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For Nursing Home Patients, Breast Cancer Surgery May Do More Harm Than Good

Liz Szabo — Wed, 29 Aug 2018 15:01:45 +0000

Surgery is a mainstay of breast cancer treatment, offering most women a good chance of cure.

For frail nursing home residents, however, breast cancer surgery can harm their health and even hasten death, according to a study published Wednesday in JAMA Surgery.

The results have led some experts to question why patients who are fragile and advanced in years are screened for breast cancer, let alone given aggressive treatment.

The study examined the records of nearly 6,000 nursing home residents who had inpatient breast cancer surgery the past decade. It found that 31 to 42 percent died within a year of the procedure. That’s significantly higher than the 25 percent of nursing home residents who die in a typical year, said Dr. Victoria Tang, lead author and an assistant professor of geriatrics and hospital medicine at the University of California-San Francisco.

Although her study doesn’t include information about the cause of death, Tang said she suspects that many of the women died of underlying health problems or complications related to surgery, which can further weaken older patients. Patients who were the least able to take care of themselves before surgery, for example, were the most likely to die within the following year. Dementia also increased the risk of death.

It’s unlikely that many of the deaths were due to breast cancer, which often grows slowly in the elderly, Tang said. Breast cancers often take a decade to turn fatal.

“When someone gets breast cancer in a nursing home, it’s very unlikely to kill them,” said study co-author Dr. Laura Esserman, director of the UCSF

breast cancer center. “They are more likely to die from their underlying condition.”

Yet most patients in the study got sicker and less independent in the year following breast surgery.

Among patients who survived at least one year, 58 percent suffered a serious downturn in their ability to perform “activities of daily living,” such as dressing, bathing, eating, using the bathroom or walking across the room.

Women in the study, who were on average 82 years old, suffered from a variety of life-threatening health problems even before being diagnosed with breast cancer. About 57 percent suffered from cognitive decline, 36 percent had diabetes, 22 percent had heart failure, 17 percent had chronic lung disease, and 12 percent had survived a heart attack.

The high mortality rate in the study is striking because breast surgery is typically considered a low-risk procedure, said Dr. Deborah Korenstein, chief of general internal medicine at New York’s Memorial Sloan Kettering Cancer Center.

The paper provided an example of how sick, elderly people can suffer from surgery. An 89-year-old woman with dementia who underwent a mastectomy became confused after surgery and pulled off all her bandages. Health care workers had to restrain her in bed to prevent her from pulling off the bandages again. The woman died 15 months later of a heart attack.

Surgery late in life is more common than many realize. One-third of Medicare patients undergo surgery in the year before they die, according to a Eighteen percent of Medicare patients have surgery in their final month of life and 8 percent in their final week.

Nearly 1 in 5 women with severe cognitive impairment, such as Alzheimer’s disease, get regular mammograms, according to a study in the American Journal of Public Health.

The new study leaves some important questions unanswered.

The paper didn’t include healthier nursing home residents who are strong enough to undergo outpatient surgery, said Dr. Heather Neuman, a surgeon and associate professor at the University of Wisconsin School of Medicine and Public Health. These women may fare better than those who are very ill.

Esserman and Tang said their findings suggest doctors need to treat breast cancer differently in very frail patients.

“People think, ‘Oh, a lumpectomy is nothing,’” Esserman said. “But it’s not nothing in someone who is old and frail.”

In recent years, doctors have tried to scale back breast cancer therapy to help women avoid serious side effects. In June, for example, researchers announced that sophisticated genetic tests can help predict which breast cancers are less aggressive, a finding that could allow 70 percent of patients to avoid chemotherapy.

The Medicare database used in this study didn’t mention whether any of the patients had chemotherapy, radiation or other outpatient care. So the UCSF researchers acknowledged that they can’t rule out the possibility that some of the women suffered complications due to these other therapies. In general, however, authors noted that only 6 percent of nursing home residents with cancer are treated with chemotherapy or radiation.

The authors said doctors should give very frail patients the option of undergoing less aggressive therapy, such as hormonal treatments. In other cases, doctors could offer to simply treat symptoms as they appear.

The new study raises questions about the value of screening nursing home residents for breast cancer, Korenstein said. Although the hasn’t set an upper age limit for breast cancer screening, it advises women to be screened as long as they’re in good health and expected to live at least another decade.

Residents of nursing homes generally can’t expect to live long enough to benefit from breast screening, Korenstein said.

“It makes no sense to screen people in nursing homes,” Korenstein said. “The harms of doing anything about what you find are far going to outweigh the benefits.”

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Cascade of Costs Could Push New Gene Therapy Above $1 Million Per Patient

Liz Szabo — Tue, 17 Oct 2017 09:00:14 +0000

Outrage over the high cost of cancer care has focused on skyrocketing drug prices, including the $475,000 price tag for the country’s first gene therapy, Novartis’ Kymriah, a leukemia treatment .

But the total costs of Kymriah and the in development — known as CAR T-cell therapies — will be far higher than many have imagined, reaching $1 million or more per patient, according to leading cancer experts. The next CAR T-cell drug could be approved as soon as November.

Although Kymriah’s price tag has “shattered oncology drug pricing norms,” said Leonard Saltz, chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center in New York, “the sticker price is just the starting point.”

These therapies lead to a cascade of costs, propelled by serious side effects that require sophisticated management, Saltz said. For this class of drugs, Saltz advised consumers to “think of the $475,000 as parts, not labor.”

Dr. Hagop Kantarjian, a leukemia specialist and professor at the University of Texas MD Anderson Cancer Center, estimates Kymriah’s total cost could reach $1.5 million.

CAR T-cell therapy is expensive because of the unique way that it works. Doctors harvest patients’ immune cells, genetically alter them to rev up their ability to fight cancer, then reinfuse them into patients.

Taking the brakes off the immune system, Kantarjian said, can lead to life-threatening complications that require lengthy hospitalizations and expensive medications, which are prescribed in addition to conventional cancer therapy, rather than in place of it.

Dr. Keith Eaton (Courtesy Eaton)

Dr. Keith Eaton, a Seattle oncologist, said he ran up medical bills of $500,000 when he participated in a clinical trial of CAR T cells in 2013, even though all patients in the study received the medication for free. Eaton, who suffered from leukemia, spent nearly two months in the hospital.

Like Eaton, nearly half of patients who receive CAR T cells develop a severe or called in which the immune system overreacts, causing dangerously high fevers and . These patients are typically treated in the intensive care unit. Other include .

The cytokine storm felt like “the worst flu of your life,” said Eaton, now 51. His fever spiked so high that a hospital nurse assumed the thermometer was broken. Eaton replied, “It’s not broken. My temperature is too high to register on the thermometer.”

Although Eaton recovered, he wasn’t done with treatment. His doctors recommended a bone-marrow transplant, another harrowing procedure, at a cost of hundreds of thousands of dollars.

Eaton said he feels fortunate to be healthy today, with tests showing no evidence of leukemia. His insurer paid for almost everything.

