Saturday, August 30, 2014

Disease for Sale

Attention Cause Marketers: Unique Opportunity Available.
Are you looking for a disease to use to generate sales? 
Hit the ground running with a new social media campaign...
October is now available. 
And if you act now, we will give you pink- for free!


October can now be yours. For all the marketing, media and promotional campaigns who are seeking a disease to sell products, October is now open for a new, fresh approach. Pick a disease, any disease and support that instead. ALS is hot, hot, hot right now. Imagine an ice bucket challenge in chilly October? There are thousands of diseases to choose from.

Everyone is aware of breast cancer. Everyone. These "awareness" campaigns actually take away from true research (and other diseases) because all the money is being spent being "publicly aware." Slap a pink ribbon on and you have done your part. Declare you are all for Saving the Tatas and with a wink and a smile you are not only aware, but you are a little naughty.

It has finally culminated in the basest form of cause marketing. This very well could be the straw that broke the pink camel's back.



The Facebook challenge cashing in on breast cancer is asking women to go bra-less on October 13 to "Support Breast Cancer." 

Healthy women of all ages displaying their bra-less images on their Facebook profiles will  "help" women afflicted with breast cancer? That is why they will be doing it?

Or is it yet another calculated target at the narcissistic mania of featuring yourself on your Facebook page doing something "noble-looking" that all your friends can "like" and comment on? "You look gorgeous!" and "Great tits!" will fill  the comment section. The adoration will be lapped up and more and more images will appear. Ice buckets will be poured over bra-less women to turn it into a wet T-shirt contest. Wait for it, you will see it. Just how will that translate to ending breast cancer? It won't. If you want to show off your wet t-shirt selves, do it because you want to show off, don't pretend you are saving lives.

And, for those of you object to this new campaign, be prepared for some rather nasty blow back. The KJR 95.7 Facebook page, one of many promoting it, had some women speaking out on the insensitivity and stupidity of this campaign, now in its second year.

Sara K. objected to a bra-less day post by saying the following:

"This is disgusting. An illness that takes the lives of so many women shouldn't have to be noticed just because it was fit to please the male gaze. There is more to breast cancer than saving breasts, it's saving a HUMAN."

Here are a few of the thousands of replies, exactly as they appeared: 

From Denise R. 
 "Whatever, my grandmother has breast cancer, which means I am a slightly higher risk for cancer. I support this type of marketing because it gets us money. It gets the research done. Don't get your panties in a bunch. Stop feeling bad for people with cancer -- so because you have cancer, you shouldn't be around sex, or sex related material? My brother had brain cancer -- he loves to make jokes about it. STFU. Why are people so fucking serious??? So because you had cancer you stop being human? If you're so depressed to think about this as offensive, then get treatment. For depression. Fast."


From Anthony W.
"There is always one person like yourself that can always ruin fun for everyone else."

From Joseph D.
"Just zip it b!tch &; show me your tits!...your going 2 show them 2 somebody !...so "why not " me?"

From Brandie N. 
 "Bras are a MAJOR factor causing breast cancer you daft bimbo. No woman should ever wear a bra!"

From Eben L.
"Lol here comes the term referred to as calm down by saying "calm your tits" ... Because in a sense it does raze awareness but obviously ppl like you have tunnel vision and only see the bad in everything. I feel sorry for morbid people like you though..."

From Alex W. 
"Feminist idiot!"

From Morgan B.

"I'm certain you've heard/read this any times in your life. Count me as one more...SHUT UP!"

Brave Dionna D. stepped in and said,

"Can't see why flaunting your healthy breast would help support any woman who has lost hers to cancer! Dumb idea!"

From Steve B.
"That's because you are a jealous idiot...."

From Nathan B.
"i support breast cancer...keeps down the population."

Yes. You read that correctly. You have heard from the public. These campaigns do nothing for breast cancer except bring out the worst in people. So if any other disease would like the spotlight this October, take it. It's yours. Let's see what they can come up with for other things that kill people.

And to add insult to injury, October 13th is also Metastatic Breast Cancer Awareness day. I am sure "Nathan B." celebrates that as well.

Tuesday, August 12, 2014

Act 3, Scene 1

(Disclaimer. This blog and the NSBCF is dedicated to fighting for our lives. We have an illness: cancer. This post is about another illness, an illness as real as cancer: depression. If you or someone you love is battling this disease, please reach out to someone or contact the suicide prevention hotline at: 1(800) 273-8255)

 

HAMLET:
To be, or not to be--that is the question:
Whether 'tis nobler in the mind to suffer
The slings and arrows of outrageous fortune
Or to take arms against a sea of troubles
And by opposing end them. To die, to sleep--
No more--and by a sleep to say we end
The heartache, and the thousand natural shocks
That flesh is heir to. 'Tis a consummation
Devoutly to be wished. To die, to sleep--
To sleep--perchance to dream: ay, there's the rub,
For in that sleep of death what dreams may come
When we have shuffled off this mortal coil,
Must give us pause. There's the respect
That makes calamity of so long life.
For who would bear the whips and scorns of time,
Th' oppressor's wrong, the proud man's contumely
The pangs of despised love, the law's delay,
The insolence of office, and the spurns
That patient merit of th' unworthy takes,
When he himself might his quietus make
With a bare bodkin? Who would fardels bear,
To grunt and sweat under a weary life,
But that the dread of something after death,
The undiscovered country, from whose bourn
No traveller returns, puzzles the will,
And makes us rather bear those ills we have
Than fly to others that we know not of?
Thus conscience does make cowards of us all,
And thus the native hue of resolution
Is sicklied o'er with the pale cast of thought,
And enterprise of great pitch and moment
With this regard their currents turn awry
And lose the name of action.

Please take a moment and read Hamlet’s words as he contemplates ending his life. Shakespeare captured the tortuous moments a deeply depressed person goes through when there seems to be no end in sight.

Depression is a disease. It has some shame to it because it is “mental” and people in deep depression are often confronted with criticisms such as, “Why doesn’t he/she snap out of it?” or “He/she has everything! What do they have to be depressed about?”  Depression strikes no matter what you have going on in your life.  Over 600,000 people attempt suicide every year in the United States.

Brilliant, creative, imaginative people seem to be the most vulnerable to depression. There is something about the creative, sensitive psyche that makes you feel things more exquisitely. The same ability to have your heart race when you see an osprey overhead carrying a fish back to the nest, or to see a sunset that can move you to tears, makes you feel other things as well. Sadness. Loneliness. Despair.  You can have all the friends in the world and you can have a loving, wonderful family, but they cannot heal your spirit. Only you can do that. And it takes a lot of work.

Before you can heal, you must travel to a very, very dark place. It was perfectly described in “Ordinary People,” written by Judith Guest, and acted, with perfection, by Timothy Hutton. When young Conrad was asked what his depression was like that led to his suicide attempt, he opened up for the first time:

Conrad: “I don't know. It was like... falling into a hole. It keeps getting bigger and bigger and you can't escape. All of a sudden, it's inside... and you're the hole. You're trapped. And it's all over. Something like that. It's not really scary... except when you think back on it. 'Cause you know what you were feeling.”

His wise psychiatrist tells him later, “ Let me tell you something about feelings, Kiddo. They don’t always tickle.”

