Clinical Trial E5103

Hello Everyone,  --- please excuse the long email, but I'm in crisis mode and need some input. I must decide on the trial in the next two days!

I really need help with some decision making and want to ask all of you how you came to your decision to join the Avastin trial.  I have a less common type of cancer ILC (Invasive Lobular Cancer) with ER+/PR+ and HER-2/neg.  The doctor is recommending the standard AC-T chemo, radiation, hormone therapy (I had a bilateral mastectomy about 4 days after diagnosis). The doctor (Hope Rugo at UCSF) gave me the option of the 5103 trial.

Here's the deal.  Because less than about 10% of any study is made up of ILC cancer patients, they have no way of knowing to what degree chemo works for my subtype of cancer. And, with my cancer my chances of recurrence remain high well after the 5-year mark (which I think is different from for IDC).  So here's what I'd like to know:

1.  Given that the adriamycin is a known cardio toxic drug, did any of you worry about the additional cardiotoxic effects of the avastin on top of it (it definitely is known to, at the minimum, cause hypertension).  I as told by a friend who works for a pharmocology company (she has a doctorate) that there is a "known risk of rebound cardiac problems even years after exposure to avastin (even if you have no symptoms during treatment)". Can any of you comment on that?

2. What about the risk for stroke or gastro perferation?

3. Why did you each of you decided to do this?  Especially those of you who are ER+/PR+?  

4. I feel like I'm getting very far out from my DX - the mastectomy was Oct. 20th and I had some complications - it's only been a week or two since I was told it's ok to do chemo and I just can't decide about this trial.  (I'd have to travel approx.2 hrs each way to San Francisco to get it). Looks like I couldn't start for another week and half (that's over two months from DX).

I only ask these questions because when you research side effects of avastin, they're pretty scary... and these things can happen even years later! 

 Can anyone weigh in on what their decision making process was.  I noticed a lot of the people here are triple-negative, did that infuence your decision.

 Thanks,

Amanda 

Hi Amanda.

I understand how hard it is to make this decision.  I start my chemo next week, and I'll probably change my mind a hundred times before then!  I am not triple negative, but my oncotype score came back high.  And I guess I felt like I owed it to my kids to take advantage of every opportunity to not let this nasty stuff get me again.  The side effects are scary to me too.  But so is the chance of recurrance.  I'm sorry you're in this boat with us.  I hope you feel peace with whatever decision you end up making.  Take care. 

Thank you everyone for your advice.

I've been very nervous about three other things:

 -- I had a complication after my mastectomy on Oct. 20th I had to have a skin graft, so the earliest I can start the trial is in a week and a half .  My question is - doesn't it seem like way too long between dx and chemo?  That's nine weeks!!!  Has anyone else had this long to wait?

-- Also, apparently the hormone therapy (after chemo) is really important because I'm ER+/PR+, but by the time I start hormone therapy it'll be 7 months from my dx.  Doesn't that seem way too long?

--My other fear is that if I get randomized to the placebo group and end up getting the taxol weekly instead of in the dose dense method that my doctor would recommend off trial, then I'm not getting the best bang of taxol.  Did this come up with any of your doctors? 

Have any of your doctors been concerned about the timing of when all this stuff should ideally happen?

I know I'm all of over the map with my questions and fears -- my sister tells me I need to start taking xanax, that I'm way overthinking this.  But, when your doctor tells you that the first chemo is your best chance for a cure, you start to obsess about everything. Just like you guys, I want to be able to tell my kids that I did everything I could to try for a cure. I've just got this sinking feeling that my indecision about the trial (along with the unavoidable delays) has created a bad situtation for me (like things aren't happening when they should, whatever that means).

Desi, can you tell me more about the timing of your treatments, it seems like you have a very similar situation to mine (except the type of cancer).

 Thanks to you all for anything you can add.

 Amanda 

Amanda,

I asked alot of questions too.  My onc told me that they like to see chemo begin within 3 months so you are still in that window.  I also asked about doing weekly taxol vs biweekly dosage.  My onc said that it is just as effective and some studies have shown more effective to do it weekly and the SE are much lower.  I didn't have neuropathy from the taxol which I believe is because I took it weekly. 