Kymriah’s sticker price is especially “outrageous” given its relatively low manufacturing costs, said Dr. Walid Gellad, co-director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

The gene therapy process used to create Kymriah costs about $15,000, according to a 2012 presentation by Dr. Carl June, who pioneered CAR T-cell research at the University of Pennsylvania. June could not be reached for comment.

To quell unrest about price, Novartis has offered patients and insurers a new twist on the money-back guarantee.

Novartis will charge for the drug only if patients go into within one month of treatment. In a key , 83 percent of the children and young adults treated with Kymriah went into remission within three months. Novartis calls the plan “outcomes-based pricing.”

Novartis is “working through the specific details” of how the pricing plan will affect the Centers for Medicare & Medicaid Services, which pays for care for many cancer patients, company spokeswoman Julie Masow said. “There are many hurdles” to this type of pricing plan but, Masow said, “Novartis is committed to making this happen.”

Masow said that Kymriah’s manufacturing costs are much higher than $15,000, although she didn’t cite a specific dollar amount. She noted that Novartis has invested heavily in the technology, designing “an innovative manufacturing facility and process specifically for cellular therapies.”

As for Kymriah-related hospital and medication charges, “costs will vary from patient to patient and treatment center to treatment center, based on the level of care each patient requires,” Masow said. “Kymriah is a one-time treatment that has shown remarkable early, deep and durable responses in these children who are very sick and often out of options.”

Some doctors said Kymriah, which could be used by about 600 patients a year, offers an incalculable benefit for desperately ill young people. Kymriah is for children and young adults with a type of acute lymphoblastic leukemia and already have been treated with at least two other cancer therapies.

“A kid’s life is priceless,” said Dr. Michelle Hermiston, director of pediatric immunotherapy at UCSF Benioff Children’s Hospital San Francisco. “Any given kid has the potential to make financial impacts over a lifetime that far outweigh the cost of their cure. From this perspective, every child in my mind deserves the best curative therapy we can offer.”

Other cancer doctors say the Novartis plan is no bargain.

About who go into remission with Kymriah relapse within one year, said Dr. Vinay Prasad, an assistant professor of medicine at Oregon Health & Science University. Many of these patients will need additional treatment, said Prasad, who wrote an editorial about Kymriah’s price Oct. 4 in

“If you’ve paid half a million dollars for drugs and half a million dollars for care, and a year later your cancer is back, is that a good deal?” asked Saltz, who co-wrote a

Dr. Steve Miller, chief medical officer for Express Scripts, a pharmacy benefit manager, said it would be more fair to judge Kymriah’s success after six months of treatment, rather than one month. Prasad goes even further. He said Novartis should issue refunds for any patient whose leukemia relapses within three years.

A consumer advocate group called also has said that Kymriah costs too much, given that the federal government spent more than over two decades to support the basic research into CAR T-cell therapy, long before Novartis bought the rights.

Rep. Lloyd Doggett, D-Texas, to the Medicare program’s director last month asking for details on how the Novartis payment deal will work.

“As Big Pharma continues to put price gouging before patient access, companies will point more and more proudly at their pricing agreements,” Doggett wrote. “But taxpayers deserve to know more about how these agreements will work — whether they will actually save the government money, defray these massive costs, and ensure that they can access life-saving medications.”

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‘How Long Have I Got, Doc?’ Why Many Cancer Patients Don’t Have Answers

Liz Szabo — Mon, 12 Jun 2017 09:00:07 +0000

In the past four years, Bruce Mead-e has undergone two major surgeries, multiple rounds of radiation and chemotherapy to treat his lung cancer.

Yet in all that time, doctors never told him or his husband whether the cancer was curable — or likely to take Mead-e’s life.

“We haven’t asked about cure or how much time I have,” said Mead-e, 63, of Georgetown, Del., in a May interview. “We haven’t asked, and he hasn’t offered. I guess we have our heads in the sand.”

At a time when expensive new cancer , patients such as Mead-e have more therapy choices than ever before. Yet patients like him are largely kept in the dark because their doctors either can’t or won’t communicate clearly. Many patients compound the problem by avoiding news they don’t want to hear.

Surprisingly, huge numbers of cancer patients lack basic information, such as how long they can expect to live, whether their condition is curable or why they’re being or said Dr. Rab Razzak, director of outpatient palliative medicine at Johns Hopkins Medicine in Baltimore.

The result: People with advanced cancer don’t know enough about their disease to make informed decisions about treatment or how they want to spend their remaining time.

“Avoiding these issues is really irresponsible,” said Dr. Ira Byock, executive director at the Institute for Human Caring of Providence Health & Services, based in Torrance, Calif.

Even the oncologists who prescribe cancer treatment might not realize that so many of their patients are clueless about what’s going on. “I don’t think they recognize the enormity of it,” Razzak said.

Some patients approaching the end of life , assuming that they’ll live much longer than is realistic. Yet doctors often have a far more pessimistic of their life expectancy, said Dr. Robert Gramling, the Holly & Bob Miller chair in palliative medicine at the University of Vermont College of Medicine.

In a study published last year in the only 5 percent of cancer patients with less than six months to live had an accurate understanding of their illness. Thirty-eight percent couldn’t remember ever talking to their doctor about their life expectancy.

And in a , 69 percent of patients with metastatic lung cancer and 81 percent of people with advanced colorectal cancer thought they could still be cured, although both conditions are generally considered fatal, said study co-author Dr. Nancy Keating, a professor of health care policy and medicine at Harvard Medical School.

Such misunderstandings can have profound consequences for patients and their caregivers. Patients who often choose overly aggressive therapy that can cause pointless pain and suffering.

Nearly one-third of cancer patients end up in the intensive care unit, or ICU, in the last month of life, Although intensive care can save the lives of younger, healthier people, it doesn’t improve or lengthen the lives of people with terminal cancer.

“It’s surprising how many people end up in an ICU, critically ill and dying, without realizing they’re dying,” said Dr. Mark Siegel, a professor of internal medicine and critical care specialist at the Yale School of Medicine.

These last-ditch measures to extend life can leave families with Siegel said. Although almost half of Americans use — which focuses on comfort care at the end of life — studies show that many people enter hospice very late in their illness, often only a week before death.

“The real question is, ‘How do these patients become overly optimistic about their prognosis and what part do physicians play in this?’” Siegel said. “What do physicians tell the patients? What are patients hearing?”

In some cases, how long they have to live. In others, patients are clearly told their prognosis, but are too overwhelmed to . Some doctors and patients enter into an a pact that researchers have described as

New treatments have made discussions about prognosis , said Dr. Jennifer Temel, director of cancer outcomes research at the Massachusetts General Hospital Cancer Center. Although advanced cancers are still usually fatal, a fraction of patients are .

Doctors can’t always be sure, though, which patients are likely to benefit, Temel said. Many patients who put their hopes in new therapies end up delaying critical decisions about end-of-life care, said Holly Prigerson, co-director of the Center for Research on End-of-Life Care at Weill Cornell Medical College in New York.

