Published in JAMA
The STUDY referred to below was published!
June 2010 - Survival NO Better After Axillary Node Dissection This abstract was presented at ASCO - the annual meeting of the American Society for Clinical Oncology. Please read it BEFORE surgery if possible. (We have to point out that it has not yet been published, BUT the most prominent names in axillary/breast surgery have long suggested that this is a real issue). Is this surgery needed at all? See the article plus comments from advocates of the National Breast Cancer Coalition.
From Stephanie A. Romig, MS, OTR CLT-LANA, 12/04:
"l am a certified lymphedema therapist and can tell you first, that your site is of tremendous help to many of my patients. In response to the inquiry regarding lymphedema and sentinel node biopsy... The occurrence is much smaller, but still there because there is the disruption of the tissue and can also be compounded by radiation therapy. The sole cause is unknown, but all we know is that our patients are predisposed for lymphedema after any type of axillary dissection or radiation treatment, unless of course the patient has primary lymphedema in which he or she is born with it. I hope this helps".
Stephanie A. Romig MS, OTR CLT-LANA
Ann's NOTE: If you choose SNB, and there are many excellent reasons to do so, remember that the false negative rate is dependent on surgeon skills. Do not get discouraged or talked out of this procedure if the surgeon does not perform it. Seek someone else for it.
If you are told that the doctor will take the sentinel node and then take more-ask why? It may be that your surgeon is still learning the procedure. It seems to take at least 20 tries to get good at it. Do you want to be one of his test subjects or do you want SNB? You decide.
7/03, it is becoming apparent that lymphedema can still result even with SNB. Some report that the radiation to the axilla (armpit) is the cause, but others have told us that lymphedema can result from surgerical removal of just 4 lymph nodes. LET US KNOW YOUR EXPERIENCE.
Am Soc of Clinical Oncology meeting, 1999
Presented by Barbara Smith, MD, PhD, Massachusetts General Hospital
Dr. Smith began by polling the audience as to who was a surgeon, oncologist or other. The majority were surgeons. Many were already performing sentinel node biopsy(SNB) per her next question. As with most of ASCO's meetings, there were many non-U.S. based practitioners.
In response to her next question, most surgeons using SNB were combining both blue dye and the radioactive material.
Dr. Smith stated that "they" were reconsidering axillary dissection in light of the increasing use of adjuvant systemic treatment, the morbidity (problems with the arm) and the cost.
Node dissection is not indicated if the patient has:
· DCIS less than 5cm in size
· LCIS (considered a marker for future cancer in either breast)
· Already been diagnosed with distant metastases (although it could be used for local control)
· Sarcomas (not adenocarcinoma, the usual diagnosis)
· Tumors that are metastatic to the breast (originating elsewhere in the body, commonly from lung cancer)
· A prophylatic mastectomy (no evidence of disease-used just for prevention)
Axillary dissection is indicated if:
· There are palpable nodes (N1 axillary disease)
· N2 or N3 downsized by prior chemotherapy (presenting with a larger tumor), would recommend radiation as well
· Patients specific nodal status will alter treatment (who are these patients, need to know)
Dr.Smith mentioned some questionable situations that were being debated. They include:
· Women with T>1 cm (tumors smaller than one centimeter), node negative-should they get radiation therapy? (Ann's Note: There has not been much correlation with increased survival in this situation)
· Younger women with post-menopausal ER+-should they get chemotherapy and Tamoxifen?
· Should we be radiating the axilla and/or the chest wall?
· Should systemic radiation be based on the number of nodes?
NSABP (National Surgical Adjuvant Breast and Bowel Project) Study B-04 demonstrated no decrease in survival when axillary dissection was done only when nodes became palpable (local relapse). Originally about 6 nodes were taken with the mastectomy. However some other studies suggest that there is a survival benefit when axillary data is known. Cabanes et al, Lancet 1992. This study was difficult to interpret but may show that nodal dissection does matter.
In a Danish study of the use of CMF or CMF with radiation (Rtx) the following figures were given:
CMF CMF with Rtx
local recurrence 32% 9%
disease progression 34% 48%
mortality 45% 54%
In this study, approximately 7 nodes were removed from each woman. As you can see from the results, survival differences are less impressive than any other aspect. (This is usual with results that are followed through).
A Canadian study where 11 nodes were removed, showed that patients with CMF alone had a 47%survival versus 57% for CMF plus Rtx. However Dr. Smith cautioned that these figures may be due to less cardiac-based mortality since patients were carefully followed (under doctor's care).
She also stated that these studies implied that local-regional recurrence after mastectomy can affect survival. This is an implication only, and it remains unproven.
Dr.Smith discussed the downside of axillary dissection:
· Longer operation
· Longer hospital stay
· Use of drains, chance of seromas (a problem for some)
· Post-operative pain with limited mobility
· Long term mild-to-moderate discomfort
· Numbness of the axilla and upper arm
· Lymphedema (Ann's Note: One of the few long term studies-a retrospective analysis by Dr. Jeanne Petrek of Memorial, Sloan Kettering shows about 40% incidence of lymphedema at twenty years)
When no dissection was done, 17% of women developed palpable disease in their nodes. A study in the 1990's showed that there was a 27% false negative rate with axillary dissection and a 6% false positive. There is a problem, she said, in identifying nodal status without dissection using other multiple prognostic factors from the primary tumor.
When radiation alone is used, there is good control of clinically negative disease (no nodes involved).
