Chemotalk Newsletter

Chemotalk Newsletter, Vol. 52: August 1, 2012

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Welcome to August... Oh, wait...We've had August all summer.

Here goes:

After the Supreme Court ruling on the Affordable Care Act, the American Society of Clinical Oncologists (ASCO) released the following statement:


The American Society of Clinical Oncology released the following statement by ASCO President Sandra M. Swain, MD, medical director of the Washington Cancer Institute at MedStar Washington Hospital Center:

Although the Supreme Court's recent decision largely upheld the Affordable Care Act (ACA), the national policy debate will continue over how to shape our health care system and provide Americans with access to health insurance in the future. There undoubtedly will be much analysis over the coming weeks about this decision, including its impact on Medicaid and other programs implementing ACA provisions.

As a leading professional organization representing physicians who care for people with cancer, the American Society of Clinical Oncology (ASCO) wishes to highlight some of the provisions that are critically important to the treatment and screening of cancer, and will help eliminate disparities in patients with cancer. As the ongoing policy debate unfolds, ASCO will continue to work with policy makers to protect and retain these core patient safeguards that are critical to individuals who have cancer or who are at risk for cancer.

These provisions, most of which have enjoyed significant bipartisan support, include:

* Protections for patient access to preventive screening for cancer. The ACA includes safeguards to provide coverage of preventive screenings for cancer (and other diseases) and to provide such coverage without charging copayments or coinsurance to individuals. The ACA safeguards apply to private health care insurance, Medicare and Medicaid. Promoting access to preventive screenings is an obvious and important step that will save lives and improve the quality of care through earlier diagnosis and better outcomes. * Protections to help vulnerable individuals with cancer secure and retain access to health care insurance. The ACA includes straightforward provisions that are critically important to provide cancer patients and cancer survivors with meaningful access to health care coverage. First, the ACA requires private insurers to allow individuals to remain covered under their parents' health insurance plan until at least age 26. Second, the ACA eliminates lifetime caps on insurance coverage so that cancer patients who need repeated courses of treatment do not lose coverage merely because they have significant health care needs. * Safeguards for individuals with cancer and other pre-existing conditions. The ACA ensures that individuals are not excluded from enrolling in a health insurance plan on the basis of pre-existing conditions, such as a history of cancer. Although we recognize the political debate over health reform has identified different approaches for addressing the issue of pre-existing conditions, there appears to be widespread agreement that meaningful steps must be taken to protect individuals with pre-existing conditions who seek health insurance coverage. * Protections for patient access to clinical trials. The ACA includes a safeguard to ensure that individuals with cancer and other life-threatening conditions are covered under private insurance if they and their physicians determine enrollment in a clinical trial (also known as a "clinical study") is their best option. In many instances, clinical trials provide individuals with cancer the best chance for a successful outcome. The ACA safeguard for patients who need access to clinical trials is similar to a protection that already exists for Medicare beneficiaries. ASCO is devoted to working with policy makers in addressing the complex issues that confront our health care system. In the context of the broader policy debate concerning our national health care system, we urge Congress and other policy makers to recognize and protect the safeguards that are especially important to Americans who are facing life-threatening forms of cancer.

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By Amy Norton, Reuters

Botox injections may provide some relief from arm tremors caused by MULTIPLE SCLEROSIS, according to a study. Botulinum toxin type A is sold under different brands, but it's best known by the Allergan brand-name Botox.

Botox gained fame for smoothing aging skin -- by blocking nerve signals and relaxing muscles under the skin -- but the product has a number of medical uses. In the U.S., Botox is approved to treat conditions like chronic migraine, excessive sweating and certain symptoms of MS: overactive bladder and muscles spasms in the arms.

The new study, published in the journal Neurology, tested the effects of Botox injections on MS-related arm tremors, which affect up to two-thirds of people with MS. Researchers found that when they gave injections to 23 patients, the treatment typically eased their tremors and improved their writing ability.

Right now, there's no good way to treat MS arm tremors, said Nicholas G. LaRocca, vice-president of healthcare delivery and policy research at the National MS Society. Physical therapy and exercise have been studied, but are usually not very effective, said LaRocca, who was not involved in the new study. Surgery is sometimes used in severe cases, but it's risky and may not have lasting benefits.