“All of these changes are requiring us to rethink how we talk to patients,” Temel said.

Bruce Mead-e, left, and his husband, Chuck Mead-e, 60, had a meeting with a pastoral care provider who emphasized the bright side of things, Bruce says. “It helped me feel hopeful.” (Eileen Blass for Kaiser Health News)

The Optimism Bias

When in doubt, both doctors and patients tend to , assuming that a treatment will work.

Delivering bad news, particularly to longtime patients, can be painful, said Dr. Ronald Adelman, co-chief of geriatrics and palliative medicine at New York-Presbyterian Hospital/Weill Cornell Medical Center.

“They have a long, connected relationship and it’s very hard to not be able to deliver what the patients are hoping for,” Adelman said.

Even doctors who want to be honest are often unable to forecast how long patients will live.

In a , only 20 percent of hospice doctors accurately predicted how long patients would survive. Most weren’t even close, estimating that patients would live five times longer than they did.

Significantly, the longer that doctors knew their patients, the more likely they were to get it wrong, suggesting that emotional bonds clouded doctors’ thinking.

Even patients with early, curable cancers often lack key information.

Nicole Wesolowski was diagnosed with early rectal cancer last year at age 27, and has endured surgery and chemotherapy in the hopes of curing it. But she said her doctor has never told her what the chances are that her cancer will come back.

“Doctors don’t want to tell you something they don’t know,” said Wesolowski, of New York City, who said there are no studies to help predict her chances of cure, both because she’s so much younger than the typical cancer patient and because she received an experimental treatment. “I don’t think [my doctor] has an answer. It might be better if I don’t know.”

For Wesolowski, her doctor’s demeanor tells her all she needs to know.

“My surgeon seems very confident,” Wesolowski said. “Statistics aren’t going to help me be less afraid. … I’m just going to trust the people who have gotten me so far in such a small amount of time.”

Saying A Lot, But Communicating Little

Oncologists for failing to give patients the news they need to plan their futures. In a 2001 study, 40 percent said they would give inaccurate survival estimates — mostly painting an overly sunny picture.

Recordings of clinic visits show that oncologists devote less than 10 percent of their time to talking about patients’ prognosis, according to in the Journal of Oncology Practice, in which researchers listened to 128 audio recordings of oncologists and patients.

One doctor in the study obscured the news that a patient’s cancer had gotten worse by quickly transitioning to treatment choices.

“The good news is there’s lots of other options here,” he said.

Doctors in the study also overused medical terms that patients might not understand, said co-author Dr. Toby Campbell, chief of palliative care at the University of Wisconsin School of Medicine and Public Health.

Such medical jargon gave Carolyn McClanahan’s mother false hope after she was diagnosed with terminal liver cancer at age 66.

A doctor told her mother that there was a 25 percent chance that her tumor would “respond” to chemo, meaning that it would shrink. McClanahan’s mother, desperate for good news, assumed this meant she had a 25 percent chance of cure — even though her cancer was incurable. While shrinking a tumor can provide some relief from symptoms, it doesn’t necessarily prolong life.

The chemo caused McClanahan’s mother to develop painful ulcers in her mouth and esophagus, which prevented her from eating or drinking, said McClanahan, a former family physician and emergency medicine doctor from Jacksonville, Fla.

Her mother became dehydrated and was hospitalized for two weeks, taking in nutrition only through a tube, McClanahan said.

Her mother entered hospice care, which focuses on providing comfort at the end of life, and died two weeks later.

“Thankfully, we had a couple good weeks before she died,” said McClanahan, who now works as a financial planner. “I’m still so angry at myself for what she went through.”

Shopping For Good News

In surveys, overwhelmingly say they want doctors to be .

In the real world, doctors can pay a price for honesty.

Cancer patients tend to prefer doctors who deliver optimistic messages, rating them as more compassionate and trustworthy, according to .

In fact, patients with the least accurate idea of their prognosis — who mistakenly believe that chemo can cure an incurable cancer — for communication.

“Patients want doctors to be honest with them, and they want doctors to honestly tell them that their disease can be cured,” Gramling said.

When faced with traumatic news, some patients are unable to process the information, even when doctors are blunt,

One-third of patients with advanced cancer mistakenly believed their disease was curable, even after reading educational material that stated, “In this setting, there is no chance of cure.”

“What doctors say and what patients hear are very different,” said Dr. Leonard Saltz, chief of the gastrointestinal oncology service at New York’s Memorial Sloan Kettering Cancer Center. “There are coping mechanisms that help people get through the day by simply not hearing that they’re going to die.”

If doctors’ words fail to get through to patients, it may be because patients value other opinions more highly.

In a , more than 70 percent of patients based how long they expected to live on personal beliefs. Six percent based their estimates on religious beliefs, while 18 percent based their estimates on information from their doctor.

“When the physician says, ‘We’ll give you this chemo and it may prolong your life,’ the patient thinks, ‘I’m sure the cure is just a few more months down the road, and this will keep me alive until the cure comes along,’” said Betty Ferrell, director of nursing research and education at City of Hope National Medical Center in Duarte, Calif.

Oncologists say they struggle to provide accurate information, without scaring patients away.

If doctors appear too negative, “patients will go out the door and see another doctor who will tell them what they want to hear,” Saltz said.

Paulette Thompson-Clinton said she “fired” an oncologist for being too negative. Thompson-Clinton, a minister with breast cancer that has spread to her bones, said she chooses to live with “faith and optimism.”

“My oncologist said, ‘The average life span is three years, so you’ll probably live about that amount of time,’” said Thompson-Clinton, 49, of Bethany, Conn., who has since survived 7½ years. “There just seemed to be no hope. I was looking for someone to partner with. It takes a lot of energy and effort.”

Paulette Thompson-Clinton, a minister with breast cancer that has spread to her bones, stands with her husband and son. Thompson-Clinton said she fired an oncologist for being too negative. (Courtesy of Ameer Brooks/DJAmeerPhotography)

Today, Thompson-Clinton said she again finds herself at a crossroads. Her previous cancer treatments have stopped working, and her doctor has recommended intravenous chemotherapy — something she doesn’t want to do. She’s considering alternative medicine, including a clinic in Tijuana, Mexico.

“I’m in a harder place than I’ve ever been,” Thompson-Clinton said. “I feel like I’m at the end of my options.”

Tailoring The Message To The Patient

Being diagnosed with breast cancer over eight years ago forced Heather Block to learn two foreign languages: the medical jargon spoken by her oncologist and the even more arcane vocabulary of insurance companies.

To avoid confusion, Block brings a notebook to every doctor’s visit, then gives her oncologist a written summary about what she sees as the next steps in treatment.

“I put it in writing so I make sure that we’re on the same page,” said Block, 54, a resident of Lewes, Del.

Like Block, some people with cancer “want to know everything.” For others, too much information is overwhelming, and they cope better knowing as little as possible, Razzak said.

Some of the women at Block’s cancer support group keep the names of their medications on cards in their handbags. It’s the only way they can remember them, she said.

