Thursday, December 6, 2012

EVERYONE TAKE A BREATH, NOT MORE PILLS

Yesterday, I had front row seats to see what happens when a story hits the media during a slow news cycle.  People are tired of hearing about the fiscal cliff which I prefer to call by its "formal name."  Does anyone recall the word?  Correct!
S-E-Q-U-E-S-T-R-A-T-I-O-N
No matter.  It seems we are ready to hang glide but I've been too busy running around a two square block area in San Antonio to pay much attention to any news.

San Antonio is lovely.  The Riverwalk is charming.  San Antonio is bustling.  There are researchers and clinicians and all sorts of folks in the breast cancer arena, from all over the globe, in that same two square blocks.

I am here as a patient advocate sponsored by the Alamo Breast Cancer Foundation.  We are a group of 31 advocates and we are a busy bunch.  Yesterday, the day began at 6:15AM.  Breakfast seminar.  Then, presentations.  Then, more presentations through lunch followed by an interview.  (There will be a video posted on the ABCF website and IF I don't look like a fool, I'll be sure to share!)  Then, a wrap up session on the official presentations and finally, a dinner seminar hosted by Novartis.  The day ended at 10PM.  Today will be the same.  Ditto tomorrow.

This medical symposium is THE event for presentation of the latest in breast cancer research.  Each paper gets presented in a 15 minute time slot.  Perfect for a chemobrain!  Not a chance of getting distracted.  If I glance away from the screen for a second, they've already moved to the next slide.  Yesterday, there was "Big News" expected.  It was "The News" for this 35th Annual Symposium.

Most people already know but some may not.  Study results were presented about tamoxifen.  They seem to indicate there is a benefit to extending the length of time tamoxifen is taken.  The study showed a benefit if the present five year regiment is extended to ten years.  Scientifically, the data presented was "statistically significant" and this is where things get a bit dicey.  Because there was statistical significance, within moments of the study presentation, the NY Times had a piece on their website and twitter was blowing up with this GROUNDBREAKING NEWS.

Hold ON.  HOLD ON.  Not So Fast!  Have we learned nothing?  Sound bites and headlines are just that.... they do not tell the story.  And the sound bites reached a fever pitch by 7PM last night.  This was approximately ten hours after the 15 minute presentation was delivered at the San Antonio Convention Center.  I was in the room.  Listening live.  And then, I had an opportunity to discuss this with a doctor.

Hint:  That interview I mentioned?  As luck would have it, one of my assignments was to interview a doctor and among the things included in my interview was the "ATLAS" study about the tamoxifen.  My debut in front of the camera as an interviewer and I got THE HOT STORY!  That, folks, is what I believe the news people call "a scoop" and I got the scoop. And then, the room full of advocates got the same scoop from a panel of FOUR medical oncologists.  This was a panel of brilliant doctors from all over the country.

I don't have the ability (at this moment) to get into the nitty gritty but I will simply say this:  "Significant" in the scope of a scientific finding is very different from significant as we know it in the real world.  Then, let's add the care we should always take when listening to anyone share statistics.  Statistics can be very funny.  Just how relevant is a particular statistic to YOUR given situation and this is the real take away from what happened yesterday.

While a benefit may have been seen in extending time on tamoxifen, does this mean it's across the board?  Of course not. Three women in one hundred might be spared a recurrence but at what cost?  It may be an FDA safe drug but y'all (my new twang, it doesn't take long....) can tell me how you feel about the medication.  Tamoxifen is really not "well-tolerated" from most patients perspective.

The medical oncologists have made it clear that they have just seen the data for the first time and they haven't had the chance to really analyze it, much less make decisions regarding how they will incorporate this information into a changing treatment paradigm.  There was immediate and unanimous consensus.  There is a small subset of patients for which they would discuss the benefits of additional treatment.  The decision would be a collaboration between doctor and patient and it would include a discussion of whether the potential benefits outweigh the known risks.

So...... NO FREAKING out over any splashy headlines.  The clinicians seem to be unsure how this is going to translate over to their patients and they were clear about their need to analyze the data before they make any suggestions or recommendations.

I'm not a doctor and I do not dispense advice or even suggest what is medically sound practice.  The only medically sound advice I have?  Sit down with your doctor.  Ask questions.  Understand how this study impacts your own set of circumstances.  Remember, there is no cookie cutter answer.  This cancer stuff is highly complex and the deeper we research, the more personalized our treatments will (and should) be.....

