“Jennie” was diagnosed with a metastatic recurrence a dozen years after being treated for early stage breast cancer. “What a shock,” she wrote on a discussion board for people living with metastatic disease. “But some people’s reaction has been even more of a shock.”

She described what happened when she contacted a group that hosts exercise programs for breast cancer survivors. “When I explained that I was interested but that I was currently in treatment for liver and bone metastasis, I was invited to participate but it was suggested that maybe I shouldn’t share my current diagnosis.”

Jennie says her family and close friends have been supportive, “but it is different than I was diagnosed in 2001. . .I must say I came away [from the exercise group] feeling totally unwelcome and wondering if this is the experience of others.”

Click on the graphic to see what people in the US said about living with metastatic breast cancer,

 Novartis’ recent survey of 1,273 women in 12 countries revealed that people with metastatic disease continue to feel alone and excluded. Nearly two-thirds (63%) of the women surveyed said they “often feel like no one understands what they are going through” while two in five women said they “feel isolated from the non-advanced breast cancer community.”

“When first diagnosed with breast cancer, women are instantly part of a vibrant breast cancer support community,” said Maira Caleffi, MD, President of Brazilian Federation of Philanthropic Institutions to Support Breast Health (FEMAMA). “But when their cancer metastasizes or if they are first diagnosed with metastatic breast cancer, it is no longer about becoming a survivor; it’s about surviving.”

The” Count Us, Know Us, Join Us” survey also found that on a global basis more than three in four women (77%) say they actively seek out information on their own; however, nearly half (45%) say it is hard to find information about MBC, and more than half (55%) say the information that is available does not address their needs, probably because most of the information available is applicable only to those with early stage breast cancer. In addition to lack of information and feelings of isolation, many women (41%) find that support from friends and family wanes over time.

Other survey highlights:

•  Three in four women (76%) would like their healthcare professional to address their emotional needs.
•  Two in five women (40%) say their relationship with their spouse or partner has been negatively impacted a lot or a moderate amount by their  diagnosis…
• …however, nearly all women (87%) say they receive sufficient support from their spouse/partner.

The survey is part of Novartis’ efforts to promote advancedbreastcancercommunity.org, a patient site the company relaunched in October, which is Breast Cancer Awareness Month in the US. The site, which includes links to patient videos, news and resources, initially launched with financial support from Bristol-Myers Squibb.

Join Us in Houston on September 20-22, 2013

Stories like Jennie’s are why MBCN exists. In 2004, Nina Schulman and Jane Soyer were determined to represent people with metastatic breast cancer, something no local or national organization did at that time. Shulman and Soyer attended major national breast cancer meetings, armed with flyers announcing the plans for what became MBCN. They were amazed at the dramatic response from other mets patients attending those meetings, people who longed for an opportunity to speak for themselves and be recognized in the breast cancer community.

We are proud to carry on Nina and Jane’s  work. Over the past decade, we’ve made some incremental progress. Slowly our stories are being heard and we are being represented at breast cancer conferences and gaining media coverage. But as Jennie’s story illustrates, we still have a lot of work to do to ensure our voices our heard.

Shirley Mertz, President of MBCN, tells her story to encourage others. “I have not hesitated to share my experiences with this disease because I want to motivate others to speak up,” she says. “Joining together with a focused message, metastatic breast cancer patients can improved outcomes in the clinic.”

Our annual conference offers a wonderful chance to share your story.  Mark you calendars: It will take place September 20-22, 2013 in Houston, Texas. We invite you to come–to learn about the latest developments but perhaps even more importantly to know that you are NOT alone.

Houston-area readers:  If you are interested in volunteering or doing a guest blog post with Houston travel and other tips, email Conference Chair Deb Tincher: d.tincher@mbcn.org

Reblogged from JHU Press Blog:

Guest post by Sue Friedman

On April 15, 2013, the U.S. Supreme Court heard arguments on whether Myriad Genetics’ patents on the BRCA genes, which are associated with hereditary breast and ovarian cancer, should be upheld. This case culminates a four-year legal tug-of-war between Myriad Genetics & Laboratories and a long list of individual, advocacy, and health care professional groups represented by the American Civil Liberties Union (ACLU) .

Read more… 845 more words

   by Katherine O’Brien

Angelina Jolie’s announcement that she is a carrier of the BRCA1 mutation and her subsequent decision to have a preventive double mastectomy has prompted a lot of discussion.

One question Jolie doesn’t touch on: the Supreme Court is currently determining if human genes can be patented. Myriad owns or licenses two human genes linked to breast and ovarian cancer. If you need BRCA1 or BRCA2 testing, as Jolie did, Mryiad has your fate in their hands. The Supreme Court ruling is expected in June 2013. We’ll look at that issue in a separate post.

In the interim, here are some basic facts about breast and ovarian cancer:

• Most cancer  just happens–it’s sporadic vs. hereditary. The majority of people who develop breast cancer didn’t inherit an abnormal breast cancer gene and have no family history. But about five percent of people have a genetic mutation which predisposes  them to cancer.
• Two abnormal genes BRCA1 (BReast CAncer gene one) and BRCA2 (BReast CAncer gene two) are associated with a higher lifetime risk of developing breast and/or ovarian cancer. (FYI, I do NOT have this mutation, my cancer is considered sporadic; I may well have some mutation for which there’s currently no test.)
• From the NCI FAQ: A woman who inherits a harmful mutation in BRCA1 or BRCA2 has an increased risk of developing breast and/or ovarian cancer at an early age (before menopause) and often has multiple, close family members who have been diagnosed with these diseases. Harmful BRCA1 mutations may also increase a woman’s risk of developing cervical, uterine,pancreatic, and colon cancer (1, 2). Harmful BRCA2 mutations may additionally increase the risk of pancreatic cancer, stomach cancer, gallbladder and bile duct cancer, and melanoma(3).
• All of us have BRCA1 and BRCA2 genes according to  BreastCancer.org: ” The function of the BRCA genes is to repair cell damage and keep breast cells growing normally. But when these genes contain abnormalities or mutations that are passed from generation to generation, the genes don’t function normally and breast cancer risk increases. Abnormal BRCA1 and BRCA2 genes may account for up to 10% of all breast cancers, or 1 out of every 10 cases.”
• Ashkenazi (Eastern European) Jews are 10 times more likely to have mutations in BRCA1 and BRCA 2 genes than the general population. Approximately 2.65 percent of the Ashkenazi Jewish population has a mutation in these genes, while only 0.2 percent of the general population carries these mutations.
• Note that most U.S. Jews are  Ashkenazi (their ancestors came from Eastern Europe) vs. Sephardic  (their ancestors came from Spain, Portugal, North Africa and the Middle East).
• Having an abnormal BRCA1 or BRCA2 gene doesn’t mean you will be diagnosed with breast cancer: Only seven percent of breast cancers in Ashkenazi women are caused by alterations in BRCA1 and BRCA2 (See www.genome.gov/10000507.)

