Polite Explanations are Welcome....

AlaskaAngel

I too had to laugh. What I was thinking about when I wrote it had nothing (as far as I know) to do with ovarian ablation or my original question. The discussion had been diverted by a book about different ways of thinking. I was thinking about how relevant metabolic research is for progress in finding more effective answers for treatments. It seems the discussion wandered back in the direction of OA.

A.A.

Kaara

VR:  I read the study with interest and can only add that when I first had my CRP and Vitamin D levels checked by my bioidentical hormone doctor, my CRP was high at 79 (I had an upper respiratory infection at the time of the blood test) and my Vitamin D levels were low at 27.  I was put on Vitamin D therapy of 5,000 IU's and my CRP test was repeated and came back at normal levels.  Fast forward to 9 months later...my Vit D levels had increased to 57 and my CRP levels were even lower...go figure.  After bc dx, I added an integrative doctor to my team and his guidance as to what supplements and diet I am on have been invaluable.  

It really is too bad that we don't study the benefit of vitamin therapy and its impact on the population.  Call me nuts, but when I've taken my vitamins and minerals in reasonable doses, I am healthy and have more energy.  When I don't take them...as I have done in the past, I always have more illnesses and lack energy, my fingernails break easily, my hair thins, and so on.  That's enough to convince me that I'm doing the right thing.  I don't personally need a scientific study for back up.

"Thinking Fast and Thinking Slow"....I will definitely read the book because I enjoy reading about how people think and make their decisions.  I read the book "Emotional Intelligence" many years ago...it was way ahead of its time, but I found that I was employing many of the author's techniques in my day to day business dealings.  As a woman who survived 35 years in corporate America working side by side with the good ole boys, you have to have a lot of intelligence, both emotional and rational, and it served me well.  There were co workers who could run circles around me on the intellectual level, but in the end, I ran the most successful unit in the system for many years.

 I've tried to use the same approach in dealing with my breast cancer...arm myself with all of the information that I can find, from both the conv and alt side and then make a decision that I "feel" is in my best interests.  There are never any guarantees..regardless.   

Beesie

AA, you say 

"I don't think of science as being antithetical to common sense, either -- although sometimes science is a bit blind." 

I agree. Sometimes science is a bit blind. And remember too that common sense is far from common. Nor is there agreement as to what constitutes common sense.  Reading this board (all forums, not just this one) often has me shaking my head at what others consider to be common sense. But who's right?

That may be part of the reason why there is so much disagreement and contention (and fortunately, some good humor and a few laughs) in your thread. You see things one way and think it's obvious and common sense but some others don't see it the same way. For example, you described OA + Tamoxifen as being "a far more immune-protective, briefer, less expensive, and less difficult therapy ".  I see OA + Tamoxifen completely diffferently.  OA affects you for the rest of your life, and you must take Tamox. for 5 years of your life. I understand that chemo can be miserable for the time that you take it and I appreciate that a small percentage of women suffer long-term side effects, but most women move on from chemo with little-to-no long term impact.  If I'm diagnosed with cancer again and if I need to this decision, from everything that I've learned about this so far, I'm pretty sure I would rather take my chances with chemo that than undergo surgery that would change and permanently affect my body. 

I'm not saying that you are wrong in how you view OA vs. chemo for yourself, but I'm not wrong either in how I view it.  It's just two different opinions. I certainly understand your frustration that more data is not available on how the results of OA compares to other treatments. I agree that information should be available for anyone who wants to consider this as an option.  But to your question about why this research hasn't been done to-date, you have to consider that for a study to be done, there needs to be: 1) a need for the study, i.e. enough interest in the option that it is worth researching; 2) a researcher interested in doing the study; 3) a facility (hospital, research facility, pharmaceutical company) to fund the study; 4) enough people willing to participate in the study so that a meaningful result can be obtained, and 5) time (probably at least 10 years if not 15 or 20 years) to get results.  As someone interested in the option of OA, you probably look at that list and think that all those criteria should easily be met.  As someone not particularly interested in OA, I look at the list and can see clearly why this research hasn't been done yet.

voraciousreader

AA... says:

"As pointed out by me in a list previously, there are those for whom chemotherapy would not be an option. If there is an assumption presented that OA + tamoxifen is "inferior to all currently used chemotherapy" when it is not, and also no proof at present that it would not be when combined with newer therapies than chemotherapies, I don't think it is harmful to raise that question"

AA. HAVE YOU READ THE SOFT AND TEXT TRIALS AND THE PERCHE TRIAL???  HAVE YOUR READ ALL OF THE FOOTNOTES IN THE NCCN GUIDELINES??? 

