Calling all TNs
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Way to go Swanny!! Hope you go out and celebrate!!!
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I wanted to pop in and say hi to everyone. I hope to catch up on the posts later tonight. I hope everyone has a wonderful day.
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Laurajane: I was just wondering where you were! You have a great day, too!
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Yesterday the Food and Drug Administration moved to revoke its regulatory approval of Avastin for metastatic breast cancer. Withdrawing a cancer treatment is almost never done, and though the decision was expected, that does not make it any less reprehensible.
The FDA said in a statement that it is removing Avastin's breast cancer indication because the biologic does not provide "a sufficient benefit in slowing disease progression to outweigh the significant risk to patients." Ponder that "sufficient." The agency is substituting its own judgments about clinical meaningfulness for those of practicing oncologists and terminally ill cancer patients.
The risks of Avastin are real, but manageable. Clinical trials do not show that the drug extends life overall in the aggregate, but they have shown that it allows women to live longer without their disease getting worse. Avastin improves progression-free survival by about four months on average. Different patients respond differently, and the drug is far more effective in some than in others, for reasons that researchers still do not understand. There aren't any perfect therapeutic options in end-stage oncology, and Avastin ought to have remained one of them.
Looking at the same data, the European Medicines Agency—the FDA's counterpart in the European Union—decided on Thursday that it would continue to approve Avastin for breast cancer in combination with chemotherapy. In October, the U.S. National Comprehensive Cancer Network—a consortium of 21 leading cancer centers that issues evidence-based medical guidelines—reaffirmed its position that Avastin is valuable in some cases.
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Genentech is contesting the FDA ruling against its cancer medication, Avastin.
But such finely graded distinctions are not part of the FDA's bureaucratic culture. The FDA provisionally (and reluctantly) approved Avastin for breast cancer in 2008 under an accelerated process for serious diseases. But the cancer drugs division believes that such flexibility is too friendly to industry and took extraordinary measures to rig the review process against Avastin's maker, Genentech, as we reported on August 18 in "The Avastin Mugging."
Genentech is contesting the ruling through a formal FDA appeals mechanism, and Avastin will remain available on an "off label" basis, because it is still approved for other cancers such as those of the lung, kidney and brain. However, private insurers are generally reluctant to reimburse for therapies that are not FDA-approved, and Medicare, which is the dominant payer in oncology, never does.
One depressing implication is what the decision says about health-care financing as government entitlements expand. Avastin is a political target because of its high cost—a typical course runs as high as $88,000—and after ObamaCare all medical questions are inevitably political questions too. In September, the FDA and Medicare proposed a "parallel review" process that will allow the two agencies to coordinate market and reimbursement approval. Medicare is also increasingly opening "national coverage determination" reviews that allow a government board to decide if a therapy is "reasonable and necessary."
Another danger is to the future of medical innovation. Cancer treatment advances incrementally. Every year doctors are better able to pair medicines with the biomarkers pointing to the individuals who are most likely to respond and learn more about tumor angiogenesis, which is the process of cancer growth that Avastin helps to choke off. The FDA's assault will make it harder to conduct and enroll patients in further clinical studies, to say nothing of its message about the regulatory risk for drugs still in development.
The greatest tragedy will fall on the women who are suffering from an incurable disease and whose caregivers are trying to improve their quality of life in the months they have left. The FDA is taking away one of their only options.
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HeidiToo: You beat me to the punch by 17 minutes! I just copied and pasted this. When I was researching my situation a year ago November, I opted to not do Avastin as it was showing signs of not working so great even then. So dissappointing for many.
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First snow today!
This was from last year, but it's getting me in the mood for more! Right now I'm sitting cozily by the fire watching it come down. Everything's canceled around here (including tonight's Christmas Party at the Nature Center).
Stay warm everyone!
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Thank you for the snow, Heidi!!! LOL!
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Heidi: It's beautiful... simply beautiful.0
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Yay Swanny! YOU DID IT YOU DID IT YOU DID IT WAHOO!!!!!!!!!!!!!!!!!
Hey LJ...every time you post I smile...you do us all good!
And Heidi...well..she is my twin...(older twin..ha ha)...but twin none the less...snowed in hey? My DD goes to Kent State and they had 20 inches! An hour south..where I live we had nowhere near that...I honestly don't mind the snow..or cold...as long as the electric stays on..keeping my fingers crossed..
I saw that article about the avastin...read about the side effects being worse than the positive effects...that sucks...
Ok..chemo..I'm a little over 16 months from chemo...side effects? I can honestly say NONE! I'm thinking back to last year at Christmas time and how I felt and I can honestly say that this year I'm better..physically and mentally...I feel..dare I say it.."normal"???????
