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Old 03-13-2008, 12:54 PM   #1
MJo
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I need some opinions

My oncologist asked me if I want to be in a clinical trial on aromatase inhibitors. I have taken arimidex for two years. I would switch to Femara for the next three years (the good thing is that I would receive it for free). At the end of three years, I will have been on aromatase inhibitors for a total of five years. Then I would continue taking Femara or a placebo for 5 more years. I would not know if I was taking a placebo.
The study is to find out if 10 years is better than 5. In other words, do a significant amount of women develop metastasis after stopping aromatase inhibitors? Do I want to become a guinea pig? Is five years still the standard for AI? If am going to stop the medicine anyway in five years, why not join the study? I'm just afraid that doctors will continue BC survivors on AI after five years, while I'm on a sugar pill without knowing it and putting myself at risk of recurrence.
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IDC, Stage I, Grade 2
Oncotype DX Score 32
Her2++ E+P+, Node Neg.
Lumpectomy 11/04/05 Clear Margins
3 Dose dense AC (Couldn't tolerate 4)
4 Dose dense Taxol & Herc. (Tolerated well)
36 weeks Herceptin (Could not complete one year due to decrease in MUGA score)
2 years of Arimidex, then three years of Femara
Finished Femara May 2011
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Old 03-13-2008, 12:58 PM   #2
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See my earlier post, Drug...Progression"

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Old 03-13-2008, 02:57 PM   #3
tricia keegan
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Hi Mjo,
I can understand your questioning this as I think I'd feel the same. A friend of mine living in the States has tolerated arimidex very well for five years so her onc has just agreed to her request to stay on it for ten.
I think if I'm hopefully still cancer free after five years I'd definatly want to remain on arimidex myself and would feel nervous about stopping it. Sorry I can't advise you, just wanted to give an opinion but I think this is a very personal decision and not an easy one. Good luck whatever you decide.
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Dx July '05 IDC 1.9cm Triple positive 3/9 nodes positive
A/C X 4 ..Taxol/Herceptin x 12 wks then herceptin 1 yr
Rads x 36 ..oophorectomy August '06
Currently taking Arimidex..
June 2011 osteopenia/ zometa x1 yearly- stopped Zometa 2015 as Dexa show normal bone density.
Stopped Arimidex July 2014- Restarted Arimidex 2015 for a further two years on the advice of my Onc.
2014 Normal Dexa scan
2018 Mammo all clear, still NED!
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Old 03-13-2008, 06:09 PM   #4
Jean
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MJO,
Maybe this will help? When I saw my onc. we had a discussion about
length of time for the AI's...he stated to me that, "It probably will
be longer than 5 yrs. more like ten."

I think since AI have been out the last few years and data is still
not available....but patients are now rounding in the 5th yr. the onc.
are discussing this issue and what will be of greater benefit for their
patients.

Hope this helps some.
Regards,
jean
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Stage 1, Grade 1, 3/30/05
Lumpectomy 4/15/05 - 6MM IDC
Node Neg. (Sentinel node)
ER+ 90% / PR-, Her2+++ by FISH
Ki-67 40%
Arimidex 5/05
Radiation 32 trt, 5/30/05
Oncotype DX test 4/17/06, 31% high risk
TOPO 11 neg. 4/06
Stopped Arimidex 5/06
TCH 5/06, 6 treatments
Herceptin 5/06 - for 1 yr.
9/06 Completed chemo
Started Femara Sept. 2006

Last edited by Jean; 03-13-2008 at 06:15 PM..
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Old 03-13-2008, 07:38 PM   #5
sassy
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MJo,