Breast Cancer (SOFT) Study

IBCSG-24-02: A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer (SOFT)

Protocol ID

04-018T

Protocol Description

Treatment with hormones has been shown to help prevent breast cancers from coming back after they have been removed by surgery if the breast cancer has hormone receptors. The hormone generally used is tamoxifen, and it is usually given for five years. It has also been shown that suppressing (shutting down) the ovaries (which stops them from making hormones such as estrogen) helps prevent breast cancers from coming back in women who are premenopausal (women whose ovaries are still making hormones).

This study is being done to see if shutting down the ovaries plus giving tamoxifen is better at preventing the return of breast cancer than just giving tamoxifen alone in premenopausal women. It will also test whether a newer hormone drug called exemestane plus suppression of the ovaries is better than tamoxifen plus suppression of the ovaries. In addition the side effects of these different treatments will be studied.

Eligibility Criteria

Patients with breast cancer

Primary Investigator(s)

• Daniel Budman, MD

AlaskaAngel

I do think that people who have never personally experienced chemo have no direct way of knowing what it is like. That includes those who have no cancer diagnosis, those whose treatment was not recommended to do chemo, those who have yet to do their treatment, or those who have chosen not to do chemotherapy, as well as those who have.

It was obvious that some here didn't even know that a trial offering trastuzumab alone was in progress, and their belief was that it would never be done because it wouldn't be ethical. There were those who believed that there was no information available about the use of trastuzumab alone and that kind of use would not happen until chemotherapy and trastuzumab was not the standard, but as I was the first to point out here, neoadjuvant treatment with trastuzumab was having some interesting results. Shortly after that, the moderators posted about the dual therapy neoadjuvant trial with trastuzumab and lapatinib that was showing good results.

HER2 positives compose only around 20 to 33% of bc patients. Unlike the larger group of all bc patients, the average age of HER2 positive patients is much younger, and presumably would have a larger pool of premenopausal and menopausal patients in it, and far fewer postmenopausal patients in it. From there, the number of HER2 positives who should be told about the option would be the HR positives. And from there, the group would be reduced even further by those who don't want to terminate their fecundity, although that also happens with chemotherapy for some, and happens sooner than it would have without chemotherapy for those who do chemotherapy.

I see enough patients posting who are HER2+ and HR+ to believe that likely that group is of sufficient number to warrant verifying whether it would be more effective, as effective, or less effective for them, and I was one of those who would have chosen it so I asked the question here because this is a forum specifically discussing possible alternatives. There are many topics discussed in this forum that interest a limited patient population.

A.A.

Beesie

I didn't require chemo so my opinion doesn't count.  I got it. 

What a shame, since I was agreeing with you that the research is lacking and should be done. I was simply trying to provide, in response to your very specific question, one explanation as to why perhaps the research has not yet been done.  But I didn't require chemo so obviously I don't understand and I'm wrong. 

Okay, never mind then.  

voraciousreader

Beesie...I was going to mention that there is no date stamp on how long research might take and possibly be completed.  Often trials build on one another and can, as you mention take decades.  I know from the research done on the DH's disease, the doctor who discovered the "Lorenzo's Oil" that he takes, took twenty years of his time to FIRST get it into a clinical trial.  The trial is presently being done....The doctor who discovered the use is now RETIRED and gave the clinical trial to the Chief of Genetic Medicine at Pittsburgh Children's Hospital.  At our last visit, I asked the doctor why he took over the trial...which might consume the next 10 years of his life...and he replied that he "believed in the treatment."  Imagine, on a hope and a prayer and a BELIEF, this physician decided to take on the torch....Thirty years of research...to help fewer than 500 people in the world with the DH's disease.  Probably a couple of more thousand within the family of disorders...But 30 years.....

AA....Could you please repost the study where Herceptin is being used as a monotherapy for Early Stage Breast Cancer.  Some how I find it hard to believe that they would be meeting their quota of participants.....

thenewme

Re: "I didn't require chemo so my opinion doesn't count. I got it. "

Yeah, Beesie, my opinion doesn't count either.  I *did* have chemo, but I'm not 10+ years out yet.  Oh, and I'm too young and premenopausal to have any input.  

