Thursday, May 15, 2014

A View of the New ASCO Screening Guidelines

 The American Society of Clinical Oncology has new screening guidelines for breast cancer patients post treatment.  The following is a review co-written by Gina Maisano, Founder of the No Surrender Breast Cancer Foundation and Constantine Kaniklidis, Director of Medical Research at the No Surrender Breast Cancer Foundation and Founder of Breast Cancer Watch.

A View of the New ASCO Screening Guidelines for Breast Cancer Patients
by Gina Maisano and Constantine Kaniklidis

When is it too late for early detection? All experts agree that finding a primary tumor at its earliest stage offers the most benefit to the patient because it may not have had a chance to spread. Surgery and chemotherapy can be started to stop its growth. The patient has the best chance of survival if her cancer is found early.

There has always been a controversy about whether there is a good time to find metastatic disease. The defeatist answer has always been, “Well, the overall metastatic outcome is not improved if found early.” After 13 years of being among women who are in all stages of cancer, from Stage 0 to Stage 4, I can categorically report that yes, indeed, if you find your metastatic tumor early, it helps. Does that mean the cancer can be cured? Cure is certainly extremely rare. Although certain types of oligometastatic disease, with single or only a few detectable metastatic lesions, can be effectively “cured.” There are some other special cases where metastatic patients can sometimes achieve durable long-term remissions. However, without question, metastatic disease remains the greatest treatment challenge facing oncology. It is also the one part of oncology that receives the least amount research.

Consider the woman who goes for regular oncology visits after her treatment has ended. She is followed every 4 months. At each visit the doctor draws a Complete Blood Count and a Tumor Marker level. Tumor Markers measure the level of cancer antigens in the body. If all are normal, then the woman breathes a tremendous sigh of relief and begins praying that all will be well at the next visit. Sometimes tumor markers are elevated. They are notoriously hyper sensitive and don’t always indicate the presence of disease. However, if they consistently rise at each visit, it could mean that something is amiss and the patient is then sent for a scan. A scan could show nothing or it could show a small mass somewhere that needs to be immediately treated. Many women who have had breast conserving surgery often find regional or local recurrence in the same or contralateral breast this way.

The Complete Blood Count seems innocuous enough. But for a woman with breast cancer, an elevated calcium level combined with an elevated alkaline phosphatase level can mean the presence of metastasis to the bone. Found early, bone metastasis can be treated quite successfully with drugs and radiation. The woman is considered Stage 4, but there are still years of living ahead of her. Why? Because she found her disease early.

If a woman is going to develop metastasis, the ability to knock down the disease while it is still small, treatable and has not spread anywhere else yet, means more birthdays, graduations, weddings, Christmases, family vacations and memories. It extends her life -  a life which is not a statistic.

At the 2013 American Society of Clinical Oncology meeting it was determined that regular blood tests are no longer needed. That goes for scans, too. The patient just needs a once-over by her oncologist every six months. And unless he has X-ray vision, what good will that do? Why even bother with visiting your doctor if they are no longer monitoring you? Some of the finest oncologists in the nation are following these guidelines. There is a window open right now where the patient can insist on blood work and when that window closes and patient insistence fails in the future, what some would call “subterfuge” will have to begin. In order to have a screening appointment, we will have to complain of some terrible pain that needs looking into. And, you can be sure, there will be a fight about that.

It should not be the case that the standard of care post treatment should also have to  include a few sessions at the Actor’s Studio so patients can be more convincing when they pretend there is something wrong with them just so they can get a test to make sure there is nothing wrong with them.

There have been a lot of changes in medical care lately. This is one of the worst. It is as if our oncologists have given up. They are not fighting for us anymore. They are not our hero generals on the battlefield. Instead, they are waving the white flag of surrender to not be proactive, to not look forward, and to not protect us.

We don’t believe in surrendering.  We believe in being your own advocate and refuse to let our  oncologists toss us into the “Well, let’s see what happens” pile. Fight back.  To that end, Constantine Kaniklidis, Director of Medical Research at the No Surrender Breast Cancer Foundation and Founder of Breast Cancer Watch has compiled a Patient Guide to arm yourself with when you next visit your oncologist.