"Exploring new treatments is important, and it's heartening to see there's some promise here," LaRocca said of the current findings. But there's still a lot to be learned, he cautioned in an interview. "This study is fairly preliminary, and it had a small number of patients," LaRocca said. Larger studies, of more-diverse groups of MS patients, are needed, he said.

The study's lead researcher agreed on the need for more work. "There are several questions that need to be answered by doing larger and longer-term studies," Dr. Anneke van der Walt, a neurologist at Royal Melbourne Hospital in Australia, said.

One is how long the benefits of repeat Botox injections might last: this study tested the effects of just one Botox treatment over three months. In real life, the injections would have to be repeated every few months, or possibly every six months for some people, according to van der Walt.

Another question is whether the side effects change over time. Muscle weakness was the most common side effect in this study, van der Walt said. It affected 42 percent of the study patients, though it went away within two weeks. Muscle weakness is a potential concern in MS patients, LaRocca noted, since that problem often comes with the disease itself.

The study included 23 MS patients with mild to moderate arm tremors. Each patient received a round of Botox injections and a round of placebo injections (containing saline), three months apart. Half of the patients got the Botox first, the other half the placebo.

On average, the patients' tremor "scores" had gone from a 5 to a 3 six weeks after Botox treatment -- which essentially means moving from "moderate" to "mild," LaRocca said. Their ability to write and draw a straight line had also improved by week six, and the benefits were still there at week 12. In contrast, there were no improvements after the placebo injections.

Larger studies, van der Walt said, should look at whether Botox is more effective for some tremors than others. Tremors limited to the hand and forearm, for instance, might respond better than tremors that also affect the shoulder. If Botox is eventually approved for this MS symptom, LaRocca said it will be important for doctors to get training in how to give the injections -- since the drug has to go into carefully chosen locations in the muscle.

"So practitioners will have to be up to speed," LaRocca said. There will also be the matter of cost. That will vary from patient to patient, depending on how many injections are needed per treatment.

According to van der Walt, the cost could range from $500 to $1,000 Australian dollars, which are roughly equal to U.S. dollars. In the U.S., Botox treatments can cost $455-$575 per injection site.

Botox maker Allergan supplied the product for the study, and two of the researchers on the work have financial ties to the company. The study itself was funded by the Box Hill MS Research Fund and the Royal Melbourne Hospital.

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The following is a story from a series that ran in The New York Times, some of which I think is based on what came out of the ASCO Convention in June. There will be another story from this series next month, by Gina Kolata, who in my opinion, is the best health writer in the media:


By Gina Kolata

ST. LOUIS - Genetics researchers at Washington University, one of the world's leading centers for work on the human genome, were devastated. Dr Lukas Wartman, a young, talented and beloved colleague, had the very cancer he had devoted his career to studying. He was deteriorating fast. No known treatment could save him. And no one, to their knowledge, had ever investigated the complete genetic makeup of a cancer like his.

So one day last July, Dr. Timothy Ley, associate director of the university's genome institute, summoned his team. Why not throw everything we have at seeing if we can find a rogue gene spurring Dr. Wartman's cancer, ADULT ACUTE LYMPHOBLASTIC LEUKEMIA, he asked? "It's now or never," he recalled telling them. We will only get one shot."

Dr. Ley's team tried a type of analysis that they had never done before. They fully sequenced the gene of both his cancer cells and healthy cells for comparison, and at the same time analyzed his RNA a close chemical cousin to DNA, for clues to what his genes were doing.

The researchers on the project put other work aside for weeks, running one of the university's 26 sequencing machines and super-computer around the clock. And they found a culprit -- a normal gene that was in overdrive churning out huge amounts of a protein that appeared to be spurring the cancer's growth.

Even better, there was a promising new drug that might shut down the malfunctioning gene -- a drug that had been tested and approved only for KIDNEY CANCER. Dr. Wartman became the first person ever to take it for leukemia

And now, against all odds, his cancer is in remission and has been since last fall.

While no one can say that Dr. Wartman is cured, after facing certain death last fall, he is alive and going well. Dr. Wartman is a pioneer in a new approach to stopping cancer. What is important, medical researchers say, is the genes that drive a cancer, not the tissue or organ -- liver or brain bone marrow, blood or colon -- where the cancer originates.

