Entries in Treatment (25)


MS Patients Might Benefit From New Oral Drug

Jupiterimages/Thinkstock(NEW YORK) -- Thousands of Americans who suffer from multiple sclerosis (MS) might one day be able to take advantage of a drug that new research suggests is both safe and effective.

Multiple sclerosis is a chronic and often disabling disease that affects nearly 400,000 people in the United States. It attacks the protective substance called myelin that covers the nerve fibers of the brain and spinal cord.

Myelin is similar to the insulation of a wire and ensures proper nerve function. Once the myelin is damaged, the disease can also damage the nerve fibers themselves, leading to scars in these delicate tissues.

This damage leads to symptoms as mild as tingling in your feet and fingers, or as severe as paralysis or blindness. Eighty-five percent of MS patients are diagnosed with what is called relapsing-remitting MS, which means they experience flare-ups of symptoms, followed by partial or complete recovery.

A team of researchers looked at nearly 1,500 patients in 28 countries taking the experimental oral drug, known for now by the name BG-12, to see whether such flare-ups decreased, as well as whether they experienced any side effects from the treatment. The patients were studied for two years.

The results were encouraging. Overall, the patients receiving the experimental drug did better than the placebo group. Those who took the drug twice daily cut their chances of experiencing a flare-up by 44 percent, while those taking it three times a day reduced their chances by 51 percent. By comparison, the researchers wrote, a drug currently used for MS only cuts flare-up rates by 29 percent. Additionally, an MRI scan revealed that patients taking BG-12 had fewer scars on their nerves and brain.

If it is more widely used, the drug might offer hope to a large number of patients. If approved by the U.S. Food and Drug Administration, BG-12 would join two other oral medications on the market for MS.

"There is a great need for effective oral agents with acceptable safety profiles for MS patients with mild disease," said Dr. Lawrence Samkoff, associate professor of neurology at the University of Rochester in Rochester, N.Y., who was not involved with the study. "These newer oral medications will inaugurate a new era in the treatment of relapsing MS, giving patients and their physicians more choices."

Samkoff added that while BG-12 has some mild side effects, including flushing and an upset stomach, such symptoms tended to decrease within one month of taking BG-12.

Still, more research might be needed before BG-12 becomes more widely available, even after this two-year study.

"[Two years] is the standard these days, but the question is: is it adequate?" said Dr. John Corboy, professor and director of the department of neurology at the University of Colorado. "[It] is quite long in general, but very short when you consider the typical duration someone has MS."

Dr. Timothy Coetzee, chief research officer of the National MS Society, agreed. "As with any new therapy, it's important to do follow-up studies to understand the impact of the treatment over the long term," he said. "This will help us gain more specific knowledge of the long-term impact of this treatment on the immune system as well as the nervous system."

Copyright 2012 ABC News Radio


New Asthma Treatment Successful but Costly

Stockbyte/Thinkstock(NEW YORK) -- For hundreds of severe asthmatics who have undergone bronchial thermoplasty -- the first nondrug treatment for asthma approved by the U.S. Food and Drug Administration in 2010 -- the results have been life-changing.

"When you've lived with it for so long, you learn to adapt to it, but it's been amazing realizing after the thermoplasty how much I was limited," said Jenny McLeland, 33, of St. Louis, who has had asthma since birth.

However, the dramatic improvement comes with a hefty price tag.

Bronchial thermoplasty is expensive, costing anywhere from $15,000 to $20,000 depending on the procedure, and most insurance companies won't pay for it.

The treatment is reserved only for patients for whom medication hasn't worked.  Although five-year follow-up studies have found the procedure to be safe and effective, most insurance companies still consider the procedure experimental.

McLeland is one of many who have bypassed the cost of the treatment by enrolling in a clinical trial.  Her husband was also successfully treated through the same trial.  This treatment is not something she could afford if it wasn't for a clinical trial, she said.  

But not all patients who qualify for the procedure necessarily qualify for a study.  Nearly 25 million Americans have asthma.  As much as 10 percent of people with asthma have what is considered the most severe form and make up the majority of the health care costs of the disease.

