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Abraxane approved for metastatic pancreatic cancer

BY ELIZABETH WHITTINGTON | SEPTEMBER 6, 2013

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Because of the hard-to-treat nature of pancreatic cancer even small gains are cause to take notice, which is why the approval of Abraxane (paclitaxel) is welcome news. Abraxane is the first treatment to be approved for pancreatic cancer in nearly eight years.

Results of the MPACT study, a phase 3 international trial that that examined Abraxane and gemcitabine, found the combo extended overall survival by more than 7 weeks when compared with gemcitabine alone. It also improved one-year survival from 22 percent to 35 percent. Those results helped the Food and Drug Administration decide to approve the regimen for first-line therapy for metastatic disease. The drug was priority review approval back in May and a decision was expected later this month.

[See "FDA approves Abraxane for late-stage pancreatic cancer" from FDA.gov]

Abraxane is a form of Taxol that is encased in a protein and administered intravenously. This formulation helps reduce severe allergic reaction, and the protein may make it easier for paclitaxel to reach cancer cells than traditional Taxol. Side effects of the combination includes fatigue and peripheral neuropathy.

[Blog: Read more about the results of the MPACT study from the 2013 ASCO GU conference]

It's believed that Abraxane helps target the stroma, a matrix of cells and molecules that are tightly knit together around the cancer. If Abraxane can weaken the stroma, gemcitabine may have a better chance in targeting the cancer cells.

Abraxane is already approved for advanced lung and breast cancers.

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Another cancer fraud?

BY ELIZABETH WHITTINGTON | AUGUST 15, 2013

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It's pretty low to fake cancer to receive money, sympathy or attention. But CNN is reporting that an oncologist in Michigan is being charged with fraud for telling people they had cancer when they didn't and profiting from the unnecessary treatments, among other complaints. He's being accused of pocketing about $35 million over two years in false Medicare claims.

Employees of the clinic, including another oncologist and nurses, have stepped forward with claims of abuse and neglect (complaint), but it breaks my heart to know this may have gone on for so long. Did it really take two years to finally charge this man? He's being officially accused of healthcare fraud, but reading over the witness accounts, I suspect there will be many more charges and lawsuits to come.

Some of the charges he's being accused of include:

-Administering unnecessary chemotherapy to patients in remission
-Deliberate misdiagnosis of patients to justify giving expensive treatment
-Administering chemotherapy to end-of-life patients who would not benefit
-Deliberate misdiagnosis of patients to justify testing
-Deliberate misdiagnosis of anemia to justify treatments

For many patients, they must now wait for their medical records to be returned from the FBI and begin the search for another doctor. We talk about the dangers of overtreatment and overscreening, but my goodness...I'm just floored.

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As cancer survivors, who is watching us now?

BY KATHY LATOUR | AUGUST 13, 2013

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As is to be expected, in a recent survey of oncologists and primary care physicians (PCPs) in regard to who should care for cancer survivors, most PCPs (51%) supported a PCP/shared care model while the majority of specialists (59%) strongly endorsed an oncologist-based model (oncologists were surveyed but they included nurse-specialists). Less than a quarter of PCPs and oncologists preferred a specialized survivor clinic. (You can read more here.)

Most PCP's thought they were better able to follow up with breast and colorectal patients, detect recurrent cancer, and offer psychosocial support, but only 32% wanted to assume full responsibility.

So where does this leave us, the cancer survivors who have to live out our lives with follow-up from doctors, most of whom are not aware, whether they are oncologists or PCPs, what late effects we need to watch for--or that there are late effects. And while they are rushed for time now, we haven't seen anything yet, as the number of survivors grows and the number of oncologists drops.

That may be a bit overstated, but it has been my experience that many oncologists don't know about late onset effects and there are a few studies that prove that out. Most did not know about cardiac toxicity when asked and, when we go in to see them, they ask how we are. We say we are tired and they never connect it to treatment but rather to getting older.

Someone has to figure out we need more than a "Howdy, you look great see me next year." I think it's even selfish reasons some of them want to keep following all of us. I had one oncologist tell me that he didn't want to give up any of his patients because with all the patients that die, if he didn't see the ones who lived, he didn't think he could go on. Well, that's great. We make them feel better because we lived. Again, who is going to look at late effects like cardiac toxicity and who is going to help with fatigue and pain for neuropathy?