One woman's BREAST CANCER may have different genetic drivers from another woman's and, in fact, may have more in common with PROSTATE CANCER in a man or another patient's LUNG CANCER.

Under this new approach, researchers expect that treatment will be tailored to an individual tumor's mutations, with drugs, eventually, that hit several key aberrant genes at once. The cocktails of medicines would be analogous to H.I.V. Treatment, which uses several different drugs at once to strike the virus in a number of critical areas.

Researchers differ about how soon the method, known as whole genome sequencing, will be generally available and paid for by insurance -- estimates range from a few years to a decade or so. But they believe that it has enormous promise, though it has not yet cured anyone.

With a steep drop in the costs of sequencing and an explosion of research on genes, medical experts expect that genetic analyses of cancers will become routine. Just as pathologists do blood cultures to decide which antibiotics will stop a patient's bacterial infection, so will genome seque4ncing determine which drugs might stop a cancer.

"Until you know what is driving a patient's cancer, you really don't have any chance of getting it right," Dr. Ley said. "For the past 40 years, we have been sending generals into battle without a map of the battlefield. What we are doing now is building the map."

Large drug companies and small biotechs are jumping in, starting to test drugs that attack a gene rather than a tumor type.

Leading cancer researchers are starting companies to find genes that might be causing an individual's cancer to grow, to analyze genetic data and to find and test new drugs directed against these genetic targets. Leading venture capital firms are involved.

For now, whole genome sequencing is in its infancy and dauntingly complex. The gene sequences are only the start -- they come in millions of small pieces, like a huge jigsaw puzzle. The arduous job is to figure out which mutations are important, a task that requires skill, experience and instincts.

So far, most who have chosen this path are wealthy and well connected. When Steve Jobs had exhausted other options to combat PANCREATIC CANCER, he consulted doctors who coordinated his genetic sequencing and analysis. It cost him $100000, according to his biographer. The writer Christopher Hitchens* went to the head of the National Institutes of Health, Dr. Francis Collins, who advised him on where to get a genetic analysis of his ESOPHAGEAL CANCER.

Harvard Medical School expects eventually to offer whole genome sequencing to help cancer patients identify treatments, said Heidi L. Rehm, who heads the molecular medicine laboratory at Harvard's Partners Healthcare Center for Personalized Genetic Medicine. But later this year, Partners will take a more modest step, offering whole genome sequencing to patients with a suspected hereditary disorder in hopes of identifying mutations that might be causing the disease.

Whole genome sequencing of the type that Dr. Wartman had, Dr. Rehm added, "is a whole other level of complexity."

Dr. Wartman was included by his colleagues in a research study, and his genetic analysis was paid for by the university and research grants. Such opportunities are not available to most patients, but Dr. Ley noted that they group had done such an analysis for another patient the year before and that no patients were being neglected because of the urgent work to figure out Dr. Wartman's cancer.

"The precedent for moving quickly on a sample to make a key decision was already established," Dr. Ley said.

Ethicists ask whether those with money and connections should have options far out of reach for most patients before such treatments become a normal part of medicine. And will people of ore limited means be tempted to bankrupt their families in pursuit of a cure at the far edges?

"If we say we need research because this is a new idea, then why is it that rich people can even access it?" asked Wylie Burke, professor and chairwoman of the department of bioethics at the University of Washington. The saving grace, she said, is that the method will become available to all if it works.

A Life In Medicine

It was pure happenstance that landed Dr. Wartman in a university at the forefront of cancer research. He grew up in small-town Indiana, aspiring to be a veterinarian like his grandfather. But in college, he worked summers in hospitals and became fascinated by cancer. He enrolled in medical school at Washington University in St. Louis, where he was drawn to research on genetic changes that occur in cancers of the blood. Dr. Wartman knew then what he wanted to do -- become a physician researcher.

Those plans fell apart in the winter of 2002, his last year of medical school, when he went to California to be interviewed for a residency program at Stanford. On the morning of his visit, he was nearly paralyzed by an overwhelming fatigue.

"I could not get out of bed for an interview that was the most important of my life," Dr. Wartman recalled. Somehow, he forced himself to drive to Palo Alto in a drenching rain. He rallied enough to get through the day.

When he returned to St. Louis, he gave up running, too exhausted for the sport he loved. He started having night sweats.

"I thought it might be mono," he said. "And I thought I would ride it out."