It's pretty clear that the only opinions that count are those who've had really, really crappy doctors who prescribed them really crappy treatment 10+ years ago, who  were 12/3/2001 at age 51 (premeno), IDC, 1.6 cm, Stage I, Grade 3, some DCIS with dirty margins, 0/1 nodes, ER+/PR+, HER2+++, lumpectomy, CAFx6 (refused blood boosters), IMRT rads with rads necrosis, 1 3/4 yrs tamoxifen, no evidence of recurrence, no trastuzumab, no taxane, no aromatase inhibitor, primarily vegarian organic diet, 1 hr exercise/day.  

Alrighty, then.

suzieq60

VR - it is being trialled in patients over 70 - AA posted the link on the HER2 forum.

voraciousreader

Susieq...I recall the study...but is it meeting it's quota?  That's the problem...not the design of the trials...but getting brave women to join.  And recall, as I mentioned to Eve, doctors will NOT recommend chemo unless they think the patients are healthy.  So the question with the over 70 co-hort...are they being recommended for the trial because they might have NOT be candidates for multiple therapies?  Not sure if they'll be able to apply the results of the trial to younger women....And again, younger women have more aggressive disease....Hmmmm... 

Thenewme...AMEN.

voraciousreader

 300 women...150 in each arm?  Wonder if they'll get enough participants. And if they do...It really is a small number of women.....

Evaluation of trastuzumab without chemotherapy as a post-operative adjuvant therapy in HER2-positive elderly breast cancer patients: randomized controlled trial [RESPECT (N-SAS BC07)].

Sawaki M, Tokudome N, Mizuno T, Nakayama T, Taira N, Bando H, Murakami S, Yamamoto Y, Kashiwaba M, Iwata H, Uemura Y, Ohashi Y.

Source

Department of Clinical Oncology and Chemotherapy, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan. m-sawaki@med.nagoya-u.ac.jp

Abstract

OBJECTIVE:

This trial is conducted to investigate the benefit of trastuzumab monotherapy compared with a combination therapy of trastuzumab and chemotherapy in women over 70 years with human epidermal growth factor receptor type-2-positive primary breast cancer.

METHODS:

Inclusion criteria are the following: histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer; Stage I, IIA, IIB or IIIA/M0; and baseline left ventricular ejection fraction is ≥55%. Patients are randomized to receive either trastuzumab (8 mg/kg loading dose, 6 mg/kg every 3 weeks for 1 year) plus chemotherapy selected from regimens specified on the protocol or trastuzumab monotherapy. The primary endpoint is disease-free survival. Secondary endpoints are overall survival, relapse-free survival, safety, health-related quality of life, comprehensive geriatric assessment and cost effectiveness.

RESULTS:

Patients recruitment has been commenced in October 2009. Enrollment of 300 patients is planned during the 4-year recruitment period.

CONCLUSIONS:

We hereby report the study concept.

AlaskaAngel

Beesie,

You are a terrific resource here, humorous, and helpful. And yes, at the same time, I had no firsthand idea what chemotherapy was like until I did it. Having done it, I would never claim that my perception of it was the same before doing it as someone who had done it.

On top of that, I did it back when there were fewer options for antinausea medications and, like the other patient recently (LadyGrey?) who had projectile vomiting through her first treatment (before getting other newer antinausea meds), my experience was different from what most other patients experience today.

Our values about what kind of research is worthwhile are going to be different because our experiences have been different. My experience at 10 years out IS going to be different than someone who has aged longer after doing treatment. Even in terms of what services are available our experiences are going to be different. I can't access counseling at my cancer center because it is only available to those who are 2 years out or less. WHY would the perception of what it is like at 10 years out be accurately portrayed to those who are fewer years out when the cancer center that tracks "what it is like" is turning us away?

A.A.

voraciousreader

Total number: 300 pts

􀁺

The primary endpoint will require 120 events in total, given a power of 80% and a

threshold hazard ratio of 1.69. A total of 260 patients will be necessary during 7

‐year

trial period to assess 120 events. The target number of registration was determined

to be 300, since exponential distribution of survival might not be shown because of

the elderly population and dropout patients were expected.

􀁺

This study has been started from October 2009 and completion is assumed to be

October 2016 with a registration period for 4 years and a follow

‐up period for 3 years

voraciousreader

http://www.csp.or.jp/cspor/company/results/2010_ASCO_BC_sawaki.pdf

Here's a detailed link for the study...

orange1

AA -

Thanks for the clarification.