My onc does feel that lenght on AI's will incease beyond 5 years. He said I may possibly be on for life.
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Rhonda (Sassy)
dx age 45
DX 2/15/05 Stage IIb (at surgery)restaged IIIa
Left mast .9cm tumor 5 of 14 nodes
Triple Positive
4 DD A/C
12 Taxol/Herceptin
33Rads
Strange infect mast site one year aft surg, hosp 1 wk
Herceptin for total of 18 months
Lupron Monthly 4 yrs
Neurontin for aches, pains and hot flashes(It works!)
Ovaries removed 11/09 stop Lupron and Neurontin
Arimidex 6 yrs (tried Femara, no SE improvement)
Tried Exemestane-hips got so bad could hardly walk
Back to Arimidex for year seven
Zometa 2X Annual for 7years, Lasix
Stop Arimidex 5/13
Stop Zometa 7/13-Bi-lateral Stress Fractures in Femurs from Zometa
5/14 Start Tamoxifen
3/15 Stem cell transplant to stimulate femur bone growth/healing
5/15 Complete fracture of right femur/Titanium rods both femurs
9/16 Start Evista stopTamoxifen
3/17 Stop Evista--unwelcome side effects!
NED and no meds.......
14YEARS NED!
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Old 03-14-2008, 10:04 AM   #6
Hopeful
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Remaining on an AI indefinitely is not without risk, as it has been demonstrated that bc can become hypersensitized to a low estrogen environment, and begin growing again, even in the extremely (but not 100%) ER deprived environment created by AI's. The way to "resensitize" the cells to estrogen deprivation is actually counter-intuitive: expose them to high levels of estrogen.

I have read about trials (which I think are going on in the UK only) to see if intermittent use of AI's after 5 years on them (i.e., three months on, three months off) is the way to go to avoid the hypersensitivity issue. At the moment, no one knows what the optimal duration for any of these drugs is.

Hopeful
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Old 03-14-2008, 10:51 AM   #7
Jean
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Hopefull,
I think the idea of 3 months holiday and then back on sounds good.
We benefit in two ways....
1) we get a break from the side effects of the AI...no joint pain....at all. 2) we then go back on after 3 months which certianly can not cause major harm as the recent data is showing from
the Femara study that delay up to 7 years is not hindering the treatment.

Sounds very interesting and offers the best of both worlds.

Regards,
Jean
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Stage 1, Grade 1, 3/30/05
Lumpectomy 4/15/05 - 6MM IDC
Node Neg. (Sentinel node)
ER+ 90% / PR-, Her2+++ by FISH
Ki-67 40%
Arimidex 5/05
Radiation 32 trt, 5/30/05
Oncotype DX test 4/17/06, 31% high risk
TOPO 11 neg. 4/06
Stopped Arimidex 5/06
TCH 5/06, 6 treatments
Herceptin 5/06 - for 1 yr.
9/06 Completed chemo
Started Femara Sept. 2006
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Old 03-14-2008, 06:11 PM   #8
Becky
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I am on Arimidex now. I do not relish the vaginal effects (using a bit of Premarin cream or not). However, when my 5 years are up, I plan on asking my onc to put me on 5 years of Aromosin. I am thinking this because of the study testing Faslodex vs Aromosin on metastatic women who failed on Arimidex (which works the same way Femara does while Aromosin and Faslodex work differently). I want something that inhibits estrogen differently than Arimidex so I am going to go that route as Femara worked in the second 5 years vs tamoxifen - perhaps because biochemically, it works differently. In the next 2+ years studies may prove differently but right now, that's my plan.
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Kind regards

Becky

Found lump via BSE
Diagnosed 8/04 at age 45
1.9cm tumor, ER+PR-, Her2 3+(rt side)
2 micromets to sentinel node
Stage 2A
left 3mm DCIS - low grade ER+PR+Her2 neg
lumpectomies 9/7/04
4DD AC followed by 4 DD taxol
Used Leukine instead of Neulasta
35 rads on right side only
4/05 started Tamoxifen
Started Herceptin 4 months after last Taxol due to
trial results and 2005 ASCO meeting & recommendations
Oophorectomy 8/05
Started Arimidex 9/05
Finished Herceptin (16 months) 9/06
Arimidex Only
Prolia every 6 months for osteopenia

NED 18 years!

Said Christopher Robin to Pooh: "You must remember this: You're braver than you believe and stronger than you seem and smarter than you think"
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Old 03-14-2008, 06:16 PM   #9
TSund
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Becky,

How did Faslodex do vs Aromosin, and which of the 4 would you recommend for one's "first" AI?