And so this leads me to Robin Williams. I keep hearing people saying, “He was so funny! How could this happen?” The person who opens their heart and makes everyone else feel good, doesn’t necessarily make himself feel better. In fact, it is a temporary tonic for them for the moment. And then they return to their lives and they are not laughing. Real life is not a stage. Real life does not include adoring fans. Real life for someone in a deep depression, who is trying to stay sober, who is facing money troubles, who has to maintain a happy face to the public, can be overwhelming. Sometimes it is just too much to be the strong, happy, brilliant, funny guy. And perhaps that is how Mr. Williams felt.

He did the only thing he felt he could do to stop the pain. It is tragic and sad. I personally loved Robin Williams. He was a genius in my mind. And geniuses fight the hardest battles.

When Christopher Reeve had his riding accident and had to get intensive therapy, Robin Williams, his roommate at Julliard, paid the expenses. He was a generous soul. He gave and gave of himself until there was nothing left to give in his mind.

In the spirit of his generous heart, if you know someone who may be suffering, reach out. It can be something as simple as, “If you ever want to have a cup of coffee or maybe just watch tv together, I would love to hang out with you.” And then, when you are together, just let them be. Don’t ask more of them than they can be. Don’t make them entertain you. Just be their friend. If you see warning signs: Lack of sleep, loss of appetite, overuse of alcohol or drugs, sleeping too much, or not caring about their appearance, seek help for them.

Suicide has been happening long before Shakespeare wrote about it so eloquently. Depression is now recognized as a legitimate disease. And people can recover from it. It takes work. And sometimes you have to feel worse before you feel better. But you can get better. So with that knowledge, if you need to hear it for yourself, believe it. Or if you need to know for a friend or someone else you love, let them know and help them find help.

Thursday, August 7, 2014

New Gene Mutation Possible Link to Triple Negative Breast Cancer and Young Women

The No Surrender Breast Cancer Foundation's Before Forty Initiative strongly advocates the importance of early screening for breast cancer in women before the age of forty and not waiting until after forty for baseline screenings. This is particularly true for women of African-American, Hispanic and Ashkenazi heritage, because when breast cancer develops in these populations, it is most often the aggressive triple negative breast cancer.

Women who have the BRCA 1 and BRCA 2 gene mutation can be tested before their cancer is found, and can take protective measures such as a prophylactic mastectomies, to reduce their risk of developing the disease.

A new gene mutation has been discovered that is most closely related to younger women and triple negative breast cancer. It is called the PALB2. The following is a report from the New York Times, detailing the findings.


Study Shows Third Gene as Indicator for Breast Cancer

By NICHOLAS BAKALAR AUG. 6, 2014


Mutations in a gene called PALB2 raise the risk of breast cancer in women by almost as much as mutations in BRCA1 and BRCA2, the infamous genes implicated in most inherited cases of the disease, a team of researchers reported Wednesday.


Previous data had indicated that mutations in PALB2 were linked to breast cancer, and many genetic tests already screen for them. But it had not been clear to what extent these mutations raised a carrier’s odds of developing the disease.


Dr. Marc Tischkowitz, an associate professor of medical genetics at the University of Cambridge, and his colleagues studied 362 members of 154 families with PALB2 mutations. None had BRCA1 or BRCA2 mutations, but all had at least one family member with breast cancer and a mutation in PALB2. There were 311 women with PALB2 mutations, of whom 229 had breast cancer, and 51 men with the mutation, of whom seven had the disease. The results were published in The New England Journal of Medicine.


Over all, the researchers found, a PALB2 mutation carrier had a 35 percent chance of developing cancer by age 70. By comparison, women with BRCA1 mutations have a 50 percent to 70 percent chance of developing breast cancer by that age, and those with BRCA2 have a 40 percent to 60 percent chance. The lifetime risk for breast cancer in the general population is about 12 percent.


The breast cancer risk for women younger than 40 with PALB2 mutation was eight to nine times as high as that of the general population. 

The risk was six to eight times as high among women 40 to 60 with these mutations, and five times as high among women older than 60.



The scientists were not able to explain why younger women with the mutations were at higher risk. And there were too few men, Dr. Tischkowitz said, to make a judgment about their risk.

The data also indicated that women with the PALB2 mutations were slightly more likely to have “triple negative” breast cancer — a form resistant to hormone treatment, more aggressive, and more likely to recur than other subtypes.


Dr. Anees B. Chagpar, the director of the breast center at Yale-New Haven Hospital, who was not involved in the work, said she was impressed with the study but cautioned that other factors must be considered in evaluating a woman’s risk.


“This has to be tailored to the patients, who may have other mutations and varying family risk,” she said. “With no family history, the increase they found is 35 percent. If you have two or more family members with cancer, they found a risk of 58 percent.”


The study used data from 14 sites in eight countries but found no significant geographic variations in its prevalence. The researchers write that larger studies are needed to detect such differences, as well as to assess the role of lifestyle and hormone use on breast cancer risk in PALB2 mutation carriers. Breast cancer risk depends not just on genes, but how they interact with the environment.


Official guidelines do not recommend screening for breast cancer genes in most women, only for those with a family history of the disease. Dr. Tischkowitz said that such women should consider testing for PALB2 mutations if they are negative for BRCA1 and BRCA2 mutations.


Dr. Chagpar said: “As the testing becomes more common, we’ll hopefully end up with studies with thousands of patients in them. We’re going to start getting answers to hard questions.”



A version of this article appears in print on August 7, 2014, on page A18 of the New York edition with the headline: Study Shows Third Gene as Indicator for Cancer.
© 2014 The New York Times Company

Monday, August 4, 2014

Link Between The Pill and Breast Cancer, Another Study

This has been a debate for a long time: Does taking oral contraceptives increase your risk of developing breast cancer? Without looking at the details of the study, let's review a few facts.
Everyone has cancer cells in their body. The question is, what makes them wake up and start to divide and spread? (Cancer was named for the zodiac sign Cancer- the Crab- because of how it crawls and spreads.)

A normal breast, without medication, goes through hormonal changes depending upon a woman's menstrual cycle.  It is a natural process. When you introduce hormones to "trick" your body into a false hormonal state, a state making the implantation of an embryo impossible, the breast tissue is affected by the changes. Do these changes cause breast cancer? No one knows for sure, but when looked at it from a distance, one can see that it certainly opens the door to the possibility of it somehow changing the breast tissue. Whether or not it changes to cancer is the question, one that clearly needs to be better understood.

From the ATLANTIC:


The Link Between Birth Control Pills and Breast Cancer

By Olga Khazan, THE ATLANTIC

The birth control pill is regularly hailed as one of the greatest medical advancements for women. Breast cancer, meanwhile, is considered one of the biggest health threats.

The only problem? There’s some evidence that the first increases your risk of the second. A new study out today suggests that having recently taken birth control pills increases breast cancer risk by about 50 percent. Women who were on a formulation of the pill with an especially elevated level of estrogen nearly tripled their risk of getting breast cancer, and a pill with even a moderate amount of the hormone increased the risk by about 60 percent.

For the study, published in the journal Cancer Research, scientists at the Fred Hutchinson Cancer Research Center and the University of Washington in Seattle followed 1,102 women diagnosed with breast cancer, most of whom were in their 40s. Rather than rely on self-report data, the researchers dug into the women’s pharmaceutical records to determine the exact oral contraceptives they were taking.

