ASCO SOFT and TEXT.......

voraciousreader

 

 

Study may open new options for younger women with breast cancer

7:31am EDT

By Julie Steenhuysen

CHICAGO (Reuters) - The estrogen-blocking drug Aromasin worked better than the long-standing therapy tamoxifen at keeping cancers from returning in younger women with early stage breast cancer, a finding that may change the way the patients are treated, U.S. researchers said on Sunday.

Aromasin, a drug developed by Pfizer Inc that is sold generically as exemestane, is in a class of treatments called aromatase inhibitors that are typically used in post-menopausal women with low levels of estrogen.

Aromatase is an enzyme that converts the hormone androgen into small amounts of estrogen.

The drugs have largely been off-limits for younger women with working ovaries that produce estrogen.

In premenopausal women with hormone-sensitive cancers, the standard for preventing recurrence is five years of treatment with a drug called tamoxifen. For high-risk women, doctors in some countries recommend exemestane plus some form of therapy to shut down the ovaries, cutting off the supply of estrogen. That practice is not typically followed in the United States because there has not been enough evidence to show a benefit.....

http://www.reuters.com/assets/print?aid=USKBN0EC1DW20140601

 

 

rgiuff

Happy to see that mention was made about the effects of menopause on young women as being an important issue to think about. Quality of life and maintaining overall body health is important too. 

grahaad1

Anyone out there on tamoxifen alone that has talked to their doctor about this study and whether they should begin ovarian suppression and an AI instead ?

rozem

me...I was already on ova suppression and was told to switch from tamox to an AI based on this but im still on the fence bc of SE/and maybe stopping the shots

  I am going to ask my second opinion MO and report back

CoastalXPat

I'm coming to this a little late, but have been thinking about this a lot since I'm supposed to start hormone therapy in about a month and am trying to figure out what to do.

My MO has left it up to me, though she lightly leaned more towards tamoxifen w/o ova suppression. I guess we'll
learn more about that when the results of the SOFT/TEXT tamoxifen-only arm come
out. She said that's because I'm stage I (even though I'm HER2+, grade 2, and just finished chemo). She did say that if I were metastatic then it'd be a different conversation, definitely go with suppression + AI's. At the same time, I'm a bit scared of getting a recurrence, those chemo treatments were tough.

So I went directly to the paper (here's the link), and even though the numbers are better for suppression + AI's, here are some things to consider (from Fig 2):

1. AIs + ova supp do better against local recurrences than tamox + ova supp, with absolute rates differing ~4% over 5 years.

2. AIs + ova supp do better against distal recurrences, but then the difference in absolute rates is only ~2% over 5 years

3. Overall survival rates were about the same. 

Now I'm no MO or MD (I am a scientist but I study rocks), but with these rates and side effects of AI's, I'm leaning towards tamoxifen. 

Wondering what others think?

voraciousreader

Coastal....nothing is written in stone!  I'm sorry for the pun.  I just had to say it!!!!!

 

But truly, nothing is written in stone.  If you head over to the NCCN website and register and read the professional version (red logo) of the breast cancer treatment guidelines, you will see all of the current data regarding all of the studies.  While the latest news that AI's with O/S is now an option, remember, it is merely an option and that means you now have more choices.  With the ATLAS and atTom studies, we learned that 10 years of Tamoxifen is now an option as well.  So basically, you have now more choices to make.  Perhaps you would like to start with Tamoxifen and if you do well and experience little side effects, continue with it for 5 or 10 years.  You can also begin with an AI and do O/S pending more data which should come our way at December's San Antonio Breast Cancer Symposium.  Or you can begin taking Tamoxifen for several years with or without O/S and then switch to an AI.  Unfortunately, once you read the NCCN guidelines there is no right answer.

 

But you also are aware that it is better to look at absolute risk over relative risk and overall survival.  Again, the data isn't quite there yet. 

 

I wish you well with your decision!  And again...since nothing is written in stone, you can always change plans depending on your side effects and as more data unfolds, you can always switch course.

CoastalXPat

Hi Voracious, thanks for the pun!  I like puns, they have a way of keeping us, um, grounded... (*groan!*)  ;-)

I have to agree that the state of knowledge does keep changing, and all you can do is work with the best available data at the time. 

That said, the message I keep hearing from the SOFT/TEXT trials is that if your goal is not having a recurrence, then OS + AI's are your treatment of choice. This is more important for higher-risk women, but how do you define higher risk? This seems critical since OS+ AI's can come with a lot more side effects, especially for us pre-menopausal gals. If the increase in risk is slim, how much do you want to put your body through?  And even then risk is kind of abstract - you either get a recurrence over a period of time or you don't. No one gets say 10% of a tumor.

But when you go to the article, it's not so simple. You make a fantastic point re. absolute numbers. Relative numbers are bigger and sound much more dramatic. Some reports (e.g. cancer.gov) only reference the relative ones. So for OS+AI's vs. OS+tamoxifen: 

28% relative reduction in any cancer recurrence, 34% reduction in breast cancer recurrence

vs

2% absolute reduction in any cancer and 4% reduction in breast cancer recurrence.

So this tells me that if you put 50 women treated w/OS+tamoxifen in one room, and 50 women with OS+AI's in another room, then after five years about 4 women in the tamoxifen room are likely to have a distal recurrence whereas ~3 women in the AI room are likely to have a distal recurrence. Since you went from 4 to 3, that's a 25% reduction (close to 28%). And 5-6 may have a local recurrence (i.e. breast) with tamoxifen vs. 3-4 for the AI room (about two-thirds, or a 34% reduction). Now of course reality isn't so simple, there are things like nodal status, size of the original tumor, degree of hormone receptivity, HER2 status, other treatments, lifestyle, genetics, environmental factors etc. that will all affect this, but I think that puts it into perspective a little.

My point is that if you didn't look at the original study, you might think you're gaining a lot more w/AI's than you actually are. It's key to consider how high-risk you are. But I also have to admit, it makes me a little bit uncomfortable that the Pfizer was one of the main funding sources for the study - Pfizer makes AI's but tamoxifen is generic. Looking at the peer-reviewed NEJM article, I sincerely believe it was written objectively and the data are good, as far as my layperson eyes can tell. However, as for the presentation to media outlets, I'm not so sure.

After all that, I'll probably start with just tamoxifen, but as you say it's not set in, um, stone. Maybe that will change as the research develops...