Related posts:

Perils of ill-informed celebrity spokespeople (kudos to Jolie):

http://ihatebreastcancer.wordpress.com/2012/11/03/help-wanted-where-is-our-metastatic-breast-cancer-celebrity-spokesperson/

“Sweet Valley High” ghostwriter explores her family’s history of ovarian and breast cancer:

http://ihatebreastcancer.wordpress.com/2012/03/09/hereditary-breast-and-ovarian-cancer-what-slyvia-pody-gail-and-elaine-had/

My experience with BRCA1 and BRCA2 testing:

http://ihatebreastcancer.wordpress.com/2011/04/16/i-didnt-realize-obrien-was-a-japanese-name/

Tony Cenicola/The New York Times; Gabrielle Plucknette/The New York Times (umbrella, socks, oven mitt); A.J. Mast/Associated Press; Nam Y. Huh/Associated Press; Kyle Kurlick/The Commercial Appeal, via Associated Press; Dr. Scott M. Lieberman/Associated Press

By Katherine O’Brien, MBCN Secretary

Editor’s Note: Peggy Orenstein’s April 25, 2013 article–the cover story for this Sunday’ s New York Times’ Magazine, demonstrates a remarkable depth and thoughtfulness. It is long–but well-worth the effort to read. For those looking for a quick overview, we’ve prepared the following summary and added our observations where appropriate. We hope it will aid readers’ understanding of this important article as well as prompt further discussions. Please share your insights in the comment section below.

Initial Treatment and Recurrence | Journalist Peggy Orenstein wrote “Our Feel-Good War on Breast Cancer,”   subtitled “The battle for awareness has been won. So why aren’t more lives being saved?” Orenstein frames the article within her own breast cancer experience.  Sixteen years ago at 35, Orenstein had a screening mammogram that revealed early stage breast cancer. Her treatment, at that time, was a lumpectomy, as well as six weeks of radiation.

In 2012, at age 52, Orenstein had a nonmetastatic recurrence. She found the lump herself, nine months after her annual mammogram. Because of her prior treatment, Orenstein’s doctor recommended a unilateral mastectomy as well as Tamoxifen.

Early Detection Doubts | In 1996, at the time of her first diagnosis,  Orenstein credited her screening mammogram with saving her life. (“I considered myself a loud-and-proud example of the benefits of early detection,” she writes.) In 2013, following  the cancer’s recurrence, she has changed her mind.

Orenstein  details the US screening mammogram debate. The popular perception,  fueled in part by some nonprofits and pink-ribbon themed efforts,  is that screening mammograms save lives. Evidence of actual mortality reduction is, in fact, conflicting and continues to be questioned by scientists, policy makers and members of the public. According to Orenstein:

“Mammograms, it turns out, are not so great at detecting the most lethal forms of disease — like triple negative — at a treatable phase. Aggressive tumors progress too quickly, often cropping up between mammograms. Even catching them “early,” while they are still small, can be too late: they have already metastasized. That may explain why there has been no decrease in the incidence of metastatic cancer since the introduction of screening.”

We Say: This article can be summed up in one sentence: “Early Detection is Not a Cure.” Metastatic breast cancer can occur 5, 10,  15 or even 20 years after a person’s original diagnosis and successful treatment checkups and annual mammograms.

Overtreatment | Orenstein explains that  breast cancer isn’t a single disease. But early mammography trials were conducted before variations in cancer were recognized: “before Herceptin, before hormonal therapy, even before the widespread use of chemotherapy.” She then raises the question of overtreatment. Dartmouth’s Gilbert Welch  co-authored a study that estimates that only 3 to 13 percent of women whose cancer was detected by mammograms actually benefited from the test.

We Say: We agree with author and patient advocate Musa Mayer who says: “If we had spent a fraction of the dollars devoted to promoting screening on research to determine which DCIS lesions and tiny invasive breast cancers actually need treatment beyond surgery, and which do not, we’d be way ahead now.” Without knowing which tumors will metastasize, we must treat all of them alike. Worse, “good” mammograms may give some women a false sense of security.

DCIS Dilemma | The article says mammograms and improved imaging technology have resulted in a dramatic increase in the number of people diagnosed with ductal carcinoma in situ (D.C.I.S.),  in which abnormal cells are found in the lining of the milk-producing ducts. DCIS and the less common lobular carcinoma in situ account for about a quarter of new breast-cancer cases — some 60,000 a year. “D.C.I.S. survivors are celebrated at pink-ribbon events as triumphs of early detection,” writes Orenstein. “Theirs was an easily treatable disease with a nearly 100 percent 10-year survival rate.”

We Say: One of our few quibbles with this article is its depiction of DCIS. We agree that most DCIS is successfully treated. But  the article cites an expert who says DCIS is “not cancer but a risk factor.”  This statement creates the overall impression is that DCIS is not a big deal. Again, in most cases DCIS does NOT go on to become invasive breast cancer, but unfortunately it can and does.

Confusing Statistics |  Orenstein say that the Komen organization, a mammogram/early detection proponent,  has been accused of citing deceptive five-year survival rates. Since these allegations first surfaced, Komen has stopped using the statistic in question.

We Say: NBCC does an excellent job of addressing this common misperception:

Mortality numbers tell the story more precisely than survival numbers. Screening skews the survival numbers:  The more we screen, the more we diagnose and treat women with breast cancers that would not have been a threat to their lives,  so it looks like survival for early stage breast cancer is 98 percent.

This is only a 5-year survival number—and includes the 20-30 percent of women who will have recurrence and may die of the disease later. . . Women die of metastatic disease, not primary breast cancer.

Incidence has risen during the past 20 years from 1 in 11 to 1 in 8, it’s now leveling off; mortality has declined slightly but a key point is incidence of stage IV breast cancer—the cancer that is lethal—has stayed the same; screening and improved treatment has not changed this.
Source: http://www.breastcancerdeadline2020.org/get-involved/tools-and-resources/toolkit/resources-and-tools-for-advocates

We Can’t Manage What We Don’t Measure: When will we start collecting meaningful statistics on metastatic breast cancer recurrence?  US cancer registry data captures data at the time of diagnosis and death. The registries don’t track what happens in between.

