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Bren

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Reply with quote  #1 
Dear Constantine,

I copied the following regarding the B-14 trial and this presentation given by Dr. Mamounas in 2005.  Can you provide any information on what the actual numbers were regarding survival/recurrence rates w/wo Tamoxifen? I was Stage I IDC, node negative, and trying to decide if I should go back on Tamox or HT.  I have had a total hysterectomy and am 52.

Thank you for any help you can provide.

Bren

29th Annual Symposium of the American Society of Breast Disease 1
April 14-16, 2005, Las Vegas, Nevada
©2005 American Society of Breast Disease. All rights reserved.
Incorporating Genomics in Early Breast Cancer Management
View slides for this presentation
Eleftherios P. Mamounas, MD
Associate Professor of Surgery
Northeastern Ohio Universities College of Medicine
Medical Director
Aultman Cancer Center


"The NSABP has conducted pivotal studies in node-negative, ER-positive patients. B-14, the first pivotal trial comparing placebo to tamoxifen, demonstrated that tamoxifen treatment improved both disease-free and overall survival times."
 
 
FLLoriK

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I have to put my two cents in here.... I have bc mets and if I knew that taking a HT would lessen my chances of getting mets, I would have done it. Unfortunately, that sneaky devil didn't give me that luxury!

Bren

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Reply with quote  #3 
Lori,
I wish you didn't have mets too, and that you could have taken the HT meds before the cancer spread.  I've only been posting here for about 5 or 6 weeks, so I don't know your entire history, but I did read back a bit. I do know that no matter what our diagnosis, we are all changed forever, and will never live another day without fear.

If I knew that taking an HT would prevent me from getting mets I would gladly be sick for the next 5-10 years too, but I can't find a doctor who can tell me that.

So for now, I'll meet with my onc again in two weeks and talk to him about it again.  I'm truly sorry and sad that talking about not taking the HT meds has upset you.

It's a personal decision and I guess I should just keep my despair about the whole situation to myself, when I know so many others have suffered so much more than I have. 

You're in my thoughts.
Bren   
edge

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Endocrine (Hormonal) Therapy and Breast Cancer Risk Reduction

 

 

Brenda / Lori:

 

The NSABP B-14 Breast Cancer Prevention Trial (BCPT) you referenced found that tamoxifen given for 5 years reduced the risk of recurrence of invasive breast cancer by approx 50%, with clinically significant increases in both DFS (disease free survival) and OS (overall survival). Additional robust data from other large-scale trials and from the invaluable periodic Oxford Trialist's meta-analyses, have further shown that the benefit of tamoxifen endocrine therapy is maintained out to at15 years after diagnosis, continuing even at the 15 year post-diagnosis point to decrease mortality as well as recurrence risk. 

 

In this context, it's important to understanding the natural history of hormone-positive disease – meaning tumor status of either single or double positive (ER+ OR PR+, or both ER+/PR+ - which shows the highest recurrence risk within the first 2 to 2.5 years, with as peak hazard of recurrence of 13.3% at the two-year post-diagnosis point, but post-peak, tamoxifen shows a pattern of persistent non-null residual risk of recurrence, averaging approximately 4.3% residual recurrence risk per year in the years between five and 12, declining very very slowly thereafter. This is a critical fact about the natural history of hormone-positive disease and entails long-term endocrine therapy to avoid recurrence and associated potential metastatic disease, but with lower hazard of recurrence associated with lower (fewer), or no, nodal involvement and smaller tumor size.  It is for this reason that the current consensus is that hormone-positive disease must be treated as a chronic disease, with extended endocrine therapy, and that such long-term endocrine therapy is deployed as an essential anti-recurrence and hence also anti-metastatic intervention. 

 

This persistence of hormone-positive disease is often poorly understood by patients and even many oncologist alike, accounting for some regrettable undertreatment.  In addition, in briefly scanning some of the questions and discussions on this and other forums, there is considerable failure for core critical information about hormone-responsive disease, endocrine therapies such as tamoxifen and the aromatase inhibitors, and anti-hormonal options such as surgical ovarian ablation (aka, oophorectomy) and medical ovarian suppression via LHRH/GnRH analogs like goserelin (Zoladex) and leuprolide (Lupron), to have been disseminated clearly and accurately, both through oncology professionals and the popular media, engendering substantial confusion as to how to optimize endocrine therapies, choose between them, manage their adverse events, and customize them in particular contexts (low versus high risk, adjuvant versus metastatic setting, etc.).

 

I hope after I return from an NCCN conference this weekend to be able to take up some of the more critical of these issues and confusions in a posting on endocrine (hormonal) disease.  In the meantime, I hope this helps to clarify your immediate concern, more to follow shortly.  

