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Chemotalk Newsletter, Vol. 106 February 1, 2017

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News for February:


By Laurie McGinley

When Brittany Galan was diagnosed with LEUKEMIA at 6 weeks old, doctors warned her parents she had little chance of surviving — she was so young and so sick. But after being treated with CHEMOTHERAPY, “I lived and lived," said the exuberant 24-year-old. “Everyone calls me the miracle baby."

The lifesaving chemo, however, took a heavy toll. It “messed me up neurologically,” Galan said. In grade school, she had trouble with reading and math and eventually went on ADHD medication. In college, the once-avid runner developed a heart problem. Recently, Galan, who juggles two part-time jobs working with children with emotional problems, began taking medication for anxiety and depression.

“Sometimes I think, ‘What’s next?'" she said. “I take a lot of pills. I feel like an old lady."

One of medicine’s greatest successes is the sharp rise in survival rates for children with cancer. But the flip side of that success is that many of those children are turning up years or even decades later with serious and sometimes life-threatening complications, including second cancers, heart disorders, cognitive problems and infertility.

“These treatments seem to accelerate the aging process,” said Greg Aune, a researcher and pediatric oncologist who works at a clinic for childhood cancer survivors at University Hospital in San Antonio, where Galan gets her care.

Aune, like a growing number of scientists and clinicians, is focusing intently on “late effects” of cancer treatments. Many of these researchers work in clinics designed specifically to monitor the health of childhood cancer survivors and alert them to potential risks. With the ranks of survivors swelling, there is an urgent need to understand the treatments' effects on the entire body, not just the tumor, and to come up with less-toxic therapies.

Aune has a personal stake in the research. As a teenager growing up on a wheat farm in eastern Washington state, he was diagnosed with HODGKIN'S LYMPHOMA and treated with intensive radiation and chemo. Two decades later, he ended up in emergency surgery to replace a badly scarred heart valve and three blocked arteries, a direct result of the treatment. At 41, he had a mild stroke while at his daughter’s gymnastics class and was diagnosed with diabetes. His childhood cancer treatment saved his life, and at 43, he appears robust, but he worries that his battered heart might fail.

“If I had been born a lot earlier, I wouldn’t have to worry about late effects because I wouldn’t be here,” Aune said.

In the 1960s, fewer than half of children with cancer were alive five years after their diagnoses; now, more than 80 percent are. There are more than 420,000 childhood cancer survivors in the United States today, and the number is expected to increase to 500,000 by 2020.

Yet the improved survival rates “came at a high cost,” said Gregory Armstrong, an oncologist at St. Jude’s Children’s Research Hospital in Memphis. He runs the National Cancer Institute-sponsored Childhood Cancer Survival Study, which tracks more than 30,000 childhood cancer survivors. In the 1980s, survivors began worrying about new health problems, but the severity and connection to their treatments were not appreciated until years later. “This is a population that appears much older than its chronological age,” Armstrong said.

8-year-old Ava Christiansen has been battling cancer for half her life. Now a new specialized cancer treatment may be able to keep her in remission. As cancer doctors realized that patients might live not just for another five years but for another five decades or more, their just-keep-them-alive impulse evolved. Doctors carefully cut back on chemo and radiation for patients who seemed unlikely to relapse.

The less-punishing therapies bolstered long-term survival. Almost 11 percent of five-year survivors diagnosed with cancer in the 1970s were dead within 15 years of their diagnoses; that dropped to less than 6 percent for those treated in the 1990s, according to Armstrong’s research.

Still, patients continue to suffer from severe late effects. By age 50, 1 in 3 women who received chest radiation for Hodgkin’s lymphoma will develop breast cancer, compared with less than 1 in 20 in the general population, Armstrong said.

People who develop cancer as adults also can suffer from late effects. But children are more vulnerable to toxic therapies because their bodies are still developing, researchers say. And they have many more years of life in which complications can occur.

Immunotherapy, a new approach that uses the body’s immune system to fight cancer, could cause less collateral damage — but its use in children is a long way off. “For every patient I saw last week, I used the same medications we have had for the last 30 years,” Aune said. “And they are very toxic."

Brittany Galan underwent chemotherapy for two years, starting when she was an infant. She has since had learning disabilities and heart problems.