Patient Guide
Questions and Answers

Q:  Some doctors seem to no longer be doing follow-up complete blood counts and chemistry panels, or CT, PET and MRI scans, or tumor marker testing. Why?

A:  ASCO - the American society of Clinical Oncology - has recently (2013) issued a guideline update on "Breast Cancer Follow-Up and Management After Primary Treatment" that states that these tests are  " . . . not recommended for routine follow-up in an otherwise asymptomatic patient with no specific findings on clinical examination". Oncologists often cite these ASCO Guidelines of 2013 as the reason for no longer offering these follow-up tests.
Q:  But are these guidelines binding on oncologists?

A:  No. ASCO in fact has explicitly disclaimed any mandatory force of these guidelines in clinical practice. Here's their disclaimer:
Disclaimer: “This information does not mandate any particular course of medical care. Further, the information is not intended to substitute for the independent professional judgment of the treating physician, as the information does not account for individual variation among patients” . . . “there is latitude for the treating physician to select other courses of action in individual cases”.

These guidelines are therefore explicitly discretionary, and they in fact instruct physicians to determine for themselves what if any of the suggestions to implement, counseling that the decision of testing  and which tests should always defer to the “independent professional judgment of the treating physician”. So ASCO recognizes that "the information does not account for individual variation among patients" and that "the selected course of action should be considered by the treating physician in the context of treating the individual patient".
Q: Are there certain cases that motivate the type of periodic follow-up testing that's been customary until now?

A: There are no formal guidelines here, but certainly a strong reasonable case can be made in advanced/metastatic disease, and in challenging higher-risk scenarios such as triple negative breast cancer (TNBC) and HER2-positive disease, which plausibly require close follow-up to monitor both disease progress as well as response to treatment, but any individual breast cancer case, even outside these, can still be a reasonable candidate for continued follow-up testing. Every case is  unique and patients should candidly expressed their views in an honest discussion with their oncologists.
Q: Is there evidence that these follow-up tests don't provide benefit?

A: In fact, there is only the absence of robust evidence decisively showing improvement to overall survival outcome, but this absence is not the same as having decisive evidence that the follow-up testing provides no benefit to the patient or her/his management. Every case is different, every patient is unique, and at least one authority (the National Comprehensive Cancer Network/NCCN) has expressed their view that although we have no decisive high-level evidence of benefit, we do have some evidence from several studies to  suggest plausible benefit.
Q:  What say, or role, does the patient have in what follow-up testing should be done?

A:  Quite a significant one. So with regard to tumor markers, NCCN (National Comprehensive Cancer Network), whose guidance on testing and treatment is authoritative for both oncologists and insurers,  states that" "The ultimate decision about whether or not to use CA 15-3 (BR 27.29) in this situation must be taken by the doctor in consultation with the patient" and they conclude that "In combination with radiology and clinical examination, CA 15-3 or BR 27.29 may be used to monitor chemotherapy in patients with advanced breast cancer", which is their stand on all follow-up testing. Therefore, you have a voice in any decision about these tests and should speak to your oncologist candidly concerning your own perspective on continuing periodic monitoring.

Team No Surrender, Constantine Kaniklidis and Gina Maisano

Breaking News

A breakthrough finding in vaccine therapy.

The following link will take you to the news of a woman whose advanced cancer was put into complete remission by a massive dose of the measles vaccine.

Further studies are pending, including a specific vaccine therapy for breast cancer.

Friday, May 9, 2014

H.R. 1984/ S. 1931: We Support the Breast Cancer Patient Education Act

May 7, 2014.

A beautiful, Spring day in our Nation's capitol was the backdrop for a very important step forward for women facing breast cancer. At the urging of the  American Society of Plastic Surgeons, a bi-partisan legislation was introduced in the House of Representatives by Reps. Leonard Lance (R-NJ) and Donna Christensen, M.D. (D-VI) and in the U.S. Senate by Senators Sherrod Brown (D-OH) and Roy Blunt (R-MO).