But then the long bones in his legs began to hurt. He was having fevers.

He was so young then -- only 25 -- and had always been so healthy that his only doctor was a pediatrician. So he went to an urgent care center in February 2003. The doctor there thought his symptoms might come fro depression, but noticed that his red ad white blood cell counts were low. And Lukas Wartman who had been fascinated by the biology of leukemia, began to suspect he had it

"I was definitely scared," he said. "It was so unreal."

The next day, Mr. Wartman, who was about to graduate from Washington University's medical school, went back there or more tests. A doctor slid a log needle into his hip bone and drew out marrow for analysis.

"We looked at the slide together," Dr. Wartman said, recalling that terrible time. "It was packed with leukemia cells. I was in a state of shock."

Dr. Wartman remained at the university or his residency and treatment: nine months of intensive CHEMOTHERAPY, followed by 15 months of maintenance chemotherapy. Five years passed when the cancer seemed to be gone But then it came back. Next came the most risky remedy -- intensive chemotherapy to put the cancer into remission followed by a bone-marrow transplant from his younger brother.

Seven months after the transplant, feeling much stronger, he went to a major cancer meeting and sat in on a session on his type of leukemia. The speaker, a renowned researcher, reported that only 4 or 5 percent of those who relapsed survived.

"My stomach turned," Dr. Wartman said. "I will never forget the shock of hearing that number."

But his personal gauge of recovery -- how far he could run -- was encouraging.

By last spring, three years after his transplant, Dr. Wartman was running se to seen miles every other day and feeling good. "I thought maybe I would run a half marathon in the fall."

Then the cancer came back. He remembered that number, 4 or 5 percent, for patients with one relapse. He had relapsed a second tine

This time, he said, "There is no number."

Hi doctors put him on a clinical trial to try to beat the cancer with chemotherapy and hormones. It did not work.

They infused him with his brother's healthy marrow cells, to no avail.

A Club in RNA

Dr. Wartman's doctor's realized then that their last best hope for saving him was to use all the genetic know-how and technology at their disposal.

After their month of frantic work to beat cancer's relentless clock, the group, led by Richard Wilson and Elaine Mardis, directors of the university's genome institute, had the data. It was Aug. 31.

The cancer's DNA had, as expected, many mutations, but there was nothing to be done about them. There were no drugs to attack them.

But the other analysis, of the cancer's RNA, was different. There was something there, something unexpected.

The RNA sequencing showed that a normal gene, FLT3, was wildly active in the leukemia cells. Its normal role is to make cells grow and proliferate. An overactive FLT3 gene might be making Dr Wartman's cancer cells multiply so quickly.

Even better, there was a drug, sunitini, or Sutent approved for treating advanced kidney cancer, that inhibits FLT3.

But it costs $330 a day, and Dr. Wartman's insurance company would not pay for it. He appealed twice to his insurer and lost both times

He also pleaded with the drug's maker, Pfizer, to give him the drug under its compassionate use program, explaining that his entire salary was only enough to pay for 7-1/2 months of Sutent. But Pfizer turned him down too.

As September went by, Dr. Wartman was getting panicky. "Every day is a roller coaster," he said at the time, "and everything is up in the air."

Desperate to try the drug, he scraped up the money to buy a week's worth and began taking it on September 16. Within days, his blood counts were looking more normal.

But over dinner at a trendy St. Louis restaurant, he picked at his chicken and said he was afraid to hope.

"Obviously it's exciting," said. But Sutent could have unanticipated effects on my bone marrow." Maybe his rising red blood cell counts were just a side effect of the drug. Or maybe they were just a coincidence.

"It's hard to say if I feel any different," Dr. Wartman said

And the cost of the drug nagged at him If it worked, how long could he afford to keep taking it?

The next day, a nurse at the hospital pharmacy called with what seemed miraculous news: a month's supply of Sutent was waiting for Dr. Wartman. He did not know at the time, but the doctors in his division had pitched in to buy the drug.

Two weeks later, his bone marrow, which had been full of leukemia cells, was clean, a biopsy showed.

Still, he was nervous. The test involved taking out just a small amount of marrow. Cancer cells could be lurking unseen.

The next test was flow cytometry, which used antibodies to label cancer cells. Again, there were no cancer cells.