VR - you wrote:""Hmmmm....Why isn't my doctor offering me O/S and Herceptin."  Mind you, AA is advocating a clinical trial to discover whether or not that is a viable option for BOTH pre and POST menopausal women.  Haven't we already been through this discussion on several threads?  However, for a "newbie" THIS TYPE OF QUESTIONING WITH ALASKA ANGEL'S ANSWERS ....AND THEN HER DISPARAGING OF THE FOLKS WHO WORK IN THE TRENCHES, creates confusion. "

When a newbie wonders why her doc isn't offering her O/S and Herceptin, she will probably ask her doc.  At which point she/he will explain that Chemo + H has been shown to reduce risk of recurrence by approx. 50% compared to chemo alone, and by about 75% compared to no chemo or herceptin.  O/S and Herceptin have not been tested.  So with your initial risk of XX (lets say for example 50% chance of recurrence), we can reduce it to approx.12.5% with chemo + herceptin.  We don't know how effective O/S + H will be because it hasn't been tested.  I am thinking there is not too much risk that they will skip the chemo/herceptin combo.  For those that are strongly against chemo for irrational reasons (as opposed for those with real medical reasons), most will never be convinced regardless. 

AA has stated her opinions are based on her experience - and I don't think - I haven't read every post - that shes just making up "facts" like so many on the alt forum do (lets talk de-toxification). She is entitled to her opinion, even if I think there is a lot of evidence that contradicts it.   And even if she is a little crazy on the subject, she is entitled to her opinion.

I kind of relate because my BC diagnosis definitely made me a little crazy too - it just manifasted itself in slightly different ways.  

voraciousreader

Orange... I was being sarcastic! In AlaskaAngelWorld... Everything spins until you're dizzy!

voraciousreader

One more thing Orange. As I quoted Daniel Patrick Moyinhan before... "everyone is entitled to their own opinion, but not to their own facts.". That seems to be her problem.

orange1

In case you are wondering - here is an example of how I have been made crazy.  Disclaimer - This has almost nothing to do with breast cancer, except for the crazy part.  Feel free to skip.

Even though the cause of my BC is likely related to not having children (big risk factor) and having long legs (height is also a big risk factor), I am going a little crazy about plastic.

I am about to have a child through gestational surrogacy.  My wonderful gestational carrier has offered to pump breast milk.  Who would not want to give their child breast milk if it is available? Not crazy me.  Breast milk is pumped through plastic tubing into plastic bags.  I will not have my baby get 100% of its nutrition coming from food that has been exposed to so much plastic.  I already ordered the glass bottles.  I will hopefully be able to extract whatever plasticizers are in the nipples by boiling them in cream several times.  My husband thinks I am crazy, but I have done enough research on the benefits of breast milk to know that for full term babies, where the risk of necrotizing enterococcus is less than 1%, there is little benefit to breast milk over formula.  Also, virtually all studies on effects of breast milk on cognitive development are deeply flawed, so he will loose the argument.  And this is from a person who doesn't even believe that her BC was caused by plastic.  

I want the right to be a little crazy, so I have to grant it for AA as well.  I am sure we all have our little corner of crazy from this disease (except for Beesie).  I have less tolerance for those that just make a bunch of s++t up and state it as fact.

voraciousreader

Orange... My humble advice to you is to take a deep breath and enjoy the next step in your life and don't sweat the small stuff! As the mother of three adult children, I can't begin to tell you what I worried about as they grew... And despite my better judgement... They grew to be wonderful adults! You'll look back in twenty years and wonder why you did all of this worrying. Then again... If you are anything like me... You'll have forgotten... Because you'll be too busy worrying about something else!



Good luck to you and your hubby! I hope you can both agree on a name!!!!Let us know when the wonderful event happens!!!! We all love good news!

AlaskaAngel

Ah yes.

I did myself out of over $600,000 by being "crazy". A friend who was pretty well off gave me an unsealed envelope to keep in the event that he died. I never once opened it. I put it in a drawer, and opened it when he died. Had I opened it, I could have told him it needed just a few tweaks to be legal. That is one boat I really, really missed.

If I wasn't crazy at birth, there are some things about life that could do it.

A.A.

orange1

VR - " And despite my better judgement... They grew to be wonderful adults!" - too funny - and it rings so true that life often ends up okay despite all our optimizing. 

Thanks so much!  I will try to take your sound advice. 

apple

orange.. i have an awareness and memory.. it's pretty good.  Breast fed babies have always seemed so much healthier to me.. glossy, plump, aware.  breast milk is a wonderful formula.  .. if you have the opportunity i would certainly go for it for the first few months. 