Ok..a little chubby..that is all.
MJB..I have to be honest with you..I just really can't do all these diets you talk about..I'm just not that disciplined...HOWEVER, can you explain some of these diets to us? I'm willing to try some things. I have to admit I ate 3 wonderful Christmas cookies today..and I loved them.
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Diet? Discipline? Not me! I am totally back to normal in what I do and eat. And happy to be there, I might add. I got tired of living a fear-based existence. I stared the beast in the eye... and the beast blinked.
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And here, for what it's worth, is the "beast" (or at least the way I felt when it was breathing down my back). Creepy enough for you?
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I find the FDA withdrawal of Avastin disturbing. For many women on this website with mets, it seems Avastin was one of the only options they had. There is a WSJ editorial which is posted on some of the other forums which suggests that Avastin was a political target because of its cost. It states that the risks associated with Avastin are real, but manageable. It is not being withdrawn from use for other cancers, and it sounds like Europe is still using it. This article calls it a tragedy for women with incurable disease. I would think especially for triple negative patients who have no other options.
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Ok ladies...i find my self stressing about the order of my chemo...Im not sure where a good place to ask these questions so im coming to my fellow TN ladies...In the clinical trial im participating in I will have taxol 12 weeks first with possible 2 other drugs (can't remember there names) and then ac (every 2 weeks for 8 weeks)...can anyone tell me the side effects of each? has anyone participated in a Clinical Trial..I will first have chemo, then surgery, then rads. I know you all will help me understand more...Is there anywhere to find this information?
I love your wonderful pictures...very uplifting...thanks girls...
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I had 4 dose dense AC and 4 dose dense Taxol..side effects are different for everyone..you may find alot of information on the chemo thread..read the group right b-4 yours and then join with the ladies that are starting when you do...you will find alot of support there..I still hang out with my chemo April 2009.
I lost my hair and ate alot! Had cravings for weird foods..like KFC and Wendy's and mashed potatoes with AC..with taxol the food cravings stopped but had leg aches..some numbness in my feet..some weird bowel issues...never slept well during the whole thing so I got alot done and was never late for work...Do you drink alcohol? It was almost like being drunk for 16 weeks but without the fun..if you know what I mean.
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Funny, and a bit ironic that when I asked my onc a couple of weeks ago what she would do if this Carboplatin/ Gemzar didn't work what she would recommend I'm pretty sure she said don't worry we'll put you on Avistan. LOL. Well, l'm so thankful that this chemo mix is going to work positive thoughts go far ! I've been busy painting. Yup! I hired a couple of guys to do most of it and I am finishing the rest. Benjamin Moore has a great paint called Aura, doesn't stink at all. So now my livingroom is smokey blue, dining room is rich carmel, kitchen is green apple with a little royal purple thrown in and my new drawing/painting studio is peach with hot pink and red. (I know this sounds like a crazy color scheme but it looks pretty cool. I have a little bungalow that was built in 1926 and I repaint all of the rooms usually at least once a year sometimes more often depending on my mood. It's funny I bought the house 8 years ago and have spent the last 8 years working on the gardens procrastinating on the interior and this year I have such a strong desire to make the inside as exciting as the outside. I'm going out with friends tomorrow to a new martini bar and then meeting a friend after to go and hear some music. I've had two weeks off from chemo due to low WBC and RBC and am feeling great. I want to have as much fun as I can before next Tuesday when I go back for more of this chemo cocktail. Well actually, I hope to continue to have fun after next Tuesday too! Loving life and making it great! Hope you all had a great day.
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Laurajane: You're up late also? I just want everything available to us triple negatives that might possibly help, whether it is avastin or PARP. I am sending positive thoughts your way that the Carbo/Gemzar works great with little side effects. Good night!
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Thanks, Lynn. I want something that works for all of us too! For now I'll go back to painting and try not to think about it. Hmmm? I actually may stop for the night and finish tomorrow. I hope you have sweet dreams and wake up tomorrow with a huge smile on your face and have a fabulous day.
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Titan: I have never been able to do a diet in my life for the same reasons. The reason I liked it was because every day it gives you a meal plan--you know what to eat for the 21 days. No brainer, nothing to think about.
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Hi again, sorry been away for a day, and I agree, you have been very busy.
Sugar, I'm up in Huntsville aka "Gods country" how are you managing with all the snow you've been having lately?
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LJ- sounds like a Thomas Kinkade cottage!
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It's going to be a great day today. After setting aside all of the bills that came in todays mail. LOL. I also recieved a beautiful silk scarf from the Good Wishes Program with a Christmas Card signed by all of their staff. I love it. I also recieved the movie Princess Bride that I had ordered from Netflix after reading all of your comments on the movie. I haven't seen it and am really looking forward to it. Two wonderful things that have happened today because of all of you sharing. Thank-you. I am trying to finish the painting today. I hope all of you have a wonderful day.