But even flow cytometry could be misleading, Dr. Wartman told himself.

Finally, a yet more sensitive test, called FISH, was done It labels cancer cells with fluorescent pieces of DNA to identify leukemia cells. Once again, there were none.

"I can't believe it," his awe-struck physician, Dr John DiPersio, told him.

Dr Wartman, alone in his apartment, waited for his partner, Damon Berardi, to come home from work. That evening, Mr. Berardi, a 31-year-old store manager, opened the door with no idea of Dr. Wartman's momentous news To his surprise, Dr. Wartman was home early, waiting in the kitchen with champagne and two flues he had given Mr. Berardi for Christmas. He told Mr. Berardi he should sit town.

"My leukemia is in remission", he said. The men embraced exultantly, and Dr. Wartman popped open the champagne.

"I felt an overwhelming sense of relief and a renewed vision of our future together," Mr. Berardi said. "There were no tears at that moment. We had both cried plenty This was a moment of hope."

Hunches and Decisions

Dr. Wartman and his doctors had fateful decisions to make, with nothing but hunches to guide them. Should he keep taking Sutent or have another bone-marrow transplant now that he was in remission again?

In the end, Dr. DiPersio decided Dr. Wartman should have the transplant because without it the cancer might mutate and escape the Sutent.

Meanwhile, Pfizer had decided to give him the drug. Dr. Wartman has no idea why. Perhaps the company was swayed by an impassioned plea fro his nurse practitioner, Stephanie Bauer.

Dr. Wartman's cancer is still gone, for now, but he has struggled with a common complication of bone-marrow transplants, in which the white blood cells of the transplanted marrow attach his cells as though they were foreign. He has had rashes and felt ill. But these complications are gradually lessening, and he is back at work in Dr. Ley's lab.

His colleagues want to look for the same mutation in the cancer cells of other patients with his cancer. And they would like to start a clinical trial testing Sutent to discover whether the drug can help others with leukemia or whether the solution they found was unique to Lukas Wartman.

Dr. Wartman himself is left with nagging uncertainties. He knows how lucky he is, but what does the future hold? Can he plan a life? Is he cured?

"It's a hard feeling to describe," he said. "I am in unchartered waters."

(* Editor's note: I miss The Hitch, and anyone who ever read his work, probably does, too.)

* * *

Also from The New York Times, this first-person piece relates to the previous one.


By Steven Petrow

Watching Robin Roberts tear up in front of millions of viewers on "Good Morning America" last month (June), I cried, too.

With equal measures of courage and fear, Ms. Roberts, an anchor of the show and a BREAST CANCER survivor, explained that the life-saving treatment she received five years ago was responsible for a new diagnosis, this time MYELODYSPLASTIC SYNDROME (MDS), a rare blood and bone marrow disease once called preleukemia.

MDS is a potentially fatal condition that can be caused by radiation and CHEMOTHERAPY, both of which Ms. Roberts had in her initial cancer treatment. In medical-speak, it's a "secondary cancer." As a cancer and chemo survivor, I know that I, too, have a higher likelihood of developing these cancers.

When I was given a diagnosis of testicular cancer in 1984, secondary cancers were primarily a threat for PEDIATRIC CANCER survivors. Their young bodies are most vulnerable to radiation and chemo, and they have more years in which to develop new malignancies. Also at risk were those beating some of the more "curable" adult cancers because of the highly toxic treatment regimens.

Secondary cancers now make up the sixth-most-common group of malignancies, in part because ore survivors are living longer. Physicians are better at limiting toxicity from radiation and chemotherapy, so fewer people die from the effects of treatments. The bad news: More people are surviving their original cancers only to be haunted by the prospect of new diagnoses later.

Cancer survivors generally fall into one of two groups when it comes to our psychological health. First are those plagued by anxiety, depression, even post-traumatic stress disorder, which may afflict up to 58 percent of us according to a recent American Cancer Society study. Then there are those who experience heightened self-esteem, a greater appreciation of life and its meaning and sometimes a new or deeper spirituality.

Which bucket do you fall into? More important can you choose where you land?

One of my heroes, Senator Frank Church Democrat of Idaho and an ardent environmentalist and survivor of testicular cancer, died of a second cancer two weeks before I joined the cancer club. After his first diagnosis, Mr. Church wrote that survival had inspired him to live life to its fullest: "Life itself is such a chancy proposition that the only way to live is by taking great chances." For Mr. Church, his original diagnosis became a metaphoric kick in the pants, resulting in a lifetime of good works.