They divided the types of pills into three categories: Those formulated with a low level of synthetic estrogen, or about 20 micrograms of ethinyl estradiol; those with a moderate dose, or 30 to 35 micrograms of ethinyl estradiol or 50 micrograms of mestranol; and those with a high dose, or 50 micrograms of ethinyl estradiol or 80 micrograms of mestranol. Estradiol is one of the two main chemicals in the pill, along with progestin.

Overall, women who recently took high-estrogen-dose pills were 2.7 times more likely to have breast cancer, while those who took moderate-dosed pills were about 1.6 times more likely. There was no increased risk for the low-dose pills.

Two specific types of pill formulations increased cancer risk the most: Those containing ethynodiol diacetate (which are sold as Continuin or Femulen) increased the risk 2.6 fold, and triphasic combination pills containing 0.75 milligrams of norethindrone (sold as Ortho 75) increased the risk 3.1 fold.

Estrogen acts as a signal to the breasts to stimulate the growth of epithelial cells. When there’s too much estrogen, “you're giving a higher signal than what's normally there,” said Rowan Chlebowski, an oncologist at the University of California Los Angeles and a spokesman for the American Association for Cancer Research. “Estrogen normally makes the breast proliferate—women get larger breasts. A few proliferations could allow the growth to continue in an unregulated way.” That unregulated growth, in turn, could become a cancerous tumor.

The results are consistent with past studies that have found that breast cancer risk increases slightly with some oral contraceptive pills, though other studies have not found such a link.


As with most things OB-GYN related, that’s frustratingly confusing. The pill is essential; not getting cancer is too. How do you choose what's more important—a lifetime of easy reproductive autonomy, or ratcheting down your risk of a deadly disease by marginal amounts?
The caveats to this study are in some ways just as important as the findings:

    •    The high-dose pills are incredibly uncommon. “I haven't seen a woman in 20 years who was on 50 or 80 micrograms. It's really uncommon, and it's not something that I prescribe,” Owen Montgomery, chairman of the department of obstetrics & gynecology at Drexel University in Pennsylvania, told me. Most of these women have specific medical issues that necessitate being on a high-dose pill, or they’ve found that their side-effects on other formulations of the pill are just too debilitating to keep taking them. Women might take a higher-estrogen pill if they have extreme breakthrough bleeding, for example. Only half of one percent of women were using the high-dose pills by the last phase of the study, which took place from 2005 to 2009.

    •    The cancer risk returned to normal for women who stopped using birth control pills. The elevated risk was only found for women who had taken the pill within a year.

    •    Breast cancer is already really rare—a woman’s risk of developing it at age 40 is only about 1.5 percent, and it’s only 2.38 percent at age 50. Increasing either of those numbers by even a factor of three makes a difference, but not much of one. Even the study’s author, Elisabeth Beaber, a staff scientist at the Fred Hutchinson Cancer Research Center, said the findings aren’t enough to suggest you should change your prescription if you do happen to be taking one of these high-dose pills.

    •    The pill has cancer-fighting effects, too. It’s been shown to protect slightly against ovarian and endometrial cancer. So if you have a family history of endometrial cancer rather than breast cancer, a higher-dose pill might still be worth taking.

    •    Finally, all medicines carry risks. “Every time I prescribe something for one of my patients, there's always a balance between risk and benefit,” Montgomery said. “If aspirin came with a package insert, you'd be scared to death to take aspirin.”
For Montgomery, all this study shows is that, “you have to make sure that with your patient, for her unique history, that you use something where the benefit outweighs the risk. For the vast majority, the usefulness of the pill outweighs the risk by a huge margin.”
And since the pill is still America’s most popular contraceptive method, despite decades of yes-it-does-wait-no-it-doesn’t cancer risk research, it seems many women agree.

This article available online at:
http://www.theatlantic.com/health/archive/2014/08/the-link-between-birth-control-pills-and-breast-cancer/375448/
Copyright © 2014 by The Atlantic Monthly Group. All Rights Reserved.

Friday, July 25, 2014

What a night

Sunday, July 20th, 2014 had perfect weather. The bright white tent was filled with colorful table linens and fresh flowers from the gardens. Food tables were set up by the finest restaurants, caterers and bakeries in the area and we even had a big barbeque blazing on the far side.

The guests mingled, sipped drinks, ate, sat under the tent or on garden chairs set up on the sweeping lawn behind Christ Church Oyster Bay.

At 8:15 the award ceremony began and our honoree and 2014 Alice Roosevelt Longworth recipient, Marguerite Casparian, accepted her well deserved recognition for ten years of unparalleled service to the Oyster Bay Community.

This was followed by the models, our Warrior Angel Survivor Models, who were accompanied by their heroes- their caregivers. Before each model stepped onto the runway, her tribute to her hero was read. Cheers, tears, and standing ovations followed. When the last model finished, the event turned to the second theme of the evening. We were saluting the Heroes-Our Caregivers, and we were remembering what happened 45 years ago that same evening on July 20th in 1969 when man first walked on the moon. This was followed a few weeks later by a little gathering up the New York State Thruway called Woodstock, and over in London, the Beatles were busy recording Abbey Road. At the same time, Paul Simon wrote, "A Bridge Over Troubled Water." What a summer that was. Heroes, love, peace and the perfect song that epitomizes what our heroes mean to us, getting us through our troubled times.

We turned the night over to the amazing Mostly Moptop Band, and the dancing began and didn't end for a very long time....

Everyone present has reported this was the best party the No Surrender Breast Cancer Foundation ever held. We agree. We also wish everyone could have been there. To give you a taste- take a look at our party here:


A very special thank you to Christ Church, Mostly Moptop, Birch Lifestyle Boutique, JMclaughlin, Periwinkles, Christina's Epicure, Jack Halyards, Suzie Cakez, The Coach, Country Plaza Caterers, Mario's and Bagel Boss.

Tuesday, July 8, 2014

Generous Grant That Will Help Us All

As readers of this blog know, we are strong advocates of the work being done at the Cold Spring Harbor Lab. If ever there was  a research institution that holds the key that will unlock the cure to cancer and other disorders, it is this group of dedicated scientists.

A wonderful, philanthropic couple have shown their support of the lab in a big way. This money will help move the innovative research forward and will make a difference in all of our lives.

We applaud Mr. and Mrs. Simons.


Simonses give $50 million to Cold Spring Harbor lab

July 7, 2014 by Delthia Ricks, Newsday
delthia.ricks@newsday.com

A Long Island couple has donated $50 million to Cold Spring Harbor Laboratory in the hope of contributing to the precision analysis of an enormous amount of molecular data being generated by human genomics, tumor biology and the genetics of autism.


The gift from hedge-fund investor James Simons and his wife, Marilyn, of East Setauket, will establish the Simons Center for Quantitative Biology on the lab's campus.


Quantitative biology is an emerging interdisciplinary field that utilizes fundamental concepts from physics, mathematics, computer science and chemistry to better analyze biological data.


The gift will allow Cold Spring Harbor scientists to expand their work and explore vast areas of biology, aiding in the understanding and treatment of numerous disorders.


"It's a transformative gift, something that will really enable the quantitative biology program to recruit a lot more people than we anticipated and support their research," said Dr. Bruce Stillman, the laboratory's president.


Quantitative biology is vital, Stillman added, because it allows other areas of science to better elucidate biological findings. "We don't want to reinvent things that have already been invented, such as algorithms," Stillman said. "But we want to use algorithms to understand biology and medicine. I am hopeful that we will add to the development of new algorithms that will benefit everybody."