That’s why it helps if doctors tailor their messages to the needs of the individual, said Dr. Richard Schilsky, chief medical officer of the American Society of Clinical Oncology. When meeting a new patient, he asks two questions: “What do you know about your cancer?” and “What do you want to know?”

These questions allow patients to take the lead, receiving only as much information as they want, Schilsky said.

suggest that palliative care — which focuses on quality of life in people with serious illness and their caregivers — improves patients’ understanding of their disease.

For patients near the end of life, talking about their goals and values can help people avoid unwanted medical interventions, said Dr. Rachelle Bernacki, associate director of the Serious Illness Care Program at Ariadne Labs, a health care research center led by Dr. Atul Gawande.

patients who had end-of-life discussions were half as likely to wind up in the ICU before they died, compared to patients who didn’t have such conversations.

The American Society of Clinical Oncology, the country’s largest group of cancer specialists, that everyone with advanced cancer receive palliative care within eight weeks of diagnosis. Several studies show that early palliative care has been shown to help patients .

Bruce Mead-e holds a piece of art depicting his former business, a cafe called The Upper Crust. He recently sold the cafe because he didn’t have enough energy to keep it operating. The walls of The Upper Crust served as a gallery for artists and photographers. (Eileen Blass for Kaiser Health News)

Palliative care conversations include questions such as “How can we continue to hope for the best but prepare for the worst?” said Ferrell, who helped write the palliative care guidelines.

Yet palliative care specialists , Ferrell said.

That’s why Ariadne Labs has created a meant to help all health providers lead these discussions. Bernacki and others have trained more than 1,700 doctors, nurses and others to use it.

After talking to a reporter for this story, Bruce Mead-e — the Delaware man with advanced lung cancer — decided to ask his oncologist whether his disease was curable.

Mead-e wasn’t surprised by what he heard. “It’s not like it will ever really be cured,” Mead-e said. With treatment, however, the cancer “could go into remission.”

His doctor typed out the goals of treatment — to slow the growth of Mead-e’s cancer, relieve symptoms and side effects of treatment, and keep him comfortable if pain arises.

Mead-e and his husband, Chuck, also have met with a pastoral care provider who works with a local hospice. The experience, which included prayer, was uplifting for both of them. The pastoral care provider “sees the bright side of things, and doesn’t dwell on what you could have or should have done,” Mead-e said. “It helped me feel hopeful.”

KHN’s coverage related to aging & improving care of older adults is supported by .

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Widespread Hype Gives False Hope To Many Cancer Patients

Liz Szabo — Thu, 27 Apr 2017 09:00:30 +0000

After Michael Uvanni’s older brother, James, was diagnosed with a deadly form of skin cancer, it seemed as if everyone told the family what they wanted to hear: Have hope. You can beat this, and we are here to help.

The brothers met with doctors at a half-dozen of the country’s best hospitals, all with impressive credentials that inspired confidence.

Michael Uvanni was in awe when he visited the University of Texas MD Anderson Cancer Center in Houston, one of the world’s most respected cancer hospitals. It was like seeing the Grand Canyon, said Uvanni, 66, of Rome, N.Y. “You never get used to the size and scope.”

Even the MD Anderson logo on buses and buildings — with “Cancer” , above the words “Making cancer history” — made the family’s battle seem winnable.

“I thought they were going to save him,” said Uvanni, an interior designer.

Patients and families are bombarded with the news that the country is winning the war against cancer. The news media to attract readers. Drug companies promise “a to boost sales. Hospitals woo paying customers with ads that s.

“I’m starting to hear more and more that we are better than I think we really are,” said Dr. Otis Brawley, chief medical officer at the American Cancer Society. “We’re starting to believe our own bullshit.”

The consequences are real — and they can be deadly. Patients and their families have bought into treatments that either don’t work, cost a fortune or cause life-threatening side effects.

“We have a lot of patients who spend their families into bankruptcy getting a hyped therapy that [many] know is worthless,” Brawley said. Some choose a medicine that “has a lot of hype around it and unfortunately lose their chance for a cure.”

Although scientists have made , and many early-stage cancers can now be cured, most of those with advanced cancer eventually die of their disease.

For Uvanni, hope gave way to crushing disappointment when his brother’s health declined and he died from metastatic melanoma in 2014.

“You get your hopes up, and then you are dropped off the edge of a cliff,” said Uvanni. “That’s the worst thing in the world.”

like Uvanni can suffer and if their loved ones are riddled with side effects and don’t survive as long as the family expected, noted Holly Prigerson, co-director of the Center for Research on End-of-Life Care at Weill Cornell Medical College.

For decades, researchers have rolled out new cancer therapies with great fanfare, announcing that science has at last found a key to ending one of the world’s great plagues, said Dr. Vinay Prasad, an assistant professor of medicine at Oregon Health & Science University. When such efforts fail to live up to expectations, the cancer world simply moves on to the next big idea.

Hyping early — based on lab tests or animal studies — can attract investors that allow researchers to continue their work. Positive results can lead biotech firms to be bought out by larger drug companies.

“It’s in the interest of almost every stakeholder in the health system to be optimistic about these therapies,” said Dr. Walid Gellad, co-director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

Michael J. Uvanni looks at some plans at his interior design business in Rome, N.Y. Uvanni was devastated when his brother, James Michael Uvanni III, 66, died from cancer following more than three years of specialized treatment. Given how optimistic his doctors were, he expected that his brother would be cured, or at least live a long time. (Mike Roy/for Kaiser Health News)

Of course, there is plenty of money to be made.

The U.S. spent nearly in 2014, with patients paying nearly $4 billion out-of-pocket, according to the American Cancer Society Cancer Action Network. Spending on cancer, a disease that most afflicts the aging,

“While many people are trying to make patients’ lives healthier and longer and better, there are others that are exploiting their vulnerability,” said Dr. Leonard Saltz, chief of the gastrointestinal oncology service at New York’s Memorial Sloan Kettering Cancer Center.

Others argue that the excitement about cancer research is justified. A spokeswoman for the Pharmaceutical Research and Manufacturers of America, an industry group, said cancer patients have good reason for optimism.

“We continue to see great strides in identifying the genetic mutations and related factors that can drive the seemingly random formation of abnormal cells in cancer,” spokeswoman Holly Campbell said in a statement. “In the last decade, we’ve seen a number of scientific advances transform the landscape of many cancers.”

Promises To Cure Abound

Even the country’s top scientists sometimes get carried away.

In 1998, Nobel laureate James Watson — who co-discovered the structure of DNA — told The New York Times that scientists would “ using drugs that block tumor blood supplies. At that time, the drugs had succeeded only in mice.

In 2003, the director of the National Cancer Institute, Dr. Andrew von Eschenbach, of “eliminating suffering and death due to cancer by 2015” by better understanding tumor genetics.

Last year, when President Barack Obama announced the , which aims to accelerate and better coordinate research, he said, “Let’s make America the country that cures cancer once and for all.”

In a recent interview, von Eschenbach acknowledged he didn’t communicate his goal well.

