Wednesday, February 9, 2011

Sentinel Node Biopsies (SNB)...Unnecessary?

Normally when I reprint an article or study for PSA purposes I don't include, within the text, my own editorial comments. In this case, with this study, I feel compelled to throw my "two cents" in ... smack dab in the middle of the reporting. My comments, editorials, opinions, etc are noted in italics. Read on...the "dogma is strong!"

Lymph Node Study Shakes Pillar of Breast Cancer Care
By DENISE GRADY (February 8, 2011 - NY Times)

A new study finds that many women with early breast cancer do not need a painful procedure that has long been routine: removal of cancerous lymph nodes from the armpit.

Medical diagram of SNB Prep
Part and parcel of my mastectomy back in August 2009 included what is termed: a sentinel node biopsy (SNB). This is where, as a matter of protocol, the surgical oncologist removes the first few nodes from the armpit, closest in proximity of the cancerous tumor. This is surgically accomplished after a lengthy prep of injecting the nodes - through the breast tissue, with radioactive material. The trick is then to keep the patient (moi) still for nearly an hour's time, to allow the radioactive material to settle into the nodes. It is this "settling" that gives the surgeon direction as to which nodes to remove. Once removed, and while the mastectomy is concurrently being done, a pathologist reviews these nodes and determines if any further excision is required.

The discovery turns standard medical practice on its head. Surgeons have been removing lymph nodes from under the arms of breast cancer patients for 100 years, believing it would prolong women’s lives by keeping the cancer from spreading or coming back.

One would think that after 100 years of post-surgical study that this "new" information / possibility / probability should have, could have been discovered / explored sooner. The latency of this revelation, in and of itself, is greatly disturbing. And there is the tiny little fact that DESPITE having had a SNB; and DESPITE the fact that I did have one positive node but current medical protocol was to ignore it as a "false positive" -- attributable to the SNB itself...nearly two (2) years to the day it is confirmed that my breast cancer has indeed spread into my lymphatic system. What does this mean? Well, because of the active lymph nodes being so close to the primary tumor site, there is a very high probability that distant organs are affected. The challenge with ILC is, however, that it is difficult to early detect any potentially affected organ because until the invasive forms into a detectable mass. Which is my cancer hx thus far.

Now, researchers report that for women who meet certain criteria — about 20 percent of patients, or 40,000 women a year in the United States — taking out cancerous nodes has no advantage. It does not change the treatment plan, improve survival or make the cancer less likely to recur. And it can cause complications like infection and lymphedema, a chronic swelling in the arm that ranges from mild to disabling.

Example of lymphedema
patient with a medical sleeve
I was very fortunate. Aside from some initial post-surgical swelling, I did not develop lymphedema -- although my med-pro team was fully anticipating I would. Because of the SNB, however, I need to ensure that during any sort of medical examination (routine or otherwise) my blood pressure is not taken on my left side -- the SNB site. Reason: lymphedema can occur at any time by this simple routine exam as a result of having had an SNB. It is notable that even when I am being examined by a member of my "cancer team" I still have to remind each and every one of them -- each and every time, not to measure my blood pressure on my left-side. Inevitably, and strangely, they all gravitate to the left.

Removing the cancerous lymph nodes proved unnecessary because the women in the study had chemotherapy and radiation, which probably wiped out any disease in the nodes, the researchers said. Those treatments are now standard for women with breast cancer in the lymph nodes, based on the realization that once the disease reaches the nodes, it has the potential to spread to vital organs and cannot be eliminated by surgery alone.

This aspect of the study particularly interests me for two reasons: (1) One of out of the three nodes that I had removed did test positive for cancer cells. I was told, however, that because of a then-recent study in 2009, protocol had changed and advised that there was a strong probability that cancer cells are unintentionally injected into the nodes as a result of the surgical procedure itself. As such, since it was my third node that was positive, the "protocol" was "to do nothing" further, surgically. (2) That said, anyone following my journey will know that I opted out of both chemo and radiation -- despite the heavy-handed pressure by my "cancer team" to aggressively pursue both. I opted out, because of: (a) the disparity within the global medical community as to the efficacy of chemo and radiation in prolonging life after cancer; (b) my own personal "efficacy" test (Oncotype DX) that concluded I would only have up to a 4% margin of efficacy if I underwent chemo; and (c) not finding one medical professional who themselves would subject themselves to radiation treatment (though none of them would "publicly" admit these personal views).