Thanks

TRS
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Terri, spouse of Ruth, Dallas/Ft. Worth area
Ruth dx 05/01/07 (age 50) Filipino
multifocal, several tumors .5 -2.5 cm, large area
Breast MRI showed 2 enlarged nodes, not palpable
100%ER+, 95%PR+, HER2+++
6x pre-surgery TCH chemo finished 9/15/7 Dramatic tumor shrinkage
1 year Herceptin till 6/08
MRM 10/11/07, SNB: 0/4 nodes + Path: tumors reduced to only a few "scattered cells"
now 50% ER+, PR- ???
Rads finished 1/16/08
Added Tamoxifen,
Finished Herceptin 05/08
NOW is the time to appreciate life to the fullest.
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Old 03-14-2008, 06:28 PM   #10
Becky
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The EFECT trial studied if Faslodex (shots) would outperform Aromosin (daily oral pill) on women with metastatic ER+ bc who progressed on Arimidex. Study showed parity (worked the same) which was great because women could continue to use another pill versus having to go to the cancer center for shots (plus some people just can't stand the thought of shots). So you can postpone Faslodex (and use it later if one progressed).

This probably isn't the answer Astra Zeneca wanted since they manufacture Arimidex and Faslodex.
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Kind regards

Becky

Found lump via BSE
Diagnosed 8/04 at age 45
1.9cm tumor, ER+PR-, Her2 3+(rt side)
2 micromets to sentinel node
Stage 2A
left 3mm DCIS - low grade ER+PR+Her2 neg
lumpectomies 9/7/04
4DD AC followed by 4 DD taxol
Used Leukine instead of Neulasta
35 rads on right side only
4/05 started Tamoxifen
Started Herceptin 4 months after last Taxol due to
trial results and 2005 ASCO meeting & recommendations
Oophorectomy 8/05
Started Arimidex 9/05
Finished Herceptin (16 months) 9/06
Arimidex Only
Prolia every 6 months for osteopenia

NED 18 years!

Said Christopher Robin to Pooh: "You must remember this: You're braver than you believe and stronger than you seem and smarter than you think"
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Old 03-14-2008, 06:38 PM   #11
TSund
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What about Aromasin vs Arimidex/Femara?

You are a wealth of info...
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Terri, spouse of Ruth, Dallas/Ft. Worth area
Ruth dx 05/01/07 (age 50) Filipino
multifocal, several tumors .5 -2.5 cm, large area
Breast MRI showed 2 enlarged nodes, not palpable
100%ER+, 95%PR+, HER2+++
6x pre-surgery TCH chemo finished 9/15/7 Dramatic tumor shrinkage
1 year Herceptin till 6/08
MRM 10/11/07, SNB: 0/4 nodes + Path: tumors reduced to only a few "scattered cells"
now 50% ER+, PR- ???
Rads finished 1/16/08
Added Tamoxifen,
Finished Herceptin 05/08
NOW is the time to appreciate life to the fullest.
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Old 03-15-2008, 06:45 AM   #12
Becky
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There is no data on how they work in a primary condition versus each other in early bc. There was one paper I know of that tests the 3 against each other in bone mets (using only an AI and no chemo). Femara was slightly better but there were only 20 women in the study and the difference was not significant. They would need to test 100s to get significance. That said, I think that all three work equally as well and one has to chose depending on side effects. I am just going to switch because I want something that works differently (unless other data comes out between now and 2 years from now). Perhaps I will need to switch back to Arimidex as I am lucky to not have joint problems on it. The vaginal issues would happen regardless of the drug (and if they didn't, I would worry that the drug itself wasn't working as well for me as Arimidex as I would think I might have a bit more estrogen floating around).

I do believe that there is a trial comparing the 3 AIs head to head in early bc. My cousin is on the Arimidex arm. She is being encouraged to carry on when she wants to switch drugs due to joint pain.
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Kind regards

Becky

Found lump via BSE
Diagnosed 8/04 at age 45
1.9cm tumor, ER+PR-, Her2 3+(rt side)
2 micromets to sentinel node
Stage 2A
left 3mm DCIS - low grade ER+PR+Her2 neg
lumpectomies 9/7/04
4DD AC followed by 4 DD taxol
Used Leukine instead of Neulasta
35 rads on right side only
4/05 started Tamoxifen
Started Herceptin 4 months after last Taxol due to
trial results and 2005 ASCO meeting & recommendations
Oophorectomy 8/05
Started Arimidex 9/05
Finished Herceptin (16 months) 9/06
Arimidex Only
Prolia every 6 months for osteopenia

NED 18 years!