My sis has celiac disease and is very sensitive to glutens.  She has four small children.  She feeds them packages of healthy food but they always get sick... runny noses, coughs, .. her house is really clean.

I know it seems counterintuitive, but if a child is exposed to germs it will develop immunities and the abilities to fight them. i.e. picking your nose is good for you.

I wish you the happiest happiness with your upcoming baby.  It is indeed easy to overthink motherhood.  The baby itself is a good communicator.. if it cries, it wants something and an adult can usually figure out what it is.

i certainly am loath to caution you on our first one to one post.. i am really happy for you.  I'd be so excited I'd be bouncing.  congratulations.

here we are, about 10 years ago..  (boy do I miss my full head of hair from back then).

voraciousreader

Boy oh boy does time fly Apple!  Wasn't it just the other day that your oldest son was operating that massive truck while building that storage unit on your property?!   You have a beautiful family!

Regarding breast feeding and allergies....I breast fed as well.  As you recall, the older son, now approaching 30, was a sickly child and had numerous ENT surgeries...right up to this past Spring.  He also had allergy shots beginning at 3 years old.  Anyway...bless the pediatrician, because without his sage wisdom, I firmly believe my son would now have a profound hearing loss.  He was always concerned for my son's well being.  Anyway...a few years ago, he was reading all about breast feeding and called me.  He was trying to figure out WHY my son had all these immunity and allergic "issues."  Then he said, "I think I know why he was so sick."  And then asked, "Did you breast feed him?"  And I replied, "Of course I breast fed him."  And then he said, "Shucks!  I thought we'd have the answer to why he was so sick...."

This son of mine was so sick and allergic..he was even allergic to disposible diapers and the fungal medicines for diaper rash!  Ended up putting all three of my kids in CLOTHE diapers!!!

And like I was telling Orange that despite my better judgement...they all grew up okay...That older son became a competitive swimmer and an ocean lifeguard!

Kaara

Apple:  Your children are just beautiful!  I have four children and nine grandchildren..one a great grandchild.  I breast fed all of mine but my youngest...by then I was worn out!  I felt guilty that he would suffer, but actually he was the healthiest of them all...never sick, even to this day.

 Back then there was no such thing as disposable diapers!  They ate healthy foods...nothing out of boxes like today.  McDonalds was a rare treat, not a daily drive thru occurrence.  They played outside and got lots of sunshine...didn't use sunscreen.  Video games didn't exist.  They walked to the bus stop and sometimes even all the way to school and back each day.  Yes...they grew up just fine, even though I became a single working mom and their sole support.

I don't always agree with the way my grandchildren are being raised, but then, it really isn't my worry...my job is to love them unconditionally, enjoy their company when I have it, and be there for them with guidance when they need it. 

apple

we grew up in the days of hotdogs, lunchmeat and chlordane (?) and walked everywhere.. 2 miles to the library on Tuesdays.. 2 miles to the pool everyday.. We got a ride home from our daddy.  I folded more cloth diapers than anyone on the planet.  I would sit legs akimbo, watch Leave it to Beaver, (heh) and fold the two loads daily.  My bro was handicapped and in diapers till age 5.  a baby came along every 18 months.  it was fun. We even walked to church in snowstorms, and to school in the rain.

3 of us 9 siblings have cancer. Leukemia, lymphoma and breast cancer.  I kind of attribute it to our diet.  My kids eat healthily altho there is a bit too much cholesterol in our diet.

Orange you are soooooo right to be concerned about plastics.  I really shouldn't have said anything.  Babies are so very cool.

digger

Orange,

Congratulations!!!  You and your husband are in for such a wonderful adventure!!  I've got twin boys myself and breast fed them for just a short time after birth, then I couldn't do it anymore and moved on to formula.  They're both strapping 6'2 teenagers now, despite being about 8 weeks preemie, and they've always been excellent health.  Each stage of their lives was so much fun.  While I'd miss the stages as they moved on and got older, each new stage was even more exciting!   There's nothing I love more than sitting around the dining room table now and shooting the bull with them.

And Apple, gorgeous children!!  Love their striking blue eyes! 

Ang7

Apple~

I love your posts.  They are often times very warm and fuzzy...

Thanks.

thenewme

Ahhhhhh, babies..... something we all apparently agree on!  :-D

AlaskaAngel

Orange1, I'd be just as particular, crazy or not!  How precious they are!

orange1

Apple - your family is beautiful!

Thanks everyone for the warm wishes.  I am soooo excited - it makes it hard to concentrate on anything else.

best-

Orange