When Aune is not caring for patients at University Hospital, he spends much of his time in nearby Greehey Children’s Cancer Research Institute, where he oversees experiments in mice on the effects of chemo, including drugs called anthracyclines that can be toxic to the heart. Much of the research on late effects involves the heart, which is especially vulnerable to aggressive childhood treatments.

On a recent day, his lab manager, Thomas Andrews, anesthetized an 8-week-old mouse before laying it on its back on a heated board. With a cotton swab smeared with Nair, he removed a bit of fur from the animal’s chest, then used a very small probe to take a scan, shown on a monitor, of the mouse’s left ventricle. The echocardiogram allowed Andrews to measure the animal’s heart-pumping efficiency.

The mouse was destined for a study looking at whether vigorous exercise can limit heart problems caused by doxorubicin, which is also known as Adriamycin and is an anthracycline. After the mice receive several doses of the drug, some are put on treadmills for exercise, and others are not. Early data suggest that the ones on the treadmills do better, Aune said.

Another mouse experiment involves a medication called dexrazoxane, which is used to prevent heart damage caused by certain chemo drugs in breast-cancer patients. Its use in children has been controversial and spotty because some older studies have suggested that the medication, which is given at the same time as chemo, increases the risk of second cancers. There have also been concerns that it could blunt the cancer-fighting effectiveness of chemo.

But those worries have been largely disproved in recent years, and now a clinical trial in humans may be paving the way for widespread use of the drug, also called Zinecard.

Eric Chow, an oncologist at Fred Hutchinson Cancer Research Center in Seattle, is leading an effort to see whether the drug prevents long-term cardiac deterioration. He and other researchers are scrutinizing the cardiac function of people who were in trials in the late 1990s and early 2000s and treated with either doxorubicin alone or the chemo drug plus Zinecard, the heart-protectant.

“We didn’t really know what happened to those patients and what happened in terms of heart disease,” Chow said. “Did the medication have any protective effects that could be detected 20 years later?"

A preliminary analysis released earlier this month showed that the Zinecard group appeared to have “more preserved” heart function many years later. One theory is that the drug interferes with a protein that makes heart tissue more vulnerable to certain chemo agents.

Saro Armenian, a pediatric oncologist at City of Hope in Duarte, Calif., is taking another approach to counter the heart-damaging effects of anthracycline drugs. He is exploring whether giving childhood cancer survivors a common blood pressure drug will prevent heart failure as they get older.

“The question is,” he said, “if you have been treated with chemo, can you take a drug to help the heart to heal?” He likened the approach to using low-dose baby aspirin to protect arteries among the general population.

Six-year-old Sammy Cuevas, decked out in black pants and a matching vest, watches videos on his mother’s phone as he waits for his checkup at the University Hospital survivors’ clinic. When he was 4 months old, he had surgery to remove a BRAIN TUMOR called a medulloblastoma, followed by a year of chemo. “There were times,” said his mother, Claudia Cuevas, “when I thought, ‘The cancer won’t kill him, but the chemo will.’ "

He already has chemo-related problems, including mild deafness, severe constipation and what his doctors call an overall “failure to thrive.” At 34 pounds and a little over 3 feet tall, the first-grader is in the third percentile for size for his age. As Sammy gets older, he will be monitored for late effects including LEUKEMIA and fertility problems.

Nevertheless, Sammy’s doctor, Shafqat Shah, is optimistic about Sammy. “Our hopes for him are pretty dang good,” she said. His mother also was upbeat. “He’s very good with numbers,” she told the doctor. “But he has a little trouble with pronunciations because of his hearing problem."

Patients are referred to the survivors’ clinic — officially called the South Texas Pediatric Cancer Survivorship Program — three to five years after they are finished with treatment, when the threat of relapse has receded. Depending on their anticancer regimen, they may get comprehensive blood tests, echocardiograms, lung function tests and hearing examinations. Red flags prompt immediate referrals to specialists.

On a recent day in a clinic conference room, a few teenagers talked about life as childhood cancer survivors. High school senior Katelyn Garcia, who developed leukemia at 14 months and struggled with learning disabilities and seizures in middle school, is now headed to college and wants to become a “child-life specialist” — someone who takes care of children undergoing cancer treatment. Her friend, Carmen Villarosa, who had a KIDNEY CANCER when she was younger, worries that her cancer treatment might make it difficult for her to have children when she is older.

