SAN ANTONIOA negative sentinel lymph node (SLN)
biopsy is an accurate indicator of the absence of nodal metastases in patients
with invasive breast cancer and predicts recurrence-free survival, according to
the early results of a study conducted at the H. Lee Moffitt Cancer Center and
Research Institute at the University of South Florida.
The study tracked 971 patients who had negative SLN biopsies
for a mean follow-up period of 23 months. There has been no regional or distant
recurrence in any of the patients to date, Sophie Dessureault, MD, PhD, said at
a general session of the 23rd Annual San Antonio Breast Cancer Symposium.
"Nodal status is the single most important prognostic
factor in patients with breast cancer," Dr. Dessureault said. The standard
of care for the management of invasive breast cancer has been complete axillary
lymph node dissection (CALND). But sentinel lymph node biopsy is a
"sensitive alternative" to CALND, she said.
Performing SLN is less expensive and reduces operative
morbidity. "Complete axillary lymph node dissection is associated with
nerve injury, chronic lymphedema, and other acute and chronic
complications," she said.
The H. Lee Moffitt Cancer Center mapped 1,706 consecutive
patients with suspected node-negative breast cancer between April 1994 and
August 2000. Lymphatic mapping to identify sentinel lymph nodes was performed
using Tc99m-labeled sulfur colloid and isosulfan blue dye.
The sentinel lymph node is the first node to receive lymphatic
drainage from a cancer tumor, although it is not necessarily the node
physically closest to the tumor, Dr. Dessureault said.
A patient may have more than one sentinel lymph node. In the
study, a sentinel lymph node was defined as any blue node and/or any hot node
with ex vivo radioactivity counts greater than 10 times that of an excised
non-SLN or in situ radioactivity count greater than 3 times the background
Lymphatic mapping was successful in 1,642 patients (96.3%).
Within that group, 551 (33.6%) were found to have metastatic disease, and 1,091
(66.4%) were node negative.
The first 120 patients who were node negative underwent CALND
to verify the accuracy of the SLN results. One patient was found to have
metastatic disease in the nodal basin, for a false-negative rate of 0.83%. The
next 971 were followed by observation alone. No cancer has recurred in this
Most patients treated with breast-conserving surgery had
radiation therapy. Many patients received adjuvant chemotherapy. The decision
to use adjuvant chemotherapy, hormonal therapy, or radiation therapy was
individualized and made by a multidisciplinary team and the
Dr. Dessureault emphasized that the study included all 971
patients who underwent SLN biopsy and were followed by observation alone. These
patients were mapped between January 1995 and August 2000 with a mean follow-up
of 23 months. The study was not skewed to focus only on patients with
microscopic or T1 lesions nor did it follow only the more recent patients, she
"More follow-up is obviously needed, but the initial
results are encouraging," Dr. Dessureault said in an ONI interview. Within
the cohort of study participants, 40 patients have had more than 4 years of
follow-up without an axillary recurrence, she said.
"Previous studies have reported 10-year nodal failure
rates of 17% to 37% in patients treated without axillary dissection or
radiation," she said. "Some studies have demonstrated that more than
three quarters of patients who developed an axillary recurrence did so within 2
The early results of the H. Lee Moffitt study are comparable to
the results of a study reported by Giuliano et al in 2000, she said. That study
also described no axillary recurrences. [See Giuliano et al: J Clin Oncol
Early Return to Work
Breast cancer patients who underwent SLN biopsy were far more
likely to return to work in less than 4 days than patients who had complete
axillary lymph node dissection, according to a prospective, nonrandomized study
conducted at the Arthur G. James Cancer Hospital and Richard J. Solove Research
Institute at the Ohio State University. William E. Burak, Jr., MD, and Emmanuel
Zervos, MD, presented the study results at a poster session of the San Antonio
The researchers divided 96 patients who had undergone
breast-conserving surgery at the James Hospital into two groups. One group
consisted of patients who had a negative SLN biopsy while the second group
consisted of patients who had an SLN biopsy and then underwent CALND either
because their SLN biopsy was positive or they fell within the validation phase
of the cancer center’s SLN biopsy protocol.
Of the group that received SLN biopsy, 70.7% returned to normal
activity, including work, in less than 4 days, compared with 7.1% in the CALND
group. The majority of patients who had CALND (73.8%) returned to normal
activity after 7 days. Only 14.7% of the patients who had SLN biopsy took
longer than 7 days to return to normal activity.
The study also found less postoperative morbidity in terms of
midarm swelling, as measured by the investigators, and subjective complaints of
arm numbness (see Table).