As Orenstein notes, 30% of those originally diagnosed with early stage breast cancer will have a metastatic recurrence. But this information is not tracked–until people die:

• NCI and SEER database record  incidence, initial treatment and mortality data. Most people do NOT present with metastatic diagnosis. The cancer registry does not track recurrence—which is how the majority of people are thrust into the metastatic breast cancer ranks.
• We say that there are 150,000 US people currently living with metastatic breast cancer, but that’s basically a guess.
• We know for sure that 40,000 US people die from breast cancer every year. We know that 5 to10 percent of those with metastatic breast cancer were Stage IV from their first diagnosis. So what about the 90 to 95% of those 150,000 currently living with metastatic breast cancer  who were previously treated for early stage breast cancer? The cancer registry does not track them—until they die.

Funding Research | We need more metastatic breast cancer research. Orenstein confirms what MBCN and METAvivor have said for years. Metastatic breast cancer research is appallingly underfunded:

According to a Fortune magazine analysis, only an estimated .5 percent of all National Cancer Institute grants since 1972 focus on metastasis; out of more than $2.2 billion dollars raised over the last six years, Komen has dedicated $79 million to such research — a lot of money, to be sure, but a mere 3.6 percent of its total budget during that period.

There’s also the intertwined issue of funding research for the prevention of metastatic breast cancer vs. treatments that will extend the lives of those currently living with the disease:

“A lot of people are under the notion that metastatic work is a waste of time,” said Danny Welch, chairman of the department of cancer biology at the University of Kansas Cancer Center, “because all we have to do is prevent cancer in the first place. The problem is, we still don’t even know what causes cancer. I’d prefer to prevent it completely too, but to put it crassly, that’s throwing a bunch of people under the bus right now.”

We Say: MBCN’s slogan is “Fighting for Treatments to Extend Life.” So we appreciate Welch’s candor and dedication.  And, if we want to prevent metastasis, we may need to rethink our current approach to clinical trials.  During last year’s annual Metastatic Breast Cancer Conference, NIH’s Dr. Patricia  Steeg made a case for redesigning clinical trials to do what she termed “phase II randomized metastasis-prevention trials.” Currently, phase I and phase II clinical trials are done in patients with advanced, refractory metastatic cancer, patients who have had many therapies. In phase II trials, researchers typically are trying to determine if a drug shrinks metastases.“But a drug that prevents metastasis may not shrink a large, refractory tumor,” said Steeg. “It has a different mechanism of action that is not picked up by the clinical trial system.”

Know The  Breast Cancer Facts | In her final paragraphs, Orenstein says we may have more breast cancer “awareness” but this “awareness” is fundamentally flawed: “All that well-meaning awareness has ultimately made women less conscious of the facts: obscuring the limits of screening, conflating risk with disease, compromising our decisions about health care, celebrating “cancer survivors” who may have never required treating. And ultimately, it has come at the expense of those whose lives are most at risk.”

We Say: Nicely done, Peggy. We’d be honored if you would join us at our 2013 Annual Metastatic Breast Cancer Conference, Sept. 21 at MD Anderson in Houston!

Mark Your Calendar: Peggy Orenstein’s article will go a long way in helping people understand breast cancer. As women living with metastatic breast cancer, we are committed to educating people about this disease. This article is a good start, but our reality remains poorly understood. That is why MBCN fought to establish  Oct. 13 as National Metastatic Breast Cancer Awareness Day. 

Let’s Keep Talking: On her Facebook post announcing the publication of this article, Orenstein said she hopes it will change the national conversation about breast cancer. We hope so, too. Peggy started the dialogue. Won’t you help us continue it?

4/29/2013 Editor’s Note: This copy has been revised to remove a disputed statistic concerning Stage II and Stage III metastatic recurrence, material that was directly quoted, as indicated,  from http://www.breastcancerdeadline2020.org/get-involved/tools-and-resources/toolkit/resources-and-tools-for-advocates. We will provide additional clarification if available.

4/30/2013 Editor’s Note: As noted above, we removed a disputed statistic we originally quoted from this site after some reader’s questioned its accuracy. [That sentence read in part: For Stage II and III, one-half to two-thirds will develop metastatic disease...] A Google search suggested the statistic came from one of advocate Musa Mayer’s articles. We asked her to comment, and with her permission, share her response. Musa writes:

“I can see I am indeed the source of this statistic, or rather what I wrote in the introductory section of “Silent Voices,” which was written in 2005.  I did get this quote from a text on breast cancer published in 1999, edited by Daniel Roses.  The figures come from an article on the treatment of metastatic breast cancer by Ruth Oratz, an NYU oncologist, written during the era when bone marrow transplants were still being investigated.  I think there may have been an earlier edition.

“There have been a few major advances in the adjuvant treatment of early breast cancer in the last 8 years, principally the use of adjuvant Herceptin, which has reduced recurrence by at least 50% in HER2+ disease, once considered among the deadliest subtype.  The use of adjuvant taxanes with AC regimens in triple-negative breast cancers has also reduced recurrence during these years.  Hormonal treatments have improved in a more incremental way, with the use of the aromatase inhibitors.  So all in all, I believe you can say that for women with non-metastatic disease, the outlook is better than it was even a decade ago.

“Just how much better?  It’s really hard to tell until the numbers mature over time, as we know recurrences can happen later now that more aggressive adjuvant treatment is in use.   The National Cancer Institute’s SEER database shows a steady increase in survival over time, looking at all invasive breast cancers.  For example, 1990 10-year survival was 77%, while in 2000 it was 84%.   But survival figures don’t necessarily represent significant gains, as they are distorted by the overdiagnosis of Stage I breast cancers, which have increased five-fold since the advent of mammography in the 1980′s.

“The numbers are very different in different populations, with low socioeconomic status (hence poor access to care) and African American race predicting higher mortality.  In fact the disparities in survival and mortality have only become greater as more effective treatments are introduced.

“The annual mortality rates for breast cancer, age-adjusted, per 100,000, which DO give an accurate picture of progress, have decreased from 33.1 in 1990 to 27.6 in 2000 to 21.9 in 2010.  That’s a decrease of about one third over 20 years.  Not large, but not trivial, either.”

Source: email correspondence with Musa Mayer

Do you remember “Love Story?” Oliver Barrett IV (Ryan O’Neal) and Jennifer Cavilleri (Ali McGraw) are the improbable lovers who defy parental disapproval and get married.

The only way to be surrounded by more sap would be to visit Vermont during the peak months of maple syrup production. Remember the hilarious send up on “Carol Burnett”?

Reviewers at Amazon call “Love Story” a cheesy sob story. (“If I ever hear Ali MacGraw say ‘preppie’ again I will probably spontaneously combust,” declares one commenter.)

Sobering Reality of Real Life…

I agree with all of those observations. And, a few years ago, I would also have hooted about a specific plot point—McGraw’s character dies at age 25 after being diagnosed with leukemia. Unfortunately, I have lost many friends to metastatic breast cancer (MBC). I know from painful experience that people do indeed die from breast cancer in their 20s and 30s.

Bridget Spence was 29.

