Thursday, May 17, 2012

Between the Headlines. You Choose.

While dire statistics about male breast cancer may have sounded like the big story from the American Society of Breast Surgeons’ (#ASBrS2012) annual conference early in May, there were others with more far-ranging consequences that didn’t hit the wire.
The name of the game for any woman facing breast surgery now is still ACOSOG Z11, the sea-changing clinical trial which showed that extensive lymph node surgery is no longer needed for women who have microscopic cancer cells in one or two lymph nodes. 
“There’s still a need to educate surgeons and patients that axillary dissection is unnecessary in many patients who have positive nodes (1-2) and who are undergoing lumpectomy and subsequent whole breast irradiation plus chemotherapy for breast cancer,” says Deanna Attai, MD, FACS, and co-moderator of the weekly #BCSM chat on Twitter.
With ACOSOG Z11 one of the pillars of breast cancer treatment, axillary lymph node dissection (ALND), took a serious hit.  Physicians know now that biology combined with staging predicts long-term survival in breast cancer patients, not just the stage at diagnosis.  This study will save thousands of women from painful, disfiguring surgery and its attendant life-long risk of lymphadema.  ACOSOG, a clinical study group of the American College of Surgeons established by the National Cancer Institute, is also looking at whether or not the same survival benefit applies to women undergoing mastectomy instead of lumpectomy as part of their treatment.  It seems logical to expect that it will.
            But to date no studies have been done to show whether or not women who receive accelerated partial breast irradiation, or APBI, could also bypass extensive lymph dissections.  Yet. 
            APBI, a form of brachytherapy, is one of the newer kids on the block in treatment.  In brachytherapy a device is implanted within the breast next to or within the original tumor site.  This is done on an outpatient basis after pathology reports confirm that surgical margins are clear and the scar from the lumpectomy incision has healed.
             Brachytherapy also has attracted some controversy.  Last December at the San Antonio Breast Cancer Symposium researchers from MD Anderson said that bracytherapy was associated with higher rate of later mastectomy, increased radiation-related toxicities and post-operative complications, compared to traditional whole breast irradiation.
            Then on May 2, the same day the ASBS conference opened, I saw this JAMA article “Association Between Treatment with Brachytherapy vs. Whole –Breast Irradiation and Subsequent Mastectomy….” with headlines like this “More Women Need Breasts Removed” right on its heels.
Coincidence?  Probably. Soothsaying has never been one of my skills.  But note that a trial ASBS presented, “Brachytherapy as Effective for Local Breast Cancer Control as Whole Breast Irradiation” wasn’t released until May 4, two days after the JAMA article appeared.
There’s a lot to say.
In both cases, the retrospective data analyzed by the MD Anderson group or the Mammosite® trial reported by the ASBrS, survival was NOT adversely affected by the use of brachytherapy or APBI in women with early stage breast cancer who had been treated with lumpectomy.  In other words, a woman does not increase her risk of death in choosing between the two.
What the JAMA issue does not analyze (nor could it) is the best candidate for the short-term course of radiation.  The JAMA data was compiled from an analysis of Medicare claim forms (not medical records) of 92,735 women – the average patient age was 74 – treated between 2003 and 2007.  And while the potential risk of mastectomy in patients treated with brachytherapy echoed loudly in headlines what were the actual numbers? 
For older women with early breast cancer, some 3.95, or close to four percent were more likely to have to undergo a mastectomy vs. 2.18 percent undergoing whole breast radiation.  Granted, if you are the woman in the differing 1.77 percent having to undergo a mastectomy after prior lumpectomy and APBI would be difficult yet the inference, that the subsequent mastectomy was related to brachytherapy cannot be inferred from claims data. The information isn’t complete.  
Another question is how many women within that 3.95 percent had cancer recur close to the original tumor? That is the million dollar question and what only trials can determine.
Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society said here, “The question has always been whether the use of these newer techniques has the same benefit of treating those silent areas that we know exist in other parts of the breast.”
The great majority of local recurrences actually occur within one centimeter of the original tumor, Dr. Attai said.  In the ASBS study, seed radiation via MammoSite® (the implanted device that delivers the radiation) is as effective as traditional or whole breast radiation in preventing local recurrence in a subset of patients with early breast cancer.  These patients have now been followed for five years.
           “Right now offering APBI outside of a clinical trial is only recommended for women older than age 45-50, with tumors <3cm, clear margins, and negative lymph nodes,” Dr. Attai said.  “It will remain to be seen if factors such as tumor grade, ER/PR and Her2/neu status, and other factors are important in the patient selection process.”
          Bottom line:  if you are currently considering brachytherapy carefully research both your surgeon and radiation oncologist. You need to ask pointed questions. Accelerated radiation, delivered twice a day for five days as opposed to 30 – 33, is a great deal more convenient for working women. It also delivers less ionizing radiation to the surrounding tissue -- remaining breast tissue as well as ribs, lung and heart -- than whole breast radiation. 
It’s important that you know what device the surgeon uses (whether MammoSite® or SAVI or Contura) and her/his experience with it.  One of the coolest things I ever encountered in my own ‘ask the doctor journey’ was when I was considering reconstructive surgery and asked the plastic surgeon how many (free) flaps he’d lost.  Without missing a beat and not minding the question at all he simply said, “none.”
But you have to ask. You also need between the headlines for the information you need to make critical decisions about radiation.  Shorter-term has its own set of side effects (physician skill is key) and benefits – better cosmetic outcome and skin damage in most cases. As with any newer procedure a surgeon’s training and experience are the best predictors for the best possible outcome.  In essence, APBI with MammoSite® is shown as effective as conventional radiation for women with some early stage breast cancer.
              “MammoSite was the first device approved and has the largest amount of associated data. Newer devices allow us to better sculpt the radiation dose and minimize excessive exposure to the skin, ribs and lungs, and potentially making this treatment available to a larger number of women,” Dr.  Attai said.
               Keep asking your questions.  Talk back to the headlines until you’re comfortable that you’ve gathered all the information you’ve needed for the best possible cancer treatment.  I think that with the right surgeon, APBI is an excellent option.  But you have to know it’s available, to even choose.