I am trip neg so I can't answer about hormone therapy. 

Teresa

Good Evening to All,

Welcome all the newbies.  As Brena said, there's plenty of answers to your questions here! I just got my surgery date (Jan 16th) to take out my port!!  I am very excited about this.  I think it will help get me back in my NORM state of being.  I have to say (to Keryl) that I am still having the sinuis issues.  Everyone thinks I have a cold and then I just tell them its leftover chemo!  Amanda, inregards to your questions....The issue w/all these toxins that we put in our bodies probably do have some effect on our heart.  The trial does monitor your heart by having EKG's and Echocardiograms.  Mine has not changed.  Does it mean later on down the road it will?  I like to think that if I maintain an active life that it will help protect the heart muscle.  I think everyone is different but sometimes we take a risk.  The SE's of avastin are nothing to blink at, but if you read the SE's from OTC drugs they can also be scary.  The trial is a personal choice and only you can determine if its right for you.  My thought is that without people in trials we would not be where we are today in medicine.  I think you are doing the right thing and getting more information so you are informed about what decision to make.  Good luck in this venture.  It's hard enough to do standard treatment let alone decide on an additional treatment.

Carolyn 

For MandaLynn, you wrote: 

--My other fear is that if I get randomized to the placebo group and end up getting the taxol weekly instead of in the dose dense method that my doctor would recommend off trial, then I'm not getting the best bang of taxol.  Did this come up with any of your doctors? 

I asked that question, and he said the 12 weekly Taxol schedule has been shown to be just as effective as dose-dense treatments two weeks apart. A large study that concluded this year confers. The conclusion is that either regimen is more effective than getting the treatments three weeks apart. For many people, the 12 weekly schedule is less toxic. That's been my experience. I have two treatments to go, and I hardly feel like I've been on meds. 

amanda, I am thinking of you, as  I know that you are focused on tomorrow. It will be fine, but I understand the anxiety as I was there.  You sound strong and focused. Go for it.

I have # 10 of 16 total my chemo treatments on xmas eve, but no more avastin until 12/30. While weekly is frequent, it becomes comforting that I am moving forward with the taxol. It is not bad at all. (for me anyway)   The chemo experience has not been awful, but manageable. I really dont think that the sides are that bad compared to the upside...... 

I had Nuelasta sent to my home and delivered by a locat RN; it worked fine. Hang in there -- 

Joanne,

I'm sorry to hear out your problems with your nose/sinus's.  I have been suffering for 8 months and I'm ready for some relief.  But still worth it in the end.

Amanda,

I know how you feel.  I felt so betrayed by my body and the whole system.  I always got my mammos, did self exams...and still I had breast cancer AND positive nodes...how is this possible and why is it possible.  No answer has come to me and in time you just accept it and move on.

Teresa

Amanda, how are you feeling?  I'm glad you were able to come to a decision and feel fairly calm about it.  The whole cancer dx still feels very surreal to me at times, and its hard to make sense of it all.  Today was the first morning I woke up without a headache ~ woohoo!  So far my SEs have not been too horrible.  I've been real tired, I've had heartburn and a pretty constant headache before today.  I also had a real hard time figuring out what I wanted to eat, but I had to keep eating a little bit here and there or I would start to feel a little bit woozy.  And my ears feel plugged up like I have a sinus infection, which is annoying but not painful. Today is day 5 for me, counting chemo day as day 1.  I hope you are doing ok, Amanda, let us know how you are.:-)

Keryl,

 Sounds like you are doing great.  Great attitude goes far while dealing w/BC.  Stay strong!

Carolyn

Teresa,

How are you feeling?  As I told Brena, my sinuis's are still outta wack.  I am hopeful w/time that will go away.  I've already wrote a book tonight so I won't keep you here.  I hope you have a wonderful Christmas w/your family because it will sure beat last years!

Carolyn 

Hi Busqueen,

 Today is day 3 for me and so far, so good.  I've been tired and my stomach feels kind of raw (I have a little heartburn too).  Haven't felt completely nauseous, just very "icky".  It's been very difficult to eat.  I'm used to eating a lot of salad/protein and the thought really turns me off.

 Have a great Holiday everyone.

Amanda