 


Constantine Kaniklidis

Medical Researcher

Breast Cancer Watch 

edge@evidencewatch.com 

Bren

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Reply with quote  #5 
Thanks again Constantine,
I really appreciate all the time you've taken to help us out.

Brenda
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Reply with quote  #6 

Bren this study was the one my mom was on. She got IDC two years after being on Tamox for 5 yrs. She and one other woman at the time were the only ones with Tamox and IDC. Since then there has been a study with Tamox vs Evista, it takes years to gather the data.

If you look under elective Masectomies thread you will see my mom's history. Tamox is not a cureal for all people, but those it helps it does do wonders.

Constantine thanks for doing all that you do!


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Reply with quote  #7 
Constantine,

First I want to say welcome and I'm so glad you're here!  I am happy that you point out the confusion and lack of information on hormone responsive disease, endocrine therapies and anti-hormonals.  I look forward to your return from the conference with a new posting on this subject for the many ladies who need to make these tough decisions.

Thank you!
Charlene
Bren

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Reply with quote  #8 
Contantine,
I copied this text from National Cancer Institute (NCI), November 30, 1995.  As you know, the study was for node neg, er+, breast cancer.


B-14 Results:

Results from the initial randomization to tamoxifen versus placebo for 5 years were reported in 1989 (1). They indicate a disease-free survival and overall survival advantage for tamoxifen. Nearly 66% of those eligible, 1172 patients, agreed to the second randomization. Of these, 1166 are eligible for analysis (591 on tamoxifen and 575 on placebo). Starting from the time of the second randomization, the average duration of follow-up is 43 months. Patient pre-treatment characteristics (age, tumor size, type of surgery, ER and PR receptor levels) are well balanced per treatment arm.

Using actuarial estimates at 4 years of follow-up since the re- randomization, the data indicate that 92% of the group that received 5 years of tamoxifen are alive and disease-free compared to 86% of the group scheduled to receive 10 years of tamoxifen.

From looking at these numbers, it appears the difference was 6% between those given Tamoxifen and those given a placebo (92% vs 86%). That same 6% is the benefit I was given when I used Adjuvant.com. I was given a 9% benefit if using an AI, according to Adjuvant.com.

In looking at Adjuvant again, my 10 yr recurrence rate was given as 78.6 w/o an HT, so a 17.7% recurrence risk (mortality being 94.1).  Arimidex gives a 9% improvement, so this would be considered a 50% improvement in recurrence risk.  Am I understanding this correctly?  What are your thoughts on Adjuvant?

This was copied from the Adjvant website
 

The St. Gallen's (International Consensus) Panel 2001 (now outdated) proposed a 3-tiered risk classification for patients with negative axillary lymph nodes. This classification, with some significant modification, was used by the NCI as described below: 

First, 3 tiers for risk for node negative patients were identified. 

The NCI/PDQ reinterpretation (as posted on their website March 2003) of the 2001 St. Gallen's guidelines is confusing and not necessarily an enhancement. There are some strengths: the NCI/PDQ guidelines distinguish prognosis and treatment recommendations of patients with 1-10 mm tumors from patients with 11-20 mm tumors.  There are some inconsistencies as well.  For example a patient with an 11-20 mm tumor, which was ER positive and Grade 2 might be classified into either the intermediate or high risk categories. In addition the NCI interpretation of the importance of tumor young age (<35), and histologic subtype is unclear as compared to the St. Gallen's Guidelines. This ambiguity is reflected in a summary paragraph in the NCI material stating, “However one chooses to characterize node-negative tumors, …”. 

 

So, what I'm thinking is that although bc is considered a chronic disease, and we know there is no cure; cancer type, tumor size, nodal involvement, er status, family history and margins obtained, all play a role in deciding our QOL issues regarding SE's and taking an HT.
 
Again, thanks so much for all your help with these issues,
Bren


lini57

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Reply with quote  #9 

Thanks Constantine and Bren for the info.  Any differentiations for ductal vs. lobular?  Mom and two aunts had ductal and two did Tamox., one Femara.  Lots of SEs from the Femara, none from the Tamox.  All were post-meno.  I'm pre-meno and 4mm lobular and was not recommended any HT.   


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Bren

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Reply with quote  #10 
Hi Lini,
I've done a lot of research on this issue, but it was for IDC.  I don't know about ILC.  I know it can be tricky though.  Your tumor was very small and you had a mastectomy, so that was really proactive. According to the Adjuvant chart, that puts you at low risk. But I'm anxious to hear what Edge has to stay about Adjuvant. 

Hopefully, when Constantine gets back from his conference, he'll be able to give you some info on lobular stats.

Love,
Bren
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