Renee Fister, an officer with the Society for Mathematical Biology, which promotes interaction between the math and biological science communities, said, "This is a substantial gift, and that means they have the people and the mechanisms in place to make important contributions."


David Usher, a professor of quantitative biology at the University of Delaware, also applauded the donation and explained that the discipline is adding to the understanding of a vast range of biological systems.


Pharmacokinetics, the study of how medications are absorbed, metabolized and excreted, is an area that has long benefited from advances in quantitative biology, Usher said.

Cold Spring Harbor Lab's new center will be chaired by Adam Siepel, an associate professor at Cornell University who has directed the doctoral program in computational biology. He joins the lab in September.


Stillman, meanwhile, sees the donation as filling an enormous void in scientific funding.
"Philanthropic support of science is becoming increasingly necessary and important," he said, "and gifts of this magnitude allow programs like ours to be supported."


He added that after the completion of the Human Genome Project more than a decade ago, federal money for basic biological research dropped 22 percent, which has meant a loss of funding for numerous investigators.


"In inflation-adjusted dollars, that's enormous," Stillman said, noting federal funding has remained flat for some scientific enterprises, nonexistent for others.


The Simonses' donation is the third they've made in recent years to fuel scientific enterprise on Long Island. In 2011 they donated $150 million to Stony Brook University, and in 2008 they gave the school $60 million.


James Simons was chairman of Stony Brook's mathematics department from 1968 to 1976 and is credited with discovering the so-called Chern-Simons invariants, which have had wide use in theoretical physics.



Marilyn Simons, president of their philanthropic foundation, holds a doctorate in economics. Her husband founded a hedge fund after his years in academia."Jim and I have been consistently impressed by the commitment of Cold Spring Harbor Laboratory's board, management and faculty to excellence in biological research and education," she said in a statement Monday.


"We are proud to provide financial support that allows this institution to recruit outstanding scientists like Dr. Siepel to pursue the most innovative research in cancer, neurobiology, genomics and quantitative biology."

Thursday, July 3, 2014

Follow the Money...

Sometimes it is hard to know which drug holds the most promise when reading about Phase 1 trials. They may sound effective on paper, but do they really work? One good indicator of a truly promising drug is if a large pharmaceutical company backs it with a great deal of money.

This is the story of a new drug that has the backing of  Roche's Genentech one that will help women with estrogen responsive breast cancer who have become resistant to estrogen blocking drugs. The words, "total estrogen annihilation" may sound foreboding, but when your cancer is feeding on the estrogen in your body, you want nothing less.
 



Roche's Genentech bags game-changing breast cancer drug in $1.7B deal
By John Carroll, Fiercebiotech.com


Just a year after Johnson & Johnson swooped in to buy up Aragon’s game-changing work on prostate cancer in a billion-dollar deal, Roche's Genentech has followed up to buy what remained: a closely-related breast cancer program that promises to change the way that disease is treated. And the big Roche subsidiary is paying a blockbuster figure, handing over $725 million in cash for the fledgling biotech Seragon Pharmaceuticals--which was spun off from Aragon after the J&J deal--and promising up to a billion dollars in milestones.

In exchange Roche is getting a Phase I cancer therapy with a stellar pedigree and a groundbreaking approach to breast cancer. Seragon has been targeting hormone-receptor positive cases, which are currently treated with drugs that wither block the estrogen receptor or prevent the production of estrogen.



The biotech has been working on a drug that doesn't just block the receptor--it's out to eliminate it altogether.

"This year, breast cancer will claim the lives of nearly 40,000 women in the United States, and up to half of these women will have a disease that is driven by the estrogen receptor," said Richard Scheller, the head of Genentech's research arm, dubbed gRED. "We believe these investigational oral SERDs (selective estrogen receptor degraders) could one day redefine the standard of care for hormone receptor-positive breast cancer."

Seragon was built on the scientific foundation laid by Aragon, a San Diego biotech created to pursue the insights of noted investigator Charles Sawyers, now at Memorial Sloan-Kettering. Standard therapies for breast and prostate cancer are designed to block the effect of the hormones, acting like "glue in the lock" of hormone receptors, then-Aragon CEO Rich Heyman toldFierceBiotech back in 2010. But over time, patients become treatment resistant and the therapy can wind up fueling the cancer. Heyman called his lead therapy for prostate cancer "super glue. It truly blocks the receptor in this resistant state."

J&J plucked the lead androgen-receptor prostate cancer work out of the company, paying $650 million in upfront cash, and left Heyman to go on to pursue the focus on breast cancer and estrogen receptors in a new company backed by some very happy investors. Last fall the new company got started with a $30 million round and a lineup of Big Pharma admirers.

This new deal with Genentech is remarkable for several reasons. Genentech is not known for paying out a lot of cash to bring in new drug programs. As any of its execs will tell you, the giant Roche subsidiary is confident that it has a big pipeline of cancer drugs and doesn't need to buy up a string of new programs. So it tends to buy or license very early stage efforts for modest amounts that complement that work--unlike Roche's pRed group based in Basel, which has been scouring Europe and the U.S. for new technologies.

The deal also underscores the promise of the work that Seragon was doing. Genentech is considered one of the best cancer drug developers in the world, so when it pays big for a drug, they're betting that they're jumping into something transformative. What was an early-stage effort at a small biotech is now a leading program at Roche. And the way fast-paced cancer drug R&D works these days, it shouldn't take too much more time before we start seeing human data on its effect on breast cancer.

Finally, these kinds of numbers in a cancer deal highlight the level of attention oncology is getting from the major players in biopharma. As much as a third of all research cash is now directed at cancer and inflammation and top assets are fetching premium prices. The $1.7 billion Seragon deal suggests that the premium just got bigger, which will only further emphasize the leading role that the biggest companies with the deepest pockets play in the field.

The Wall Street Journal's Helen Thomas, though, used her 'Heard on the Street' column to raise an early warning, calling it “disconcerting.”  Rarely in other sectors do companies shell out vast sums for assets that could quite possibly amount to nothing." And she went on to note the chronically high failure rate of experimental drugs as well as the fact that Seragon was formed only last year.

True enough. Thomas, though, overlooks the years of research that had already been done in Aragon and more recently at J&J on these receptor-related drugs, to say nothing of Sawyers' earlier work. Also, investigators have been changing the odds on cancer R&D in recent years.

Roche and Genentech are gambling big sums, their task now is to prove they know how to do it wisely.

 From fiercebiotech.com


Monday, June 23, 2014

A Celebration of Our Heroes- The Caregivers

They are our waiting-room-seat-warmers, chauffeurs, confidantes, chefs, doctor decipher-ers, bouncers, phone screeners, prescription pros, brave-face-holders, silly-joke-providers and unsung heroes, until now.

On Sunday, July 20th, the No Surrender Breast Cancer Foundation is honoring our heroes, the people who cared for us during our illnesses. It is not limited to breast cancer, either. We are inviting everyone to Nominate Their Hero to publicly acknowledge them at our event and in our journal.

As ever, the party features a special fashion show starring our Warrior Angel Survivor Models who will walk the runway this year with their heroes. Two wonderful shops in Locust Valley, New York, are providing the clothes for our models, "Birch" and "JMclaughlin."