We also can't expect insurance companies to keep up with all these follow-up appointments. I remember one friend who was going to his surgeon, his oncologist and his PCP after treatment had ended. He dropped the surgeon, but then told the oncologist and PCP to get their heads together and figure out who was going to follow him because the insurance company was not going to pay for both. They never did and he continued to get requests for follow up by both.

This brings up all those other things we need to see our PCP for--you know... those things we need to do as we age, such as colonoscopies and heart follow-up. And I am not talking about follow-up when we are still at risk. Some cancer patients need the specialization that their oncologists bring to the table for quite a while. When they can be cut loose is up to the doc.

The article once again brings focus to survivorship care plans that give us a sense of what we need to watch for in the future.

Do you have one? Tell me what you think about being followed and who you see doing this as you move out from treatment.

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CATEGORIES [ DIAGNOSIS, NEWS, GENERAL ]

Redefining the word "cancer"

BY DEBU TRIPATHY | AUGUST 2, 2013

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Can a simple act of a few individuals change how we think about cancer?

Well, not a few, anymore, but a growing choir of voices are now redefining the term "cancer." We have known for a long time that there is a continuum from benign to cancerous growth. We even have names for some of these, such as borderline malignancy of the ovary. In the case of ductal carcinoma in situ of the breast (DCIS), the survival of patients is equal to the general population, but it is often treated with surgery, radiation and tamoxifen.

The Institute of Medicine has called for not just a redefinition of names, but a realignment of the cancer culture of "detect and eradicate." A recent article (Overdiagnosis and Overtreatment in Cancer: An Opportunity for Improvement) in the Journal of the American Medical Association highlights this problem in cancer screening, where the knee-jerk reaction for any cancer is to treat low- and high-risk cancer with many of the same treatment, therefore exposing everyone to side effects and complications while many derive no benefit--because their chance of dying or having their life affect by their "cancer" was minimal.

Solutions proposed in this article include getting rid of the word "cancer" and using terms like "indolent lesions of epithelial origin"--this may alter behavior both on side of the medical team and the patient. Of course, one cannot just declare a new system into existence.

The medical system must provide safeguards that truly dangerous cancers will be diagnosed and treated appropriately. Even some cases of DCIS can recur as invasive cancer, which can then potentially spread and lead to death. This means more research on prognostic tests – a huge ongoing needed in oncology that involves molecular/biological assays and large follow-up studies to validate these tests. We have a long way to go on redefining cancer, but perhaps starting with labeling changes is at least a symbolic start – but hopefully will be followed by both a scientific and cultural shift.

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Past generations influence today

BY KATHY LATOUR | JULY 31, 2013

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Two really interesting studies crossed my desk this week. The first looked at new insights of behavioral epigenetics, the study of changes in the DNA and how they impact physiological issues in our lives.

This study takes the case of nurture vs. nature to a whole new level by examining not only how our early environment may impact us as we grow up, but also how experiences of our grandparents may influence us not only physically but also in ways more connected to who we are.

The two scientists who have been studying this area both come from McGill University in Montreal. Moshe Szyf, a molecular biologist and geneticist, and Michael Meaney, a neurobiologist, began to explore changes to the DNA back in the early '90s. Already understood, especially for those of us with cancer, is that people can be born with a DNA mutation that results in cancer -- or they can acquire the mutation from some kind of exposure during their lifetime.

These two guys took that idea a step farther and asked whether, in the same way that we are born with genetic mutations from generations past that can result in physical issues, what if the result of events in the lives of our ancestors, such as traumatic experiences, could also be passed on in the family DNA.

What if in addition to physical issues we could acquire psychological and behavioral tendencies as well?

For example, when I learned a decade ago that they had identified a gene for alcoholism, I wasn't surprised. I had only to look at my father's family to see the thread of alcoholism that warned me away from using alcohol to cope. But what if there was a tendency toward depression that drove that alcohol issue that I never saw? Could that tendency be passed on too?

I like to think it was my mother's resiliency that balanced that out in my life and kept me from searching for self medication.

What these two researchers are looking at is the impact of life experiences and whether "how" we respond to issues and how we "cope" with life could also be something that is inherited based on events that may have happened before we were born. That sounds like what my dad used to call "character."

