Friday, February 22, 2013

Breaking News.........

F.D.A. Approves Breast Cancer Drug  
By ANDREW POLLACK


The Food and Drug Administration on Friday approved a new type of drug that combines the widely used breast cancer medicine Herceptin with a powerful toxin to more effectively kill cancer cells while potentially reducing side effects.

The drug, which will be called Kadcyla but was known as T-DM1 during its development, extended the median survival of women with advanced breast cancer by nearly half a year in a clinical trial.

Genentech, which developed the drug, said it would cost about $9,800 a month, or $94,000 for a typical course of treatment. That is about twice the price of Herceptin itself, which is also made by Genentech, but it is similar to the price of some other new cancer drugs. It is approved for patients with HER2-positive breast cancer, about 20 percent of cases.
Kadcyla is one of the first successful examples of a new class of drug that link toxins to proteins known as monoclonal antibodies. The antibodies latch onto tumors and deliver the toxic payload. Because the toxin is not activated until it reaches the tumor, some side effects are avoided.

Such medicines, known as antibody-drug conjugates, are a hot area for cancer drug developers, with around two dozen such drugs in clinical trials. Another antibody-drug conjugate, Adcetris, developed by Seattle Genetics, was approved in 2011 as a treatment for two rare types of lymphoma.

The linker and toxin used in Kadcyla was developed by ImmunoGen, based in Waltham, Mass., which will receive royalties on sales of the drug. This is the first approved product for ImmunoGen, which has been working on antibody-drug conjugates for three decades.

The main clinical trial leading to approval of Kadcyla involved 991 patients with metastatic breast cancer that was worsening despite treatment with Herceptin and a taxane chemotherapy drug, such as paclitaxel. Half the women were given infusions of Kadcyla and the other half took two pills now commonly used for such patients: Tykerb, also known as lapatinib, and Xeloda, also known as capecitabine.

The patients getting Kadcyla lived a median of 30.9 months, compared with 25.1 months for those getting the two pills. The median time before the disease worsened, a measure known as progression-free survival, was 9.6 months for those getting Kadcyla, compared with 6.4 months for those getting the other drugs.

While having greater efficacy, Kadcyla also had fewer side effects. About 43 percent of patients on Kadcyla had serious side effects compared with 59 percent for those getting the two pills.



Still, the label of Kadcyla has a warning saying the drug can cause liver toxicity, heart toxicity and death. It also can cause serious birth defects or fetal death, so women of childbearing age taking the drug are urged to use contraception.

Herceptin, also known as trastuzumab, binds to a protein on the surface of breast cancer cells called HER2. Since Kadcyla incorporates Herceptin, it too is approved only for the roughly 20 percent of breast cancer cases with an overabundance of HER2.

Kadcyla’s approval is for use after a patient has already failed to respond to Herceptin and a taxane. But Roche, the Swiss company that owns Genentech, is already testing it for use as an initial treatment for metastatic cancer. It is also testing it in combination with Perjeta, another of its drugs for HER2-positive breast cancer, which was approved last June.



Roche executives say they hope that Kadcyla, along with Perjeta, will make Herceptin somewhat obsolete by the time it could face competition from cheaper biosimilars, which are similar to generics. Roche says the United States patent on Herceptin expires in 2019.

Herceptin had global sales of 5.9 billion Swiss francs ($6.3 billion at current exchange rates) in 2012. It was the world’s best-selling drug used only for cancer in 2012.

Genentech tried to win approval for T-DM1 in 2010 as a treatment for breast cancer patients who had run out of options, based on a small trial without a control group. But the F.D.A. turned down the application, angering some patients and patient advocates.


Dancin' the Happy Dance - Keep on Dancin"

Friday, February 15, 2013

A Belated Happy Valentine's Day to you all.

Not much to report.    I had an ECHO on Wednesday to make sure the old ticker is tolerating the chemo treatments.  So far so good.  Next was chemo which besides being stuck twice and it leaving a very colorful black and blue mark was uneventful.

Rumor is that this trial chemo (Hercepton DM-1) I have been on for one year now should be approved by the FDA the end of this month.  There are so many women out there who have been trying to get it that I hope this isn't another false alarm.  I try not to read too much about others experience because it could really start bringing you down when you hear some of it, but I did glance at a few comments from those who have been on it for the past few years and are doing remarkably well.  As I always say your only as good as your last CT scan and I don't want to get too far ahead of myself.

I declare that March 1 is the start of spring.  I'm so tired of being cold.

Until there is more to report.......  Lace up those dancing shoes!

Keep on Dancin"

Friday, February 1, 2013

My Birthday

Today’s my birthday. In the past I wouldn’t have cared much except for the fact that I was growing older. Just another reminder that I couldn’t do the same things I did ten or twenty years ago which would be reinforced every time I looked in the mirror and saw the increase of lines on my face (although no gray hair yet). Evident in my slower pace, falling asleep in the recliner and the fact that I would rather spend the evening watching TV or reading a good book then going out.