Americans spend nearly $18 billion on asthma, the majority of which is spent on treating the illness through emergency hospital visits and multiple medications, according to the Asthma and Allergy Foundation.

"Knowing that we have another way to attack asthma and have another tool in our toolbox is extremely exciting," said Dr. Sumita Khatri, co-director of the Asthma Center for the Cleveland Clinic.

Bronchial thermoplasty works by delivering thermal energy to the airway wall through a catheter to burn away smooth muscle that is inflamed in asthma patients.  The procedure, completed in three sessions, widens the airways enough to decrease the ability of the airways to constrict in response to a trigger and reduce the frequency of asthma attacks.

It is currently available in more than 150 medical centers in 40 states.  Studies suggest that the average patient who undergoes bronchial thermoplasty is likely to experience a 30 percent reduction in asthma symptoms and an 82 percent reduction in asthma-related visits to the emergency room.

But the procedure isn't expected to rid patients of medications completely.  While bronchial thermoplasty is FDA-approved to reduce asthma symptoms, it has not been shown to improve lung function or reduce over-response in the airways that triggers the need for rescue medications.

"Your asthma will not be cured," said Khatri, who said that research is still under way regarding the procedure.  "All of these [procedures] are nice and good, and hopefully we'll find more benefits in the longer term, but you'll still need to be on your asthma medications."

Copyright 2012 ABC News Radio


Prostate Cancer: Surgery Rarely Best, Researcher Suggests

iStockphoto/Thinkstock(NEW YORK) -- Robert Ginyard is a 49-year-old small business owner from Baltimore. He started having prostate-specific antigen (PSA) testing earlier than most -- age 40 -- because his father had been diagnosed with prostate cancer when he was in his 40s. When, at age 47, his PSA went from 4.8 to 7.1 he was referred to see a urologist. His biopsy showed cancer.

And then there's Eddie Carrillo, 67, a contractor from Los Angeles. He saw his doctor when he was 53 for abdominal discomfort and had a PSA of 7. His biopsy also showed cancer.

Ginyard said he discussed his options at length with his wife and two daughters. Ultimately he opted for surgery. After six months of difficulty with urinary continence and sexual performance, he found himself cancer-free and with no difficulties. He says he is "100 percent satisfied" with his decision to remove his prostate.

Carrillo said he felt pretty healthy, had a number of family members who had side effects from treatment for prostate cancer, and "just didn't like invasive operations." He selected a "watch and wait" approach. For the last 14 years, he has undergone periodic PSA testing and prostate biopsies. He is still feeling healthy, living with prostate cancer. His approach to prostate cancer is "not to be afraid of it. Deal with it, because you can't run from it and it can be lived with."

Two men who opted for very different approaches to basically the same disease.

Now, a new study is stirring the coals as to whether doctors should urge more men to opt for Carrillo's approach and avoid prostate cancer surgery. At stake, potentially, is the health of millions of American men. And not all doctors agree that surgery -- and PSA testing along with it -- should be taken off the table.

The goal of a new study in the New England Journal of Medicine was to see whether observation would be better than surgery for early prostate cancer.

It included 731 men diagnosed with prostate cancer after having high PSA levels. Half of the men were assigned to have surgery, while the other half were assigned to be observed -- with PSA testing every six months and bone scans to look for tumor spread -- every five years.

After 12 years, 47 percent of men assigned to surgery died, compared to 49.9 percent of men assigned to observation -- a difference that was not statistically significant. Meanwhile, more than one in five of the men who underwent surgery had adverse effects from their operation -- though men with very high PSA scores (greater than 10) did have a significant benefit from surgery.

Based on their findings, Dr.Timothy Wilt, lead author on the study, concluded that "observation is a wise and right decision for men with prostate cancer detected by PSA." He said that his study agreed with the recent recommendation by the United States Preventive Services Task Force (USPSTF), which in May 2012 said that PSA should not be tested in men for prostate cancer screening.

Nearly all of the experts contacted by ABC News acknowledged that this study helps identify which patients do not require surgery for their prostate cancer.