Experts say that the new findings, combined with similar ones from earlier studies, should change medical practice for many patients. Some centers have already acted on the new information. Memorial Sloan-Kettering Cancer Center in Manhattan changed its practice in September, because doctors knew the study results before they were published. But more widespread change may take time, experts say, because the belief in removing nodes is so deeply ingrained.

“This is such a radical change in thought that it’s been hard for many people to get their heads around it,” said Dr. Monica Morrow, chief of the breast service at Sloan-Kettering and an author of the study, which is being published Wednesday in The Journal of the American Medical Association. The National Cancer Institute paid for the study.

This again begs my initial question -- why did this "radical change" take 100 years to publicly disseminate.

Doctors and patients alike find it easy to accept more cancer treatment on the basis of a study, Dr. Morrow said, but get scared when the data favor less treatment.

The above statement makes me ponder just how many of us "patients" they polled. Sadly, I find that many of my fellow breast cancer-club member's have made far-reaching medical decisions solely based on their initial fears. On the other hand, I have also found, and continue to find, a growing number of club members who share my belief that decisions can only be made after extensive research and questioning. And, after extensive research and questioning many of us discover that the "science" behind adjuvant treatment does not play out in our favor; so we opt-out.

The new findings are part of a trend to move away from radical surgery for breast cancer. Rates of mastectomy, removal of the whole breast, began declining in the 1980s after studies found that for many patients, survival rates after lumpectomy and radiation were just as good as those after mastectomy.

The trend reflects an evolving understanding of breast cancer. In decades past, there was a belief that surgery could “get it all” — eradicate the cancer before it could spread to organs and bones. But research has found that breast cancer can begin to spread early, even when tumors are small, leaving microscopic traces of the disease after surgery.

Sentinel node biopsy incision
To the credit of my surgical oncologist (Lise Walker) she was not so arrogant as to believe that surgery could "get it all."  Indeed, she and I had a spirited discussion of the known microscopic cancer cells that were left in my body post-mastectomy. FYI - I did not have the option of a lumpectomy. My tumor was 6.2 cm - i.e., of such expanse that it spread throughout my entire left breast. BTW - it was in Lise Walker's office that I first discovered the book: "What Your Doctor Won't Tell You About Breast Cancer."

The modern approach is to cut out obvious tumors — because lumps big enough to detect may be too dense for drugs and radiation to destroy — and to use radiation and chemotherapy to wipe out microscopic disease in other places.

Modern? Cut, slash and burn has been the protocol for over 50+ years.

But doctors have continued to think that even microscopic disease in the lymph nodes should be cut out to improve the odds of survival. And until recently, they counted cancerous lymph nodes to gauge the severity of the disease and choose chemotherapy. But now the number is not so often used to determine drug treatment, doctors say. What matters more is whether the disease has reached any nodes at all. If any are positive, the disease could become deadly. Chemotherapy is recommended, and the drugs are the same, no matter how many nodes are involved.

This latter sentence is frightening. Not because it causes me to reflect on my choice not to undergo adjuvant treatment. But because it is these types of statements that were used to try and bully me into acquiescing to chemo and radiation -- despite the undisputed medical conclusion that I would not benefit from chemo. It is these types of statements that plant fear into persons dealing with breast cancer and emotionally and mentally inhibits them from becoming informed patients.
Injection of the the radioactive material
in prep for the node biopsy

"...and the drugs are the same, no matter how many nodes are involved." This admission also sends chills down my spine. It should be a big ol' red flag that in light of it taking the med-pros 100 years to publicly declare this "nodal" revelation, that the med-pros are still unwilling, as a community, to reveal that the "standard protocol" for treating breast cancer reached a plateau decades ago. Refer back to my "audience with the Great Oz back in September, 2009."

The new results do not apply to all patients, only to women whose disease and treatment meet the criteria in the study.