But birthdays since my diagnosis have taken on a whole new meaning. In fact I have instituted an event called “birthday week” where I celebrate all week instead of one day. Birthdays now mean I have made one more year then I thought I would. It’s not about celebrating turning a year older, it’s about life. Time I have been given to be with my family and friends. When I was at the hospital last week the nurse who checked me in mentioned we shared the same birthday. My response was something positive (sorry I don’t remember my exact words because her come back to me knocked me for a loop) and she said “just another year closer to dying”. For once I was speechless. Here she was working in a department where all the patients she saw were hoping and praying to see many more birthdays and saw them as positive events in their lives while she looked at the negative of getting older. My guess is that every patient having chemo that day would have gladly traded places with her,

So, did I mention today’s my birthday??? I have been celebrating it all week and will continue to into the weekend. As I look at the cake glowing brightly with one more candle added to it I’ll be thankful that I’ve added yet another year.

Wearing my new birthday Dancin’ shoes and singing Happy Birthday to me!

Friday, January 25, 2013

It's been a long week to say the least.  CT scan Tuesday morning, blood test Monday and Tuesday (still having bilirubin issues) and chemo on Wednesday.  I feel like a porcupine with all the needle sticks I've endured this week.

Good new on the CT scan.   One doctor opinion was a slight reduction in tumors in liver and lung area.  My doctor who is  a little more guarded in interpretation said she sees it as being stable.  Either way she was happy with the results.

No real side effects except being tired.  This weekend should tell a story if the past few months have been a cold or if the fever and head cold symptoms are a result of the chemo.  Stay tuned.....

Looks like winter has arrived if only for a few days since it's suppose to be in the 50's on Tuesday.

Until next time I have my snow shoes on and ready to dance1

Keep on Dancin"

Friday, January 11, 2013

Happy New Year!   Sorry I've been out of touch for a while but the holidays were busy.  I was all set on writing about new years resolutions until it took me one day to break mine.  I was going to strive to have more patience which was promptly broken on January 2 when I waited 4 hours from my appointment time until I was called for my chemo treatment.  They explained it was due to the holiday and being closed on January 1 for which I replied that New Years Day was not a new holiday that popped up on the calendar and happens every year so how could they not be prepared.  Of course you just get blank stares when you start thinking logically so I just sat and kept quiet.

I've been under the weather fighting a head cold this past week which hopefully will be gone by the end of the weekend.   Just planning on resting this weekend with no big plans.

Next CT scan is January 22 to see how the chemo is working.  No matter how many times I've gone through in the past + 2 1/2 years I still get nervous.  Speaking of CT scans I counted that I had 20 scans last year.  With all the radiation I could be lighting up the streets of Chicago. 

Until I feel better and have more to share I'll be putting on my dancing slippers and resting.

Keep on Dancin'

Wednesday, December 19, 2012

                                              My Gift


I received my Christmas gift last Friday and couldn’t wait to tell you about it. I was so excited when I received it. It wasn’t expensive jewelry or the newest electronics or fancy clothes that I don’t really need. No, it wasn’t a trip to an exotic place or a gift certificate to an upscale restaurant. Give up (I’m running out of adjectives)?????? What I received was a day (a full day at that) where I felt like my old self.

Mark and I took the day off and planned a whole day and evening downtown (OK truth be told I did the planning but he went along with it), I was a little concerned considering I just had chemo two days before but was ready to attempt it. We arrived downtown at approximately 11:30AM and proceeded to go all day and evening (with a small break back at the hotel to rest and change for the evening) doing all the things we use to do. We must have walked a several miles that day and didn’t arrive back to the hotel until midnight. It was great to be able to visit all the places we use to go (4th Presbyterian Church, 95th Signature Room for lunch, Water Tower and all the shops in between) and the evening was spent at the Christkindlmarket, The Goodman Theater to see A Christmas Carol and dinner afterward at Petterino’s.

What I have learned from this experience is not to take anything for granted, even the simplest of tasks. What seems easy today may not be as achievable tomorrow. Experience as much as you can while you are able and savor those memories. A lot of us have the attitude of “it can wait until I retire”. Hopefully we all will have that opportunity and be healthy enough to enjoy it, but things change so quickly. Take the time to enjoy life a little bit at a time so your not looking back thinking – I wish I had…..

I truly received a great gift this year. Even though it wasn’t flashy or fancy or expensive it fit perfectly.

I wish you all a very Merry Christmas and a Happy and Healthy New Year.

Put on those fancy Christmas shoes and Keep On Dancin’

Monday, December 10, 2012

                          It’s NOT Beginning to Look A Lot Like Christmas

It’s hard to believe Christmas is right around the corner. I know it’s on the way because of the Christmas specials on TV, the bright Christmas lights on homes at night, the crowded malls and the Christmas music playing on every other radio station.

But it just doesn’t feel like Christmas. I think I lost the spirit somewhere over the past few years. What use to be my favorite time of the year with the music, the decorating, cookies, holiday parties, cookies, Christmas shopping and wrapping gifts (did I mention cookies?) is now a big blur like I’m standing still and everything is happening around me. What happened to that old feeling of excitement and anticipation?

As positive as I try to stay I must admit Christmas to me now is a time to stop and reflect. Is this my last Christmas or will there be more to celebrate? I guess there are no guarantees in life and anyone can ask the same question. However, for me it’s more a reality. There’s no Ghost of Christmas Future to take me by the hand, fly me through the sky and show me what the future is bringing. I have to admit it’s kind of lonely and scary at the same time wondering what the next year will bring.

With that said, I will put on a smile, participate in the usual Christmas activities, try to capture some of the past and try not to think about the future - at least not now.

I wish you all a very Merry Christmas and a Healthy and Prosperous New Year!

With visions of sugar plums dancing in you head remember to slow down and enjoy the holiday. It will be over before you know it.

Keep On Dancin’