However, most of these experts disagreed with the notion that all prostate cancer detected with PSA should simply be observed.

"With early diagnosis and improvements in treatment during the past 20 years, the prostate cancer death rate has decreased by 44 percent in the U.S.," said Northwestern University's Dr. William Catalona, medical director of the Urological Research Foundation and the doctor who developed the PSA test for cancer screening. "This trial should not provide men with another excuse not to get tested or treated for prostate cancer."

"Rather than characterizing the study as showing no benefit from surgery compared to observation, this study provides evidence that surgery will reduce metastasis and death from prostate cancer particularly in men with intermediate or high risk tumors," said Bruce Trock, professor and director of the Division of Epidemiology in the Brady Urological Institute.

Many even felt that the study actually supports testing for PSA.

"This study does not undermine the value of PSA but underscores the importance of proper use of PSA in appropriate populations," said Dr. Phillip Kantoff, professor of medicine at Harvard's Dana Farber Cancer Institute. "The USPSTF fails to distinguish the value of PSA in saving lives from the problem of overtreatment."

While the experts could not agree on how to interpret the findings of this study, they all felt that more research was needed to find better tools to identify which prostate cancers would be slow-growing and harmless -- and which ones could be lethal. Technological advances such as prostate MRI and targeted biopsy are promising options undergoing study.

In the meantime, Ginyard and Carrillo had similar advice for patients who get the news they have prostate cancer.

"Really take time to do your research," Ginyard said. "Make the decision by gathering as much information as you can."

"Make sure you get a second opinion," said Carrillo.

Doctors agreed that this is sound advice.

"Prostate cancer is not a one-size-fits-all disease. It's really a spectrum," said Dr. Martin Sanda, a urologist at Harvard's Beth Israel Deaconess Medical Center.

"The message to patients should be, get tested, have a biopsy if necessary, but be very careful before agreeing to treatment," said Dr. Peter Scardino, chief of surgery at Memorial Sloan-Kettering Cancer Center in New York. "Make sure you have a cancer that really poses a serious risk to your life and health and that the treatment is not worse than the disease."

Copyright 2012 ABC News Radio


Ginseng May Banish Cancer Fatigue, Study Finds

iStockphoto/Thinkstock(NEW YORK) -- Cancer can leave patients feeling run down, worn out and overall fatigued by their disease and the treatments that fight it.  The malaise often lingers even after cancer treatment is over.  But a new study from the Mayo Clinic found that ginseng may be a tool for fighting cancer-related fatigue.

Researchers gave 2,000 milligrams of pure ground American ginseng or a placebo pill to 340 patients being treated for cancer and cancer survivors who had finished their treatment.  After four weeks, patients reported little change in their cancer-related fatigue.  But after eight weeks, the patients taking ginseng reported feeling generally more energized than their sugar pill-popping peers.  The response was particularly strong among patients who were currently undergoing cancer treatment.

The study was presented Monday at a meeting of the American Society of Clinical Oncology.

Dr. Debra Barton, an associate professor of oncology at the Mayo Clinic and the study’s lead author, said knowing how to combat fatigue, one of the most common side effects reported during and after cancer treatment, is becoming increasingly important.

“We are making progress in cancer treatment, and we do have more survivors than ever before, so we can’t just ignore these quality-of-life factors once the cancer is gone,” she said.

Doctors often caution patients against taking supplements that might interfere with their cancer treatment drugs.  According to the National Center for Complementary and Alternative Medicine, potential adverse interactions with prescription medications are one of the primary safety concerns with taking herbs and other supplements.  In recent years, patients undergoing cancer treatment have reported adverse reactions after taking ginseng.

Barton said it’s important for patients to tell their doctors about all the supplements they’re taking.  But she said recent research on ginseng is encouraging.

“Ginseng is one of the more studied herbs,” she said.

Some studies have shown that ginseng decreases inflammation and the stress hormone cortisol, both of which may be contributing factors to cancer-related fatigue.  Barton and her team plan to study how ginseng affects these biological factors in the patients in the current trial.