My father's mother, who raised five children in the shadow of my alcoholic grandfather, was the kind of woman who told the kids not to play in the front yard on Friday, knowing their father would probably come down the hill in the car in a payday alcoholic stupor. She was a frontier woman who moved her brood across the country for a better life and remained a loving and giving woman to the end. Did her loving personality, which my mother also had, give me an ability to bounce back time and time again. And was it my mother's mother, who ran the Philadelphia draft board way before women did that kind of thing, give me some of my drive to succeed? It all makes sense when we look at what we already know from other sociological studies about the impact early life has on children, specifically where they grow up and the kind of nurturing they receive, will have a direct impact on their success – or inability to succeed. When we hear stories of those who have overcome their beginnings, they attribute it to a person who believed in them. This research would say it may have been the character of the person, whose DNA they received, as well as their nurturing. It's an interesting idea.

The second study looked at social stress and its impact on the development of breast cancer. Researchers looked at genes in fat cells in mammary glands of mice that had been given a genetically altered mouse model of triple-negative breast cancer. One part of the group was raised in isolation with no social support, an established model of chronic stress, and compared to those raised in small groups.

All the mice developed triple-negative breast tumors, but those that had been isolated developed much larger tumors. The reason, it seemed, was because those mice that were socially isolated at birth had fat cells that secreted substances that caused nearby precancerous epithelial cells to proliferate more rapidly, which accelerated the development of breast cancer.

The researchers were surprised to find no difference in circulating hormones between the two groups, but the fat cells in the mammary glands of the stressed mice had significant increases in the expression of three genes that are crucial to the use of glucose, the primary source of cellular energy. The increase in metabolic activity of the stressed group resulted in a cascade effect of the release of chemicals that resulted in the proliferation of epithelial cells in the mammary gland.

What would happen in human tissue is still to be explored, and I would like to see how immune function might ameliorate some of those insults.

These studies seem to say that where we come from, indeed the fabric of who we are and how we were treated as infants could impact us in ways not considered before. What do you think?

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CATEGORIES [ NEWS, GENERAL, BREAST CANCER ]

Whose genome is it anyway?

BY DEBU TRIPATHY | JULY 3, 2013

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It may confuse most of us how our DNA, a product of nature that defines our identity and personal traits, could have been patented in the first place. Some claim that patent protection for years of hard work is needed to continue our efforts to isolate and identify genes in order to help develop diagnostic tests and therapies for the good of the general public. [Nature: Myriad ruling causes confusion]

Myriad, the gene diagnostic company that has been in the cross hairs of the recent Supreme Court to invalidate key portions of their patent on the breast and ovarian susceptibility genes BRCA1 and 2, should be credited for their diligent work. They have helped thousands of patients know their cancer risk and act accordingly, and have allowed the medical community to better understand which mutations are actually harmful – something that requires access to large amounts of pooled information.

However, the prices commanded for testing no longer reflect the state of the art of gene sequencing that has dropped precipitously with newer "next generation" sequencing technology. [CURE: Can a Human Gene Be Patented?] Furthermore, the discovery of the BRCA genes were not made in isolation but rather grew out of earlier work to pinpoint the general location of these genes dating back nearly two decades earlier.

Nimble and efficient gene diagnostic companies are popping up like Internet start-up companies of the 1990s. Their day has now arrived as they find new freedom to operate.

The Supreme Court's decision is not fully sweeping and its effects will not be seen overnight [New York Times: Justices, 9-0, Bar Patenting Human Genes]. Larger companies like Myriad still retain significant intellectual property and will probably switch over to offering more complex gene panels tests and tissue assays that go beyond the effect of single gene mutation, but rather the biological impact on tissues. This too, will move the field forward. But will competition in the free market lower prices of testing at the cost of reciprocal stifling of investment and innovation? Only time will tell, but history seems to be on the side of healthy completion equaling continual improvements in both quality and value in most other areas.

We hope the same will pertain to the matter of our genes.

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Cost of care varies from place to place

BY KATHY LATOUR | MAY 10, 2013

I am beginning to feel like I used to when my dad would say, "Shop around" before I got my car fixed. I am being facetious, but the new reports on the varying costs for procedures coming from hospitals reminds me of the day I asked my plastic surgeon how much a procedure cost, and his reply was, "You have insurance don't you."