And WE must be a partner in our own care.  Talk to your doctor.  Frankly, I wasn't impressed with the numbers but I'm not a scientist or a clinician.  I'm just a woman trying to look at something as emotionally detached as possible.  Not so easy with this cancer stuff, but still.... logic and evidence based science should be the steering factors.  Not emotions.  Not splashy headlines.  Not scare tactics.

Evidence based science.  And a good discussion with your doctor.  At your next scheduled appointment.  I'm not cueing up the confetti on this one.  At least not yet and definitely not for a long time, IF EVER.....  Just sayin'  .... OK?  O-KAY!

17 comments:

  1. Anne Marie, Great advocacy in reporting - and calming - from San Antonio! It's complicated! Beth

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  2. Anne, Read today's blog with great interest. Just yesterday my friend mentioned to me she heard about the Tamoxifen and how good it was supposed to be. We need the facts before jumping on a bandwagon. Great job of letting us know.
    Mom xoxoxo

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  3. Totally agree, thanks for a great piece.

    Also, it sounds like this study compared the group to a group of women who had tamoxifen followed by nothing--but many women follow tamoxifen with aromatase inhibitors, and that's the comparison that really needs to be studied: Is ten years on tamoxifen better than a few years on tamoxifen followed by a few more years of aromatase inhibitors?

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  4. Great post and very good advice. The patients who took tamoxifen for 10 years experienced a 2.8% reduction in mortality. That might be significant for one person and not another, or not enough to outweigh side effects. We're getting better at personalizing recommendations but realize that we don't necessarily have the answer regarding what is right for YOU. We don't have a crystal ball. But I agree - take some deep breaths, and talk to your physician; come up with a plan that you feel comfortable with.

    Fern - we don't yet have a study yet on 10 years tamoxifen vs. tamoxifen followed by an aromatase inhibitor. The standard treatment for a premenopausal woman has been tamoxifen for 5 years only; AI's can only be used in post-menopausal women.

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  5. Thank goodness for your rational approach. I was slightly flipping out this morning after having read the news (apparently late) and wondering what’s up with the stats, the study sponsor, the results, and my situation. But you are right. It’s better to take a breath and just let this settle. Coincidently, I’ve got an oncology appointment next week. So, might as well save the concerns for him.

    Thanks! (And very interesting about the response at the conference, by the by. Good for you for grabbing the scoop!) ~Catherine

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  6. AnneMarie there were about 15 news stories about ATLAS and Tamoxifen when I went to put my newspaper articles together for my breast cancer articles newspaper (http://www.scoop.it/t/breast-cancer-news), and I was amazed at how skewed they were. As a patient who just finished five years with awful side effects from that drug, the last thing I wanted to read about was the ATLAS study. Luckily, as you wrote in this fantastic post, medical journals and the great panel of medical oncologists with Alamo at SABCS were not so fast to say this would become the new treatment regimen as a result. I am so glad you wrote this to show people they have to look deeper at the data, and what exactly the trial entailed and base their conclusions from that as well as professional medical oncologists interpretations and opinions. Thank you! -Susan

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  7. AnneMarie, I completely agree that the real world benefits aren't as great as they seem at first blush. And, I agree that every woman should carefully consider any potential benefits and side effects of any medication. However, I respectfully disagree on one point, that is the somewhat understated point that tamoxifen is bad. I did quite a bit of research when I was first offered tamoxifen as a chemoprevention. On every web site I visited with a board or public commenting area I found lots of women who complained about the side effects (some who never even took tamoxifen made complaints.) And yet, every real life woman I asked, including my sister and eight friends) not one of them had any problem at all with tamoxifen. I decided that the women on the boards were like the squeaky wheel. I started taking tamoxifen and never had an issue. Unfortunately, I still developed a triple negative metaplastic cancer but it wasn't tamoxifen's fault. When I was initially was offered the drug my doctor said this. "Women keep telling me they wish there was some magic pill they could take that would prevent them from getting cancer and I always tell them there is, it's tamoxifen." Thanks for the updates from SABC!

    ~Maria

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  8. Wow--I'm so impressed with your scoop! How exciting! I admit, though, that when my first reaction to the idea of 10 years of tamoxifen was "oh, hell no!" I'll take your advice and weigh the options, though. Glad you're enjoying SA. Get yourself a Texas-sized margarita!

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  9. AnneMarie, Your comment about statistics is right on. It is hard for a lay person to make sense of study statistics. Do not jump the gun! Talk to your doctor.
    Also, Maria, I agree with you about Tamoxifen. As a retired oncology research nurse that has seen Tamoxifen go from being recommended for the worst case scenario to evolving as a preventative treatment makes a good case for this drug albeit,as with all drugs, some of the side effects are risky. It is sometimes a crap shoot!
    Carla

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  10. The first article I read about this (before seeing this post) said "(t)he study was funded by AstraZeneca, which makes tamoxifen, as well as Cancer Research U.K., Medical Research Council, the U.S. Army and the European Union." When the pharma company is listed first, I question the results. Sorry, just paranoid.