Copyright 2012 ABC News Radio


Lou Gehrig's Disease: Patients Take Research into Their Own Hands

Courtesy Eric Valor(SANTA CRUZ, Calif.) -- Though his body betrays him, Eric Valor's mind is still strong.  Diagnosed with Lou Gehrig's disease in 2004, the 43-year-old relies on machines to move, talk, eat and breathe.  But that hasn't stopped him from running his own drug trial.

With help, Valor has been injecting sodium chlorite, a chemical used by water treatment plants, into his paralyzed body through a feeding tube.  He's convinced it's the active ingredient in NP001, an experimental drug made by Neuraltus Pharmaceuticals Inc., and other patients are following his lead.

"My original plan was to keep it secret until I could report with confidence that it was safe and even marginally effective," said Valor, who started taking sodium chlorite in October 2011.  "But the secret got out, so I made a website to try to capture data as best I could."

From a special bed in his Santa Cruz home, Valor uses only his eyes to control a ceiling-mounted computer -- an invention from his days as a computer specialist.  He is able to track his disease progression and that of more than two dozen other patients taking sodium chlorite.

He hopes the makeshift drug will buy them all time until NP001 is approved by the U.S. Food and Drug Administration.

But experts say the DIY approach is dangerous.

"It's pretty frightening," said Dr. Jonathan Glass, neurologist and director of the Emory ALS Center in Atlanta.  "I think it's a cry of desperation for these folks, using something not made to strict standards with no evidence it works."

But people with Lou Gehrig's disease, also known as ALS, are eager to find out whether sodium chlorite works quickly and on their own terms.  Frustrated with the pace of clinical research, they've joined forces to tackle the best leads on short order, from off-label drugs to stem cell transplants, and now makeshift NP001.  It's a far cry from a properly designed clinical trial, which has a control group to weed out the infamous placebo effect.  Still, the DIY design puts patients back in control.

Research papers and patent filings suggest the vaguely-named NP001 could be sodium chlorite, but Neuraltus Pharmaceuticals Inc. has not publicly confirmed the drug's formula.  Calls to the company were not immediately returned.

The results of a phase 2 clinical trial of NP001 are expected to come out later this year.

Copyright 2012 ABC News Radio


Are Nanoparticles the Next Cancer Treatment?

iStockphoto/Thinkstock(CAMBRIDGE, Mass.) -- The word nanoparticles may make people think about objects floating around in space, but according to new research, they show very early promise as a cancer treatment.

A team made up of academic researchers and scientists from BIND Biosciences, a biopharmaceutical company, developed specially programmed nanoparticles that targeted tumors and delivered high doses of a chemotherapy drug in a series of animal and human trials.

The nanoparticles are about one-thousandth the width of a human hair and made of the same chemical substance used in biodegradable sutures, said Robert Langer, a co-author and professor at the Massachusetts Institute of Technology.

“They are made out of very safe chemicals,” he said.   “They are also very small so they can be taken up by the cells.”

In an early-stage ongoing trial, about 17 patients with different types and stages of cancer receive doses of a nanoparticle containing the chemotherapy drug docetaxel every three weeks.

So far, Langer said, the particles seem to be safer and able to maintain a high concentration of the drug in the body.

“We don’t see the same adverse effects we see with the drug, and there is also much more of the drug circulating and targeting the tumors,” he said.

There has also been some tumor shrinkage in some of the patients, which is also encouraging.

“At this point, it seems to be more effective than the drug by itself,” he said.  “Some tumors we normally wouldn’t be able to treat we’re able to treat here.”

But it’s too early to be overly optimistic about the potential of nanoparticles since the study involving the cancer patients is primarily a trial designed to determine whether the treatment is safe.

“We still need to do more advanced clinical trials with many more patients,” Langer said.

Copyright 2012 ABC News Radio


Why a Cancer 'Cure' Is So Elusive

iStockphoto/Thinkstock(NEW YORK) -- In the realm of targeted cancer treatment, Carla Leslie is a success story.