Bryon Martinez, who was diagnosed with leukemia in the fifth grade and gets annual echocardiograms to check for heart problems, is an accomplished cross-country runner who hopes to go to Georgetown University and become a pediatric oncologist. When his mother, Ana Isabel Martinez, speaks in Spanish about his illness, she weeps quietly. “It was extremely difficult," she said.

Aune knows what the survivors are going through. When he was diagnosed with Hodgkin’s lymphoma, he said, “people told me it was a good cancer, because it was fairly curable. Everyone said I should just get through the treatment, and then life would go back to normal."

At the time, his mother wisely urged him to bank his semen, an experience the 16-year-old found almost unbearably embarrassing. “My doctors didn’t mention it,” he said, “My mother read about it in Reader’s Digest."

After he had surgery for the cancer, Aune had radiation to his chest and abdomen for nine weeks and received eight chemo drugs over nine months. He lost 70 pounds. It was years before he felt normal again.

Later, as a 35-year-old training to become a pediatric oncologist at the University of Texas Health Science Center, he became so exhausted that he could not walk more than 30 steps — a fatigue he attributed to a demanding job and four small children but was actually due to the radiation and, probably, the chemo. (By then, he and his wife had managed to have two sets of twins via artificial insemination.)

After having heart surgery, he switched his career focus to late effects, vowing to fill research gaps and work with survivors. Having already dealt with a raft of medical problems, he is philosophical about his future. “You never know what’s going to come your way,” he said, “so you better do what you want to do now."

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By Laurie McGinley Harley, a 4-year-old boxer who has LEUKEMIA, receives an infusion of his own T cells at the University of Pennsylvania’s Ryan Veterinary Hospital. The cells have been genetically modified to help combat his cancer.  Flyer, a 70-pound golden retriever, lies patiently on her left side on an examination table as technicians scurry around, placing little sandbags on her legs and neck to keep her still. She’s getting chest X-rays to answer a critical question: Has a deadly BONE CANCER spread to her lungs?

When the session is over, Martha MaloneyHuss, a veterinarian at the University of Pennsylvania’s Ryan Veterinary Hospital, glances at the images. “I don’t see anything hugely obvious,” she says, “but we’ll see what the radiologist says.” Oblivious to the good news, Flyer hops down the hall on three legs, eager to find her owner.

After the 8-year-old retriever began limping last year, she was diagnosed with osteosarcoma, a painful, aggressive cancer that often strikes Great Danes, Irish wolfhounds and other large breeds. At Penn Vet, she got the standard treatment: One of her left legs was amputated, and she underwent CHEMOTHERAPY.

Yet even as she adjusted to chasing squirrels, her prognosis was bleak. Most dogs die in about a year when the disease resurfaces in the lungs. The Penn vets recommended an experimental vaccine designed to prevent or delay the cancer’s return; Flyer’s owner was enthusiastic. The dog got three intravenous doses as part of a clinical trial and now returns to Penn periodically for X-rays.

“Every day I pray that she will stay cancer-free,” said her owner, Bob Street, who lives in Mullica Hill, N.J. “And that this treatment will work for other dogs and for people."

Flyer is part of a burgeoning field called “comparative oncology.” It focuses on finding new ways to treat cancer in pets, mostly dogs, in an effort to develop innovative treatments for people and animals.

The growing interest in dogs reflects researchers’ frustration with the standard approach to developing cancer treatments: testing them in lab animals, especially mice. Mice don’t normally get cancer — it must be induced — and the immune systems in many strains of lab mice have been altered. That makes them especially poor models for immunotherapy, a rapidly growing field of medicine that directs patients’ own immune systems to fight their cancer.

Dogs, on the other hand, get cancer naturally, just as people do, and have intact immune systems.

“Genetically, you are a lot more like your dog than that mouse running around a cage in the lab,” said Nicola Mason, a veterinarian and immunologist who oversees the vaccine and several other canine trials at Penn’s School of Veterinary Medicine. “Where dogs really stand out is in the way they generate tumors and react to treatments, which is a lot like people."

The vaccine Flyer got, for example, is now in an early trial for people after it showed impressive results in a previous Penn dog study. The company sponsor hopes to develop it for children and adolescents, who are more likely than adults to get osteosarcoma.

