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Patentholder on Breast Cancer Tests Denied Injunction in Lawsuit

Patentholder on Breast Cancer Tests Denied Injunction in Lawsuit | Cancer Research You can Trust | Scoop.it

"Myriad Genetics, which lost a closely watched Supreme Court case last year involving the patenting of genes, has suffered another setback in its efforts to protect its main genetic test from competition.

A federal judge on Monday denied Myriad’s request for a preliminary injunction that would have immediately stopped a rival company, Ambry Genetics, from offering a similar test.

Myriad’s lucrative monopoly on testing for mutations in two genes linked to breast cancer risk was shattered last June by the Supreme Court’s ruling that genes were not eligible for patents because they were products of nature.

Several laboratory companies, including Ambry, quickly began offering tests, in most cases undercutting the $4,000 Myriad charged for a full analysis of the two genes, which are known as BRCA1 and BRCA2. Ambry announced a price of $2,200.

Myriad sued most of these companies, contending their tests infringed other patent claims that were not invalidated by the Supreme Court.

 

But Judge Robert J. Shelby of the United States District Court in Salt Lake City said in an opinion on Monday that Ambry had raised “substantial questions” concerning whether those remaining claims were eligible for patents. He said therefore that Myriad had not established that it was likely to succeed in the case on the merits of its arguments, which is a legal requirement to win a preliminary injunction.

The upshot is that Ambry can continue to offer its test pending the outcome of a trial or a settlement, said Dr. Robert M. Cook-Deegan, a research professor at Duke University who has closely followed the case and the issue of gene patents.

Charles Dunlop, chief executive of Ambry, called the ruling “a victory for the entire genetics community.” He said in a statement that Myriad’s lawsuit, after last year’s Supreme Court decision, “was a blatant attempt to maintain a monopoly state. We idealistically stood by our convictions throughout this process and are exhilarated by today’s ruling.”

Ronald Rogers, a spokesman for Myriad, said Myriad looked forward to presenting its case in court. Monday’s ruling, he said in an email, “is a denial of the preliminary injunction only” and “isn’t a ruling on the underlying merits of the case.” 


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[BRCA]

 

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Susan Zager's curator insight, March 13, 2014 4:09 PM

Myriad Genetics was denied an injunction against Ambry Genetics from offering the BRCA gene test for less money. Myriad has also tried to stop other companies but for now the other companies are winning and offering the test for less. Ambry announced a price of $2,200, for a full analysis of the two genes, which are known as BRCA1 and BRCA2, undercutting the $4,000 Myriad charged.

Cancer Research You can Trust
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Suspected research fraud: difficulties of getting at the truth

How credible is this article about suspected research fraud? Seems fair but vendetta?
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Lies, Damned Lies, and Medical Science

Lies, Damned Lies, and Medical Science | Cancer Research You can Trust | Scoop.it
Much of what medical researchers conclude in their studies is misleading, exaggerated, or flat-out wrong. So why are doctors—to a striking extent—still drawing upon misinformation in their everyday practice? Dr. John Ioannidis has spent his career challenging his peers by exposing their bad science.

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JAMA - Changing Clinician Behavior When Less Is More

The American Board of Internal Medicine Foundation intended for the Choosing Wisely campaign to support conversations between clinicians and their patients about what care is necessary.1 The campaign sought to do so by involving professional societies in creating lists of unnecessary tests and procedures and disseminating the lists to their membership. At the same time, the campaign partnered with Consumer Reports to produce consumer-friendly briefs of Choosing Wisely recommendations and to disseminate the briefs to consumers. It remains an open question whether clinicians or consumers at large are aware of specific Choosing Wisely recommendations or have changed their attitudes toward unnecessary procedures and tests.

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Hispanic women catch their breast cancer at later stages

Hispanic women catch their breast cancer at later stages | Cancer Research You can Trust | Scoop.it

"New studies confirm that Hispanic women develop breast cancer at a younger age than others, but get examinations at a later stage of the disease. Their tumors are likely to be larger and more aggressive. It is the most common form of cancer in Latinas, yet so many wait so long for help. Could it be cultural reluctance, perhaps a language barrier, family finances or lack of medical coverage? Possibly a combination of all of the above.

