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10 Years of Hormone Therapy Reduces Breast Cancer Recurrence Without Compromising Quality of Life – A “Rebuttal”

When I read that headline (title of this post) recently, I thought, really? What planet was that clinical trial done on? As I thought more about the content of the article (because you cannot go by headlines, as we all know), I decided I needed to write a “rebuttal” of sorts. Of course, my response here isn’t scientifically based. I don’t have data to prove my points, but I do have a fair number of readers out there who I’m pretty sure would disagree with that headline, and adamantly so. Don’t believe me? Check out this post. The comments keep coming.

First of all, a little summary about the article I am referencing, which was put out by the American Society of Clinical Oncology and presented at the recent ASCO Annual Meeting. The article summarized the results of a clinical trial called the MA.17R. The trial, which was  coordinated by the Canadian Cancer Trials Group and partially funded by Novartis, enrolled 1,918 post-menopausal women with early-stage, HR-positive breast cancer and who had received five years of one of the three aromatase inhibitors as initial treatment or after any duration of tamoxifen. The intent was to study disease-free survival (DFS) rates and quality of life (QOL). Participants were followed for a median of 6.3 years. Half received letrozole (Femara) and half received a placebo. Also, interesting to note, Novartis is the maker of Femara.

A second article I want to cite is one titled, Extended AI Therapy Improves DFS in Postmenopausal HR–Positive Breast Cancer, recently published in the ASCO Daily News. I will get to this one later.

So what is disease-free survival?

As stated on the National Cancer Institute’s site, disease-free survival means:

In cancer, the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Also called DFS, relapse-free survival, and RFS.

A few key results of the MA.17R study:

The annual incidence rate of contralateral breast cancer (cancer in the opposite breast) was 0.21% for participants on letrozole and 0.49% on placebo. At five years followup, 95% of women on letrozole were disease free compared with 91% on the placebo. Both findings are considered significant. There were also more bone fractures and more new cases of osteoporosis in the the letorzole group.

However, at five years there was no significant difference in overall survival between the two groups.

And again, taken from NCI’s site, overall survival means:

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works. Also called OS.

So basically, overall survival wasn’t impacted and disease-free survival was to some extent.

The study also looked at quality of life and how it was impacted.

This study concluded that QOL was not impacted much differently between the groups, although it was noted there were more vasomotor issues and sexual functioning was worse in the letrozole group. But it wasn’t significant the study summarized. Yep. That’s right.

This is the part that got me all hot and bothered.

Okay, bad pun ‘cuz as many of us know, hot flashes (known as vasomotor symptoms in medical jargon, just fyi) are a major QOL side effect for many women, as is sexual dysfunction. Various nasty side effects women often comment to me about include:  loss of libido, vaginal dryness and atrophy, bone loss, weight gain, joint pain, hair loss/thinning, difficulty concentrating, mood swings and fatigue, to name a few.

My observations/concerns about study results:

  • What exactly were the questions asked regarding QOL and how were they asked? Both are important.
  • Since the study’s participant’s had all completed five years of AI therapy already, perhaps the pool consisted of women who were experiencing fewer and less severe side effects to begin with, which could potentially skew the results. 
  • I didn’t see a mention about how many women in the study groups had had bilateral mastectomies (but I might have missed it). This component matters (to me anyway).
  • I was troubled by the cavalier attitude about bone loss in the second article I cited above. Ian E. Smith, MD, of Royal Marsden Hospital, United Kingdom, stated the following: 

    “We make a big fuss about this (bone-related toxicities), but the figures suggest it is not a big deal.” 

    I beg to differ. Speaking as someone who now has osteopenia (my bone health was excellent prior to hormone therapy), bone health is a VERY big deal. This side effect should not be brushed aside. Bone health matters. A lot.

  • Troubling side effects deserve validation and also a plan for how to manage them. This isn’t happening a whole lot, or at least not often enough. This is one more reason survivorship plans are so important. And btw, without meaningful survivorship plans and assistance in following them, you can keep your fake, patronizing National Cancer Survivorship days, as far as I’m concerned.
  • The 4% difference in disease-free survival is reported as significant, but to an individual patient, an individual woman leading and individual life, I’m not sure 4 points is significant to her.
  • I worry that women opting out of taking these drugs for various and personal reasons might be judged even more harshly for not “toughing it out”. (Yes, this happens already)
  • 100 deaths occurred in both groups. So again, no difference in OS, but troubling because that’s a lot of deaths. Maybe I’m missing something, but isn’t OS/number of deaths the most important thing?
  • Maybe I’ve been on the wrong AI. I suffered horribly on Arimidex. I’m doing better on Aromasin. I wonder how I’d be doing on Femara (letrozole) and if there are similar trials being done on the other two AIs. I hope so because maybe there is a big difference between them as side effects go. My experience so far has been sort of like finding out what’s behind door #1, #2 and #3.

You can read the QOL abstract conclusions here and the disease free-survival abstract results here.

Again, this study concludes that extending AI treatment to 10 years significantly improves disease-free survival without compromising QOL and without OS difference. But of course, this is only one study and its focus was on only one of the three commonly prescribed aromatase inhibitors. It’s not about to become “law” anytime soon.

And to be clear, I am glad these drugs exist; I’m still on one, for crying out loud. But I sure wish we had better options and at the very least, that women received more help in managing side effects when needed. I also hope all three AIs are being looked at and compared for efficacy and QOL impact.