Nicola Mason, associate professor of medicine and pathobiology at Penn's School of Veterinary Medicine, leads clinical trials of novel immunotherapies developed to treat dogs with cancer. Some could also benefit humans fighting the disease.

The dog and human versions of that cancer involve many of the same genes and are biologically similar. “What we learn in one species can be applied to the other,” said Robert Petit, chief scientific officer of Advaxis, the company testing the vaccine in people.

Across the country, medical and veterinary schools are partnering to find new treatments for malignancies from LYMPHOMA and MELANOMA to BRAIN and BLADDER cancer. The National Cancer Institute is overseeing canine trials at almost two dozen academic vet schools, and animal-health foundations are stepping up their support.

Immunotherapy is the latest rage in veterinary medicine, just as in human cancer treatments. Researchers hope studies in dogs can help explain why some people benefit from the approach and others don’t. Amy LeBlanc, director of NCI’s Comparative Oncology Program, said dog data can give drug companies “the necessary reassurance” to move forward with a promising treatment.

Not everyone is sold on the idea that pets will be that helpful for testing treatments in people. Many experiments are in the early stages. Laurence Baker, an oncologist at the University of Michigan who specializes in bone cancer, said that while he is “agnostic” about using pets for research, “in this area, as in too many areas of research, there is a lot more hype than success."

Proponents of comparative oncology dispute that, saying the similarities of some cancers suggest benefits for both species. Cancer is the biggest health threat facing dogs, killing half of those 10 and older. “They are patients, not lab animals,” said Mason, whose office is filled with photos of dogs she has treated, including Aspen, a greyhound wearing bunny ears, and Bogie, a Great Dane.

Most cancer drugs for dogs were developed first for humans. Take Harley, a striking 4-year-old black boxer with aggressive leukemia. He recently came to Penn for a treatment called CAR T-cell therapy, which has shown some promising results in trials for people with blood cancers. The immunotherapy procedure for dogs is similar to the human one: T-cells, a key component of the immune system, are extracted, genetically modified in the lab to bolster their cancer-killing abilities, increased in number and then reinfused.

Mason began working on the treatment for dogs when she was a postdoctoral fellow in the lab of Carl June, a prominent researcher at Penn’s Perelman School of Medicine and a CAR T-cell pioneer. She consults with him frequently.

Owners of dogs in the Penn Vet trials get much of the care free, including treatments and follow-up visits. But there can be related expenses. In the osteosarcoma trial, owners are required to pay for the amputation and chemo.

If these canine treatments end up being sold outside clinical trials, they could carry hefty price tags. The human version of CAR T-cell therapy, for example, which is still in clinical trials, could cost hundreds of thousands of dollars once it hits the market. Scientists hope more progress will lower the cost for people and dogs alike.

The notion of using canines as a model for human cancers goes back decades. When veterinary oncologist Stephen Withrow was an intern at the Animal Medical Center in New York in the 1970s, he attended rounds at nearby Memorial Sloan Kettering Cancer Center and realized that animal and human medicine could help each other. “It opened my eyes,” he said.

Children with OSTEOSARCOMA have benefited from that insight. Withrow, who went on to found Flint Animal Cancer Center at Colorado State University, developed a surgical technique that allowed dogs with bone cancer to avoid amputation. He then collaborated with an orthopedic surgeon to adapt the limb-sparing technique for children.

In the 1990s, when an 11-year-old Colorado girl named Emily Brown was diagnosed with an especially complicated case of osteosarcoma, her doctors asked Withrow if there were any new canine treatments. He suggested an experimental therapy that Brown, now 30, credits with saving her life.

The sequencing of the dog genome in 2005 increased interest in comparative studies. “If the human genome is a deck of cards and you shuffle it, you end up with a rabbit — and shuffle it again, and you end up with dogs,” said geneticist Matthew Breen, whose lab at North Carolina State University’s veterinary school was involved in the sequencing project.

Marie Cary, who lives near Myrtle Beach, S.C., turned to Breen’s school a few years ago when her retriever, Gracie, developed a tumor on her upper jaw. After the cancer failed to respond to chemo, veterinary oncologists recommended an experimental treatment in which tiny particles were injected into the tumor with a light-sensitive compound called psoralen. X-rays then were used to target the particles, which responded by emitting ultraviolet light. That activated the compound and caused it to interfere with the tumor cells’ DNA and incite an immune response.