The tumors were early, at clinical stage T1 or T2, meaning less than two inches across. Biopsies of one or two armpit nodes had found cancer, but the nodes were not enlarged enough to be felt during an exam, and the cancer had not spread anywhere else. The women had lumpectomies, and most also had radiation to the entire breast, and chemotherapy or hormone-blocking drugs, or both.

The study, at 115 medical centers, included 891 patients. Their median age was in the mid-50s, and they were followed for a median of 6.3 years.

After the initial node biopsy, the women were assigned at random to have 10 or more additional nodes removed, or to leave the nodes alone. In 27 percent of the women who had additional nodes removed, those nodes were cancerous. But over time, the two groups had no difference in survival: more than 90 percent survived at least five years. Recurrence rates in the armpit were also similar, less than 1 percent. If breast cancer is going to recur under the arm, it tends to do so early, so the follow-up period was long enough, the researchers said.

One potential weakness in the study is that there was not complete follow-up information on 166 women, about equal numbers from each group. The researchers said that did not affect the results. A statistician who was not part of the study said the missing information should have been discussed further, but probably did not have an important impact.

It is not known whether the findings also apply to women who do not have radiation and chemotherapy, or to those who have only part of the breast irradiated. Nor is it known whether the findings could be applied to other types of cancer.

The results mean that women like those in the study will still have to have at least one lymph node removed, to look for cancer and decide whether they will need more treatment. But taking out just one or a few nodes should be enough.

Dr. Armando E. Giuliano, the lead author of the study and the chief of surgical oncology at the John Wayne Cancer Institute at St. John’s Health Center in Santa Monica, Calif., said: “It shouldn’t come as a big surprise, but it will. It’s hard for us as surgeons and medical oncologists and radiation oncologists to accept that you don’t have to remove the nodes in the armpit.”

Dr. Grant W. Carlson, a professor of surgery at the Winship Cancer Institute at Emory University, and the author of an editorial accompanying the study, said that by routinely taking out many nodes, “I have a feeling we’ve been doing a lot of harm.”

Indeed, women in the study who had the nodes taken out were far more likely (70 percent versus 25 percent) to have complications like infections, abnormal sensations and fluid collecting in the armpit. They were also more likely to have lymphedema.

I can attest to the abnormal sensations (euphemism for pain), that continue each and every day, to this day, since the SNB and mastectomy in August 2009.

But Dr. Carlson said that some of his colleagues, even after hearing the new study results, still thought the nodes should be removed.

“The dogma is strong,” he said. “It’s a little frustrating.” 

This understated sentiment can be broadly applied in all aspects of the breast cancer industry.

Eventually, he said, genetic testing of breast tumors might be enough to determine the need for treatment, and eliminate the need for many node biopsies.

BRCA Genes I & II Mutation
Had extensive genetic testing prior to the SNB and mastectomy. Did not alter the course of treatment adamantly lobbied for by the "cancer team."

Two other breast surgeons not involved with the study said they would take it seriously.

Dr. Elisa R. Port, the chief of breast surgery at Mount Sinai Medical Center in Manhattan, said: “It’s a big deal in the world of breast cancer. It’s definitely practice-changing.”

Dr. Alison Estabrook, the chief of the comprehensive breast center at St. Luke’s-Roosevelt hospital in New York said surgeons had long been awaiting the results.

“In the past, surgeons thought our role was to get out all the cancer,” Dr. Estabrook said. “Now he’s saying we don’t really have to do that.”

But both Dr. Estabrook and Dr. Port said they would still have to make judgment calls during surgery and remove lymph nodes that looked or felt suspicious.

The new research grew out of efforts in the 1990s to minimize lymph node surgery in the armpit, called axillary dissection. Surgeons developed a technique called sentinel node biopsy, in which they injected a dye into the breast and then removed just one or a few nodes that the dye reached first, on the theory that if the tumor was spreading, cancer cells would show up in those nodes. If there was no cancer, no more nodes were taken. But if there were cancer cells, the surgeon would cut out more nodes.

Although the technique spared many women, many others with positive nodes still had extensive cutting in the armpit, and suffered from side effects.

A lymphedema patient, without
the medical sleeve
“Women really dread the axillary dissection,” Dr. Giuliano said. “They fear lymphedema. There’s numbness, shoulder pain, and some have limitation of motion. There are a fair number of serious complications. Women know it.”

