Among patients with early-stage breast cancer that had spread to a nearby lymph node and who received treatment that included lumpectomy and radiation therapy, women who just had the sentinel lymph node removed (the first lymph node to which cancer is likely to spread from primary tumor) did not have worse survival than women who had more extensive axillary lymph node dissection, according to a study in the Feb. 9 issue of Journal of the American Medical Association.
"Sentinel lymph node dissection (SLND) accurately identifies nodal metastasis of early breast cancer, but it is not clear whether further nodal dissection [removal] affects survival," the authors wrote. "ALND [axillary lymph node dissection], as a means for achieving local disease control, carries an indisputable and often unacceptable risk of complications such as seroma, infection and lymphedema."
Armando E. Giuliano, MD, of the John Wayne Cancer Institute at Saint John's Health Center in Santa Monica, Calif., and colleagues sought to determine the effects of ALND on overall survival in patients with SLN metastases treated with lumpectomy and radiation therapy. The trial was conducted at 115 sites and enrolled patients from May 1999 to December 2004. Patients were women with T1-T2 invasive breast cancer, no palpable adenopathy and one to two SLNs containing metastases.
The researchers randomized patients with SLN metastases identified by SLND to undergo ALND or no further axillary treatment. Those randomized to ALND underwent dissection of 10 or more nodes. Of 891 patients, 445 were randomly assigned to the ALND group and 446 to the SLND-alone group.
As the researchers expected, there was a difference between ALND and SLND-alone treatment groups in total number of removed lymph nodes and total number of tumor-involved nodes; the median total number of nodes removed was 17 in the ALND group and two in the SLND-alone group. At a median follow-up of 6.3 years, there were 94 deaths (SLND-alone group, 42; ALND group, 52).
Giuliano and colleagues also found that the use of SLND alone compared with ALND did not appear to result in statistically inferior survival, with the five-year overall survival rates being 92.5 percent in the SLND-alone group and 91.8 percent in the ALND group. Disease-free survival did not differ significantly between treatment groups, with five-year disease-free survival being 83.9 percent for the SLND-alone group and 82.2 percent for the ALND group.
The rate of wound infections, axillary seromas and paresthesias among patients in the trial was higher for the ALND group than for the SLND-alone group (70 percent vs. 25 percent).
These results, according to the authors, suggest that breast cancer patients, such as those in this study, do not benefit from the addition of ALND in terms of local control, disease-free survival or overall survival, and 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," they concluded.
In an accompanying JAMA editorial, Grant Walter Carlson, MD, and William C. Wood, MD, from Emory University in Atlanta, wrote that the adage that less is more may be applicable regarding surgery for breast cancer.
"Giuliano and colleagues have made an important contribution to the surgical management of SLN metastasis in breast cancer," Carlson and Wood wrote. Following the lead of other clinical investigators, "these randomized clinical trials have shown that less surgery combined with more radiation and chemotherapy have improved survival for women with breast cancer. Taken together, findings from these 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."