“We all fall into that trap,” said von Eschenbach, now a senior fellow at the Milken Institute, a health and public policy think tank. “We’re offering what we have, but making it appear that it’s more than what it is.”

It’s easy to see how patients’ hopes are raised, said Timothy Turnham, former executive director at the Melanoma Research Foundation, an advocacy group. Researchers are frequently overly enthusiastic about early discoveries that have little chance of leading to a new drug.

“There is a disconnect between what researchers think is statistically significant and what is really significant for patients,” Turnham said. “Patients hear ‘progress,’ and they think that means they’re going to be cured.”

A Marketing Blitz

Uvanni said his brother’s experience was nothing like the in which smiling cancer patients hug their grandchildren, hike in the mountains and lead dance classes.

A TV commercial for the Bristol-Myers Squibb drug projects the words “a chance to live longer” on the side of skyscrapers, as a captivated crowd looks on. In much smaller type, a footnote reveals that lung cancer patients taking Opdivo lived just 3.2 months longer than others.

(Screenshot of Opdivo TV Commercial)

A TV ad for Merck’s features reassuring images of a smiling, healthy patient hugging her family — not fighting for breath or struggling to walk. Although the commercial notes that the people in the ad are portrayed by actors, the commercial claims the drug provides “a chance for a longer life. It’s Tru.”

“Your heart sinks when you see those ads,” Uvanni said. Seeing the family depicted in the ad, he said “makes you wonder if they’re going down the same path that we did.”

The Keytruda ad notes that 71 percent of patients given the drug were alive “at the time of patient follow-up,” compared with 58 percent of those who received chemotherapy. The ad doesn’t mention that the “time of follow-up” was 11 months.

(Screenshot of Keytruda TV Commercial)

“It’s not false; it’s just incomplete,” said pharmacist Harold DeMonaco, a visiting scientist at the Massachusetts Institute of Technology in Boston. “They don’t give patients or the patients’ family enough information to make a reasonable decision.”

In an interview, Merck senior vice president Jill DeSimone said that the company aims to be responsible with its advertising, noting that the Keytruda ad reminds patients to talk to their doctors. “The physician is the ultimate decider on treatment,” DeSimone said.

In a statement, Bristol-Myers’ senior vice president Teresa Bitetti said that Opdivo ads play “an important role in educating patients about new treatment options and fostering informed conversations between patients and their doctors.”

Hospitals also have for overstating their success in treating cancer. In 1996, Cancer Treatment Centers of America, a for-profit chain, settled that “they made false and unsubstantiated claims in advertising and promoting their cancer treatments.”

The company’s current commercials — dozens of which are — boast of offering “genomic testing” and “precision cancer treatment.”

The commercials don’t tell patients that these tests — which aim to pair cancer patients with drugs that target the specific mutations in their tumors — are rarely successful, Prasad said. In clinical trials, these tests have matched only 6.4 percent of patients with a drug, according to Prasad’s . Because these drugs only manage to shrink a fraction of tumors, Prasad estimates that just 1.5 percent of patients actually benefit from precision oncology.

In a statement, Cancer Treatment Centers of America said, “We use national media to help educate cancer patients and their families about the latest diagnostic tools and treatment options. … All of our advertising undergoes meticulous review for clinical accuracy as well as legal approval to ensure we tell our story in an informative and responsible manner, and in compliance with federal guidelines.”

Spending on ads for hospitals that treat cancer soared 220 percent from $54 million in 2005 to $173 million in 2014, according to a . Ads for Cancer Treatment Centers of America accounted for nearly 60 percent of all total cancer center advertising.

Targeting Melanoma

For more than a decade, the Food and Drug Administration approved for metastatic melanoma. Patients typically .

Since 2011, however, the , including several immunotherapies, which aim to harness the immune system to fight cancer. Last year, that the median survival of patients taking the drug Keytruda had grown to two years. Forty percent of patients were alive three years later, according to the clinical trial, presented at the American Society of Clinical Oncology.

Researchers have tested immunotherapies against a variety of tumors, leading to approvals in lung cancer, kidney cancer, bladder cancer and others.

Such success has led doctors to label cancer immunotherapy as a “.” Newspapers and magazines call it a “.” And hospitals laud them as “.”

Yet these treatments — which were initially assumed to be gentler than chemotherapy — can provoke on the , , and other organs.

And there are no approved immunotherapies for tumors of the breast, colon, prostate and pancreas.

Only about 10 percent of all cancer patients can expect to benefit from immunotherapy, Prasad said.

Uvanni’s brother — who tried immunotherapy, as well as a number of other approved and experimental treatments — survived 3½ years after his diagnosis. That might lead many oncologists to describe his story as a success.

Uvanni sees no reason to celebrate. He wanted more than short-term survival for his brother.

“I thought we were going to have a treatment where we’d at least have a good block of quality time,” Uvanni said.

But treatments meant to control the cancer only made him sick. Some caused flu-like symptoms, with fever, chills and shakes. Others left him nauseated, unable to eat or move his bowels. Others caused dangerous infections that sent him to the emergency room.

“I hope that if something like that happens to me,” Uvanni said, “I would be strong enough to say no to treatment.”

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Sticker Shock Forces Thousands Of Cancer Patients To Skip Drugs, Skimp On Treatment

Liz Szabo — Wed, 15 Mar 2017 12:19:47 +0000

John Krahne received alarming news from his doctor last December. His brain tumors were stable, but his lung tumors had grown noticeably larger.

The doctor recommended a drug called Alecensa, which sells for more than $159,000 a year. Medicare would charge Krahne a $3,200 copay in December, then another $3,200 in January, as a new year of coverage kicked in.

For the first time since being diagnosed 10 years ago, Krahne, now 65, decided to delay filling his prescription, hoping that his cancer wouldn’t take advantage of the lapse and wreak further havoc on his body.

With new cancer drugs commonly priced at $100,000 a year or more, Krahne’s story is becoming increasingly common. Hundreds of thousands of cancer patients are delaying care, cutting their pills in half or skipping drug treatment entirely, a Kaiser Health News examination shows.

One-third of Medicare patients who were expected to use Gleevec — a lifesaving leukemia medication that costs up to — failed to fill prescriptions within six months of diagnosis, according to a in the Journal of Clinical Oncology.

Researcher Stacie Dusetzina and her colleagues at the University of North Carolina found that patients with private health insurance with relatively high monthly copayments ($53 or more) were 70 percent more likely to stop taking Gleevec or take fewer doses than prescribed, according to a .

Leukemia patients aren’t the only ones rationing care.

A 2013 study in found that 24 percent of all cancer patients chose not to fill a prescription due to cost, while about 20 percent filled only part of a prescription or took less than the prescribed amount. A February had similar findings, with about 10 percent skipping medication or taking less than prescribed, and 14 percent delaying filling a prescription.

Given that more than are likely to be diagnosed with cancer this year, that suggests 168,000 to 405,000 ration their own prescription use.