The No Surrender Breast Cancer Foundation is a proud  supporter of this Bill. As our founder, it was an honor to present before a distinguished group of physicians, law makers, survivors and the press. It was important for those present to hear from the trenches of breast cancer to illuminate how vital this subject is.

Back in 1997, a law was passed that insurance companies had to cover breast reconstruction. What that did was help women fight back if they were denied coverage. The problem with the law is that only 30 percent of breast cancer patients know about it. Seven out of ten women facing breast cancer surgery are unaware of their choices. It's no wonder, when you think about the soul-er vortex one enters after you hear you have cancer. Suddenly everything is at warp speed and you rely on your doctor to tell you what to do. If your doctor doesn't refer you to a breast reconstructive surgeon, or even start a conversation about what is available to you, it creates even more anguish because there are no options. You don't even get the opportunity to make a choice about what will happen to you. What's more, among minority groups, those for whom our Before Forty Initiative was created, the information provided after a diagnosis is even lower.

I was one of those women who was not offered anything other than a lumpectomy, which is a nice way of saying what it really is, a partial mastectomy.  I had an extremely aggressive tumor. I underwent 6 months of chemo and radiation that caused such extensive burns that it required even more breast tissue to be removed. This was followed by years of scares, scars and scans. And then, five and  a half years later, the cancer returned to the opposite breast. This time the tumor was even larger and had node involvement. I cannot help but wonder what would have happened if I had a bilateral mastectomy with reconstruction the first time. Would I have been spared the second round of nine months of chemo and more radiation?

I did ask about getting a mastectomy and was told, "No, no, you don't need that." Imagine if I had heard, "Yes, you should investigate that option, here is the name of a reconstructive surgeon who can take you through the steps...."  

That is what this Bill is trying to do. It won't cost the taxpayers anything. It would simply be making sure that women know their choices. It is going to be tough, but I think we can prevail. Awareness goes beyond the pink parades, it is details like these that women really need to know. And that is what I spoke about at the Capitol. I talked about how women are being screened too late. Breast density makes it almost impossible to see a tumor by mammography. Ultrasound and breast MRIs should be the standard of care for those with dense breast tissue. Women who have had reconstruction many years ago, such as an implant that has become hard and painful due to scar tissue, need to know that their insurance company must cover corrective surgery. Women with single mastectomies, need to know that they can get their other breast augmented or lifted to match their new breast.  Women who chose not to reconstruct, need to know what is available to them from prostheses providers.

This is not an issue about vanity. It is about choices, information and taking charge of your own health. Removing a breast offers a higher rate of survival than a lumpectomy alone. If you have certain types of breast cancers, a bilateral mastectomy is a must. Such is the case with lobular cancer, the kind I had the second time, because it tends to be in both breasts and is very hard to detect until the tumors are very large. There are women I know through the No Surrender Breast Cancer Foundation who have had their cancer return to their "saved" breast and look back wishing they had known all of their options.

There are a few hurdles to overcome such as will the high deductibles with the new Affordable Care Act  prevent women from moving forward? The insurance company may have to cover the procedure, but the hospital costs, especially with the deductible, will create a problem. Then there is the access to board certified breast reconstructive surgeons who may not accept ACA or Medicaid plans. And then the most mind blowing of all: Hospitals lose accreditation if they perform "too many" mastectomies. Just how many are too many? Especially when you take into consideration that you reduce your risk of recurrence by 90 percent with a mastectomy. And women, like me, who originally had a lumpectomy, became a frequent flyer at the ambulatory care center because of all the biopsies I had to endure because they "saved" my breast. Do they prefer you have a lumpectomy because they know how many times you will have to be back for suspicious lumps?

I was happy to be able to bring to life what really goes on in our world. From our fears, to our challenges with body image post treatment. I talked about the feedback I have received from my book, Intimacy After Breast Cancer, and the many women who felt empowered to reclaim their lives again after reading it.

I am more than happy to step up for this issue, and I applaud the ASPS and the many legislators who are on board already.