What can you say about a 29-year-old-girl who died? That she was beautiful. And brilliant. And that this just totally sucks.

Bridget was diagnosed with breast cancer at 21. She had no family history. I used to think cases like hers were rare. Now I’m not so sure. As a patient advocate for people with metastatic breast cancer, I know a lot of people with both early and advanced breast cancer and they are young, old,  and all points in between. But I was frankly shocked when I saw the turnout for the “Under 40 & Living With Metastatic Breast Cancer” panel at the 2012 MBCN Conference.

Jen Smith, 36, has been living with Metastatic Breast Cancer since age 31, shortly after her son’s birth.

It seems like I know an awful lot of young mothers like Jen Smith  with metastatic breast cancer. Now, I consider myself fairly well informed on breast cancer risks such as gender, family history, dense breasts and so on. I knew that NOT having children increased a woman’s risk, due to the unopposed flow of estrogen. But until this year, I never knew that recent childbirth can temporarily increase one’s breast cancer risk. As noted on www.cancer.gov: 

Women who have recently given birth have a short-term increase in risk that declines after about 10 years. The reason for this temporary increase is not known, but some researchers believe that it may be due to the effect of high levels of hormones on microscopic cancers or to the rapid growth of breast cells during pregnancy (15). [Source: http://www.cancer.gov/cancertopics/factsheet/Risk/reproductive-history]

I don’t recall ever seeing any article or other information on this issue. I would guess that many obstetricians assume—as seems reasonable—that cancer is a disease of aging. And nursing mothers have a host of potential breast problems: blocked milk ducts, soreness, etc.

But I don’t seem to be the only one who thinks more young women—mothers and non-mothers alike—are getting metastatic breast cancer.

Is MBC Incidence  Rising in Young Women?

Rebecca H. Johnson, MD, of Seattle (Washington) Children’s Hospital and the University of Washington in Seattle, noticed that evidence from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) database suggested that  incidence of metastatic breast cancer in young women is on the rise. Johnson and her fellow researchers recently released a study that found “a small but statistically significant increase” in metastatic breast cancer over the last three decades among U.S. women aged 25 to 39 years.

The researchers found that in women aged 25 to 39 years, the incidence of breast cancer with distant involvement at diagnosis increased from 1.53 per 100,000 in 1976 to 2.90 per 100,000 in 2009, representing an average compounded increase of 2.07% per year over the 34-year period. No such increase was seen in any other age group or in any other extent-of-disease subgroup of the same age range.

The rate of increasing incidence of distant disease was inversely proportional to age at diagnosis, with the greatest increase occurring in women aged 25 to 34 years.

Dr. Johnson was diagnosed with breast cancer (presumably early stage) at age age 27. “I’d meet young women patients with breast cancer and it seemed like a lot of friends of friends had breast cancer,” she told @newsJAMA. “And yet the literature kept saying that breast cancer in young women was rare.”

Her  study didn’t  evaluate cause. “The next steps for researchers will be to examine potential causes for this trend and look at etiologies,” she said. “Given there’s such a change over a short amount of time, we may find modifiable risk factors or potentially toxic exposures that are fueling this increase.”

She further explained that the research shouldn’t be taken out of context.  “What the average young woman [under 50] should not do is go get a mammogram, because while on a population level we saw a statistically significant increase, it’s not a large increase of risk for an individual. One thing that has the potential to affect young women’s survival is earlier detection—seeing a physician if you find a lump instead of ignoring it.”

How Can We Manage What We Don’t Measure?

CURE magazine’s Dr. Debu Tripathy noted that the research is based on “cancer registry data, which is very good at capturing data at the time of diagnosis, but not long-term follow-up (other than death). So this is really looking at the less common situation of women who actually present with metastases at the time of their original diagnosis – which only happens about 5 to 10 percent of the time, and perhaps more so in women who do not have access to health care and present with higher stage cancers.”

Dr. Tripathy is correct about that cancer registry data. NCI and SEER database record only incidence, initial treatment and mortality data. And, as Dr.Tripathy further correctly observes, most people do NOT present with metastatic diagnosis. The cancer registry does not track recurrence—which is how the majority of people are thrust into the metastatic breast cancer ranks.

So here’s the good news: Most people don’t start with metastatic breast cancer, which is what the cancer registry tracks.

…And the bad news: We really have no idea what’s going on with, you know, the MAJORITY of people who are diagnosed with metastatic breast cancer after a recurrence. As Dr. Tripathy says, other than death, the cancer registry doesn’t concern itself with long-term data.

So to recap: We know for sure that 40,000 US people die from breast cancer every year. We know that 5 to10 percent of those with metastatic breast cancer were Stage IV from their first diagnosis. So what about the 90 to 95% of those who had a metastatic recurrence? The cancer registry does not track them—until they die.

“While [Dr. Johnson’s] report should not cause alarm or even affect any of our care guidelines, it may be a wake-up call to truly understand what might be driving this,” concludes Dr. Tripathy.

May be a wake up call?

MAY???

Well, gosh, no rush or anything. I mean, if it wouldn’t be a bother, maybe somebody could work on that truly understanding thing.

If I sound angry, it’s because I am. And so are my fellow patient advocates.

If Not Now, When?

“We need focused research to change incurable metastatic breast cancer into a treatable, chronic condition like HIV-AIDS–where patients can now live for 20-30 years with treatment after their diagnosis,” says Shirley Mertz, President of MBCN. “If gay men, who were then scorned by society in the 1980s, could demand and receive focused research and treatments for their disease, why can’t we women–who are wives, mothers, daughters, sisters and grandmothers AND over half of the population–receive similar research that will find strategies to keep us alive for 20-30 years?

“Are we not worthy of this effort?  Are we ignored because we quietly live with our disease?”

So, yes, Dr. Tripathy, you bet your stethoscope this is a wake-up call.

Because as Shirley says, “How many more thousands of us must die before the public and our sisters, who have survived early stage breast cancer, stand with us and for us?”

Cancer at any age and any stage is a terrible thing. But it is especially cruel when it happens to young people–women like Bridget Spence, who at age 29 should have just been getting started in life. There are too many women like Bridget, too many of my friends.

Olga Simkin was 34.

Maria Madden was 37.

Jennifer Lynne Strutzel Berg was 37.

Susan Niebur was 39.

Samantha Pritchett was 40.

Dana Robinson was 41.

Rachel Cheetham Moro was 42.

Zoh Vivian Murphy was 45.

Suzanne Hebert was 47.

Martha Rall was 49.

I have to repeat Shirley’s question. How many thousands more of us must die?

Harper has just published this memoir.