After armpit surgery, 20 percent to 30 percent of women develop lymphedema, Dr. Port said, and radiation may increase the rate to 40 percent to 50 percent. Physical therapy can help, but there is no cure.

The complications — and the fact that there was no proof that removing the nodes prolonged survival — inspired Dr. Giuliano to compare women with and without axillary dissection. Some doctors objected. They were so sure cancerous nodes had to come out that they said the study was unethical and would endanger women.

“Some prominent institutions wouldn’t even take part in it,” Dr. Giuliano said, though he declined to name them. “They’re very supportive now. We don’t want to hurt their feelings. They’ve seen the light.”


  1. Three words: No tort reform. Frivolous lawsuits-as well as the kind of suits that have true merit but are so devastating to innovative industry due to the absurd awards that juries agree to give to clients who have lawyers that have made it the norm to ask for amounts that are so ridiculous, that only the unscrupulous lawyers and the equally unscrup. ins. companies win in the long run. This practice of awarding t astronomical amounts in non-negligence cases has done unimaginable damage to technologies and innovation because of the expense it has caused literally everyone in this country and not just 2 litigants (unless class action, of course, and then the damage is exponentially higher)but greatly hampers the public (private) ability to invent medicines, technologies, genetically superior food stuffs due to fear of devastating lawsuits that cripple. This affects mostly the truly innocent individual inventor's ability to create and improve human life for real fear of the type of lawsuit where they will be found innocent but will have to pay amounts so exhorbitant in legal rep that they are unable to fund research and technology due to the lack of finances that Big Pharma sets aside for just these situations. The true innovators in medicine and other technologies are small business owners;the gov't, which is in the pocket of and almost wholly owned by the ATLA (as admitted to by Howard Dean when asked why there was no tort reform in that monstrosity commonly referred to as the Obamacare bill,) yet room for every perk and boon which have in common both the deleterious effects of yet more gov't intrusion and the resulting effects of artifical monopolies that decrease efficiency and drive up cost;by removing the effect of demand creating monopolies that the market would never support prevent natural laws that cause bad companies to fall when there is a lack of demand due to preference (ie, lousy customer service)-consumers (and shareholders) would never support a company that made it a practice to perform as poorly as the govt mgmt.of federal workers (nobody EVER gets fired or has pay raises based on performance like in private cos.) and non- fiscal restraint or responsibility that EVERY single govt agency without exception, exhibits. If a private business did what the lawmakers assist our govt agencies in doing, they would be charged with defrauding shareholders and major malfeasance of a financial nature-think Madoff vs. SSAdmin(our national ponzi scheme.) These troubling govt created monopolies, which are against the law, btw, are coupled with laws inserted into the bill that also have in common a complete lack of anything having remotely related to health care what so ever, in order to get lawmakers to hold their noses and vote for something the majority of voters were clearly not in favor of, even by the most jaded lawmaker's stretch of imagination. The new college loan law comes immediately to mind,though unfortunately not limited to something so ridiculous in a health care bill, there are many, many more laws inside which have a sole purpose of creating more (taxes)and govt bureaus (sp?)which have nothing at all to do with making health care cheaper or more affordable and will cause the opposite effect-even if unintentionally creating a completely forseeable mess. Apologies for hijacking your blog, and basic topic, although the resulting mess of govt intrusion, caused by lawmakers who are too short sighted to realize the long reaching effects of their "unintended consequences" as well as creating another entitlement class dependent on anyone other than themselves, is,the typical result of any bureaucrat controlled (read: little men with a little bit of power creating legislation, despite the fact that they have no authority to do so; power always corrupts the small minded.) Final mini-rant now over, with apologies, again.

  2. Sorry for the above grammatical errors and unacceptable abreviations, but my rant became too long and I had to cut corners in order to for the program to be able to post it. Limits on the amount of characters, you see.

  3. The new college loan law comes immediately to mind,though unfortunately not limited to something so ridiculous in a health care bill, there are many, many more laws inside which have a sole purpose of creating more (taxes)and govt bureaus (sp?)which have nothing at all to do with making health care cheaper or more affordable and will cause the opposite effect-even if unintentionally creating a completely foreseeable mess. Personal Statement UCAS