Dr. Giuliano said that it seems counterintuitive to leave behind some cancer (in the nodes that were found to be positive). But these women underwent whole-breast irradiation and adjuvant systemic therapy after their breast-conserving surgery, and it seems likely that these treatments treated the low level of metastases that was seen in the positive lymph nodes in these women, resulting in the lack of survival difference.
Dr. Giuliano and colleagues said they hoped that surgeons embrace the findings, and that they forgo ALND in this set of patients. "Implementation of this practice change would improve clinical outcomes in thousands of women each year by reducing the complications associated with ALND and improving quality of life with no diminution in survival," they wrote.
Now practice change is recommended in the new update to the ASCO guidelines, which replaces the document issued in 2005. Since then, there have been 9 randomized controlled trials (including the Z0011) and 13 cohort studies assessing the issue. The evidence from these studies now supports using the less invasive SLNB technique in a larger group of patients, say the authors.
The updated guidelines recommend, on the basis of randomized clinical trial data, that ALND should not be performed on women who were found to have no cancer in the sentinel lymph nodes, and also should not be performed (in most cases) on women found to have cancer in 1 to 2 of the sentinel lymph nodes, and who are planning to undergo breast-conserving surgery with whole-breast radiotherapy.
However, women with sentinel lymph node metastases who have decided to undergo mastectomy may be offered ALND.
The new document also updates 2 groups of recommendations based on cohort studies and/or informal consensus:
Women with operable breast cancer and multicentric tumors, and/or ductal carcinoma in situ (DCIS) who will have mastectomy, and/or had prior breast and/or axillary surgery, and/or had preoperative/neoadjuvant systemic therapy may be offered SLNB.
Women who have large or locally advanced invasive breast cancers (tumor size T3/T4), and/or inflammatory breast cancer, and/or DCIS, when breast-conserving surgery is planned, and/or are pregnant should not receive SLNB.
The ASCO committee noted that in some cases, evidence was insufficient to update previous recommendations.
"We strongly encourage patients to talk with their surgeon and other members of their multidisciplinary team to understand their options and make sure everybody's on the same page," said Gary Lyman, MD, MPH, FASCO, cochair of the expert panel. "The most critical determinant of breast cancer prognosis is still the presence and extent of lymph node involvement and, therefore, the lymph nodes need to be evaluated so we can understand the extent of the disease," he said in a statement.
"It is essential that physicians and surgeons involved in the management of early-stage breast cancer have a discussion about the therapeutic options and reason for the recommendations," Dr. Lyman told Medscape Medical News. "Key to the discussion around management of the axilla is the understanding that for most patients without palpable adenopathy who are candidates for lumpectomy and conventional whole-breast radiation, there is no difference in the risk of breast cancer recurrence in foregoing complete axillary dissection if only 1 or 2 sentinel nodes are involved without extranodal extension. By forgoing completion axillary dissections, the patient is significantly less likely to experience complications from the procedure. Doctors understandably do not want to put patients through procedures with significant risk of short- and long-term complications without evidence that they improve other important outcomes, such as disease-free or overall survival."
"In my own experience, with proper communication, patients are generally understanding and accepting of the recommendations," he said.
J Clin Oncol. Published online March 25, 2014. Abstract
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Cite this: ASCO Updates Node Dissection Guideline in Early Breast Cancer - Medscape - Mar 25, 2014.