After a few rounds, the tumor disappeared; Gracie is now 10. The vet school is working with Duke Cancer Institute and the sponsoring company, which hopes to move the therapy into human trials.

Some comparative-oncology studies use cats for cancers such as oral malignancies and breast cancer, which have similarities to the human versions. But cats are used less frequently in studies than dogs, researchers say, because less is known about their tumors and they tend to get more stressed out interacting with people.

Osteosarcoma is diagnosed in about 10,000 dogs a year in this country, and researchers suspect that most die because the disease has already spread to their lungs. About 800 people also are diagnosed here annually, many of them children and young adults. Almost three-quarters are treated successfully with chemo; the rest die of advanced disease.

At Penn Vet, the vaccine trial in which Flyer was enrolled sprang from a collaboration between Mason and Yvonne Paterson, a microbiologist in the university’s medical school who survived breast cancer. The vaccine, which Peterson developed, uses genetically modified listeria bacteria to target cancers that are positive for a protein found in osteosarcoma, as well as in breast, gastric and other cancers. The bacteria, weakened so as not to cause illness, is designed to stimulate the immune system to recognize and eliminate any cancer cells remaining after chemo.

Mason launched the first trial in 2012 with 18 dogs. All got the standard treatment — amputation followed by chemo — then three vaccine doses. The first participant was Sasha, an American bulldog. She survived 738 days, compared with a median 423 days for dogs that had been treated in the past with amputation and chemo alone.

“I was a little worried about the possible side effects, so I put her in the ICU and sat with her for three days,” Mason said. “But it was anticlimactic. She did great.”  Many of the dogs did even better than Sasha, with median survival of 956 days. The vaccine now will be tested in a nationwide trial involving dozens of dogs.

In the meantime, Advaxis got the go-ahead from federal regulators to start an early-stage human trial with adults. Mason’s dog data was especially important in allaying concerns about possible heart damage. The company wants to launch a study next year for children with the aim of improving their treatment response and reducing relapse.

A few weeks after Flyer got a clean bill of health, Harley arrived for the CAR T-cell therapy for his leukemia. Mason had treated four dogs with lymphoma, but the first three had advanced disease and died quickly. The fourth survived for seven months.

To try for better results, Mason’s team changed the way it modified the T-cells, bringing its procedures more in line with the techniques used for people.  Harley’s T-cells had been withdrawn during an earlier visit, genetically altered and then multiplied. Now it was time for the 20-minute infusion. Erika Murphy of Franklinville, N.J., a teacher and mother of a young son, wept as she talked about the dog’s illness. “He’s our first boy," she said.

Mason sat with him on a plaid blanket on the floor of a treatment room. MaloneyHuss administered the altered T-cells via an intravenous catheter. Harley panted heavily but was calm, watching as a collie and other dogs strolled by.

The following week, he was back for tests. “He looks great,” Mason said, but the signs were mixed. “The cancer is coming back, but we are also seeing the T-cells starting to expand. Will they be able to start knocking back his cancer? We are all on tenterhooks to see."

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Just in case you think rising drug prices is a problem unique to the States:


Cancer patients are living longer and in many cases the disease is becoming chronic rather than acute. Access to drugs that help extend life and improve quality of life, and fair prices for those drugs are therefore essential for more and more people. But patients are badly served in this respect, with delays in the availability of new treatments and incomprehensible price rises for well-established therapies, including generics, researchers will tell the European Cancer Congress 2017 today.

There is no value for patients if new cancer drugs are developed and approved but they are unable to benefit from them, says Markus Hartmann PhD, Principal Consultant of European Consulting and Contracting in Oncology, a regulatory affairs consultancy based in Trier, Germany.

Approval decisions for cancer drugs are currently granted centrally by the European Commission, in order to ensure that risk/benefit judgments are applied on the same basis across the European Union. But decisions on reimbursement and pricing, and therefore on access to new medicines, are taken at individual EU Member State level, and this results in major differences in the overall availability as well as the time taken before patients are able to obtain new medicines, adds co-author Daniel Dröschel, Market Access Consultant at MArS Market Access & Pricing Strategy GmbH, Weil am Rhein (Germany).