By Katherine O”Brien, Secretary and PR Chair, MBCN

I know that Valerie Harper isn’t Rhoda, her old character from “The Mary Tyler Moore Show.” But when I hear her name, I think of her in that role. I loved Rhoda’s brash attitude and her many sarcastic comebacks.

“Rhoda was the sass to Mary’s spunk, the head scarf to Mary’s beret,” writes EW’s Jessica Shaw. “She was so beloved that she transcended sidekick status and scored a show of her own.” 

In my mind, Valerie Harper is ageless–she will always be the same age as Rhoda on “The Mary Tyler Moore Show.” But of course that’s not the case. Harper is now 73 years old. She recently  announced she is  undergoing chemotherapy for brain mets. This past January she was diagnosed with  leptomeningeal carcinomatosis, a  complication of her lung cancer in 2009. (Two to five percent of women with metastatic breast cancer experience leptomeningeal metastases (LM), read more here.)

Rhoda? Cancer? Brain Mets?  No way!

I was so sorry to learn of Harper’s diagnosis. “Inspiration” is a word that is often overused when writing about cancer patients, but I believe it applies here. No one would fault Harper if she preferred not to discuss her illness or her diagnosis. That’s her choice–as indeed we all have the right to determine what if any information we will share about our personal lives.

But she choose to be very open about having an incurable disease.

“This could draw more attention to cancer research. I think there’s an opportunity to help people,” Harper told  People magazine.

Harper, a nonsmoker, was  incredulous when she was diagnosed with lung cancer four years ago. “I’ve since come to learn that more women are dying of lung cancer than [from] all the breast, colon and pancreatic cancers combined [according to statistics from the National Cancer Institute]. And many of them are nonsmokers…Society thinks lung cancer equals smoking. But when I told my doctor that I don’t smoke, he said that 20% of his patients are nonsmokers. He also sees people who quit smoking – and 20 years later, this disease bites them in the butt.”

Harper thought she had beaten the cancer but in  August 2012, she experienced a “belt-like sensation” across her midsection. Then in mid-January 2013, Harper experienced numbness in her jaw. Subsequent tests ultimately revealed leptomeningeal carcinomatosis.

“I just want folks to see me, that I’m OK, that I’m not suffering so far,” said Harper. “There may be pain. There may be a lot of things ahead, but whatever they are, they’re ahead. They’re not now.”

In the past week, Harper gave many interviews. Writer Donna Kaufman compiled “The 10 Most Inspiring Things We Learned from Valerie Harper”:

1. Don’t blame yourself for tragedy. “If you die, you’re not a failure,” Harper said on Today. ‘You’re just somebody who had cancer. And that’s the outcome.”

2. Live in this moment, right now. “I’m not dying until I do,” Harper told Today. “I have an intention to live each moment fully.”

3. Remember that death is part of life. “I really want Americans, all of us, to be less afraid of death,” Harper said on The Doctors. “Know that it’s a passage, but don’t go to the funeral before the funeral. While you’re living, live.”

4. Let yourself be sad — but stay hopeful. “I don’t mean this to be Pollyanna! I allow myself the grief,” Harper told Today‘s Savannah Guthrie, when asked if she ever felt sad. “What I’m saying is keep your consciousness, your thoughts open to infinite possibility and keep yourself open to miracles.”

5. Don’t give in to despair when there’s more pasta to eat. When Harper first heard her diagnosis, she said on The Doctors, “I broke down. I absolutely sobbed. I let myself do it. Then I said, ‘Okay, you’ve been the drama queen. Now get over it and make the pasta.’”

6. Deal with your battles in the way that makes sense to you. When one of the Doctors asked Harper why she was spending her final days on a press tour, she responded, “Dr. Travis, this is not for everyone. This is my way of dealing with it.”

7. Don’t live in denial. “I’m trouble,” Harper admitted in a video message for People, “but when the smoke clears, I’ll be standing. Until I’m not. And I’m ready for that, too.”

8. Don’t forget to live just because you’re dying. “‘Incurable’ is a tough word. A lot of people were calling — ‘Can I come by the house?’ ‘Are you in a wheel chair?’ — because they hear it as this death sentence,” Harper said on Today. “Which it may be. But I’m not dying until I do. I promise I won’t.”

9. Never be afraid of what’s next. “I don’t know what’s ahead, but I’m ready for it. Onward!” Harper told fans in her People message. “I love you. And know that I’m okay. I am okay on this venture.”

10. Keep your loved ones close. Harper says she’ll be spending her final months with her husband and daughter while she undergoes treatments to try and slow the progress of her disease. “My doctor said it’s incurable — so far,” Harper said on GMA. “And I love that possibility. We all need to live in infinite possibility.”

In addition to her inspiring words, Harper is taking this opportunity to campaign for universal health care. “Health care for all! I mean, I’m lucky: I have my union, I have the greatest husband in the world, and the wonderful Cedars Sinai hospital,” she told People, “and that should be for everybody. It shouldn’t just be for me.”

On a forum for people with lung cancer, one poster wrote, “Rhoda was on [television] about her terminal cancer, what an interview God bless her and her family for those of us who saw this. This gave me strength and understanding of the diagnosis. Talk about lung cancer being the number 1 killer in the US,  great stuff today.”

Harper’s message also moved people with metastatic breast cancer. “I found myself uplifted by the words of a woman with only three months to live,” wrote one participant on a board for people with Stage IV breast cancer. “She does not fear death, she is ready, but in the meantime, she will keep her friends and loved ones close and live her life. While we all know these words to be true, hearing them from someone most of us grew up laughing at and admiring really hit hard. I applaud her spirit and her bravery and I pray that her remaining days are everything she needs them to be, and that her passing will be peaceful.”

Me too.

Thank you, Laura for allowing MBCN to reblog your remarks on the breast cancer research landscape and on NBCC projects and priorities, given during the opening plenary of the Collaborative Summit on Breast Cancer Research in Washington D.C., held January 31- February 1. The goal of the Summit was to gather researchers, funders, advocates, and industry representatives together to assess the breast cancer research landscape and to develop collaborative projects for moving forward.

 We have added emphasis and subheadings to some sections. Original blog at: Laura Nikolaides Speaks at Collaborative Summit on Breast Cancer Research in Washington, DC

WHAT ABOUT OUR DAUGHTERS?

I am excited to be here and to have the chance to talk about the bigger picture of breast cancer research, where we have been and where we should be going. So much of the year is spent down in the weeds when it comes to breast cancer research, when we attend the ASCO meeting or SABCS, or when we review grant proposals, so it is gratifying to have this opportunity to for all of us to pull our heads up from the weeds and to discuss the long view.

And for me, the long view, means thinking about my 13-year-old daughter. Where do we need to be by the time she and her friends are adults? Are we on track?

Will things be dramatically different in ten, twenty, thirty years when it comes to breast cancer?