Edith Rubalcaba decided to do something three years ago, after seeing her mom’s fight with cancer and resulting double mastectomies. She chose to be tested for the hereditary mutant gene that spells trouble. She explains, “I saw her battle cancer and it’s something I wouldn’t want to go through. And I have a little girl as well and I need to be here for her.” Turns out Edith had the gene and chose a prophylactic, or preventive, mastectomy. She was 27. “It was very difficult, especially because I was so young. I guess cancer doesn’t have an age.”

Finding that gene early and acting is critical. Dr. Cassie Connerty at the Baylor Scott & White Breast Cancer Center points out, “It increases their risk significantly for breast cancer. An average woman has a 12% risk, some of these women with gene mutations can have a 90% lifetime risk of developing the disease.”


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Susan Zager's curator insight, October 12, 2015 7:03 PM

To see more information go to: "Cancer statistics for Hispanics/Latinos, 2015" at:

http://onlinelibrary.wiley.com/doi/10.3322/caac.21314/full



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Most Americans Will Be Victim of Wrong or Late Diagnosis: Report

Most Americans Will Be Victim of Wrong or Late Diagnosis: Report | Cancer Research You can Trust | Scoop.it
Most Americans will get a wrong or late diagnosis in their lifetimes, a new report finds, often with devastating effects.

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Denise Silber's curator insight, September 22, 2015 5:22 PM

Opportunities for diagnostic software - it's been around for quite some time

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3 Questions on… The New Way(s) to Get Oncology Drugs Approved

3 Questions on… The New Way(s) to Get Oncology Drugs Approved | Cancer Research You can Trust | Scoop.it

We’ve seen kind of an explosion of requests—and I don’t think anybody really expected that,” Suparna B. Wedam, MD, Medical Officer at the U.S. Food and Drug Administration, said about the FDA’s four expedited programs, which she discussed here at the 2015 Breast Cancer Symposium in her talk “FDA Drug Approvals: Getting Drugs to Patients Sooner.” Those four programs include three designations (breakthrough therapy, priority review, and fast track designations) and one approval pathway (accelerated approval).

 

In an interview after the talk, she summed up these key points and elaborated on what these approval programs mean for the future of oncology drugs.

 

1. You spent a lot of time during the talk on breakthrough therapy designation, which is the newest program of the four—what should oncologists know about the designation?

“With breakthrough therapy designation, you have to have clinical evidence that this [drug] is substantially better than a significant endpoint, and for fast track designation, non-clinical data can be used. Having said that, we do not accept non-clinical data usually for oncology—typically we require at least some clinical data. Especially in oncology, we feel that [non-clinical] data that comes from cell lines or animals does not always translate well into humans.

 

“And the other part is the level of senior level involvement. Once a drug has the breakthrough therapy designation, it really is an all-hands-on-board situation from the top down, where the senior manager is helping with the whole process—so, it’s the intensity of involvement that differentiates it.”

 

 


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'Sky is the limit' for health providers who use social media - FierceHealthcare

'Sky is the limit' for health providers who use social media - FierceHealthcare | Cancer Research You can Trust | Scoop.it
Social media can be a minefield, but platforms such as  Facebook, LinkedIn, Instagram and Twitter can also provide physicians and other healthcare professionals with an array of previously unheard-of advantages and the ability to confer with other professionals--no matter where they are in the world. 

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Q&A: Dr. Susan Love

Q&A: Dr. Susan Love | Cancer Research You can Trust | Scoop.it
Instantly recognizable, sometimes controversial, Dr. Susan Love may just be the most famous cancer advocate on the planet. The surgeon, researcher, activist and author talked to Fred Hutch News Service about research trends, cancer treatment and her research cohort, Army of Women.

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What Breast Cancer Really Looks Like

What Breast Cancer Really Looks Like | Cancer Research You can Trust | Scoop.it
Behind every pink ribbon is a real woman with a real, unique story. Photographer Christine Benjamin helps these five share theirs.
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Tumblr: An Unexpected Cancer Support Group

Tumblr: An Unexpected Cancer Support Group | Cancer Research You can Trust | Scoop.it
Bloggers using Tumblr to write about their cancer experiences find the community to be an unconventional source of support and genuine interaction.

