Select Patients Can Be Spared Axillary Dissection Breast Cancer Study Shows No Recurrence Advantage Over Sentinel Node Dissection Christina Frangou Sentinel lymph node dissection (SLND) alone provides “excellent” locoregional control in many women with node-positive cancers—with eight-year recurrence rates almost identical to women who underwent additional axillary dissection, according to researchers in a major randomized trial. “We conclude from this trial that removal of nonsentinel axillary nodes does not impact survival of patients with a low to moderate axillary tumor burden,” said lead author Armando E. Giuliano, MD, director of the Margie and Robert E. Petersen Breast Cancer Research Program at John Wayne Cancer Institute in Santa Monica, Calif. Dr. Giuliano presented the study at the 2010 annual meeting of the American Surgical Association in Chicago. Surgeons said they expect this study will lead to clinical practice changes throughout the United States. Today, completion axillary dissection is routine and considered the gold standard for patients who are undergoing breast conservation and sentinel lymph node biopsy. “I believe this study will reduce the number of patients with tumor-positive sentinel lymph nodes who undergo completion axillary lymph node dissection [ALND],” said Kelly McMasters, MD, PhD, Sam and Lolita Weakley Endowed Professor of Surgical Oncology and professor and chair in the Department of Surgery at University of Louisville School of Medicine in Kentucky. In the randomized controlled trial of nearly 900 women with node-positive breast tumors, no recurrence advantage was shown for SLND with ALND compared with SLND alone. With a median follow-up of 6.3 years, 4.1% of women who underwent ALND experienced a locoregional recurrence—a rate not statistically different from the 2.8% recurrence rate for women who had SLND alone. This is the first large, randomized study to show that completion ALND offers no advantage with respect to locoregional recurrence in women with one or two tumor-positive sentinel nodes. Surgeons who spoke with General Surgery News stressed that the results apply to a small proportion of breast cancer patients. The women in the study had early breast cancer with T1 and T2 tumors less than 5 cm. They underwent lumpectomy and whole breast radiotherapy; none of the women had matted nodes or three or more involved sentinel nodes. “We don’t want patients to interpret that this study says all patients with positive nodes do not need axillary node dissection. This is still a pretty select group of patients who were clinically node negative,” said Shawna C. Willey, MD, director of the Betty Lou Ourisman Breast Health Center at Georgetown University Hospital in Washington. One of the largest randomized trials studying ALND in women with sentinal node-positive breast cancer (ACOSOG Z0011) involved 891 patients and 165 investigators at 177 institutions. All women enrolled had clinical T1/T2 breast cancer with metastases detected by hematoxylin and eosin staining in the sentinel node. They underwent lumpectomy with whole breast irradiation and with the choice of adjuvant systemic therapy between May 1999 and December 2004. Approximately 58% of participants underwent chemotherapy and 46% had hormone therapy. As expected, patients in the ALND group had more lymph nodes removed than patients in the SLND-only group (median, 17 in the ALND group and 2 in the SLND-only group; P<0.001). Approximately 27% of patients who underwent ALND had a nonsentinel lymph node tumor. However, removal of nonsentinel nodes failed to further reduce long-term locoregional recurrence rates. Locoregional recurrence was not associated with the number of positive sentinel nodes, the size of the nodal metastases or the number of lymph nodes removed. Only an age of 50 years or younger and a higher Bloom-Richardson score were associated with locoregional recurrence, according to multivariable analysis. The study was not without shortcomings. The trial failed to achieve its target accrual of 1,900 patients. Many women and their surgeons were reluctant to participate in the trial because they were concerned about the consequences of skipping standard ALND. Additionally, the overall survival end point of the study has not been reported and the study will not have adequate statistical power to detect small differences in survival. Despite its limitations, the trial results still offer strong evidence that some women with positive nodes can forego ALND, said both authors and surgeons who participated in the study but were not in the final analysis. Although the number of patients in the trial were fewer than planned, the women were followed for a median of 6.3 years. With this follow-up, a recurrence rate of less than 1% in the axillary node is unlikely to be clinically insignificant. “This is substantially less than the risk for ipsilateral breast tumor recurrence for patients undergoing breast conservation,” Dr. McMasters said. “I think this study will change the practice somewhat. I think it also will make some practitioners uncomfortable with changing that practice because they didn’t accrue the numbers to reach the statistical significance they wanted,” Dr. Willey said. Experts predict an increase in the number of surgeons who will not obtain a frozen section or perform a touch prep analysis of the sentinel nodes intraoperatively and who will postpone the decision to perform ALND until the final pathology report is available. “This study will help with that decision making, whether you need to go back and do a completion axillary dissection,” Dr. McMasters said. “For patients coming in now, it’s important to discuss the new findings as well as our current standard practice,” said Deanna Attai, MD, a breast cancer surgeon in private practice and chair of the American Society of Breast Surgeons’ Public Relations Committee. “This will open the door for more discussion with each patient individually, and as we already do, review the available data and come up with a treatment plan that works best and makes the most sense for each individual patient. My feeling is that more information— in terms of what we glean from research trials—is better than less. An issue we all deal with, however, is how best to apply our new information to each individual,” she said. This year marked the 130th annual meeting of the American Surgical Association. Established in 1880, the American Surgical Association is the oldest surgical association in the United States.
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