Denied

Today the FDA denied Roche's application for fastrack approval of TDM-1 based on what seems to be a technicality. It was generally thought, given the convincing results of Phase II trials conducted in heavily pre-treated woman, that the drug would be approved for commercial use in the first months of 2011. It has now been delayed until at least mid-2012.

You can read the full story here.

This is devestating news for women with HER2 positive breast cancer. This development does not affect me directly because I am guaranteed, through my participation on the clinical trial, to have uninterrupted access to TDM-1 as long as it continues to work for me. But indirectly, I am sad, mad and frustrated for the thousands of women who did not qualify for clinical trial (the requirements are very specific) and will run out of time before 2012 arrives. I know I would have, had I not been accepted into the trial.

TDM-1 (not at all discounting divine intervention) has saved my life, plain and simple. It is a travesty that women who have no other options cannot receive this drug.

I certainly understand the importance of properly conducted clinical trials. I definitely believe that drugs, before they are released to the public, need to be thoroughly evaluated. But why isn't there a provision for the compassionate use of drugs which, though not completely evaluated, show such promise that they just might turn the tables for someone who has no other option and is surely going to die without at least a try? It seems to be only humane.

In the meantime, keep at it, Roche--and I'll keep providing you the data you need to help bring this baby to market.

At Last It Has Arrived

This year we officially gave up the pretense--we are not a soccer family, or a baseball family or a basketball family. We have participated in those sports in the past only to kill time until the real action begins, so this year we didn't bother. We just waited. Patiently. And now it's time!

Last night Joey and Sam both opened their season with a scrimmage and did pretty well. They missed some blocks, they were not perfect, but overall it seems that we are in for a great season. Both boys are playing first string offense, Joey at Tight End and Sam at Tackle. This is a huge accomplishment for Joey in particular, as he has worked hard for two years to have a chance on the starting line. Joey is also starting Defensive End and loving it. Jay caught this action in particular last night:

This is Joey charging the running back behind the line of scrimmage. He completed the tackle, resulting in a loss of 5 or 6 yards for Palmdale. Good times, good times.

This, of course, is Sam. He shows a lot of promise and has no fear, so I think he will have a great season. By the second half last night he found his groove and was consistently driving his opponents back a number of yards. Number 68, by the way, was Jay's high school number, so it's pretty neat to hear them call another Di Silvestri by that number over the loudspeaker.

Welcome to fall--we are definitely fans!

Two Weeks Under His Belt

For those of you wondering what I finally decided to do with my little man Tony, here is a photo of him at pick up time during his first week of Kindergarten at Valley View, our local public school.

So far, he absolutely loves it and I feel comfortable that I made a good decision. We are calling this "Kindergarten 1", and he knows that he will be going to Sacred Heart next year for "Kindergarten 2."

Only time will tell if this was the right thing to do, but as parents all we can do is the very best we know how to do at any given moment...and for me, this was it.

Thanks to you all for your willingness to share your opinions and experiences in this matter--ulitmately, it was all of your comments that let me to my decision.

Scanxiety Alleviated

Just got the results of my latest PET/CT and bone scans...everything is stable, thanks be to God.

My favorite quotes:

-"No evidence for solid organ metastases." (Hello, beautiful liver of mine!)
-"Stable metastatic disease to the axial and appendicular skeleton without metabolic activity."
-"No new nodules."
-"Subcentimeter right and left axillary and subpectoral lymph nodes remain stable."

What does it say about my life that these lines read like the finest poetry to me? (That is a rhetorical question, by the way.)

So, to summarize, some disease remains and doesn't seem to be going away. However, it is not active or growing, nor is it on a vital organ, so it does not impact me at the moment. Treatment will continue as is for another nine weeks, at which time we will scan again and see where we are.

Here's to another nine weeks. Yippee!