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The DNA damage response goes viral: A way in for new cancer treatments

The DNA damage response goes viral: A way in for new cancer treatments | Cancer Research You can Trust | Scoop.it
Every organism must protect its DNA at all costs, but precisely how a cell distinguishes between damage to its own DNA and the foreign DNA of an invading virus has remained a mystery.
Now, scient ...
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Fatigue as a result of radiation; can psychological therapy help? - Medivizor

Fatigue as a result of radiation; can psychological therapy help? - Medivizor | Cancer Research You can Trust | Scoop.it

Share In a nutshell The authors aimed to determine whether psychological therapy could relieve patients with fatigue (extreme tiredness) who are undergoing breast cancer radiation (uses high energy radiation to kill cancer cells by damaging their...


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New tool will compare costs versus benefits of cancer treatments

New tool will compare costs versus benefits of cancer treatments | Cancer Research You can Trust | Scoop.it
As options for cancer patients become increasingly complicated, and expensive, the most influential source for U.S. oncology treatment guidelines will for the first time offer a tool to assess the costs versus benefits of available therapies.
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The National Comprehensive Cancer Network (NCCN) has developed a tool to assess the price, effectiveness, safety, quality and consistency of clinical evidence of drugs for multiple myeloma and chronic myeloid leukemia. NCCN said it will launch the tool in October and will follow-up with tools for other cancers.

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Myeloma Highlights from #ASH15

Myeloma Highlights from #ASH15 | Cancer Research You can Trust | Scoop.it
Jack Aiello shares the highlights and his thoughts from ASH 2015.

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What You Should Know About The New Breast Cancer Screening Guidelines

What You Should Know About The New Breast Cancer Screening Guidelines | Cancer Research You can Trust | Scoop.it
The new recommendations come at a time of growing awareness about the potential downside of screening and the harms of over-diagnosis.

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Susan Zager's curator insight, October 20, 2015 3:36 PM

The American Cancer Society has come out with new guidelines. for breast cancer screening. This could have a great impact on what insurance will allow..

To see the JAMA article go to: http://jama.jamanetwork.com/article.aspx?articleid=2463237

To see the Young Survival Coalition's response go to: http://blog.youngsurvival.org/acsguidelinechanges/


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5 Promising New Goals for Breast Cancer Awareness Month

5 Promising New Goals for Breast Cancer Awareness Month | Cancer Research You can Trust | Scoop.it

Many people with breast cancer (or a history of it) dread October.   Instead of enjoying autumn’s oranges, reds and yellows, they see a flood of pink ribbons and awareness paraphernalia.  Some question how this all started.

How did the Breast Cancer Awareness Month Begin?

The American Cancer Society and Imperial Chemical Industries (now AstraZeneca) founded October as National Breast Cancer Awareness Month in 1985.  The Awareness goal? Promoting mammography as a screening tool to “fight” breast cancer.

In a recent study, seventy-eight percent (78%) of women agreed that mammography should be conducted (in addition to healthcare provider exams and self-exams).  It seems that many women are aware of mammograms.  Perhaps it’s time for new objectives.New Breast Cancer Awareness Goals

         

                Goal One:  Awareness of What “Cured” Means

There is much confusion about “the cure.”  In a video by MetaVivor, Cece Curry shared her experience,

 “They called me cured, that’s what they told me…so I didn’t think that it would ever come back….I think it is a good idea for them not to use that word anymore…even if it’s as early as stage 1 or 0.”

Cece died of metastatic breast cancer on June 1, 2013.

In medical language, someone is “cured” of cancer if they survive without a relapse for 5 years after completion of treatment.  For some cancers, “cure” is living for 10 years without relapse or spread of cancer to other organs.

 

    Goal Two: 1 in 5 people diagnosed with breast cancer, will relapse.

So, when organizations say they are raising money for “the cure” of breast cancer, what does this mean?  Are they raising money to cure breast cancer?

After 30 years of mammogram awareness, although there is some variability, the conservative figure for relapse is 1 in 5 or 20%.