The evening begins with cocktails and "A Taste of Summer" provided by the finest restaurants, caterers, bakeries and specialty shops on the North Shore of Long Island. This will be followed by our Hero Ceremony and the 2014 Alice Roosevelt Longworth Award will be presented to our hero: Marguerite Casparian. For the past ten years, she has lovingly cared for the Oyster Bay Community and was one of the first volunteers at our new Oyster Bay Outreach Center. Marguerite and her husband, the Rev. Peter Casparian, are retiring and moving to Texas this fall. Our party will give the entire community a chance to thank Marguerite for all she has done. She has touched so many lives, and we will miss her very much. The award presentation will be followed by our fashion show.

When the fashion show concludes, the dance party begins.




We are happy to announce that "Mostly Moptop" will be performing the greatest songs of the Beatles and the sixties and they will help us pay homage to the "Summer of '69" through music.

And what a busy summer it was...





Forty-five years ago, on another magical July 20th evening, in 1969, man first walked on the moon.






A couple of weeks later, a little festival took place up the New York thruway called Woodstock, and the Beatles were in Apple Studios recording their last album, Abbey Road.

If you are in the area, or want to make a special trip, grab your hero, some Tang, your love beads and let's all "Come Together" in Oyster Bay!

Reserve your ticket by July 13th. This link will take you to our party page.

All proceeds from our event will go towards the new Oyster Bay Outreach Center. You can read about that here.

Sunday, June 15, 2014

Specific Research Aimed at Metastatic Disease

Metastatic breast cancer kills over 40,000 women a year. While there is vast research on detection, treatment and management of early disease, metastatic disease receives the least amount of funding. Since our founding in 2007, the No Surrender Breast Cancer Foundation has deeply respected the work being done at the Cold Spring Harbor Laboratory. We still do. 

Today, they announced a new research grant specifically targeting how cancer cells return after chemotherapy is over. 

We are proud to support all the work at CSHL and encourage all of our readers to support them as well.


"Metastatic disease is what kills people. If we can stop metastasis, then we can cut the cancer mortality rate."

LI Researcher Wins Grant to Solve a Cancer Mystery
Originally published: June 14, 2014 NEWSDAY

By Delthia Ricks


Months to years after cancer treatment has seemed effective, some malignancies come back -- rebounding with a vengeance and spreading to distant sites.


Understanding how and why potent treatments are rebuffed in certain breast cancers underlies a series of groundbreaking studies at Cold Spring Harbor Laboratory overseen by Dr. Mikala Egeblad, who late last week won a highly coveted $2.5 million research award from the Department of Defense.

The grant will aid in her efforts to find out why some breast cancers spread.


"This will really help in speeding it up," Egeblad, 43, said of her work and the additional scientists she will be able to bring onboard to delve deeper into a critical question: How cancers reseed themselves.


Known as the The Era of Hope Scholar Award, the grants are aimed at scientists still in their early career years. The defense department has been funding investigations through its Breast Cancer Research Program since 1992.


Four other scientists won grants out of more than 50 who applied for this year's awards.
Egeblad is exploring the phenomenon scientists call resistance, a cancer's capacity to repel chemotherapy. An estimated 40,000 people nationwide are affected annually by breast cancers that become resistant to treatment.


In her Cold Spring Harbor lab, Egeblad has found that a patient's own immune system cells known as macrophages play a key role in sending subversive signals that are used by tumor cells to spread.

 Normally, macrophages -- chubby cells with a big mouth-like orifice -- are friends, not foe. They gobble up dead tumor cells and virtually any kind of debris, including infectious organisms. Picture the old Pac-Man video game that consumed dots.

But macrophages, Egeblad said, also send signals in the vast communication network of the body allowing cells to "talk" to each other.


"What we found is that when you give chemotherapy, the macrophages come in and clean up all these dead cells but they are also sending signals to the [tumor] cells that are not killed in the first round of chemo. And those signals are making it easier for the tumor to bounce back after chemo," she said.


Precisely what those signals are, no one knows. Egeblad is trying to decode them. She has developed a highly innovative microscopic technique that is allowing her to view -- in mice -- the activity of macrophages in real time.


Egeblad said she consulted with breast cancer survivors to better hone her work toward critical problems patients face.


One of the survivors, Joanne Marquardt of the West Islip Breast Cancer Coalition, said by zeroing in on resistant cancer cells, Egeblad is helping to unlock a critical mystery.


"Metastatic disease is what kills people," Marquardt said of cancer's spread. "If we can stop metastasis, then we can cut the cancer mortality rate."


"Right now we are getting much longer survival periods, but if you look at the mortality rates and statistics, most of the [cancer] mortality occurs in patients with metastatic disease."


Marquardt, a North Babylon resident,  is a past consumer member of the Defense Department’s Breast Cancer Research Program. She has evaluated other researchers’ work and said she was excited to learn Egeblad, who lives in Cold Spring Harbor, had won a grant.


"Mikala is very humble," Marquardt said, but added her investigations are cutting-edge and she is a rising star among cancer researchers.

Thursday, May 15, 2014

A View of the New ASCO Screening Guidelines

 The American Society of Clinical Oncology has new screening guidelines for breast cancer patients post treatment.  The following is a review co-written by Gina Maisano, Founder of the No Surrender Breast Cancer Foundation and Constantine Kaniklidis, Director of Medical Research at the No Surrender Breast Cancer Foundation and Founder of Breast Cancer Watch.


A View of the New ASCO Screening Guidelines for Breast Cancer Patients
by Gina Maisano and Constantine Kaniklidis


When is it too late for early detection? All experts agree that finding a primary tumor at its earliest stage offers the most benefit to the patient because it may not have had a chance to spread. Surgery and chemotherapy can be started to stop its growth. The patient has the best chance of survival if her cancer is found early.

There has always been a controversy about whether there is a good time to find metastatic disease. The defeatist answer has always been, “Well, the overall metastatic outcome is not improved if found early.” After 13 years of being among women who are in all stages of cancer, from Stage 0 to Stage 4, I can categorically report that yes, indeed, if you find your metastatic tumor early, it helps. Does that mean the cancer can be cured? Cure is certainly extremely rare. Although certain types of oligometastatic disease, with single or only a few detectable metastatic lesions, can be effectively “cured.” There are some other special cases where metastatic patients can sometimes achieve durable long-term remissions. However, without question, metastatic disease remains the greatest treatment challenge facing oncology. It is also the one part of oncology that receives the least amount research.


Consider the woman who goes for regular oncology visits after her treatment has ended. She is followed every 4 months. At each visit the doctor draws a Complete Blood Count and a Tumor Marker level. Tumor Markers measure the level of cancer antigens in the body. If all are normal, then the woman breathes a tremendous sigh of relief and begins praying that all will be well at the next visit. Sometimes tumor markers are elevated. They are notoriously hyper sensitive and don’t always indicate the presence of disease. However, if they consistently rise at each visit, it could mean that something is amiss and the patient is then sent for a scan. A scan could show nothing or it could show a small mass somewhere that needs to be immediately treated. Many women who have had breast conserving surgery often find regional or local recurrence in the same or contralateral breast this way.

The Complete Blood Count seems innocuous enough. But for a woman with breast cancer, an elevated calcium level combined with an elevated alkaline phosphatase level can mean the presence of metastasis to the bone. Found early, bone metastasis can be treated quite successfully with drugs and radiation. The woman is considered Stage 4, but there are still years of living ahead of her. Why? Because she found her disease early.