· 20-40 failure for palpable nodes
· Complications are similar to surgery, no arm numbness but all other problems including lymphedema
There are drawbacks to universally administered chemotherapy as well:
· Acute and chronic toxicities
· Premature menopause with negative cardiovascular and bone effects
· Many patients WILL NOT benefit from chemotherapy (Ann's emphasis)
· Chemotherapy is not cheap
· Financial costs and morbidity/quality of life
The choices for surgeons now are:
· SNB/dissection versus no treatment
· SNB/dissection versus axillary Rtx
· SNB/dissection versus systemic chemotherapy which may not be given otherwise
"Standard" axillary dissection has a lot of variation in success. Some surgeons consistently get 20+ nodes, some get 8-10. 1% of patients havedisease in the IIIrd level. 2% have it in level II. Due to the dangers of morbidity, this level is usually not probed. The previous methods used by pathology made it more likely that very small metastatic disease could be missed. Arm edema was reported by Dr. Smith as 5% with level I-II, 15% with level III and higher when radiation is added.
Sentinel node biopsy predicts with high accuracy if:
· there is pretty specific drainage
· if the biopsy cavity is not large or if there is no large seroma as these can confuse the identifying nodes.
The pooled data from surgeons has shown about a 6% false negative (range is 0-12%). 5% is the standard set by the American College of Surgeons.
· Shorter, outpatient procedure
· Minimal post-op pain
· No drains needed
· Seromas are rare
· Rapid return to work/daily activities
· Minimal numbness
· Minimal lymphedema cases
Pathology departments are now using a variety of measurements for examining nodal status. The use of immunohistological staining as well as serial sections has enhanced the ability to pick up micro-metastases. However, the management of micro-metastases is currently being debated. How do doctors treat this? Standards have not been established, the notion is new altogether. Additionally it is unclear how doctors should handle tumors that drain to the internal mammary nodes.
Dr. Smith then discussed surgical techniques and methods of performing SNB. To be performed properly, with the least amount of false negatives or false positives requires at least 20-30 practice surgeries. Prior studies have demonstrated that in the hands of a trained surgeon, the technique is remarkably accurate. Unfortunately some patients are just plain being lied to by their doctors about SNB. It should be done under the conditions outlined above. Ann's Note: I believe almost all patients should try the SNB first since the value to a patient is very high. It is clear that the vast majority of those diagnosed with DCIS should NEVER have axillary node dissection as a first line.
Studies have shown about a 7% rate of nodal involvement with DCIS.
There are two new randomized trials beginning soom that will examine SNB under various conditions. The trial criteria is somewhat controversial in light of what we already know/suspect.
· A prior breast biopsy is not a contra-indication
· Patient must have a single T1-T2 primary tumor (T1,T2 refer to size)
· No large hematomas (bruise) or seroma at biopsy site
· No neo-adjuvant therapy (may shrink nodes) or previous axillary surgery
· If sentinel node is negative, patients will get long term followup but no further treatment
· If node is positive, they will get a standard axillary dissection
· Radiation therapy will be given
· Observation and delayed dissection is a possibility
Ann's Note: I remain convinced that this technique is a wonderful advance for patients. It is less difficult to endure, no need to work the arm back into shape, if the node(s) is negative, there will be NO damage to the arm. There is very little chance of lymphedema (it appears) with this method. The surgery can be done same day, perhaps in the doctor's surgical suite or office. It will be less expensive, making it more likely our insurance system will quickly reimburse for it.
The caveats are that the surgeon MUST know what they are doing. Getting good at the technique absolutely requires practice. Ask how many the doctor has performed. Ask what his/her false negative rate is. The closer it is to 5%, the better.
Summary of overview
Emergence of SNB as Standard of Care
J Clin Oncol 2010; 28(7s): Abstract CRA506.
Advocate Comments as posted on LeadGradsOnline.org
Lymph Node Surgery NOT needed in SOME women
information from an RN
who is a patient herself
A link that provides useful
information on SNB
No swelling, less pain,
SNB and Anaphylactic Reactions
Sensory Morbidity:Prospective Study
SNLB Compared to Axillary:Unwanted Effects
One-year After Sentinel Node Biopsy 1/4 Mild Arm Symptoms
Seroma Formation Axillary Dis w/ & w/o Drains
Study on DFS and low-risk women
Optimal Use of SNLB:Decision Analysis
10/00 Surgical overview
indicates location of nodes important
Postinjection Massage & SNLB
Injection Site Critical For SNB
Microsurgical Lymph Node Transplantation
Lancet Study, January 2001
Drainage in Mulitcentric Bca
Doctors' Guide, 6/01
Abstract on Micro-Mets
Current Thinking on Micro-mets
Breast SNLB: Pathology Disparities
Am J of Roentgenology,
This study shows tumor size or
prior biopsy no problem
Subareolar Injection Simplifies Mapping Procedure
About False Negatives in SNB
Intl J Rad Onc Biology Phys 11/01
Predictive Model of Axillary LN Involvement
Fine-needle Aspriation of Axillary Lymph Nodes
Axillary Dissection Unnecessary if Small Cancers
Debate from Europe-Axillary Disecction Needed?
No Survival Benefit for Full Axillary Dissection
Axillary Dissection in Elderly Patients w/No Clinical Nodes
J Arch Surg, 10/02
Ambulatory SNB w/Local Anesthesia
Nature Biotechnology, 1/04
Intl J Rad Onc, Bio, Phys, 11/02
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