The European Society of Medical Oncology states that “Approximately 5% to 10% of breast cancers are metastatic at diagnosis; of these, approximately one-fifth will survive 5 years."


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Susan Zager's curator insight, October 13, 2015 4:02 PM

Great article by Dr. Kathleen Hoffman setting five great goals for breast cancer. #MetastaticBreastCancerAwarenessDay

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What the Headlines Got Wrong about the New DCIS Study

What the Headlines Got Wrong about the New DCIS Study | Cancer Research You can Trust | Scoop.it

"Recent news headlines have suggested that women with the earliest form of breast cancer should rethink undergoing treatment because it may not impact their long-term survival. But breast cancer experts interviewed for this article say the study results that spurred those headlines should not be interpreted as a message to forego or change standard treatment.

In the observational study, available online ahead of print in JAMA Oncology (doi:10.1001/jamaoncol.2015.2510), scientists at the Women's College Research Institute in Toronto analyzed data from the National Cancer Institute's Surveillance, Epidemiology, and End Results database, which included information on 108,196 women with ductal carcinoma in situ (DCIS) who were followed for 20 years.

DCIS is the presence of abnormal cells inside a milk duct in the breast, the earliest form of breast cancer, sometimes called Stage 0. The lead study author, Steven A. Narod, MD, Senior Scientist and Director of the Familial Breast Cancer Research Unit, explained in an interview that DCIS is usually discovered during a mammogram, and that three standard treatment courses are typically available: lumpectomy, lumpectomy with radiation, or mastectomy. Sometimes medication is also prescribed. All the women in the study had received some type of treatment, he said.

Narod is also Professor in the Dalla Lana School of Public Health and the Department of Medicine at the University of Toronto, as well as a Tier 1 Canada Research Chair in Breast Cancer. ".


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Susan Zager's curator insight, September 22, 2015 7:26 PM

Great insight into understanding issues related to DCIS thanks to Dr. Don Dizon, Dr. Deanna Attai, JENNIFER LITTON, MD and others. 

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Updated Risk Estimates for DCIS Show Improvements

Updated Risk Estimates for DCIS Show Improvements | Cancer Research You can Trust | Scoop.it

"Women diagnosed with ductal carcinoma in situ (DCIS) have been choosing mastectomy and even bilateral mastectomy more in recent years, but some of their decision-making may be based on risk estimates for local recurrence that are out of date. That was the conclusion of a retrospective study from researchers at Memorial Sloan Kettering Cancer Center scheduled to be reported here tomorrow at the Breast Cancer Symposium, which showed that patients with DCIS who were treated between 1999 and 2010 had a 40 percent lower risk of cancer recurrence than those treated in an earlier period, between 1978 and 1998.

 

Specifically, five-year recurrence rates fell from 13.6 to 6.6 percent over the course of these two periods.

 

Senior author Kimberly J. Van Zee, MD, Attending Surgeon in the Breast Service and Professor of Surgery at Weill Medical College of Cornell University, and colleagues evaluated a prospectively maintained database of 2,996 women who underwent lumpectomy at Memorial Sloan Kettering between 1978 and 2010."

 


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Gene test finds which breast cancer patients can skip chemo

Gene test finds which breast cancer patients can skip chemo | Cancer Research You can Trust | Scoop.it

"Many women with early-stage breast cancer can skip chemotherapy without hurting their odds of beating the disease — good news from a major study that shows the value of a gene-activity test to gauge each patient's risk.

The test accurately identified a group of women whose cancers are so likely to respond to hormone-blocking drugs that adding chemo would do little if any good while exposing them to side effects and other health risks. In the study, women who skipped chemo based on the test had less than a 1 percent chance of cancer recurring far away, such as the liver or lungs, within the next five years.

"You can't do better than that," said the study leader, Dr. Joseph Sparano of Montefiore Medical Center in New York.

An independent expert, Dr. Clifford Hudis of New York's Memorial Sloan Kettering Cancer Center, agreed.

"There is really no chance that chemotherapy could make that number better," he said. Using the gene test "lets us focus our chemotherapy more on the higher risk patients who do benefit" and spare others the ordeal.