Or will mothers, grandmothers and young women and even men still be dying of breast cancer? Will we know by then why breast cancer cells can lay dormant for 15 years to reemerge and metastasize? Will we know how to eliminate those dormant cells from the beginning? And what about women who have aggressive disease from the get-go. Will we understand why it developed and more importantly know how to stop the progression for the long-term?

TOO MANY QUESTIONS REMAIN UNANSWERED

Unfortunately, I don’t see dramatic change on the horizon with current approaches.

The ACS [American Cancer Society] predicts that over 300,000 women will be diagnosed this year with in situ or invasive breast cancer. Dr. Gil Welch and others predict that between 30 to 50% of those could be considered overdiagnosis. We continue to add more women into the equation, putting them at risk of harm from treatments, and yet, are we seeing a difference in the measures that matter? Yes, we have seen steady, incremental declines in breast cancer mortality since the early 90s, but there has been no acceleration in this decline. And do we know what this really means? What IS working for women and what is not? Do we know how many women have died from the treatments? Do we know if death from breast cancer is being delayed rather than prevented? Are we really any closer to knowing how to prevent breast cancer or a breast cancer death for an individual woman?

NO REAL PROGRESS ON THE METASTATIC FRONT

What we do know is that the rate of diagnoses of Stage IV disease has remained constant for 30 years. What we do know is that 40,000 women and men will die from the disease again this year. What we do know is that the median survival for metastatic breast cancer has remained constant, at about three years.

With billions in resources and decades of effort, we see discovery of new targets, and development of new agents, that extend life by three to four months at a time, if we are lucky. We are learning a lot about the DNA of breast tumors, and the layers of complexity involved, but are we really gaining a better understanding of the why and how of breast cancer? The kind of understanding that will allow for development of gamechangers?

A pharma analysis report prepared a few years ago concluded that with what is currently in the pipeline, and based on historical trends, the median survival for metastatic breast cancer will inch forward from three years, to three years and six months by the year 2021.

Important progress and critical efforts, yes, but is it good enough? No, it is not good enough. We can and must do better. We need new approaches to complement the old ones. We need new ways to look at the disease. We need to find approaches that give us hope of doing better. Targeting of mutations alone, in a disease that constantly grows and mutates, will never be enough.

NBCC’S 2020 DEADLINE TO END BREAST CANCER

In 2010, NBCC set a deadline. By the end of the decade we need to understand much more about metastasis and about development of primary breast cancer, so that we can prevent deaths and end this disease. The deadline is a tool to cause disruptive change.

The purpose is to shift the focus, to look at the disease differently, to consider new approaches that give us hope of doing better.

How do we get there?To achieve success we have to do more than bring everyone together who works in the field, increase funding, and see what happens.

We need to demand more focused research with the end results in mind. We need to bring new perspectives to the table. We need more translational research. And we need to measure what matters. It may just take having specific goals in mind, timelines, and yes, deadlines to get us there.

Many say to us, that’s not how science works. But, I know how science works. I did graduate work in nutritional biochemistry at Cornell University, I carried out a large thesis project involving lactating rats, looking at the impact of malnutrition on milk composition. I know that science works by asking questions, and figuring out how to test theories about the answers to those questions.

SCIENTISTS CAN MEET DEADLINES

So what if we can all agree on what those questions should be? Questions that will help drive us to an understanding of how to prevent deaths from breast cancer? Science can work towards meeting goals and yes – even meeting deadlines. I know I had to answer my research questions in a certain time to finish my thesis and graduate. Scientists meet deadlines all the time.

Right now, in the field of breast cancer research, we have many people asking many questions in an infinite number of directions. We are producing incredible volumes of information. But for all of that effort we are seeing minimal benefit for women. Something has to change.

We need leadership and coordination of efforts, sharing of information, all of us working together on common goals. We need the will to ask the right questions, and the resources to explore those questions. And then we have to measure what matters to judge success.

PATIENT ADVOCATES AND RESEARCHERS COLLABORATIONS

NBCC has spent the last two years exploring how to do this on a small scale with what we call Artemis Projects. These are a series of collaborations among patient advocates and researchers from diverse perspectives. The purpose of the collaborations is to develop strategies, research plans and timelines for answering key breast cancer questions. Patient advocates are there to make sure efforts are always focused on the end result.

The first of our Artemis Projects was launched in 2011, bringing together a group of advocates and scientists to take a strategic, systematic yet broad approach to the development of a breast cancer preventive vaccine within five years. We bring together a group of close to 40 each year to assess progress and to readjust plans. We also hold smaller meetings to bring together experts to bear on particular issues as needed, and have an online community for the project to keep things moving in between meetings.

SEED GRANTS TARGET VACCINATION RESEARCH AND MORE

As most of you know, we don’t typically fund research directly. But through the generous support of National Philanthropic Trust (NPT), NBCC has awarded two seed grants as part of this project, one to Dr. Paul Spellman and Dr. Joe Gray of Oregon Health and Science University to identify possible vaccine targets using existing and developing human genomic data within different breast cancer subtypes.

And a second seed grant was awarded to Dr. Paul Ewald at the University of Louisville, and Dr. Vladimir Belyi of The Cancer Institute of NJ to look at infectious agents and breast cancer. Bioinformatic tools will be used to take a systematic approach to intersect the genomes of known viruses and a broad array of cellular pathogens to identify their presence and prevalence in breast cancer genomes relative to normal breast tissue. Initial data from both of these seed grants will be presented at the next annual meeting in March.

MORE METASTATIC RESEARCH

We will also be kicking off a second Artemis Project on Metastasis in June to focus on tumor dormancy.

As with the Artemis Project on the Preventive Vaccine, our goal is to bring together investigators with diverse perspectives to brainstorm and develop innovative strategies for accelerating progress.

EYES ON THE PRIZE

In summary, I think we do have the will and the resources to come together on asking the right questions. We have heard from others this morning about new initiatives focused on prevention and metastasis. I see positive steps being taken to prove that pharma analysis wrong. If we can keep the end result in mind, where we want to be when all of those 13 year olds are 21 year old adults and beyond, I feel hopeful we can change the course. I look forward to the rest of the meeting for further discussion on how we are going to get there. Thank you.

Editor’s note: Shirley Mertz will represent the Metastatic Breast Cancer Network at the Tumor Dormancy Summit in June.

Recent commercials for the Komen 3 day walk make this claim: a 30% drop in breast cancer mortality rates since the early 90′s due to early detection. Is this true?

According to Wikipedia, mortality rate is a measure of the number of deaths in a population, scaled to the size of that population, per unit of time. Mortality rate is typically expressed in units of deaths per 1000 individuals per year. So a breast cancer mortality rate of 31.6 in 1992, for example, means there were approximately 31 deaths for every 1000 individuals living with breast cancer at that time.