Leslie was diagnosed in September 2010 with Stage 3C breast cancer, a disease that kills 50 to 60 percent of those who have it within five years.  She was treated at MD Anderson Cancer Center in Houston with chemotherapy plus Herceptin, a drug that targets a specific genetic mutation in certain kinds of breast cancer.  The results were remarkable; Leslie is now in remission.

Stories like Leslie's are becoming more common.  Yet, as any doctor will tell you, even today the prospect of a cure for most kinds of cancer is elusive.

Doctors have had some success using drugs like Herceptin, which tailor a patient's treatment to their specific genetic makeup.  This practice, known as "personalized medicine," is an effective approach in some cases.  But the cancers that cannot be treated with these personalized approaches -- in other words, most of them -- are so complex that any simple approach to treating them remains elusive, at least for now.

New research, published Wednesday in the New England Journal of Medicine, reinforced this idea, demonstrating that the tumor cells of a particular kind of cancer can vary not only throughout a particular patient's own body, but even within a single tumor.  Each of these different variations of the same kind of cancer cell is known as a mutation, and each of these mutations can be thought of like a target. So while a given treatment might hit some of these targets, others are left unscathed, and the cancer remains.

In this study, researchers took multiple samples of tumors from four patients with a kind of cancer originating in the kidneys called metastatic renal cell carcinoma.  By analyzing these samples, they found that cancer cells within a single tumor and at places where the cancer had spread showed a large amount of variation, with 60 percent of tumor mutations not uniformly detected in every part of the tumor.

This has implications not only for treatment, but for diagnosis as well.  In some cases, the researchers found mutations associated with both good and bad prognosis in different parts of the same tumor.

The variation among tumor cells might actually help cancer to survive and could explain why some cancers become resistant to chemotherapy.

These findings highlight new challenges in the management of cancer and suggest that, in many cases, the idea of "personalized medicine" might be too simplistic for cancer treatment.

Copyright 2012 ABC News Radio


Cancer Patients Fume Over Counterfeit Avastin

J.B. Reed/Bloomberg News(OCEANSIDE, Calif.) -- Cancer patients are furious that a counterfeit version of the drug Avastin has landed in U.S. clinics.

Avastin, which is made by the Oceanside, Calif.-based company Genentech, is used in combination with chemotherapy to treat cancers of the colon, brain, kidneys and lungs. But the counterfeit lacks the tumor-starving ingredient some patients need to survive.

"It's an outrage," said Diane Barraza, 48, who takes Avastin for stage IV colon cancer. "For a company to sell this drug, put it in our blood, it's an outrage."

The U.S. Food and Drug Administration announced Tuesday that 19 clinics in California, Texas and Illinois may have purchased the phony Avastin from Quality Specialty Products, an "unapproved" foreign supplier also known as Montana Health Care Solutions. The counterfeit vials are labeled "Avastin" but indicate "Roche" as the manufacturer. Roche is the parent company of Genentech.

"The counterfeit contains no Avastin, no generic Avastin, no active ingredient whatsoever," Genentech spokesman Ed Lang told ABC News. Lang said the contents of the vials are still under investigation.

For patients like Barraza, a fake cancer drug would be the cruelest con.

"To sit in the chemo chair and watch that stuff drop into my veins," said an emotional Barraza, who lives in Fullerton, Calif., with her 6-year-old daughter. "It's all I've got. And it might just be water?"

Avastin is expensive, costing upwards of $650 for a small vial. But Montana Health Care Solutions sold the counterfeit vial for $480, according to one of the clinics -- a cost savings of 25 percent.

"Obviously it makes good business sense to try to get the drug at a reduced cost," said Dr. Jack Jacoub, a medical oncologist at Orange Coast Memorial Medical Center in Fountain Valley, Calif. "But when you start to get drug pricing that's markedly different from that of the standard distributor, it should raise a red flag."

Only four U.S. distributors are authorized to sell Avastin to doctor's offices; another four can sell the drug wholesale to hospitals. Montana Health Care Solutions is not an authorized Avastin distributor. Jacoub, who treats Barraza, said his clinic buys Avastin in bulk from an approved distributor for $593.20.

