Section 1
Sentinel Node Biopsy: Implications
to Medical Oncology
ACCURACY:
FALSE-NEGATIVE RATE
The overwhelming
bulk of the data clearly shows that there is a learning curve,
and after 20-30 cases, most surgeons can at least find the
sentinel node 90 percent of the time. The key is the false-negative
rate. The proof of principle of the sentinel node question
has been answered by the many thousands of women who have
had a sentinel node biopsy and axillary dissection. NSABP
trial B-32 will tell us how well a very diverse group of surgeons
can do this procedure. Ultimately, if only select, high breast
cancer volume surgeons can achieve a false-negative rate of
one or two percent, it may not be the best treatment for all
women.
—Monica
Morrow, MD
| Morrow
M et al. Learning sentinel node biopsy: Results of
a prospective randomized trial of two techniques.
Surgery 1999;126(4):714-20; discussion 720-2.
Abstract |
| NSABP
B-32 Trial: Phase III Randomized Study of Sentinal
Node Dissection with or without Conventional
Axillary Dissection in Women with Clinically Node-Negative
Breast Cancer
Protocol |
|
Eligibility |
Invasive cancer with clinically negative nodes |
|
ARM 1 |
Sentinel
Node Resection with Axillary Dissection |
|
ARM 2 Sentinel
Node Resection |
 |
+Sentinel
Node |
 |
Axillary Dissection |
| -
Sentinel Node |
|
No Axillary Dissection |
|
|
AXILLARY
DISSECTION FOR SENTINEL NODE-POSITIVE PATIENTS
For
20 years, we have been hearing that axillary surgery is a
staging procedure. However, once you have a positive node,
the patient is staged, so does it make sense to subject her
to the morbidity of an axillary dissection? I think the answer
to that right now is, yes, for several reasons.
First,
we know that axillary dissection will maintain local control
in the axilla in 98-99 percent of patients — whether
they’re node-positive or node-negative. That’s very
important because uncontrolled axillary disease is extremely
difficult to treat and extremely morbid. Also, medical oncologists
need to accurately estimate the risk of recurrence to educate
patients about the risks and benefits of adjuvant therapy.
To do that, in general, you need to know the number of positive
nodes.
The
therapeutic benefit of axillary dissection remains open. NSABP
B-04 showed no survival benefit to this procedure, but the
trial was basically a pre-mammography era study so the patients
had larger tumors, and no adjuvant therapy was being used
at that time. Also, the sample size was not large enough to
exclude a small survival difference that today we would think
is clinically relevant.
Currently,
the standard management of a positive sentinel node is to
complete the axillary dissection, although there are individual
circumstances where that may not be appropriate. I’m
proud to say that our center has the second-highest accrual
to the American College of Surgeons trials — basically
asking the same question as NSABP B-04 but in a modern setting.
Without these trials, we will still be asking the question
ten years from now and making random decisions.
—Monica
Morrow, MD
| NSABP
B-04 Trial: A Protocol for the Evaluation of Radical
Mastectomy versus Total Mastectomy with and without
Radiation in the Primary Treatment of Breast Cancer
(closed to accrual) |
|
Eligibility |
Operable breast cancer |
Randomization for Clinically Node-Negative Patient
|
ARM 2 |
Total
mastectomy followed by axillary dissection
only in
patients who subsequently develop clinically
positive nodes |
|
ARM 3 |
Total
mastectomy plus regional radiation therapy |
Fisher
B et al. Ten-year results of a randomized clinical
trial comparing radical mastectomy and total mastectomy
with or without radiation. N Eng J Med
1985;312:674-681.
Abstract
|
|
| American
College of Surgeons Z-11 Trial: A Phase III Randomized
Study of Axillary Lymph Node Dissection in Women
with Stage I or IIA Breast Cancer Who Have
a Positive Sentinel Node.
Protocol |
|
Eligibility |
Positive sentinel node from ACOS Z-10 trial
(Z-10 requires breast conservation therapy) |
|
ARM 1 |
ALND
(> level I and II) + whole breast
radiation |
|
ARM 2 |
Whole
breast radiation |
|
|
SELECT
PUBLICATIONS
|
Grube
BJ et al. A decade of sentinel lymph node mapping
in breast cancer: A hypothesis-driven journey toward
a new paradigm. Poster, 2001 Miami Breast Cancer
Conference.
Full-Text
Haigh
PI et al. Surgery for diagnosis and treatment: Sentinel
lymph node biopsy in breast cancer. Cancer Control
1999;6(3):301-306.
Full-Text
Hsueh
EC et al. Intraoperative lymphatic mapping and sentinel
lymph node dissection in breast cancer. CA Cancer
J Clin 2000;50(5):279-91.
Full-Text
Mansel
RE. The UK Almanac Trial (MRC) - Early Results.
Poster, 2001 Miami Breast Cancer Conference.
Full-Text
Owen
DH. The Intradermal Sentinel Node: Update 2000.
Poster, 2001 Miami Breast Cancer Conference.
Full-Text
Woolam
GL. What's new in breast cancer surgery? CA
Cancer J Clin 2000; 50(5):276-8.
Full-Text
|
OTHER
RESOURCES
Beitsch PS.
SLNB slide presentation with photographs of the procedure.
Web link
Comprehensive
NCI patient education piece on SLNB: Includes review of NSABP
and ACOS trials.
Web link
|