“Patients are being harmed daily” by high treatment costs, said Dr. Hagop Kantarjian, a leukemia specialist and professor at Houston’s MD Anderson Cancer Center. “It’s causing more deaths than necessary.”

Stopping drugs like Gleevec could be cutting years from some patients’ lives. Instead of dying in five to seven years, patients with chronic myeloid leukemia who take Gleevec and similar drugs can survive nearly as long as anyone else, and with a good quality of life, Kantarjian said.

Given that his lung cancer has grown slowly over the years, Krahne’s doctor thought it would be safe to wait until January to begin his new medication.

“We hope it doesn’t hurt my chance of cure,” said Krahne, from Santa Rosa, Calif. “It was an educated risk that we didn’t take lightly.”

Krahne made repeated calls to patient-assistance programs throughout January, trying to find help with his out-of-pocket costs.

“The anxiety during those days or weeks was probably almost as bad as the day I was diagnosed with cancer,” Krahne said.

Doctors have a term for Krahne’s problem: “financial toxicity.”

“We’re talking about huge numbers of patients,” said Dr. Scott Ramsey, director of the Hutchinson Institute for Cancer Outcomes Research at the Fred Hutchinson Cancer Center in Seattle. “It’s an epidemic. And it’s not going away.”

Even patients with good insurance can face a financial crisis when trying to pay for cancer therapy. Medicare pays for the bulk of cancer care in the United States because . And, although it covers a high percentage of the cost, copays for patients such as Krahne can easily reach $10,000 a year, Dusetzina said.

John Krahne, a lung cancer patient, and his wife Audrey, sit in their kitchen in their home in Santa Rosa, California, on February 21, 2017. (Robert Durell/for Kaiser Health News)

Unlike many commercial plans, Medicare doesn’t set an upper limit on what patients pay out-of-pocket. Patients with chronic lymphocytic leukemia who begin oral medications this year, for example, can expect to have lifetime out-of-pocket costs of $57,000, according to a January study published in the .

High drug costs are a particular problem for the elderly, half of whom have in available assets, and many have more than one expensive chronic condition, such as heart disease, diabetes or emphysema. The median income for people on Medicare was $24,150 in 2014, according to the .

Medicare patients with cancer spend an average of 11 percent of their income on treatment, according to a . Patients who don’t have supplemental insurance, which pays for treatment not covered by traditional Medicare, spend 23 percent of their income on cancer care. Ten percent of elderly patients without supplemental insurance spent 60 percent of their income on cancer expenses.

In John Krahne’s case, persistence finally paid off. After making repeated calls to patient-assistance programs in January, Alecensa’s manufacturer, Genentech, agreed to help pay Krahne’s out-of-pocket costs. He began taking the drug Jan. 27, six weeks after it was first prescribed.

It’s impossible to know whether Krahne’s health will be affected by the delay, said Ramsey.

“Most oncologists are OK with delays of up to a month, but after that they start getting anxious that further delays will harm chances for survival,” Ramsey said.

When thinking about having to find the money for more than $10,000 in cancer treatment a year, Krahne said: “Hopefully, I won’t have to do this year after year.”

Yet Krahne acknowledged that paying high prices is the cost of surviving cancer today. “So, hopefully, I will have to do this year after year.”

Big-Ticket Designer Drugs

While cancer has always posed a financial hardship for patients, the jaw-dropping costs of new cancer medications have led to widespread criticism of the pharmaceutical industry, on Capitol Hill and beyond.

List prices for oral cancer drugs doubled from 2011 to 2016, rising from an average of $20 for a day’s supply to $40, according to , a pharmacy benefit manager. Six of the 39 cancer drugs on the market in 2010 doubled or tripled in price by 2016; one quadrupled in price; one drug’s price increased eightfold.

Treating melanoma patients with Keytruda, an immune therapy that has led to long-term remissions in some patients, costs $152,400 a year.

Such costs are leading to , who often struggle to help patients decide if drugs are worth the consequence of depleting their life savings, or going into debt or even bankruptcy.

“My job is to prescribe the best treatment,” said Dr. Yousuf Zafar, associate professor of medicine and public policy at the Duke Cancer Institute in North Carolina. “But I’m not doing my job if I prescribe a drug and walk away and leave them with tens of thousands of dollars in immediate debt.”

In a statement, the Pharmaceutical Research and Manufacturers of America, an industry group, noted that drug costs are only one part of the problem. “Many factors contribute to financial hardship for cancer patients … physician services, transportation expenses, and the inability to work, among other medical and non-medical factors, drive the cost burden on patients. We have also seen a rapid rise in the number of health plans with high deductibles for medicines.”

In a statement, officials at Gleevec’s manufacturer, Novartis, noted that the company provided financial aid to 130,000 patients last year, including those struggling to pay for Gleevec.

“We price our medicines to reflect the value they bring to patients and society,” said Novartis spokesman Eric Althoff. “We also continue to invest in new treatments so that we can find ways to make more cancers survivable.”

Patients Go For Broke

The high cost of cancer medications can burden patients for years even after they finish treatment.

Liza Bernstein, 52, was diagnosed with breast cancer three times from 1994 to 2009. She emptied her savings account after her second diagnosis and gave up her apartment because she couldn’t pay her rent. Bernstein sold some belongings and put the rest in storage, where they remain. She has been living with friends and relatives ever since.

“People say ‘Call this foundation or that foundation’” for help, said Bernstein, a freelance designer and patient advocate in Los Angeles who was unable to work for several years due to her illness. People don’t understand “the cognitive and emotional exhaustion of trying to manage this and wrap your brain around everything you need to do.”

Cancer often limits patients’ ability to hold down a job. Four years after diagnosis, one-third of previously employed breast cancer survivors were unemployed, according to a . Patients who lose a job don’t just lose a paycheck; they often lose their health insurance.

Liza Bernstein (Courtesy of Christopher Kern)

In a 38 percent reported one or more financial hardships as a result of treatment, such as being forced to sell or refinance their home or losing more than 20 percent of their income, even though nearly everyone in the study was insured. Seventeen percent borrowed money from family or friends, at an average of more than $14,000.

Twenty-three percent were in debt 20 months after their diagnosis, with an average debt of $26,860, according to the study. Even patients without severe hardship saw their fortunes change due to cancer, as they sold stocks and drew on savings.

About 3 percent of patients with cancer declare bankruptcy, said Ramsey, whose found cancer patients are 2.7 times more likely to file for bankruptcy than those who’ve never been diagnosed.

Although Bernstein considered declaring bankruptcy, she said she couldn’t afford the $500 to $600 it would have cost for a lawyer and filing fees.

Bankruptcy isn’t just financially devastating.

Mortality rates among cancer patients who filed for bankruptcy are, on average, 79 percent higher than those of other patients, according to Ramsey’s 2016 study in the . Bankruptcy is associated with an especially high risk of death for certain cancers. For example, mortality rates are 2.5 times higher among patients with colorectal cancer who filed for bankruptcy compared with patients who didn’t file.

