ALND not always warranted in breast cancer patients
MedWire News: Certain women with breast cancer who undergo sentinel lymph node dissection (SLND) do not benefit from the addition of axillary lymph node dissection (ALND) to their treatment plan, results of a phase III clinical trial show.
Armando Giuliano (John Wayne Cancer Institute, Santa Monica, California, USA) and colleagues note that their findings are only applicable to women similar to those who participated in the American College of Surgeons Oncology Group Z0011 trial; ie, women with one or two positive SLNs and clinical stage T1-T2 tumors undergoing lumpectomy with radiation therapy followed by systemic therapy.
The trial was set up to determine whether complete ALND affects the survival of patients with SLN metastasis of breast cancer.
Breast cancer patients recruited from 115 sites between 1999 and 2004 underwent initial SLND; those with SLN metastases were then randomly assigned to undergo ALND (n=445) or no further axillary treatment (n=446).
As expected, the women who underwent ALND had more lymph nodes removed than those who had SLND only, at 17 versus two, but there were no other clinical or tumor-related differences between the groups.
At a median follow-up time of 6.3 years, 94 patients had died: 42 in the SLND-only group and 52 in the ALND group. The results showed that the use of SLND alone compared with ALND did not result in statistically inferior survival, with 5-year overall survival rates of 92.5% and 91.8%, respectively.
Similarly, disease-free survival did not differ significantly between the SLND only and ALND treatment groups, with respective 5-year disease-free survival rates of 83.9% and 82.2%.
Giuliano and co-authors comment that the low rates of locoregional recurrence at 5 years and the nearly identical overall and disease-free survival rates between the treatment groups suggests that differences in survival between the groups are unlikely to emerge with longer follow-up, as ALND would only affect survival by virtue of improved locoregional control.
They conclude in JAMA that ALND may no longer be justified for certain 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."
Grant Carlson and William Wood of Emory University, Atlanta, wrote in an accompanying editorial that "Giuliano and colleagues have made an important contribution to the surgical management of SLN metastasis in breast cancer."
They concluded that the findings, along with those of other clinical investigators, "provide strong evidence that patients undergoing partial mastectomy, whole-breast irradiation, and systemic therapy for early breast cancer with microscopic SLN metastasis can be treated effectively and safely without ALND."
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By Laura Dean