Statistics can be very confusing. When I first saw this claim of a 30% drop in mortality back in 2011, I was shocked and sure that Komen was wrong. Did this mean that 30% fewer people were dying from breast cancer? That sounded too optimistic.  I wrote to my friend who has a masters in applied math and economics and she enlightened me:
The mortality rate in 1992 was 31.60 and on average has dropped 2.2% every year. In 2008, for example the mortality rate was 22.14. Over that 17 year period, the mortality rate dropped by 9.46. (31.6 in 1992 minus 22.14in 2008= 9.46) See charts below:

So what about the 30%? Shouldn’t it be 9.46%? Ahh…welcome to the mysterious world of  statistics.

The % change in the mortality rate that Komen is quoting is calculated differently. It is a % of a % calculation. The actual rate change of -9.46% is divided by the original rate of 31.6%, giving a % change in mortality rate over 17 years of (-9.46/31.6) or 29.9% change. This is the figure that Komen is referencing. (30% drop in BC death RATES over a given period of time)

Here’s a simpler example. If we raised the tax rate from 5% to 10%, we have doubled the rate (100% increase because 5% change divided by the original 5%rate = 100 —also look at it this way: 10 is twice 5, a 100% increase) although the actual rate change is an additional 5%. If you were the angry taxpayer, you would probably report this as a 100% increase in your tax rate, rather than saying it was an addition of  5%. Both are accurate statistically, but you can see the potential for spinning the numbers to support your campaign.

I read another example in the newspaper this morning. The headline said: “ADHD cases up 24% in a decade.” I immediately envisioned almost a quarter more of ADHD children, the same way I envisioned 30% fewer people dying from breast cancer. Neither is true. The ADHD article went on to explain the basis of the 24%: “The disorder was detected in 3.1 percent of children who received care at Kaiser Permanente Southern California in 2010, compared with 2.5 percent in 2001, according to the study, published Monday [1/20/13] by the journal JAMA Pediatrics.” In other words, 2.5% rose to 3.1 %, an additional .6%, but compared to the initial rate, a 24% change in rates (.6%/2.5%= 24%)

I told you it’s confusing!! You can usually find some statistic to make your position look good. That being said, in the metastatic bc community, we usually focus on the NUMBER of people dying and not the RATES. Despite early detection and advances in treatment, the actual number of deaths over the last 20 years has remained essentially unchanged, hovering around 40,000 deaths per year.

NBCC explains it this way:

Truth #5: Breast cancer mortality rates are declining

TRUE. Breast cancer death rates changed little between 1930 and 1990, but decreased 27% from 1990 to 2005.

Between 1994 and 2003, the mortality rate for women of all races combined declined by 2.4% annually. In white women, breast cancer mortality declined by 2.5% annually. In black women, mortality declined by 1.4% annually during the same period. Some good news, but remember there are still 40,000 women who will die of breast cancer this year.

While these statistics are encouraging — we don’t actually know why mortality rates decreased. We need more research to figure out what factors led to the reduction in death from breast cancer so that we may continue the downward trend — and we need to make certain it’s the same for all women. We must continue pushing to find out what causes this disease.

Komen attributes all of the change to early detection. Certainly changes in treatment have also helped. The American Cancer Society 2011-2012 report states: “The decline in breast cancer mortality has been attributed to both improvements in breast cancer treatment and early detection.”

What’s the lesson here for those of us living with metastatic breast cancer? I hope after this little math lesson that you are forever grateful that you don’t have to sit through Statistics 101! My friend the economist who explained all this to me, ended her email, saying: “Hope this helps.  Anyway, it would make me much happier if the mortality rate were 31.6 – 29.9!”

I hope you understand better the statistics being quoted and will read articles closely in the future, where the same type of statistic is used. While legitimate statistically, the percent change in mortality rates hides the reality of a hard core of stage IV patients who continue to die. After forty years of research in the War on Cancer, we still don’t know what causes breast cancer or what causes it to spread. We need to continue to advocate and raise awareness of metastatic disease and the lack of progress in preventing and stopping metastases.

Shirley at the 34th Annual San Antonio Breast Cancer Symposium

At a 2009 breast cancer seminar, I met two Chicago-area MBCN volunteers: Joani Gudeman and Shirley Mertz. I had never met another person with metastatic breast cancer. Joani and Shirley made me feel less alone. Their activism inspired me.

The meeting was held in a hotel ballroom on a Sunday morning. There were several hundred people in attendance and most were casually dressed. Shirley, however, was  professionally attired in a perfectly tailored suit. Who would get dressed up on the weekend? Certainly not me. But there was Shirley, dressed for success. Although she was not part of the medical panel fielding questions, Shirley was summoned to the stage to read a proclamation about October 13,  National Metastatic Breast Cancer Awareness Day.

In 2008, Shirley and her fellow volunteer, the late Susan Davis,  launched MBCN’s drive to formally establish October 13 as National Metastatic Breast Cancer Awareness Day. In October 2009, they succeeded: The Senate and House each unanimously passed a resolution to support that designation.

I remember watching Shirley striding purposefully to the stage. She absolutely belonged up there–she commanded attention and respect. Almost a year later, I met Shirley again in Indianapolis at MBCN’s  2010 Annual Conference on Metastatic Breast Cancer. Again, I was struck by Shirley’s leadership–she moderated several sessions. As I got to know her a little bit better, I saw flashes of Shirley’s humor–and that made me like her even more. She’s serious in her advocacy efforts, but she enjoys a good joke and will often tell one on herself.

In 2011 and 2012 as I did more volunteer work with MBCN, I learned that Shirley, a former high school principal from northwest suburban Chicago, also earned a law degree. I don’t think Shirley divulged this information–she did share, however, that she is a proud graduate of the National Breast Cancer Coalition’s (NBCC) Project Lead, a science training program for activists. Shirley became a consumer reviewer for the DOD Breast Cancer Research Program and advocate for national health care reform. In 2008, she personally asked Senator Evan Bayh to sponsor a Senate Resolution for MBC Awareness Day and then co-chaired the team that traveled to Washington to lobby for Congressional passage. In 2011, she was honored as a Champions of Change in breast cancer at the White House.

Shirley Mertz with the University of Chicago’s Olufunmilayo Olopade, MD

Shirley was diagnosed with metastatic breast cancer in 2003, twelve years after being treated for DCIS. Like me, she wanted to meet other people dealing with a diagnosis of metastatic breast cancer. She was appalled to learn how few resources existed and determined to make a difference. “My passion is being a voice for metastatic breast cancer patients,” Shirley told me. “I have not hesitated to share my experiences with this disease because I want to motivate others to speak up. Joining together with a focused message, metastatic breast cancer patients can improve outcomes in the clinic.”