The financial stress takes a toll on survivors as well. A study published found that patients with more financial strain had worse overall health and more pain, depression and impairment compared with those with more resources.

Financially stressed patients may skip pain medications and miss doctor’s appointments. And those who skip taking drugs to relieve nausea and vomiting, Ramsey said, can die from dehydration.

John Krahne, right, a lung cancer patient, and his friend Don Stranathan, who also has lung cancer, walk near Krahne’s home in Santa Rosa, California, on February 21, 2017. (Photo by Robert Durell/for Kaiser Health News)

A found that breast cancer patients who stopped taking hormonal therapy earlier than scheduled, or who took less than the prescribed amount, were more likely to die.

Some patients “have to choose between paying their meds and heating their home,” said Carla Tardif, chief executive officer at Family Reach, a New Jersey charity that provides financial aid to families dealing with cancer. “I went into a home and there were two sleeping bags on the kitchen floor. The mom said, ‘We sleep by the stove because I can’t afford the heat.’”

Molly MacDonald (Courtesy of The Pink Fund)

Molly MacDonald, who was diagnosed with breast cancer at age 54, when she was a divorced single mother of five, opted not to undergo reconstructive surgery because of the cost. She worried about the increased risk of infection and hospitalization, which she knew she could not afford.

“All of my decisions were based on cost,” said MacDonald, of Beverly Hills, Mich. “We sold things. I cut the kids’ hair myself. Friends brought food. Then I found myself in line at the food bank. I used to have groceries delivered. It was interesting to find out how quickly someone can find themselves in a place of need.”

In October 2006, after MacDonald got back on her feet, she began soliciting donations for a nonprofit she created called The Pink Fund, which helps to pay breast cancer patients’ bills. The fund now pays about $65,000 in bills a month. “We’ve helped people who are living in storage units, living with their families, living in cars.”

MacDonald often draws from her experience when offering financial advice. Consider selling your house to prevent it from being taken away, she suggests. Remember, that as bad as the situation is, it’s not permanent. But she also asks clients, “What in your house can you sell?”

Correction: This story was updated on March 15 to correctly state the cost of Keytruda, which is $152,400 a year.

KHN’s coverage related to aging & improving care of older adults is supported by and coverage of end-of-life and serious illness issues is supported by .

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Dozens Of New Cancer Drugs Do Little To Improve Survival, Frustrating Patients

Liz Szabo — Thu, 09 Feb 2017 21:28:32 +0000

Marlene McCarthy’s breast cancer has grown relentlessly over the past seven years, spreading painfully through her bones and making it impossible to walk without a cane.

Although the 73-year-old knows there’s no cure for her disease, she wants researchers to do better. It’s been years, she said, since she has found a drug that has actually helped. McCarthy said she’s frustrated that the Food and Drug Administration is approving cancer drugs without proof that they cure patients or help them live longer.

“That simply isn’t good enough,” said McCarthy, of Coventry, R.I. “I understand [why] that could be satisfactory for some people. It isn’t to me.”

Pushed by patient advocates who want earlier access to medications, the FDA has approved a flurry of oncology drugs in recent years, giving some people with cancer a renewed sense of hope and an array of expensive new options. A few of these drugs have been clear home runs, allowing patients with limited life expectancies to live for years.

Many more drugs, however, have offered patients only marginal benefits, with no evidence that they improve survival or quality of life, said Dr. Vinay Prasad, assistant professor of medicine at the Oregon Health and Science University, who has about the FDA’s approval process for cancer drugs.

Overall cancer survival has barely changed over the past decade. The 72 cancer therapies approved from 2002 to 2014 gave patients only 2.1 more months of life than older drugs, according to a study in

And those are the successes.

Two-thirds of cancer drugs approved in the past two years have no evidence showing that they extend survival at all, Prasad said.

The result: For every cancer patient who wins the lottery, there are many others who get little to no benefit from the latest drugs.

“We are very concerned about the push to get more drugs approved, instead of effective drugs approved,” said Fran Visco, president of the National Breast Cancer Coalition, who said the last game-changing breast cancer drug, Herceptin, was approved nearly 20 years ago.

In a published in JAMA Internal Medicine, researcher Diana Zuckerman looked at 18 approved cancer drugs that didn’t help patients live longer. Only one had clear data showing that it improved patients’ lives, such as by relieving pain or fatigue.

Two drugs harmed quality of life. For example, thyroid cancer patients taking the most expensive drug, cabozantinib, scored worse on a scale measuring five symptoms: diarrhea, fatigue, sleep disturbance, distress, and difficulty remembering, Zuckerman said.

“Our patients need drugs that provide the greatest possible benefit, particularly when you put that in the context of cost,” said Dr. Richard Schilsky, senior vice president and chief medical officer at the American Society of Clinical Oncology, which represents cancer specialists. “You begin to question what is the real value of a therapy when the benefit is small, the toxicity may be similar to a previous drug and the cost is much higher.”

Cancer drugs approved last year cost an average of $171,000 a year, according to the at New York’s Memorial Sloan Kettering Cancer Center. Although the high prices can lead patients to think they’re getting the Mercedes of cancer drugs, research shows that a medication’s price has .

“We cannot have a system where drugs that may not even work are being sold for these amazingly crazy amounts of money,” said Zuckerman, president of the National Center for Health Research, a nonprofit in Washington that aims to explain research to consumers.

Recognizing the slow pace of progress, the American Society of Clinical Oncology has of extending life or controlling tumors for at least 2.5 months. The bar was set relatively low because “it’s not very often that we come across a transformative treatment,” said Dr. Sham Mailankody, an assistant attending physician and myeloma specialist at Memorial Sloan Kettering.

Yet in a study published in September in , Mailankody found that only one in five cancer drugs approved from 2014 to 2016 met those standards.

Even those slim gains, achieved during carefully controlled clinical trials, can evaporate in the real world, where patients are often older and sicker than those who participate in research studies, said Hanna Sanoff, an associate professor and section chief of the University of North Carolina School of Medicine Gastrointestinal Medical Oncology Program.

Cancer is primarily a disease of aging; 59 percent of patients are over 65 and 30 percent are older than 75. Yet only 33 percent of participants in cancer trials are over age 65 and just 10 percent are over 75, according to a

In a study published in September in Sanoff found that a drug that improved survival in liver cancer by three months offered no survival advantage among Medicare patients outside the clinical trial.

McCarthy, who reviews breast cancer research for the Department of Defense, said she was twice turned down for clinical trials because of her age. When researching experimental therapies, “I’d get excited by something that seemed promising, only to be told I was too old to join the trial, because the cutoff age was 70,” she said.

Marlene McCarthy, 73, from Coventry, R.I., works on a computer as her husband Joe McCarthy, looks on. Marlene McCarthy, a mother of four, was first diagnosed with breast cancer at 44. Seven years ago, the disease returned in her bones, a condition that is not curable. (Katye Brier/for KHN)

Lowering The Bar

FDA officials said there are good reasons why many promising cancer drugs lack evidence of improved survival.