I had read his advice a few years before my own diagnosis ... And ignored it. But after I started chemo, I revisited those words, and in the years that followed I took some decided risks of my own. Some of them worked out beyond my imagining. I left a Ph.D. program to compile an oral history of the AIDS epidemic, and found a life as a writer. I lost other gambles, notably a relationship that crashed and burned, as so many do.

` Along the way, I became aware that you couldn't really take big risks without well, taking big risks Though cancer liberated me from what had seemed like a small life, for me, and for many survivors, freedom does not last forever.

Back when I was treated, there were no data showing TESTICULAR CANCER survivors living more than 20 years. If you survived, you got a reprieve, but a limited one.

At 26, that seemed like a lifetime. As I approached the 15-year survival mark, not to much.

As time moved on the fear of a secondary cancer engulfed me -- I began to hear what I feared was the tick-tock of the death clock. And then entering my 40s, the alarm bell rang.

My doctors discovered a new tumor on a grainy ultrasound. Two months and three opinions later, the mass turned out to be a phantom. But the damage was done I took a desk job with a matching 401(k) and a Cadillac health insurance plan. I paid off my student loans and credit card debt. I said goodbye to great chances.

My life shrank again as I toiled in an office the sun never even winked at. And I was single again. As my 20th year of survival approached, I started to have panic attacks, my heart seemingly exploding out of my chest. Eventually a therapist helped me understand that while I was morphing, so, too, was medicine. Testicular cancer survivors now live beyond 20 years. I was part of that data set.

That was eight years ago.

For the nearly million cancer survivors, including Ms Roberts and me, life is a roller coaster of a ride knowing that the treatments administered to us may one day exact a heavy price. Neither the reprieve nor the freedom it brings is permanent -- but with more awareness of these mental health issues and new therapeutic interventions, doctors and patients are much better equipped than ever before to fight these demons.

After I found the bottom of the bucket of fear, I looked again to Mr. Church. Again, I am trying to seek out his notion of great chances but it is more challenging in my 50s, with a mortgage and aging parents.

I now understand that the senator's credo was not meant solely for those with life-threatening conditions. Are you happy in your relationship? Does your work satisfy you? If not, take your own great chance. You don't need to have had cancer to benefit from this life lesson.


** I realize that the person who writes the headlines at a newspaper is almost never the same person who writes the story. However, I think it bears saying, yet again, that There Is No Cure For Cancer. This is a fact, and to write or say or think otherwise, is dangerously deceptive.

* * *

Finally, an interesting study done on mice, involving a toxic plant. The yew tree is toxic, too, and we know where that led ...


By John Carroll

A toxic plant native to the Mediterranean gave investigators the pieces they needed to craft a "molecular grenade" capable of attacking tumors in mice. And they say it holds out the prospect of a new therapy that might one day address a broad range of CANCERS.

Led by investigators at Johns Hopkins Kimmel Cancer Center, the team developed the drug G202 out of Thapsia garganica, a plant that contains thapsigargin, long known to be lethal to the animals that occasionally consume it. The team modified the main ingredient chemically, allowing it to travel harmlessly through the bloodstream until it encounters tumors. At that point a protein released by the tumors--prostate-specific membrane antigen--pulls the pin on the grenade and delivers the toxic element right on target.

In the animal study, the researchers say the experimental cancer drug appeared to devastate not only tumor cells but also surrounding cancer cells and the blood vessels that feed them. And the nature of the drug makes it unlikely that the body can develop a tolerance for the toxic element.

"Our goal was to try to re-engineer this very toxic natural plant product into a drug we might use to treat human cancer," said Dr. Samuel Denmeade, the lead author. "We achieved this by creating a format that requires modification by cells to release the active drug."

In an unusual comparison study, the investigators treated mice with G202 as well as the chemo drug docetaxel. The preclinical therapy was able to reduce 8 out of 9 tumors by more than half after three days of therapy, compared with only 1 of 9 tumors in the docetaxel group.

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See you in September (when the East cools off, and we heat up)

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And if you have any thoughts of how this newsletter could be improved, please email me directly, at

Elaine Jesmer

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