#  # #

1) May 7, 2012 Tweetchat:  Findings from the ARBrS2012 Conference
2) American Society of Breast Surgeons: APBI Selection Criteria

Disclosure:  I am a patient liaison for the American Society of Breast Surgeons, a voluntary advocacy role.  I was not asked to nor did I accept any payment for this article.  But I did ask questions because hearing both sides of the story, especially in regard to breast cancer therapies, is always important to me.


Sally Church said...

Nice post, Jody - thanks for summarising this - I learned a lot!

Anonymous said...

Thanks for posting this, Jody. It's so important to take some time to really read through the studies and understand the science, not just react based on headlines. Thanks for providing some needed clarification. And women should ALWAYS feel that they can ask questions - it's their care.

Jackie Fox said...

You are one heck of a journalist. THANK YOU for putting your formidable intelligence to work on this.

3laine said...

Great post - great info and really informative. Fascinating stuff!

The Accidental Amazon said...

Great post, Jody. Looking behind the headline hype is crucial to advancing real understanding. Thanks for another stellar analysis.

Anonymous said...

Sigh! I so wish I had known then what I am learning now Jody about treatment options. I feel so angry when I realize all the wrong choices I made (not knowing any better) at the time of my treatment from full axillary clearance (no lymph nodes involved - not necessary) to fertility implications and now brachytherapy options. I am living with the longer term consequences of these decisions but at least I know that by spreading more information like this, we can help those who come after us, to make more informed decisions for themselves.

Jody said...

Oh, Marie, I truly feel badly for the array of consequences you're still dealing with from treatment. It's one thing when you understand that you may have some side effects down the road. But life-altering consequences puts that on an entirely different scale. It certainly reinforces the need for all of us to keep advocating in the way we do.

I'm increasingly convinced that we need to find a way to find more women at the point of diagnosis -- when some of the decisions with the life-long consequences are made.

Thanks for reading, Amazon:)

The Accidental Amazon said...

Marie, your comment certainly resonates with me and with many. Still living with long-term, lasting consequences of treatment myself, and I get tired of talking aboout them and putting up with them. But one long-term, lasting consequence of all this is that we are all blogging about it, hopefully making it better for others. Hugs to you.

Jan said...

Jody, this information is critical to the breast cancer community. How many patients even know about the axial dissection study, let alone the new radiation options? Without knowledge from Dr. Google, bloggers or their doctors or nurses, they forge ahead with blinders on. I'm going to share this post with my facebook readers. It's must reading, even for those who are at risk for, or have, lymphedema. xx

Beth L. Gainer said...

Jody, thank you for this very informative post! You are an awesome reporter, and giving us this information is so useful. I had the full axillary node dissection, and I've had lymphedema. It all could've been avoided, but at the same time, science is ever-changing, hopefully for the better,

Exciting things are on the horizon.

Jody said...

Thank you both - Beth and Jan. I agree; unless we keep getting the information our to our readers only those whose surgeons are up-to-date on current practice will benefit. That is alarming to me...since medicine, like many multi-layered systems are slow to change. In some ways patients are moving faster. We need to make sure that newly diagnosed women are aware of information like this.

And Beth - yes, I had the full axillary node dissection as well and that caused a string of problems, including lymphadema. It's wonderful that a woman's mortality won't be affected by bypassing a full dissection...under the right circumstances, of course. Amazing, indeed.

David Haas said...

I have a quick question about your blog, do you think you could email me?

Mihir Sarkar said...
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