Because some cancers grow slowly, it can take many years for a study to show whether a new drug helps people live longer, said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence. While individual drugs may only modestly improve survival, “when used sequentially or in combination, they can transform a disease,” Pazdur said.

The design of some cancer trials also can make it hard to tell if drugs help patients live longer. That’s because many trials now allow patients in the control group the opportunity to “cross over” to get the drug being studied, if preliminary data suggests it could help them, Pazdur said. While such crossover benefits people in the study, who are facing a life-threatening disease, it can lead to inconclusive findings.

Lastly, Pazdur said that overall survival rates also don’t reflect the fact that some drugs, such as targeted therapies for lung cancer, allow a subset of patients to do extremely well, surviving for years instead of months.

The number of patients with advanced melanoma who survive five years after diagnosis has increased from 5 percent before the advent of immune therapies to 30 percent to 40 percent today, said Dr. Steven O’Day, director of immuno-oncology and clinical research at the John Wayne Cancer Institute at Providence Saint John’s Health Center in Santa Monica, Calif. Immune therapies work by stimulating a patient’s natural immune system to combat cancer cells.

“There is a lot of excitement about these [immunotherapy] drugs, and for good reason,” Schilsky said. “There’s no diminishing the progress that’s been made.”

The FDA wants to give patients the chance to benefit as soon as possible, rather than waiting for definitive proof of improved survival, Pazdur said. In some cases, the FDA requires pharmaceutical companies to perform long-term studies after drugs are approved, to measure whether drugs live up to their early promise.

But many of these studies never provide an answer, Zuckerman said. Once a drug is approved and is available to anyone, patients have no incentive to participate in a clinical trial. So studies can end with no clear conclusion.

In a , Prasad looked at 36 drugs approved without proven survival advantages. More than four years later, only five had evidence of improved survival.

Otis Brawley, chief medical officer at the American Cancer Society, said he’s concerned that the FDA is lowering its standards.

“We’re getting less rigorous scientifically because we want to get these drugs out to people faster,” Brawley said.

Unless the FDA requires companies to provide survival data before approving a drug, “we may never have answers,” Zuckerman said. “We will have all of these expensive drugs on the market and we will never have the information we need about how well they work or even how safe they are.”

President Donald Trump has vowed to cut regulations at the FDA and recently told pharmaceutical industry leaders that he wants to further speed up the drug approval process.

Helpful Or Harmful?

Cancer patients, who are making decisions at a time of intense stress, don’t always understand the full risks and benefits of therapy, Brawley said. Studies suggest that both and drugs’ benefits, but underestimate their risks and side effects.

A study of 2,944 people in found that 39 percent mistakenly believed the FDA only approves “extremely effective” drugs, while 25 percent mistakenly believed the agency only approves treatments without serious side effects.

Even doctors think “we are better than I actually think we are,” Brawley said. “The thought that these drugs could be harmful is foreign to them.”

Patients “see the survival benefit, and of course these are scared, desperate people trying to get themselves any chance they can get,” said Dr. Ellyn Lee, who guides patients about cancer treatments as director of Seattle’s Swedish Palliative Care Services. “However, the survival benefit is not often realized, or it’s three months of misery due to side effects and bankruptcy at the end. Is that really fair?”

One of the biggest recent changes at the FDA is that more drugs are being approved based on “progression-free survival” — medical jargon for the amount of time that patients live while their tumors are under control.

Because small changes in tumor size aren’t always clearly visible on scans, doctors consider tumors to be under control as long as they don’t grow more than 20 percent, Brawley said.

Doctors always hope that a drug that delays tumor growth will help patients live longer. But in a Prasad found that most statistical analyses have found the link between progression-free survival and overall survival to be very weak.

Measures such as progression-free survival “are just a guess as to whether or not the drug actually works,” Brawley said. “The problem with approving a drug based on a progression-free survival is that you don’t know if the drug is actually doing anything positive for the patient.”

Brawley said he’s concerned that patients could be harmed by oncology drugs whose long-term side effects are unknown.

The drug Avastin, which was approved for breast cancer in 2008, without evidence that it improved survival, three years later, after studies showed it did not help people live longer. The FDA concluded that life-threatening side effects, which included heart attacks, bleeding and high blood pressure, outweighed the drug’s benefits.

“There are all these drugs that we used for a long, long time, but we ended up taking them off the market because we finally realized they were harmful,” Brawley said. “We are setting ourselves up for that again.”

“Breast cancer doesn’t seem to have a road map to cure. It’s just a damn sneaky disease,” said Marlene McCarthy, 73, from Coventry, R.I. She lives with advanced breast cancer that has spread to her bones, a painful condition that makes it difficult to walk. She uses a cane to walk. (Katye Brier/for KHN)

McCarthy has been disappointed in the new cancer therapies she’s tried. The last drug that kept her tumors from growing was letrozole, which was approved in 1997. It kept McCarthy’s tumors under control for three years.

In 2015, after her tumors began growing again, McCarthy began a new breast cancer drug, called The FDA approved Ibrance because it improved progression-free survival by 10 months when combined with a standard hormonal therapy. Four months after McCarthy began the drug, however, scans found new bone tumors.

A spokeswoman for Pfizer, Sally Beatty, noted that Ibrance’s proven benefits have improved since then. In a , women taking the Ibrance combination lived 24.8 months with limited tumor growth, compared to 14.5 months for women who took the hormonal therapy alone.

McCarthy opted not to try another breast cancer drug, Afinitor, after doctors warned her that it posed too many risks. The in 2012 because it limited tumor growth for four months longer than placebo.

“That’s nothing to be excited about,” said McCarthy, who has four children and four grandchildren. “I want to live more than four months.”

But keeping tumors in check can be a huge help to patients, said Pazdur, who notes that there are many ways for drugs to help patients, even without extending life. Shrinking a bone tumor, for example, can relieve pain. Shrinking a lung tumor can make it easier for someone to breathe.

“Most patients are pleased if they go to the doctor and the doctor says, ‘Your scan says everything is stable. There are no new lesions,’” Schilsky said. “I’ve given that result to patients many times over the years and they are all happy about it. Are they as happy as they would be if the tumor were gone? Of course not. But being free from progression and otherwise feeling OK is not such a bad outcome.”

As someone with incurable cancer, McCarthy remains frustrated with the pace of progress. Scientists, she said, aren’t asking the right questions.

McCarthy said she wants researchers to focus on prevention of cancer, and to learn why breast cancers like hers can remain dormant for years before suddenly reactivating. Her cancer, which was first diagnosed when she was 44, disappeared for two decades before reappearing in her bones.

“The status quo isn’t good enough,” said McCarthy. “I want us to have a breast cancer vaccine to prevent my granddaughter from getting cancer. I’ll be working for that with my dying breath.”

KHN’s coverage of end-of-life and serious illness issues is supported by and coverage related to aging & improving care of older adults is supported by .

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For Nursing Home Patients, Breast Cancer Surgery May Do More Harm Than Good

Khnlizszabo — Wed, 29 Aug 2018 15:01:45 +0000