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  11. Hi girlfriend! Left my comment on Lori's website. Great job of reporting! I will call Lori's cell, early in the morning and we'll make plans to meet. 2-3pm works for me.

    XOXOXO,
    Brenda

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  12. When I heard about this study, my first thought was, so is this finding just for premenopausal women? Because it wasn't really clear.

    Thanks for being the beacon of cutting-edge news! Have fun in SA, Lois Lane! ;-)

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  13. Spot on, AnneMarie. I commented on the fly about this last night on FB and another blog but my sentiments (may) have been taken out of context. I completely agree with you and others that weighing the risks and benefits of extending Tx is a decision that needs to be made on a case by case basis and rooted in a patient's risk profile which takes into account tumor characteristics, lymph node involvement, stage at diagnosis and a host of other unique factors. A 2-3% decrease may be insignificant to one patient and mean a world of hope to someone else. I just want to reiterate that in case I've been taken out of context anywhere.

    However, what I DO take issue with (as someone who works in the field of corporate communications) are the doctors who reported the study (or more specifically, their PR teams) as well as the media for not providing a responsible statistical context. Every media outlet under the sun (and many journalists whom I greatly respect) were all heralding the 25% figure. And at face value, that is irresponsible and misleading, at best.

    I'll never forget the volume of emails I received after I was diagnosed every time another "ground breaking study" hit the airwaves. Someone helpfully sent me a piece on Herceptin that I should discuss with my doctors (clearly not understanding that I was ER+ which meant I was not a candidate for that regimen). Have I considered an AI inhibitor? Well, perhaps I might --- AFTER MENOPAUSE. And so on. The point being that the average lay person simply DOES NOT understand how to interpret these studies. I've even had discussions with the anchors at my local station over the past three years, but when network's resident medical "experts" such as Richard Besser, Jennifer Ashton, and heck, even Dr. Oz are reporting the headlines verbatim without interpretation, things get messy and in my opinion, do the public a disservice.

    My prior comments were not meant to offend anyone that might feel a 2-3% reduction in risk is worthwhile, but as my oncologist is fond of saying, the results are simply "not ready for prime time". As you aptly pointed out, even the oncologists in the room need to digest this and decide what subsets might benefit the most initially. It would be nice to see a panel of doctors shape the message rather than letting the media run amok with it.

    As we always discuss on #BCSM, headlines like this are problematic for all patients. The same way no one should be accused of not eating enough broccoli or other super food if they are diagnosed, studies like this contribute to a cycle of (unnecessary) judgment and speculation. There will be those that blame themselves if they couldn't tolerate Tamoxifen or chose not to take it beyond the prescribed five years. That is anxiety that none of us needs.

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    1. I agree with you assessment. I'd like to point out my colleague Liz Szabo did give the absolute terms for this study in her article on USA Today.

      "In absolute terms, 12% of women on tamoxifen for 10 years died of breast cancer within five to 14 years after diagnosis, compared to 15% of those who stopped at five years."

      http://tinyurl.com/baagrul

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  14. Anne Marie, great scoop! And really good perspective/advice given... When I first read about this new NEWS on twitter I was expecting more. More in the way that when I read the numbers, I wasn't all that impressed. And to be honest, I got a bit anxious at first when I saw the new magical number to be 10 years... worrying what this would mean for me and my decision making down the road. So many decisions we have to make! Thanks for sharing your take on this info. I think we need to wait and hear my info on this study... was it all pre-menopausal? Was it a study funded by the Pharma company that makes Tamoxifen? Hmmm...

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  15. Thanks, AM, for adding another voice of reason to the discussion about the ATLAS study. OY, already! When there is a way of targeting only the estrogen that triggers breast cancer and leaves all our other tissues alone, then I'll get excited.

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  16. Thanks to all for the comments left here.... I have much to say but I have MUCH to unpack, too.....

    I've read all of your comments.... and I think we are all "right" in our thinking.

    One thing I will mention to all... I believe (and I have to go back and read my notes and go through the study data) the actual benefits are not seen until AFTER the 10 years. I recall the docs talking about 15 year mark.....

    The point? If someone starts today on the 10 year plan, I'm guessing there will be things to change the protocol plenty more times. And, medical knowledge doubles quickly.... so we will ABSOLUTELY be in a very different place with breast cancer treatment in 15 years.

    Going to shake some sense back into my brain!

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