If a woman is going to develop metastasis, the ability to knock down the disease while it is still small, treatable and has not spread anywhere else yet, means more birthdays, graduations, weddings, Christmases, family vacations and memories. It extends her life -  a life which is not a statistic.

At the 2013 American Society of Clinical Oncology meeting it was determined that regular blood tests are no longer needed. That goes for scans, too. The patient just needs a once-over by her oncologist every six months. And unless he has X-ray vision, what good will that do? Why even bother with visiting your doctor if they are no longer monitoring you? Some of the finest oncologists in the nation are following these guidelines. There is a window open right now where the patient can insist on blood work and when that window closes and patient insistence fails in the future, what some would call “subterfuge” will have to begin. In order to have a screening appointment, we will have to complain of some terrible pain that needs looking into. And, you can be sure, there will be a fight about that.

It should not be the case that the standard of care post treatment should also have to  include a few sessions at the Actor’s Studio so patients can be more convincing when they pretend there is something wrong with them just so they can get a test to make sure there is nothing wrong with them.

There have been a lot of changes in medical care lately. This is one of the worst. It is as if our oncologists have given up. They are not fighting for us anymore. They are not our hero generals on the battlefield. Instead, they are waving the white flag of surrender to not be proactive, to not look forward, and to not protect us.

We don’t believe in surrendering.  We believe in being your own advocate and refuse to let our  oncologists toss us into the “Well, let’s see what happens” pile. Fight back.  To that end, Constantine Kaniklidis, Director of Medical Research at the No Surrender Breast Cancer Foundation and Founder of Breast Cancer Watch has compiled a Patient Guide to arm yourself with when you next visit your oncologist.

Patient Guide
Questions and Answers

Q:  Some doctors seem to no longer be doing follow-up complete blood counts and chemistry panels, or CT, PET and MRI scans, or tumor marker testing. Why?


A:  ASCO - the American society of Clinical Oncology - has recently (2013) issued a guideline update on "Breast Cancer Follow-Up and Management After Primary Treatment" that states that these tests are  " . . . not recommended for routine follow-up in an otherwise asymptomatic patient with no specific findings on clinical examination". Oncologists often cite these ASCO Guidelines of 2013 as the reason for no longer offering these follow-up tests.
 
Q:  But are these guidelines binding on oncologists?


A:  No. ASCO in fact has explicitly disclaimed any mandatory force of these guidelines in clinical practice. Here's their disclaimer:
Disclaimer: “This information does not mandate any particular course of medical care. Further, the information is not intended to substitute for the independent professional judgment of the treating physician, as the information does not account for individual variation among patients” . . . “there is latitude for the treating physician to select other courses of action in individual cases”.

These guidelines are therefore explicitly discretionary, and they in fact instruct physicians to determine for themselves what if any of the suggestions to implement, counseling that the decision of testing  and which tests should always defer to the “independent professional judgment of the treating physician”. So ASCO recognizes that "the information does not account for individual variation among patients" and that "the selected course of action should be considered by the treating physician in the context of treating the individual patient".
 
Q: Are there certain cases that motivate the type of periodic follow-up testing that's been customary until now?


A: There are no formal guidelines here, but certainly a strong reasonable case can be made in advanced/metastatic disease, and in challenging higher-risk scenarios such as triple negative breast cancer (TNBC) and HER2-positive disease, which plausibly require close follow-up to monitor both disease progress as well as response to treatment, but any individual breast cancer case, even outside these, can still be a reasonable candidate for continued follow-up testing. Every case is  unique and patients should candidly expressed their views in an honest discussion with their oncologists.
 
Q: Is there evidence that these follow-up tests don't provide benefit?


A: In fact, there is only the absence of robust evidence decisively showing improvement to overall survival outcome, but this absence is not the same as having decisive evidence that the follow-up testing provides no benefit to the patient or her/his management. Every case is different, every patient is unique, and at least one authority (the National Comprehensive Cancer Network/NCCN) has expressed their view that although we have no decisive high-level evidence of benefit, we do have some evidence from several studies to  suggest plausible benefit.
 
Q:  What say, or role, does the patient have in what follow-up testing should be done?

A:  Quite a significant one. So with regard to tumor markers, NCCN (National Comprehensive Cancer Network), whose guidance on testing and treatment is authoritative for both oncologists and insurers,  states that" "The ultimate decision about whether or not to use CA 15-3 (BR 27.29) in this situation must be taken by the doctor in consultation with the patient" and they conclude that "In combination with radiology and clinical examination, CA 15-3 or BR 27.29 may be used to monitor chemotherapy in patients with advanced breast cancer", which is their stand on all follow-up testing. Therefore, you have a voice in any decision about these tests and should speak to your oncologist candidly concerning your own perspective on continuing periodic monitoring.



Team No Surrender, Constantine Kaniklidis and Gina Maisano

Breaking News

A breakthrough finding in vaccine therapy.

The following link will take you to the news of a woman whose advanced cancer was put into complete remission by a massive dose of the measles vaccine.

Further studies are pending, including a specific vaccine therapy for breast cancer.

http://www.washingtonpost.com/news/morning-mix/wp/2014/05/15/womans-cancer-killed-by-measles-virus-in-unprecedented-trial/?tid=hp_mm

Friday, May 9, 2014

H.R. 1984/ S. 1931: We Support the Breast Cancer Patient Education Act

May 7, 2014.

A beautiful, Spring day in our Nation's capitol was the backdrop for a very important step forward for women facing breast cancer. At the urging of the  American Society of Plastic Surgeons, a bi-partisan legislation was introduced in the House of Representatives by Reps. Leonard Lance (R-NJ) and Donna Christensen, M.D. (D-VI) and in the U.S. Senate by Senators Sherrod Brown (D-OH) and Roy Blunt (R-MO).

The No Surrender Breast Cancer Foundation is a proud  supporter of this Bill. As our founder, it was an honor to present before a distinguished group of physicians, law makers, survivors and the press. It was important for those present to hear from the trenches of breast cancer to illuminate how vital this subject is.

Back in 1997, a law was passed that insurance companies had to cover breast reconstruction. What that did was help women fight back if they were denied coverage. The problem with the law is that only 30 percent of breast cancer patients know about it. Seven out of ten women facing breast cancer surgery are unaware of their choices. It's no wonder, when you think about the soul-er vortex one enters after you hear you have cancer. Suddenly everything is at warp speed and you rely on your doctor to tell you what to do. If your doctor doesn't refer you to a breast reconstructive surgeon, or even start a conversation about what is available to you, it creates even more anguish because there are no options. You don't even get the opportunity to make a choice about what will happen to you. What's more, among minority groups, those for whom our Before Forty Initiative was created, the information provided after a diagnosis is even lower.

I was one of those women who was not offered anything other than a lumpectomy, which is a nice way of saying what it really is, a partial mastectomy.  I had an extremely aggressive tumor. I underwent 6 months of chemo and radiation that caused such extensive burns that it required even more breast tissue to be removed. This was followed by years of scares, scars and scans. And then, five and  a half years later, the cancer returned to the opposite breast. This time the tumor was even larger and had node involvement. I cannot help but wonder what would have happened if I had a bilateral mastectomy with reconstruction the first time. Would I have been spared the second round of nine months of chemo and more radiation?