That's not the point, but let me back up.

For those of you who have been on a desert island, the government has for the first time released data on what hospitals are charging Medicare for specific medical procedures.

You can get the gist of this by reading the New York Times article, but if you Google it you can go directly to the list of hospital charges yourself. Prepare to be stunned.

While some of the differences are bound to be clerical and the distinction between what one hospital includes in a defined service compared to another, it's fairly clear we have some significant discrepancies here, and we are all being hurt by them. You can see where they biggest costs accumulate with an excellent map created by National Public Radio that has the South looking rather greedy.

Medicare is under the gun. My last blog had to do with cuts to cancer clinics that are sending cancer patients on Medicare to hospitals for treatment. These hospitals may be hundreds of miles from the patients' homes and require that they acclimate to all kinds of new procedures and people that require difficult, confusing and stressful transitions. For those clinics that try to hang on to their patients, the cuts will be made in support staff and other overhead.

What galls me the most about this whole cost structure issue remains the bottom line for the poor. These procedure costs are not just for Medicare, they are the costs for the procedure, and they are also billed to insurance companies who can negotiate a lower rate based on the fact that they are insurance companies and that is how they operate. So insurance companies speak for the insured and Medicare speaks for the elderly and in some instances Medicaid speaks for the destitute.

The people who get hit with the whole bill are the hard working lower middle class who don't have insurance and aren't poor enough to get Medicaid.

We already know that anyone who gets cancer, insured or not, will probably declare bankruptcy. Yes, your read right, with insurance. If your insurance pays 80 percent that still leaves 20 percent for those without really good insurance. Add up 20 percent of $300,000 for two years and you have massive debt, and that does not account for loss of income and all the personal expense that goes into a cancer diagnosis.

I really don't know where to go from here – except England. Oh, except I don't believe in socialized medicine either.

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Sequester and cancer

BY KATHY LATOUR | MAY 7, 2013

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For most of us the "sequester" has just been a weird word that meant small airports were going to have to shut down because of less federal money to keep them open.

But for those of us in the cancer community, the sequester is now emerging as something that will impact us in a number of ways -- some immediate and some long term.

Last week I heard a story on NPR about less money being granted for research by NCI and other funding agencies in Washington because of the sequester. They interviewed a young cancer researcher who spent most of her time trying to find funds to set up her lab. She had been unsuccessful, and by the end of the interview said she was considering looking into other areas for a career.

Folks this is the brain trust that will find the cure for us – and they can't get the money to do their work. Score one for Sequester – 0 for cancer.

Now it's cancer treatment for our Medicare patients who are being cut off due to the sequester. To follow the impact of the sequester and Obamacare in general, read the Washington Post blog by Sarah Kliff. One of her latest blogs, which you can see her discuss here in a video blog, pointed out that the small clinics around the country that take Medicare patients are having to turn them away because of the Medicare cuts required by the sequester.

Right now the oncologists who administer expensive chemotherapy drugs, and many are very expensive, are reimbursed by Medicare plus 6 percent for storage and all the costs associated with giving the drug. The cost of the drug isn't going down, so it's the associated costs that are being cut.

These are costs associated with running the clinic and hiring staff called nurses. The critical part of cancer care we have been fighting in the cancer community for more of not fewer. The answer found by the clinics is to turn the patients away and tell them to go to hospitals for treatment, which ultimately will be more expensive, and, by my way of thinking, less personal than their clinic setting.

Indeed, a study done by Millman found Medicare patients ended up with an average of $650 more in out-of-pocket costs when they were seen only in a hospital. And for rural cancer patients, traveling to a larger cancer center may mean significant travel they can neither afford nor endure.

One report even had Rush Limbaugh eating his words. When he announced that the so called cuts to Medicare were, in fact, inaccurate and that Medicare was protected, one of his own followers, a conservative oncologist called in and explained that, actually, Medicare cuts were causing Medicare patients to be sent to other locations or to be turned away.

What does all this mean. Medicare is supposedly one of our protected rights. We worked for it, but it's looking more and more like it will be gone by the time many of us get a chance to use it -- and if we can there won't be any doctors left who take it. And as for those who have the misfortune to be diagnosed with cancer while on Medicare, well, . . .