Montana Health Care Solutions claimed to be based in Belgrade, Mont. But the company's recently disconnected phone number has a New Brunswick, Canada, area code. It's unknown whether Montana Health Care Solutions knew the Avastin was counterfeit. They also sold other cancer drugs, including Neulasta and Faslodex, at a significantly discounted price.

The FDA was alerted to the possible counterfeit in December 2011 by the Medicines and Healthcare Products Regulatory Agency in the UK, according to Genentech's Lang. In a Feb. 10 letter, the agency urged the 19 clinics known to have purchased through unapproved distributors to "retain and secure" any unused drugs. The counterfeit Avastin vials have the lot numbers B86017, B6011, B6010, and the labels are slightly different.

Counterfeit or illegally imported drugs are rare in the U.S. but not unheard of. In 2008, heparin (a blood thinner) imported from China killed 81 Americans.

"Counterfeit drug makers have reached a level of sophistication where the real and fake products look almost identical," said Peter Pitts, president of the Center for Medicine in the Public Interest and former associate commissioner for the FDA. Pitts estimated that counterfeit drugs generated $75 billion in 2010, a figure expected to grow by 20 percent annually. "It's a low-risk, high-reward proposition. It's almost a perfect crime -- people aren't getting the drugs they need and they end up dying."

For Barraza, who will have four more Avastin treatments over the next two months, the thought of criminals profiting from her disease is sickening.

"I wish they could understand what it feels like to be a cancer patient, to take a drug and to suffer," she said. "I'd do anything to stay alive, but I need the right medication."

Copyright 2012 ABC News Radio


Women's Chronic Pain Misdiagnosed, Undertreated, Dismissed

Keith Brofsky/Photodisc/Thinkstock(WASHINGTON) -- Women make up the vast majority of the nation's 116 million chronic pain sufferers, yet doctors frequently dismiss their complaints as all in their heads, sending them on years-long searches for relief, a patient told senators Tuesday.

Although studies have observed women's chronic pain is more frequent, more severe and longer lasting than men's, many women still are told "their problem isn't real. Your pain doesn't exist, you must be imagining this," Christin Veasley testified.

In her case, she said, back and neck pain from an old car accident became "an unwanted companion for 21 years." Since 2008, migraine headaches, facial pain and jaw pain piled on more misery, she said.

"From the moment I open my eyes each morning, the first thing I feel is pain," said Veasley, executive director of the non-profit National Vulvodynia Association, which aims to help the one in four American women and "countless adolescents" suffering invisible but excruciating genital pain at some point during their lives.

Veasley, who has recovered from vulvodynia she had in her 20s, testified on behalf of the Chronic Pain Research Alliance. She said she hopes Congress will lead the way in enacting "long overdue change to help us regain our quality of life and ability to contribute to society."

She was among five witnesses appearing at a Capitol Hill hearing on "Pain in America: Exploring Challenges to Relief," called by Sen. Tom Harkin, D-Iowa, chairman of the Senate Committee on Health, Education, Labor and Pensions.

The hearing followed publication last year of an Institute of Medicine report that included recommendations for improving diagnosis, treatment and research into chronic pain, as well as boosting health professionals' recognition of both the problem and its toll.

The cost of chronic pain exceeds $600 billion each year -- more than cancer, heart disease and diabetes combined, the IOM report found. Chronic pain is defined as pain that lasts several months or more, according to testimony from Dr. Lawrence A. Tabak, principal deputy director of the National Institutes of Health. It may crop up as persistent pain after an injury heals, or arise as a debilitating symptom of long-term diseases like arthritis, diabetes or cancer.

Often, Tabak said, people suffer from chronic pain associated with more invisible conditions like fibromyalgia, irritable bowel syndrome, chronic headaches or jaw pain -- all more common in women than men.

"The majority of my patients are women," said Dr. Timothy A. Collins, a neurologist with the Duke Pain and Palliative Care Clinic in Durham, N.C., who was not involved in the hearing.

He said migraine headache is "three times as common in women compared to men." Fibromyalgia "appears more common in women than men," and "a number of pain conditions are directly caused by abuse (sexual and physical) and unfortunately, women are more commonly on the abused side of the equation."