I did ask about getting a mastectomy and was told, "No, no, you don't need that." Imagine if I had heard, "Yes, you should investigate that option, here is the name of a reconstructive surgeon who can take you through the steps...."  


That is what this Bill is trying to do. It won't cost the taxpayers anything. It would simply be making sure that women know their choices. It is going to be tough, but I think we can prevail. Awareness goes beyond the pink parades, it is details like these that women really need to know. And that is what I spoke about at the Capitol. I talked about how women are being screened too late. Breast density makes it almost impossible to see a tumor by mammography. Ultrasound and breast MRIs should be the standard of care for those with dense breast tissue. Women who have had reconstruction many years ago, such as an implant that has become hard and painful due to scar tissue, need to know that their insurance company must cover corrective surgery. Women with single mastectomies, need to know that they can get their other breast augmented or lifted to match their new breast.  Women who chose not to reconstruct, need to know what is available to them from prostheses providers.

This is not an issue about vanity. It is about choices, information and taking charge of your own health. Removing a breast offers a higher rate of survival than a lumpectomy alone. If you have certain types of breast cancers, a bilateral mastectomy is a must. Such is the case with lobular cancer, the kind I had the second time, because it tends to be in both breasts and is very hard to detect until the tumors are very large. There are women I know through the No Surrender Breast Cancer Foundation who have had their cancer return to their "saved" breast and look back wishing they had known all of their options.

There are a few hurdles to overcome such as will the high deductibles with the new Affordable Care Act  prevent women from moving forward? The insurance company may have to cover the procedure, but the hospital costs, especially with the deductible, will create a problem. Then there is the access to board certified breast reconstructive surgeons who may not accept ACA or Medicaid plans. And then the most mind blowing of all: Hospitals lose accreditation if they perform "too many" mastectomies. Just how many are too many? Especially when you take into consideration that you reduce your risk of recurrence by 90 percent with a mastectomy. And women, like me, who originally had a lumpectomy, became a frequent flyer at the ambulatory care center because of all the biopsies I had to endure because they "saved" my breast. Do they prefer you have a lumpectomy because they know how many times you will have to be back for suspicious lumps?

I was happy to be able to bring to life what really goes on in our world. From our fears, to our challenges with body image post treatment. I talked about the feedback I have received from my book, Intimacy After Breast Cancer, and the many women who felt empowered to reclaim their lives again after reading it.

I am more than happy to step up for this issue, and I applaud the ASPS and the many legislators who are on board already.

Monday, April 7, 2014

Metastatic Breast Cancer Treatment Hope?


Potential Breakthrough in Treatment of Hormone Responsive Metastatic Breast Cancer?


Guarded Optimism After Breast Cancer Drug Shows Promising Results
 

By Andrew Pollack April 6, 2014
http://www.nytimes.com/2014/04/07/business/breast-cancer-drug-shows-groundbreaking-results.html?hpw&rref=science&_r=0   

SAN DIEGO — Researchers say that a new type of drug can help prevent advanced breast cancer from worsening, potentially providing an important new treatment option for women and a blockbuster product for Pfizer.



In a clinical trial, the drug cut in half the risk that cancer would worsen, or progress, researchers said here on Sunday. The median time before the disease progressed or the women died was 20.2 months for those who received the drug, compared with 10.2 months for the control group.


“The magnitude of benefit we are seeing is not something commonly seen in cancer medicine studies,” Dr. Richard S. Finn, a principal investigator in the study, said in an interview. Dr. Finn, an oncologist at the University of California, Los Angeles, called the results “quite groundbreaking.”


The drug, known as palbociclib, also appeared to prolong survival but not by a statistically significant amount. Those who received the drug lived a median of 37.5 months compared with 33.3 months for those in the control group.


The results from the Phase 2, or midstage, study were presented here at the annual meeting of the American Association for Cancer Research. They are being closely watched on Wall Street, because palbociclib is considered a jewel in Pfizer’s product pipeline, with analysts predicting annual sales of billions of dollars. Amgen is entitled to an 8 percent royalty on sales of the drug.


As strong as the results were, it is possible they will be a bit of a letdown to some investors.
That is partly because they were not quite as good as interim results presented about halfway through the trial. At that point, the difference in median progression-free survival was 26.1 months for palbociclib versus 7.5 months for the control group.


The lack of a statistically significant survival benefit could also give investors pause.


Dr. Finn said, however, that a statistically significant survival benefit should not have been expected at this point because only 61 of the 165 patients in the trial had died. Also, patients can use other drugs after leaving the trial, which can dilute any effect of palbociclib.



Palbociclib slows the runaway proliferation of cancer cells by inhibiting the activity of two related enzymes involved in cell division — cyclin-dependent kinases 4 and 6.


While Pfizer is in the lead to bring this new class of drugs to market, Novartis has begun late-stage testing of its own CDK 4/6 inhibitor. Eli Lilly is at an earlier stage, with some results for its drug presented here. While breast cancer is the initial focus, the drugs are being tested for other cancers.


Breast cancer specialists not involved in the study were encouraged but somewhat cautious. “These results are strikingly positive and with a large potential impact to patients,” Dr. José Baselga said in a speech at the conference discussing the results.


But Dr. Baselga, the physician in chief at the Memorial Sloan-Kettering Cancer Center, said the results might have been biased because the study investigators, who determined whether tumors had progressed, knew which patients were getting palbociclib.


Dr. Eric P. Winer, chief of women’s cancers at the Dana-Farber Cancer Institute in Boston, said larger studies were still needed.

“This is a small Phase 2 trial — not tiny, but not the kind of study that would typically lead to a change in practice,” he said.



The study, sponsored by Pfizer, involved 165 post-menopausal women receiving their initial treatment for recurring or metastatic breast cancer. The cancers were estrogen receptor-positive, meaning their growth was fueled by that hormone, but negative for Her2, a different protein.

About 60 to 65 percent of breast cancers fit that description, according to Dr. Dennis J. Slamon of U.C.L.A., another investigator in the study. Analysts at the ISI Group, an investment research firm, estimate that about 50,000 American women a year would be eligible for palbociclib.


All the women in the trial took letrozole, a drug that blocks the synthesis of estrogen. Such drugs are standard initial therapy for this type of breast cancer. About half the women also received palbociclib, which was taken orally once a day for three out of every four weeks.


The biggest side effect, experienced by about three quarters of patients, was a decreased white blood cell count. But that did not lead to infections as it usually does, according to Dr. Finn, who said that the drug was generally well tolerated.


Still, many patients had their doses reduced because of side effects, and 13 percent of patients who received palbociclib dropped out of the study because of side effects, compared with 2 percent in the control group.


A big question is whether Pfizer will be able to win approval of the drug based on this study. The Food and Drug Administration normally requires larger Phase 3 studies, but sometimes makes exceptions for drugs for cancers and other life-threatening illnesses.


If Pfizer can get early approval, the drug could probably reach the market next year. If the company must complete a Phase 3 study, which is already underway, approval might be delayed a couple of years, according to the ISI Group.


Garry Nicholson, president of Pfizer’s oncology division, told analysts on Sunday that the company “can envision the possibility” that the data from the Phase 2 trial would be sufficient for approval. He said the company had not gotten far enough in its discussions with the F.D.A. to be able to decide whether to seek approval now, however.