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Kiss your nurse day

BY KATHY LATOUR | APRIL 26, 2013

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Washington DC has become the City of Angels this week as more than 3,500 oncology nurses have gathered to attend the Oncology Nursing Society's 38th Annual Congress. CURE is present to confer our Extraordinary Healer award on one oncology nurse nominated by you, our readers.

This is the 7th year we have had the event and last night there was standing room only when some 750 nurses gathered in the ballroom of the Washington Convention Center to hear the three finalists read their essays before we awarded the top prize and an all expenses paid spa weekend in the Austin Hill Country.

Our mistress of ceremonies, actress Marlee Maitlin, was the youngest actress to win an Academy Aaward for Children of a Lesser God. It was mesmerizing to watch her sign her presentation while her interpreter, Jack Jason, spoke about her family's struggles with cancer and her feelings that, like deafness, cancer does not define a person.

This was the first year we didn't have all three essayists there to read their essay. In fact we had two who were seen on video.

Julie Hinson, RN, BSN, OCN, a nurse from the Gynecologic Oncology department at the Salem Cancer Institute at Salem Hospital in Salem, Oregon, was nominated by her patient Joyce Lowry. Lowry teaches in Okinawa, Japan, and couldn't travel to be with us.

Another essayist, Anne Ott of Metairie, Louisiana, stayed with her husband in the transplant unit of M.D. Anderson Cancer Center in Houston. She also delivered her essay about nurse Angela Krach on video and was represented by her parents John and Margaret Falgoust at the event.

The third finalist was Steven Cuzzilla, RN, ADN, from the Myelosuppression Bone Marrow Transplant Unit at Vanderbilt University Medical Center in Nashville, Tennessee. He was nominated by Cassie Jones of Ingleside, Texas.

Each of these nurses went above and beyond in their nursing careers for their patients -- from the mounds of forms needed by Lowry to travel back and forth when she learned she had had a recurrence of her cancer to Cuzzilla, who changed his career to oncology nursing after losing his wife to melanoma so touched was he by the loving care they received while she battled her cancer.

Angela Krach, RN, BSN was instrumental in helping Ann and her fiancé James get married in the chapel at M.D. Anderson. The couple was putting the finishing touches on their wedding for last summer when James was diagnosed and they picked up their lives and moved them to Houston from Metarie.

The event was made possible by sponsorship from Amgen Oncology and Millennium: The Takeda Oncology Company.

When Angela Krach was announced the winner, it was time to celebrate oncology nursing and the strength of these amazing women and men who have come this week to learn how to be there for us in our hour of need.

So if you haven't thanked your oncology nurse today, you might want to give him or her a call.

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Understanding the Affordable Care Act

BY KATHY LATOUR | APRIL 17, 2013

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We are all looking forward to the Affordable Care Act. At the same time, we are hoping that someone will be around to tell us how it relates to us. Let's face it. The administration didn't do a very good job of selling it or explaining it. Each of us is figuring out how it will apply to us as small issues surface.

We know that our kids can stay insured until 26, and we know as cancer survivors that our history can't be used against us.

Today there was a good piece in the Kaiser Health News feed that is available through email sign up. There are a number of these health care feeds available, and to be a knowledgeable consumer, I recommend you find them and sign up. Today they focused on screening tests for colon and rectal cancers.

Most health plans cover preventive health services if it's one of those recommended by the U.S. Preventive Services Task Force, and since colorectal cancer is the second leading cause of cancer death in the United States, it is one of those covered. Finding colon cancer early is the key to survival and that means removing polyps discovered during a colonoscopy before they turn into cancer.

The colonoscopy is one of those tests that should not cost the patient anything – unless, of course, polyps are found and removed, and that's when it gets complicated.

Because if polyps are removed to see if they are cancerous, the test can then be judged to be therapeutic or diagnostic rather than screening, and the patient can be billed for the cost – around $2,000 or more. Right now, half the people who get screening colonoscopies have polops removed.

And what about patients who have a positive fecal occult blood test before their colonoscopy? Is that colonoscopy part of the screening process or diagnostic? And what if they have a family history?

In February, according to Kaiser, the government clarified that high-risk patients who qualify for more frequent screening should not have to cost share.

Take the time to educate yourself on the specifics so you will know what you do and do not have to pay for.

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