Shirley’s own story illustrates some key messages for people with metastatic breast cancer. “Allow yourself time to cry, then put on steel armor and learn to take charge of your care,” Shirley told a University of Chicago interviewer. ” You must be your own advocate.”

After her recurrence, Shirley’s former oncologist based her treatment on the biological characteristics of the 2003 tumor. But it was clear the treatment was failing. Shirley lobbied for a new biopsy–and ultimately got one, after pursuing a second opinion. The biopsy revealed the pathology of Shirley’s cancer had changed–it wasn’t the same subtype as her original diagnosis.   “A great oncologist will never be offended if you ask for a second opinion,” she says. By sharing her story, Shirley has helped untold people.

Earlier this year, MBCN named Shirley as its president. In addition to targeting underserved areas of the US, she’s committed to raising the group’s profile with metastatic researchers. “If scientists could meet us and personally hear our needs, that would be a powerful message,” she says. “With the board’s help and enthusiasm, we will take our commitment to patients to another level.”

You go, Shirley!

Katherine O’Brien is MBCN’s Secretary and Public Relations Chair

from SHARE blog:

Joan is a SHARE helpline volunteer and co-chair of SHARE Leaders, consumer reviewer for the Department of Defense, Breast Cancer Research Program

This year’s annual San Antonio Breast Cancer Symposium was busy as usual with many oncologists and scientists from around the world presenting clinical trial results and discussing the development of new treatments and care of patients and survivors. Some clinical trials showed promise in treating women with metastatic breast cancer.

Perjeta Brightens Outlook of HER2+ Survivors

The long awaited results for overall survival (OS) in the CLEOPATRA trial showed that Perjeta extended overall survival in metastatic HER2-positive breast cancer patients.

The drug maker made the announcement about the phase 3 trial at the symposium.

The combination of Perjeta, Herceptin, and Taxotere significantly improved OS by 34%, compared to Herceptin, Taxotere, and a placebo. As of the analysis, the median OS of patients in the treatment arm had not yet been reached, as half of those patients continued to survive. In the control arm, it was 37.6 months. As a result of the survival benefit, patients in the placebo arm were allowed to cross over to the Perjeta arm.

Perjeta was FDA approved in June for first-line treatment when it met the trial’s primary endpoint of progression-free survival (PFS). The drug improved PFS by 6 months, from 12.4 months in the standard arm to 18.5 months in the experimental arm.

In the current analysis, the Grade 3 side effects of neutropenia (low white-cell count) and diarrhea remained the same as in the initial report in June. Although Herceptin may cause congestive heart failure, the addition of Perjeta did not increase the chance of heart problems.

Genentech, which makes Perjecta, expects the FDA to approve T-DMI in the first quarter of 2013. T-DM1 is another drug that has also shown benefit in women with advanced HER2+ breast cancer.

Higher Faslodex Dose Improves Benefit in Advanced ER+ Breast Cancer

Postmenopausal women with locally advanced or metastatic estrogen-receptor positive breast cancer who recurred or progressed on prior endocrine therapy did better when taking 500 mg of fulvestrant (Faslodex), rather than 250 mg. Fulvestrant is an intramuscular injection.

The higher dose showed a significant 4.1-month improvement in overall survival (OS) when compared with the lower dose, from 22.3 months to 26.4 months. It also resulted in a 19% drop in the risk of death.

For the phase 3 CONFIRM trial, investigators enrolled 736 women and randomly assigned roughly 50% of them to receive 500 mg of fulvestrant on days 0, 14 (2 placebo injections), and 28, and 28 days thereafter. The other half received 250 mg every 28 days. When the analysis was shown to favor the higher dose, women who were in the 250 mg arm of the trial were permitted to cross over and receive 500 mg. The median age of the enrollees was 61.

The 500 mg dose of fulvestrant did not significantly increase toxicities. About 10% of the women taking the higher dose experienced at least one serious adverse event (SAE), compared with roughly 7% in the 250 mg arm. SAE’s were acute myocardial infarction, acute renal failure, cardiopulmonary failure, dyspnea (shortness of breath), and hypertension.

Angelo Di Leo, M.D., Ph.D., presented the final results of the CONFIRM trial at the symposium. He is head of the department of medical oncology at the Hospital of Prato, Instituto Toscano Tumori in Prato, Italy.

Targeted Compound Improves PFS in Advanced ER+ Breast Cancer

Women with postmenopausal advanced breast cancer who received a targeted agent along with the aromatase inhibitor letrozole (Femara) showed a meaningful improvement in median progression free survival (PFS), according to the results of a phase 2 trial.

The data showed that postmenopausal women who took the oral drug PD 0332991, or PD991 for short, had a significant, median PFS of 26.1 months compared with 7.5 months for women in the control arm.

The researchers enrolled 165 women in the trial. The enrollees had estrogen-receptor positive, HER2 negative metastatic breast cancer.

PFS was the primary endpoint. Secondary endpoints included response rate, overall survival, safety, and biomarker studies.

The response rate was 45% for the combined regimen and 31% for letrozole alone. The clinical benefit rate, which showed complete and partial responses, as well as stable disease, was 70% versus 44%, respectively.

In an attempt to determine meaningful biomarkers, the researchers also studied tumors that were amplified for CCND1 and/or had loss of p16. Both have sensitivity to PD991 in vitro. CCND1 is a gene that regulates cell cycle progression. It may contribute to tumorigenesis. The protein p16 relates to the ability of the body to suppress tumors.

Based on the promising data, the researchers plan to begin a phase 3 trial in 2013.

The results were reported by Richard S. Finn, M.D., associate professor of medicine at the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles.

Neoadjuvant Chemo May Provide Clues for mTNBC

Scientists are looking at the response of triple negative breast cancer (TNBC) tumors in the neoadjuvant setting to potentially identify cell abnormalities that can lead to treating TNBC in the adjuvant and metastatic settings.

In early stage breast cancer, neoadjuvant chemotherapy is administered prior to breast surgery and can result in either complete or partial shrinkage of the tumor.

The authors of this study genetically examined residual tumor tissue from 114 women after the patients completed neoadjuvant chemotherapy. They discovered that 90% of the samples had an abnormality in at least one of five cell pathways. The pathways have clinically actionable targets: DNA-repair targeting agents and inhibitors of PI3K/mTOR, RAF/MEK, cell cycle/miotic spindle, and RTK.

Research has already shown that not all TNBC’s are alike, and the results of this study suggest that women with metastatic disease could be grouped into clinical trials depending on the abnormalities of their tumor, in order to test pathway inhibitors.

Justin M. Balko, Pharm.D., Ph.D. presented the results of this study. He is with Vanderbilt-Ingram Cancer Center in Nashville, Tenn.