So my question is this:  are the conclusions of this study somewhat misleading?

I say yes. The jury is still out on the benefit of extended AI therapy.

As usual, the benefit must be considered along with how an individual woman’s QOL is impacted.  Sweeping conclusions/statements about QOL may not be a good idea in this instance.

What do you think?

Are you on one of three aromatase inhibitors and if so, has your QOL been impacted?

Have you started extended AI therapy (the ten-year plan) yet or do you plan to?

Are you on letrozole (Femara) and if so, has your QOL been impacted?

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Deb Maes

Monday 1st of January 2018

Hi , I had a double mastectomy with 1 lymph node positive 10 years ago . Have been on tamoxifin for most of the ten years .one oncologist tried to put me on aromisin but the mood swings etc were so bad I had to go off it. I then had two periods and found I had pre cancerous cells in my uterus so back on tamoxifin. Since they really don't check your chest after a mastectomy and I had implants after two years I kept having ultra sounds done at my request . Found spots on my lung a few years later but they didn't grow . In the last year one did . It's back (mestatic breast cancer) . I don't know what kind of treatment yet but it has been suggested that one of these aromitase inhibitors be used. If there is all these side affects n only 4 percent benefit why are they being used?

Nancy

Wednesday 3rd of January 2018

Deb, I am sorry to read about your cancer recurring. Good luck on your new treatment. As for your question, not everyone finds the side effects intolerable and research does suggest there is benefit on staying on the drugs for some, but you're right about the number who do being questionable. I don't have the answers. Each person, along with her/his doctor must decide what's best for her/him. Thank you for sharing.

Cindy Dutton

Monday 10th of July 2017

I am so glad to have found this website wo read about others going through what I am so I don't feel so alone. I was diagnosed 2 1/2 years ago with metastatic lobular carcinoma and had a bilateral mastectomy. I was first diagnosed stage 2b and they took 2 lymph nodes out during surgery and both had cancer thus making it metastatic. I had 6 rounds of chemo/neulasta and then 28 radiation followed by 7 boosts. Now on Anastrozole. I had to go to my primary care doctor to get a scan as my oncologist did not think it necessary. I had no peace of mind until then. One day my oncologist said I was cancer free and I said no it is in my lymph nodes. I asked how we know how far it went because it was in both they removed. I was told they don't know. But obviously, I am more concerned about it than then. I don't have to tell any of you that cancer beats you up. I am now 64 and feel 84 most of the time. I am thankful to be alive and live with my loss of breasts. My surgeon must have been drunk or sleeping through my surgery and having had a total of 10 surgeries, counting my mastectomy, I am not able physically, mentally or emotionally to go through what would have been 2 more. My family is very supportive but I don't think they can truly understand what any of this is like. Thanks for sharing your stories and we can learn from each other's experiences and know that we are not in this alone.

laurie

Tuesday 20th of June 2017

Beth I'm so sorry to hear how you're struggling. I know it's no small consolation but you are among many who are suffering being on these drugs. I've joined to FB groups, one of which is a Tamoxifen support group. The sad thing is these drugs are the only arsenal doctors have to give us. Until such time as we collectively speak up and out, and we would be a vocal bunch given the number of new diagnoses, things aren't apt to change. When I asked my oncologist "what have you got TODAY to give me aside from Tamoxifen or Arimedex" he said "well studies are being done and things are in development". Again I said "what have you got to give me TODAY" and he said "nothing". After 25+ years this is their best defense?!? It makes me so angry!!!

Beth

Sunday 23rd of April 2017

Thank you for your review of this study. I have been on arimedex for almost one year. I can't remember names of things, my feet hurt all the time, I've gained 10 lbs., my skin is changing right before my eyes, I hot flash all day and night, my vag is drying up and I'm getting bladder infections on the regular. I'm 48. I am starting to consider taking it every other day. When I said my feet and hips hurt I was told it usually takes years for that symptom to happen. When I said I was tired of hot flashes I was offered an anti depressant. When I said I was getting bladder infections and sex hurt I was recommended estrogen cream (are you kidding?) She said it was OK. Well originally before I got this cancer I was given estrogen cream to rub on my legs. It stopped my hot flashes then, so obviously this little amount of cream gets into the body and affects hormone levels so how can that be OK? My urologist thought she was nuts.

Christine V

Monday 30th of January 2017

I was switched to Tamoxifen a few months ago. Fortunately I'm tolerating it pretty well. The previous aromatase inhibitors I took caused me an enormous amount of joint pain; I could barely stand up straight in the morning. Both of my hands developed a trigger finger and thumb. My GP referred me to a hand surgeon for cortisone shots (egads did those hurt...but they helped) and I asked if he had heard of a.i.s causing this and he said "YES!" Not so much from Tamoxifen though. In fact, he sent me a journal article about it. I forwarded that to my oncologist because she totally dismissed that being a side effect. A small victory! I agree with some of the previous commenters. Have your onco take this stuff for a month or two and she how she feels. It's been about 2 years now since my diagnosis and I'm dealing with weight gain and neuropathy in my feet. I was told that the a.i.s are not responsible for that, it's the chemo. Reading some of these comments, I'm not so sure. I take a very low dose of gabapentin. It helps a little. My onco wants me to up the dose but when I do that I feel like a zombie. I have gained almost 10 pounds since my chemo ended and I am frustrated as hell trying to lose any of it.

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