The researchers studied approval processes for the 48 new cancer drugs that were evaluated between 2011-15 by the European Medicines Agency for use in the European Union. In 17 cases, approvals were based on a principal trial using overall survival as the primary endpoint; in 19 cases on trials using progression-free survival; and in 12 cases on trials - most often single-arm trials - using overall response rate as primary endpoints.

"These new drugs all show clinical benefit," says Dr Hartmann. "Our data indicate in the overall survival group a median survival gain of 3.0 months, while in the progression-free survival group the median gain was 3.8 months. However, the trial design, trial endpoint and magnitude of effect is evaluated quite differently by the health technology assessment (HTA) authorities in the UK, France and Germany, even though they reviewed the same, or very similar, clinical data."

These disparities in national HTA outcomes depend on a number of factors. Additionally, HTAs use different methodologies in their assessments: France, as well as the UK's National Institute for Clinical Excellence (NICE) and the Scottish Medical Council, apply health economics that have an impact on the final reimbursement decision, whereas Germany relies purely on a benefit assessment followed by price negotiations.

"In our study, in France and Germany around 80% of decisions were positive, whereas for UK's NICE, every third assessment ended with a negative outcome," Dr Hartmann will say. Patients' access to new cancer drugs in England and Wales is also hampered by later decision-making compared with Scotland, France and Germany, he adds.

In a second presentation, Dr Andrew Hill, Senior Research Fellow in the Department of Pharmacology and Therapeutics, University of Liverpool, UK, will tell the congress that UK prices for cancer drugs, including generics, have recently shown a sharp rise. Between 2011 and 2016, prices for some common drugs increased by more than 1000%. At a time when the UK Cancer Drugs Fund is being re-examined because of the pressure caused by high prices, this is particularly worrying, says Dr Hill.

"We were surprised to find several companies consistently raising the prices of cancer treatment. Twenty treatments have shown rises of over 100% in the last five years, and in two - busulfan (used to treat leukaemia) and tamoxifen (breast cancer) - prices have increased by over 1000%. We have found that some companies take over the supply of some generic cancer medicines and then raise the price progressively," Dr Hill will say.

In the UK, the Department of Health is aware of this issue and has introduced the Health Services Medical Supplies (Costs) Bill in order to be able to regulate prices in the future, he says. Companies found to be raising prices with no clear justification will be referred to the Competition and Markets Authority, and could face fines.

Paying these high prices puts undue strain on health systems, and the long-term result could be negative consequences for disease progression and survival. The researchers say that they are finding similar cases in other European countries. In Spain and Italy, failure to accept the high prices demanded for some generic treatments has led to warnings from companies that they could stop their supply.

"We hope that, by explaining what we have found in the UK, other European countries will take note and protect themselves against these kinds of price rises," says Dr Hill. "At a time when cancer patients are living longer and better lives due to effective treatments, this situation is particularly worrying."

Ms Melissa Barber, from the London School of Hygiene and Tropical Medicine, London, UK, will describe to the congress the results of her analysis of the manufacturing costs of all the medicines used to treat cancer included in the World Health Organisation's (WHO's) Essential Medicines List.

The results show that several key cancer treatments could be manufactured for less than one per cent of the prices charged in the US and UK. "For example, tamoxifen, used to treat breast cancer, can be manufactured for less than two US dollars per month of treatment, and imatinib, used in the treatment of chronic myeloid leukaemia, can be produced for $54 per month," Ms Barber will say.

Costs this low could form the initial step in setting up programmes in low and middle income countries for the mass treatment of certain cancers, following the successful precedent of mass treatment for HIV and AIDS. The researchers would like to see the expansion of pilot studies for such treatments; such pilots exist already for cancer treatment in Rwanda and Haiti.

"Showing that certain cancers could be treated for very low prices could transform the future of people with these cancers in very low-income countries where there are usually few or no treatment options," Ms Barber will conclude.

Professor Ian Banks, ECCO Board Member and chair of the Patient Advisory Committee, who was not involved with the research, commented: "Research presented at the ECCO Congress covers the whole of the cancer field, including important policy issues like those raised in these abstracts. The availability and pricing of treatments are of great interest and concern to cancer patients, and we consider it important to encourage the widest possible debate on them, as well as on other issues that affect patients' quality of life."

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Until March...

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

Elaine Jesmer

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