Said Christopher Robin to Pooh: "You must remember this: You're braver than you believe and stronger than you seem and smarter than you think"
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Old 03-15-2008, 10:44 AM   #13
TSund
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Becky, do you know if the studies that compared the AI's against tamoxifen took into account the non-metabolizers of tamoxifen?

Thanks again my friend!

TRS
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Terri, spouse of Ruth, Dallas/Ft. Worth area
Ruth dx 05/01/07 (age 50) Filipino
multifocal, several tumors .5 -2.5 cm, large area
Breast MRI showed 2 enlarged nodes, not palpable
100%ER+, 95%PR+, HER2+++
6x pre-surgery TCH chemo finished 9/15/7 Dramatic tumor shrinkage
1 year Herceptin till 6/08
MRM 10/11/07, SNB: 0/4 nodes + Path: tumors reduced to only a few "scattered cells"
now 50% ER+, PR- ???
Rads finished 1/16/08
Added Tamoxifen,
Finished Herceptin 05/08
NOW is the time to appreciate life to the fullest.
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Old 03-15-2008, 11:55 AM   #14
Becky
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Dear Terri

Since the issue of Tamoxifen non-metabolizers is new, I am sure they did not take that into consideration at all. Especially since the ATAC trial (Arimidex or Tamoxifen or both) just published the 100 month followup.

The key trial though is the Femara one - taking Femara after 5 years of Tamoxifen and the fact that the women who took Femara did better so when the trial was over, they offered the Femara to the women who were controls. Those that opted to take Femara - even years and years after they completed the Tamoxifen still did better than those who only took the 5 yrs of Tamoxifen. And with those women - many had to be metabolizers since they remained NED up to 7 years AFTER ending Tamoxifen (Tam does provide long-ongoing protection as do ai's after the initial treatment is over).

However, your question is valid on how much better is an AI over Tamoxifen if you are a metabolizer. I do not remember the % of women who are not (to do some worst case scenario math. I say worst case because all you can assume is that all non-metabolizers would recur but that is not a true statement. And you also cannot say that all metabolizers would also not recur (at least during the time of treatment)).
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Kind regards

Becky

Found lump via BSE
Diagnosed 8/04 at age 45
1.9cm tumor, ER+PR-, Her2 3+(rt side)
2 micromets to sentinel node
Stage 2A
left 3mm DCIS - low grade ER+PR+Her2 neg
lumpectomies 9/7/04
4DD AC followed by 4 DD taxol
Used Leukine instead of Neulasta
35 rads on right side only
4/05 started Tamoxifen
Started Herceptin 4 months after last Taxol due to
trial results and 2005 ASCO meeting & recommendations
Oophorectomy 8/05
Started Arimidex 9/05
Finished Herceptin (16 months) 9/06
Arimidex Only
Prolia every 6 months for osteopenia

NED 18 years!

Said Christopher Robin to Pooh: "You must remember this: You're braver than you believe and stronger than you seem and smarter than you think"
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Old 03-16-2008, 07:59 PM   #15
TSund
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Hmm...I guess I didn't know how new. I thought the AI's were pretty recent research also...
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Terri, spouse of Ruth, Dallas/Ft. Worth area
Ruth dx 05/01/07 (age 50) Filipino
multifocal, several tumors .5 -2.5 cm, large area
Breast MRI showed 2 enlarged nodes, not palpable
100%ER+, 95%PR+, HER2+++
6x pre-surgery TCH chemo finished 9/15/7 Dramatic tumor shrinkage
1 year Herceptin till 6/08
MRM 10/11/07, SNB: 0/4 nodes + Path: tumors reduced to only a few "scattered cells"
now 50% ER+, PR- ???
Rads finished 1/16/08
Added Tamoxifen,
Finished Herceptin 05/08
NOW is the time to appreciate life to the fullest.
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