The Good Archbishop

Last week Jay had the pleasure of meeting Archbishop Jose Gomez, the new co-adjutor archbishop of Los Angeles, in a small group setting. The Archbishop celebrated mass, visited both before and after with the attendees, and stayed for dinner as well. Jay was particularly impressed that Archbishop Gomez was among the first to arrive and the last to leave, making sure all who wanted to speak with him had the chance to do so.

All reports of the Archbishop's kindness, generosity of self and obvious love of Christ were confirmed by Jay, who was beyond thrilled to have the opportunity to speak with him during the evening. Jay told the Archbishop about me and asked for his prayers on my behalf, which he readily agreed to offer, even asking Jay my name twice to be sure he had it right. Quite humbling for me, I assure you!

We are very fortunate indeed to have this man as our new Archbishop. I wish him all the best in his tenure in Los Angeles.

Health Update

It has been awhile since I've posted anything about my health (how's that for a postive change!?) and I know many of you are wondering how I'm doing, so I thought I'd take a minute to share what's been going on.

Right now I am exactly where I want to be: my last few scans have shown no active cancer, only evidence of where cancer has been. My doctors tell me that Stage IV cancer cannot be cured, which means that even when the cancer is inactive and too small to be seen, it is still there lurking and a potential threat. Therefore, they use words like "control" rather than "cure", and "stable" rather than "clear". At the end of the day, this is all just semantics, and the summary is that I'm doing as well as I could possibly be doing and can potentially remain in this state for years to come.

Or, it could all change at any time, which keeps things exciting.

I will continue with my treatments of TDM-1 every three weeks as long as my liver can process the medicine and as long as my heart muscle is not damaged by it. So far, both of these measures are just fine. The treatments vary in how hard they hit me--some are hardly noticible and some deal me a bit of a blow, but nothing life-stopping. I am truly fortunate in this, as it means that I can continue treatment without giving the cancer a break to regroup, as I would need to if I were on traditional chemo.

I will continue to be thoroughly scanned every nine weeks as long as I am in treatment. I will always post those results here as I get them. My next scans are this Thursday and the following Monday so look for news probably around the end of next week.

I will not be having surgery. My oncologist and surgeon agree that once the cancer has spread around as mine did, there is no benefit to surgery at the original tumor site. Plus, there is no detectable tumor left in the breast anyway, so they would basically be cutting off a healthy breast to prevent nothing. I am good with this.

So, that's about it for now. The medicine is working beautifully, I feel pretty good most of the time (more often than not I feel normal, which was unexpected six months ago), and I am hopeful for a good, long run at this status quo.

Thanks for keeping me in your thoughts and prayers for so long.

Decisions, Decisions

Tony's birthday is in July. Since he just turned five, he is eligible to start Kindergarten at Sacred Heart this year and, until recently, I had no doubts that he would be doing just that.

In the last few weeks, however, I have been strongly contemplating holding him back for a year and having him start Kindergarten next year when he has just turned six. If I send him now he will be the youngest in his class (or close to it), and if I wait he will be among the oldest.

I have heard many arguments in favor of holding him and few in favor of sending him. He himself likes the idea of going to our local public school for a year of Kindergarten before starting "for real" at Sacred Heart, especially since his very good friend will be doing the exact same thing. This is the same public school that gave Joey such a positive experience, so I do not worry about sending him there in general.

By all tests, Tony seems ready to start Kindergarten. Yet, giving him an extra year to mature (especially since he is a boy, and since our children are notoriously handwriting challenged anyway) and develop his fine motor skills seems like it might give him confidence in the long run. If he ends up struggling academically, I will always kick myself for not having done this. Plus, if he ends up being bored, I can move him up easier than hold him back later, right?

I am interested to see if any of you have an opinion about this. Valley View starts on Monday, so I am going to have to make a final decision over the weekend one way or another. Have any of you held your children back or started them early? What have you done with your "summer birthdays" and how have they fared? Any advice or thoughts are appreciated!