The study was sponsored by the National Cancer Institute. Results were published online Monday by the New England Journal of Medicine and discussed at the European Cancer Congress in Vienna."

 

 

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Susan Zager's curator insight, September 28, 2015 4:49 PM

To see the published study go to: http://www.nejm.org/doi/full/10.1056/NEJMoa1510764


Guy Van Elsacker's curator insight, September 29, 2015 8:52 AM

Yes but it is  a test which is not included in the social insurance protocols. It also goes against the profits of Big Pharma.

 

Prof. Guy Van Elsacker Dr.Sc.

www.elsacker.org

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Why Doctors Are Rethinking Breast-Cancer Treatment

Why Doctors Are Rethinking Breast-Cancer Treatment | Cancer Research You can Trust | Scoop.it

"Too much chemo. Too much radiation. And way too many mastectomies. 


“What if I decide to just do nothing?”


It was kind of a taunt, Desiree Basila admits. Not the sort of thing that usually comes out of the mouth of a woman who’s just been diagnosed with breast cancer. For 20 minutes she’d been grilling her breast surgeon. “Just one more question,” she kept saying, and her surgeon appeared to her to be growing weary. She was trying to figure out what to do about her ductal carcinoma in situ (DCIS), also known as Stage 0 breast cancer, and she was already on her second opinion. The first surgeon had slapped a photograph of her right breast onto a viewer, pointed to a spot about 5 cm long and 2.5 cm wide and told her there was a slot open the following week for a mastectomy.

Basila’s first reaction to her diagnosis was an animal-instinct panic that she registered as “10,000 bricks” crushing into her chest when she woke up in the morning. After that, Basila, who is now 60 and teaches high school science in San Francisco, did a little research. She learned that there were a lot of unknowns about the progression of DCIS, which is noninvasive–it’s confined to the milk ducts–and is the earliest stage of breast cancer. She also learned there was some disagreement in the field about how to treat it.

She knew she wasn’t ready to have one or both of her breasts cut off. And she wasn’t sure she wanted a lumpectomy either. That’s why when Dr. Shelley Hwang, then a surgeon at the University of California, San Francisco (UCSF), recommended a lumpectomy, Basila grew frustrated. She was coat in hand and ready to walk out the door when she issued that half taunt. And when she did, Hwang said this: “Well, some people are electing to do that.”



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Immunotherapy Trials Offer Hope to Patients with High-Risk or Metastatic Breast Cancer

Immunotherapy Trials Offer Hope to Patients with High-Risk or Metastatic Breast Cancer | Cancer Research You can Trust | Scoop.it

"Although the cure rate for breast cancer has risen steadily in recent decades, recurrent or metastatic disease remains difficult to control. To fight metastatic breast cancer and forestall the recurrence of high-risk primary disease, researchers at The University of Texas MD Anderson Cancer Center are using various techniques to boost the body’s immune system. Clinical trials of many of these therapies are already under way.

Patients with metastatic breast cancer treated with standard chemotherapy followed by the STn-KLH vaccine who also received endocrine therapy (tamoxifen) had a longer median overall survival than did those treated with standard chemotherapy followed by a control vector. Adapted from Ibrahim NK, et al. J Cancer 2013;4:577–584.

Recent research findings have sparked interest in the role of immunotherapy in breast cancer treatment, said Elizabeth Mittendorf, M.D., Ph.D., an associate professor in the Department of Surgical Oncology. “For a very long time, breast cancers were not thought to be immunogenic,” she said. “But data published in the past 2 years have shown that there are immune cells, including T cells, in breast tumors. This suggests that breast tumors are indeed immunogenic.”

 

 
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Breast Cancer Pioneer Examines Novel Therapies for Metastatic Breast Cancer

Breast Cancer Pioneer Examines Novel Therapies for Metastatic Breast Cancer | Cancer Research You can Trust | Scoop.it

"The inhibition of CDK 4/6 and PD-1 represent two of the most exciting developments in the field of metastatic breast cancer. Following an accelerated approval in February 2015, the CDK4/6 inhibitor palbociclib (Ibrance) has continued to make headlines as an exciting new agent for patients with HR-positive metastatic breast cancer. Additionally, PD-1 and PD-L1 inhibitors have shown early signs of promise for patients with metastatic triple-negative breast cancer (TNBC).