Collins said U.S. culture encourages women "to voice feelings, emotions and physical complaints" while generally discouraging such complaints in men.

"This tends to affect the perception of the care provider -- if there are significant emotional issues, the other complaints may become attributed to the emotional complaints," he said.

In other words, if a woman with chronic pain also suffers from depression, a doctor may attribute all of her complaints "to being depressed, so no further evaluation or treatment is needed," Collins said.

Women with chronic pain also are subject to some of the same gender discrimination that contributes to their under-treatment for cardiac disease and or arthritis. For example, a 1999 study published in the New England Journal of Medicine found that white women (and black men) were 40 percent less likely to be referred for potentially life-saving cardiac surgery.

A 2008 study published by the Canadian Medical Association found doctors were more likely to recommend knee replacement surgery to male patients with knee arthritis than to female patients, suggesting that gender discrimination might contribute to women being three times less likely to undergo knee replacement than men.

In addition, when it comes to doctors' decisions about managing pain, a February 2003 study of doctors' pain management knowledge and attitudes, published in The Journal of Pain, found that women were less likely than men to receive "optimal treatment" for post-surgical or cancer-related pain. That study also found doctors set lesser goals for chronic pain relief than for acute pain and cancer pain.

Copyright 2012 ABC News Radio


Trials Show Improved Outcome in Metastatic Breast Cancer Patients

Comstock/Thinkstock(SAN ANTONIO) -- Two trials presented Wednesday at the San Antonio Breast Cancer Symposium may offer some relief for breast cancer patients undergoing treatments and surgeries.  Both were shown to improve "progression-free survival," a term experts use to measure the length of time during and after medication that the cancer does not get worse.

In the BOLERO-2 trial (Breast Cancer Trials of Oral Everolimus), lead study author Dr. Gabriel Hortobagyi, professor and chairman of MD Anderson's Department of Breast Medical Oncology, said the findings demonstrated for the first time that the combination therapies are more effective than a single hormonal treatment in patients who have already tried hormonal therapy.

"Over the years, our treatment approach for such women with metastatic breast cancer has been sequential use of as many hormone therapies as possible, keeping metastatic disease under control for as long as possible," Hortobagyi said. "These findings may allow us to change our approach.  In this group of heavily pre-treated patients, all of whom progressed on prior endocrine therapy, the addition of this mTOR inhibitor resulted in significant prolongation of progression-free survival and an improved response rate, with only a modest addition of toxicity."

Researchers enrolled 724 metastatic breast cancer patients into the international phase 3 trial. Study participants were post-menopausal and most had been treated with extensive hormone therapy treatments.  Patients were randomized, then 485 received a combination of everolimus (a medication that stops cancer cells from reproducing by decreasing blood supply to the cancer cells) and exemestane (a medication that decreases estrogen in the body).  Those patients were then compared to the 239 participants who received exemestane and a placebo.

Participants who received the combination therapy experienced 7.4 months of progression-free survival, compared to the 3.2 months that patients experienced on the placebo.

The trial was partially funded by pharmaceutical giant, Novartis.  Hortobagyi acts as a consultant and receives research fund from the company, as well.

In a similar, second study presented at the symposium, researchers of the CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) trial found that adding pertuzumab (a medication that is believed to slow tumor growth) and certain chemotherapies lengthened progression-free survival by an average 6.1 months in patients with metastatic breast cancer patients.

"This is huge," Dr. Jose Baselga, lead author of the study and professor of medicine at Harvard Medical School," said in a statement.  "It is very uncommon to have a clinical trial show this level of improvement in PFS. ...The fact that we now have an agent that can be added to current treatment to delay progression is very exciting."

While Dr. Vered Stearns, co-director of the Breast Cancer Program at Johns Hopkins, said the results of both trials could be game changers for treatment of metastatic breast cancer patients, progression free survival is a complicated point of treatment.

"The breast cancer community, government agencies and stakeholders should be evaluating what endpoints are most relevant and set proper guidelines," said Stearns.

Copyright 2011 ABC News Radio

ABC News Radio