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Titan: Here is the link if you want to look at the "diet". To me it was just learning a better way to eat and to easily get rid of weight in my tummy area. I now have to work on muscle tone. BTW: It's the 28 day Fresh Start Challenge that has been over for awhile, but it's still available to do and to read on line: Hope you like fish! http://www.dailyperricone.com/2010/01/28-day-start-fresh-challenge/
Luarajane: I live in a 1930's building now, but my last two homes were 1920's buildings although not a cottage, an apartment. When we lived in Silverlake we had a buttery pale yellow living room, a two toned orange & chili red dining room, a black and white diagonal kitchen floor with white and chili red accents, a green hallway, an apple green bedroom with purple accents, a soft red back bedroom and a soft aqua bath. Loved that place! It was only 650 sf but it had a huge covered patio off of the bedroom with a skylight and a front porch and it felt like a house. My work moved and so I had to either move or change jobs. Now I kinda wish I had changed jobs. Sounds like you are going to have an amazing day. Me, I'm still working on the challenge that is my home before our annual xmas bash, which I didn't get to do last year. Hope I am up to it.
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Laurajane: Just found out about a product that boosts NK Killer cells and it's on sale for half off right now. My dr recommends it for boosting our immune system. This is great for those of us going through chemo (only take it on the off days of your regiment) and also for those about to or just completing surgery. I purchased it through NutritionLeaders.com and it's called ImmPower.
Just read this article on the holidays and drinking:
This time of year is the season to enjoy delicious food, delightful libations and good company. Unfortunately, the libations can be problematical because of the body's proinflammatory response to alcohol.
Having a glass of wine with your meal is not a problem, because wine can provide some important antioxidants called polyphenols that do help protect the body. I suggest drinking a glass of wine with your meal, rather than before, to avoid a rapid rise in blood sugar and the ensuing burst of inflammation throughout the body.Whether combined with sugary mixers or taken straight, drinking hard liquor causes inflammatory problems in the body. Alcohol is detoxifed by the liver. The alcohol content of hard liquor is very high. The metabolites of alcohol are molecules called aldehydes. Aldehydes cause damage to the cell plasma membrane as well as to various portions of the interior of the cell, causing and inflammatory reaction along with this destruction. In summary, wine is fine, but forget the martini.
Happy Friday!
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Hi Titan - It seems like we both had the same regimen, dose dense AC and Taxol. I am wondering how you are doing today? Since yours was in 2009, you are done over a year ago. I am doing my last two taxol. I am wondering whether the toxicity ever gets out of our bodies. I read something on this website today regarding toxicity which greatly bothered me. Will our bodies ever become pure again, like it used to be? With my third taxol, I have begun to cough like crazy and although have finished 8 antibiotics given by my onc., the cough is till very bad. I have a feeling it is the side effects of taxol. Are you back to your normal healthy self, after chemo? Or do you notice any weird things in your body. Did you do rads after chemo? what is your opinion of that, please? thanks.
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I just received a beautiful wrap from the Gaila Fund...its beautiful! not sure how to tie it but will learn...
What a sweet surprise on this Friday afternoon! Hope everyone is enjoying today!
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Moe- I just went on and ordered one. They look so cool and give the illusion of hair.
MJB- Thanks for the info. I don't actually drink martinis or any hard alcohol except for an occasional bloody mary. But I think it is really sweet of you to send me that info. I think it is so cool that the apt. you described sounds so similiar to my house. I even have the black and white checkerboard floor in my kitchen. My studio is looking wild crazy colors may inspire me to paint even more.
Hiedi- I love my cottage it's kind of more Mary Englebright'ish. I think that is her name. By the way looking at past post I see you have the same evil demon that I have. Wild that that is exactly how I picture my demon.
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This gal does a nice job on ecards:
http://www.jacquielawson.com/viewcard.asp?code=2007134554829&source=jl999
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Lovelyface: I had a horrible cough with my first 2 TC treatments, accompanied by a lot of post nasal drip and over salivation. When I had my 3rd treatment Tues, my Onocologist recommended Claratin, and the cough disappeared. hard to say whether the cough was due to the taxatore, the cytoxen, or just some random bug, but you might give it a try!
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I had surgery on Dec. 2nd and the 1.3cm tumor was removed with clear margins & no cancer in the lymph nodes. (doc said he removed a plum sized section of my breast.
Monday will be my first meeting with the Med/Onc Dr. Any suggestions of questions that I should ask? I am assuming that because I am TN, that I will be getting chemo.
Thanks in advance for your support.
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