The phase II PALOMA-1 trial,1 which was the basis for the approval of palbociclib, found that the novel CDK 4/6 inhibitor in combination with letrozole (Femara) reduced the risk of disease progression by 51% compared with letrozole alone. The median progression-free survival (PFS) with palbociclib was 20.2 versus 10.2 months for letrozole alone (HR, 0.488; P = .0004).

At the 2015 ASCO Annual Meeting, the PALOMA-3 trial found that palbociclib plus fulvestrant (Faslodex) improved PFS compared with fulvestrant alone in women with HR-positive, HER2-negative metastatic breast cancer following progression on prior endocrine therapy.2 At the time of the interim analysis, the median PFS was 9.2 months for palbociclib plus fulvestrant and 3.8 months for placebo plus fulvestrant (HR, 0.422; 95% CI, 0.318-0.560; P <.0001).

In addition to this now FDA-approved approach, two early phase clinical trials have shown potential for PD-1/PD-L1 inhibition in pretreated patients with TNBC. In the KEYNOTE-012 trial,3 pembrolizumab demonstrated an overall response rate (ORR) of 18.5%. In a similar patient population, the PD-L1 inhibitor atezolizumab showed an ORR of 19%.4 Larger trials are now looking to confirm these findings.


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Is ER the new HER2 (which used to be the new ER)? Drs Lisa Carey and Eric Winer elaborate

Is ER the new HER2 (which used to be the new ER)? Drs Lisa Carey and Eric Winer elaborate | Cancer Research You can Trust | Scoop.it

The very first educational video our CME group produced — entitled “Hormonal Manipulation for the 1980s” — featured a homemade animation from the nascent University of Miami audiovisual department depicting the mechanism of action of tamoxifen complete with side-by-side Pac-Man-like images of the drug and an estrogen molecule scooting across the cell membrane and racing to the nucleus to bind with a reverse-Pac-Man-looking estrogen receptor.

Back then this biology was very cool, and although we welcomed aromatase inhibitors (AIs) and fulvestrant to clinical practice, for a long time thereafter it seemed like there wasn’t much progress beyond this primitive concept of the very first form of targeted treatment of cancer. Instead the new target on the block, HER2, was generating considerably more interest as dashing figures like Dr Dennis Slamon regaled us with impressive science and trial results to match.

It was only in 2011 that research on endocrine treatment began to awaken from its long slumber, when data from the Phase III BOLERO-2 study demonstrated an impressive progression-free survival (PFS) hazard rate (HR) of 0.36 with the addition of the mTOR inhibitor everolimus to exemestane in patients with ER-positive advanced disease. Unfortunately, the toxicity of this agent, particularly mucositis, somewhat dulled our collective enthusiasm.



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Top Takeaways from ASCO: Survivorship

Top Takeaways from ASCO: Survivorship | Cancer Research You can Trust | Scoop.it
CHICAGO — In forums including a data-driven plenary and a special educational session, attendees of ASCO 2015 gathered to discuss Top Takeaways on survivorship in pediatric and adult cancer.Results from a late-breaking abstract offered clinicians evidence on the improvements, both in quantity and quality of life, that childhood cancer survivors stand to gain through careful monitoring and

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Cancer cells programmed back to normal by US scientists - Telegraph.co.uk

Cancer cells programmed back to normal by US scientists - Telegraph.co.uk | Cancer Research You can Trust | Scoop.it
Scientists have turned cancerous cells back to normal by switching back on the process which stops normal cells from replicating too quickly
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Clinical Trials 2.0: Reinventing Research For The Social Age

Clinical Trials 2.0: Reinventing Research For The Social Age | Cancer Research You can Trust | Scoop.it
Clinical research is changing. No longer the sole preserve of clinicians and researchers, the Internet and new digital technologies are reinventing the way in which patients take part in the clinical trials process.

In the past decade there has been a revolution in how patients access health information. The Internet is increasingly the first ...

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