In 2008, the F.D.A. granted accelerated approval to Genentech’s Avastin as a treatment for breast cancer based on a single trial in which the drug delayed disease progression by about five and a half months.


But the women who got Avastin did not live significantly longer, and subsequent studies showed a smaller effect in delaying progression. In 2011, the F.D.A. revoked approval of Avastin for breast cancer treatment.

Monday, February 17, 2014

Another Study, Another Dangerous Message

We breast cancer survivors are an opinionated bunch. There are the pinkers who believe in everything that is pink and the anti-pink people who abhor it as sappy symbol for a serious disease. There are the proponents of do-everything-you-can-to-kill-this and the we're-not-doing-anything women. No one is right, no one is wrong. It is your body. You can choose to deal with your cancer any way you can.

Another raging debate is on the value of mammography screening. Almost two years ago the US Task Force announced that women don't need mammograms until after the age of 50 and then only every two years. Readers of No Surrender are well aware of how I feel about this approach. Have I run my own study? Yes, in a way. Through the stories of the thousands of women I have met in Cancerland since 2001.

Last week, yet another study came out. It can be read HERE on the NY Time's site. This "study" states that mammograms not only don't work, but they are dangerous and find tumors that would be just fine if left alone. And if there is any doubt, give the patient Tamoxifen and she'll be fine.

Tamoxifen may help early stage breast cancers that are responsive to estrogen. But not all breast cancers are. When you are diagnosed with Triple Negative Breast Cancer, there is no magic bullet. There is nothing to do but get it removed from your body as soon as you possibly can and treat it as aggressively as you possibly again. Then, and only then, do you have a chance of beating it.

A young woman cannot walk around with a triple negative breast cancer tumor and be "safe." The tumors are more aggressive when you are young. If you wait too long, it may have had a chance to spread to other organs. Thirty percent of breast cancers are metastatic, which means they have spread to other organs, and it also means there is no cure.

My message to the people publishing these studies is personal. I was young. I had a whole life before me. I could have had children. I had no fear of cancer because it didn't run in my family. Cancer? Me? I was so stupid then. Eighty percent of breast cancers are found in women with no family history. I also didn't have a tumor that could be "controlled" with Tamoxifen, as this study dangerously suggests as a panacea.

Because I have a gynecologist who believes in early screening, he got me into the radiology office long before I turned 40, the age, back then, where women were told to get their first mammo. The radiologist found a shadow. She told me to wait six months and watch it. My gynecologist had me scheduled with a breast surgeon for surgery within three days. The biopsy was malignant. The pathology was triple negative breast cancer. It rated the highest score on Bloom-Richardson aggressiveness scale.  They removed it by lumpectomy and I endured six months of chemotherapy that I am, today, grateful for. Even though I spent the three days after each treatment on the bathroom floor I was so sick from it, I thank God for it.

Women don't walk away from triple negative breast cancer. You can't just "have" it and it can be managed, as this study suggests. The study only discusses estrogen responsive tumors. I had no history. I do not come from Ashkenazi heritage. I never smoked. I was young and I had the most aggressive breast cancer out there. If this study came out in 2001, I could have said to my doctor, "Hey listen, I don't need this for years. I'm not going for a mammogram."  And, today, I would be dead. It is interesting to note that my tumor back then only could be seen on mammogram, and wasn't detectible on sonogram.

On February 7th, I hit the seven year mark of my second breast cancer diagnosis. This one was responsive to estrogen. More surgeries, nine months of chemo, followed by more surgeries and estrogen blocking drugs for rest of my life were the result of that one. This was the kind tumor the study talks about. Estrogen responsive tumors, according to them, may not be dangerous and we are over-diagnosed, medicated and treated. Well, this harmless tumor spread to my lymph nodes. We found it just in time.

I beg you to not let these studies lull you into a false sense of pink security. There is so much insane cheerfulness surrounding the marketing of breast cancer today that all the pink cotton candy has camouflaged the women who are dying from this hideous disease. We've lost so many. We are losing 40,000 a year. But you wouldn't know it from reports like the one that just came out and all the cute Save the Bodacious Tatas frat party mass marketing of breast cancer. The woman dying isn't smiling. She isn't covered in pink. She has her family around her or she may be alone.  Are we going to add to 40,000 deaths because we are now telling women that mammography is unnecessary?

It's up to you. Tell my story. Tell your story. Read the No Surrender forum and tell their stories. People die from this disease. Some don't have to. Telling a woman to not be proactive about her health is one of the most dangerous messages out there. Step in to stop it.

Please read about our Before Forty Initiative which helps spread the word among African American women and their increased risk of developing triple negative breast cancer at a young age. Tell your friends. You may save their lives. You may save your own.

Thursday, February 6, 2014

Defeating Metastatic Triple Negative Breast Cancer

When I was diagnosed with triple negative breast cancer twelve years ago so much was still unknown. Now, doctors know that the standard courses of chemo should not be one-size-fits-all. Platinum based drugs and/or anti-angiogenesis drugs have been found to be more effective for the treatment of both early and later stage TNBC.

Released today from the Oncology Nurse Advisor is breathtaking news on the future of conquering TNBC metastasis.

Key mechanisms discovered to inhibit triple-negative breast cancer

Critical complex mechanisms involved in the metastasis of deadly triple-negative breast cancers (TNBC) have been identified. These tumors are extremely difficult to treat, frequently return after remission, and are the most aggressive form of breast cancer in women. The discovery of this critical interaction of mechanisms could be used to develop new life-saving treatments to kill metastatic tumors in TNBC.

"In previous findings published over the past 10 years, our teams have described key mechanisms in these critical proteins," said Khalid Sossey-Alaoui, PhD, of the Lerner Research Institute of the Cleveland Clinic in Ohio. "A key component in the deadly metastatic potential of TNBC tumors is that they spread through tissues outside the breast very quickly. The two proteins that we studied, WAVE3 and TGF-β, when together, promote tumor aggressiveness."

"We found important biological implications," said William Schiemann, PhD, of Case Western Reserve School of Medicine and Case Comprehensive Cancer Center, also in Cleveland, Ohio. "For the first time, we uncovered an interplay between the two proteins that can inhibit or suppress TNBC—a discovery that has the potential to inhibit proliferations of the tumor."

The next step in the research process is to find a way to deliver inhibitors to the tumor. Using nanoparticles, the Sossey-Alaoui/Schiemann team hopes to deliver therapies directly to the site of the tumor and reverse the disease. Their goal is to move this basic research into clinical trials in the next 3 years. The current study was published in Breast Cancer Research and Treatment (2013;142[2]:341-355).

Metastasis is a complex, multistage process in which primary tumor cells invade the surrounding cells, tissues, and organs; integrate into blood vessels; and survive and move throughout the body. Metastasis of primary mammary tumors accounts for the vast majority of deaths in breast cancer patients. The 5-year survival rate for patients with breast cancer drops precipitously from 98% for patients with localized disease to 23% for those with metastatic disease.

This study found that the transforming growth factor-β (TGF- β) induces the expression of WAVE3 in metastatic breast cancer cells. WAVE3 is an actin-binding protein with roles in cell morphology, actin polymerization, cytoskeleton remodeling, cell motility, and invasion. When expression of WAVE3 was depleted, TGF-β could not initiate the epithelial-mesenchymal transition that cells undergo in the process of metastasis. This research suggests that inactivating WAVE3 may stop the metastasis that TGF-β stimulates.