Drug Shows Early Promise for Advanced Lung Cancer
Keytruda is already approved to treat melanoma
SUNDAY, April 19, 2015 (HealthDay News) -- A new drug that boosts the immune system's cancer-fighting potential is showing early promise for some patients with advanced lung cancer.
The drug, marketed as Keytruda, was recently approved in the United States for treating advanced melanoma, but is not yet approved for lung cancer.
Still, experts were encouraged by preliminary findings reported Sunday at the annual meeting of the American Association for Cancer Research in Philadelphia, and published simultaneously in the New England Journal of Medicine.
In a study of nearly 500 patients with advanced lung cancer, those with high levels of a particular protein in their tumor cells responded well to the drug, researchers reported.
Close to half of these patients saw their tumors shrink, and so far, the effect has typically lasted beyond a year.
"The duration of patients' response is particularly exciting," said lead researcher Dr. Edward Garon, an associate professor of medicine at the University of California, Los Angeles.
Dr. Benjamin Creelan, a lung cancer researcher who was not involved in the study, agreed.
"The durability of these responses is impressive," said Creelan, who is with the thoracic oncology program at the Moffitt Cancer Center, in Tampa, Fla.
The results add to recent advances in battling advanced lung cancer -- a disease that historically has had a poor prognosis. According to the U.S. National Cancer Institute, only about one-third of patients see any tumor shrinkage with standard chemotherapy, and even with treatment, people typically survive for a year.
Some newer drugs that target certain abnormal proteins on lung cancer cells have become available, Garon noted, but not too many patients have those specific abnormalities.
Keytruda (pembrolizumab) belongs to a new group of drugs that block a "pathway" called PD-1, which then frees up the immune system to attack cancer cells. Last September, the U.S. Food and Drug Administration approved Keytruda for treating advanced melanoma that no longer responds to other drugs.
The drug's manufacturer, Merck, priced it at $12,500 a month.
Last month, the FDA approved another PD-1 drug -- nivolumab (Opdivo) -- for treating some cases of advanced lung cancer.
In the new study, Creelan said, the effectiveness and safety of Keytruda, which is given by IV, "appeared comparable to nivolumab."
And that's good news, Creelan said. "Trial results like these represent a revolution in care of lung cancer patients," he said.
The Merck-funded study involved 495 patients in the advanced stages of non-small-cell lung cancer, which accounts for the vast majority of lung cancer cases in the United States.
All of the patients received infusions of Keytruda every two to three weeks. Garon's team also analyzed their tumor samples to measure levels of a protein called PD-L1.
The point was to see whether patients' PD-L1 levels correlated with their likelihood of responding to the treatment, Garon explained. If they did, that could give doctors a way of targeting the drug to patients likely to benefit.
As it turned out, PD-L1 was a good predictor.
Of the whole study group, 19 percent responded to the treatment, meaning their tumors shrank by at least 30 percent, Garon said.
But among patients with PD-L1 activity in at least half their tumor cells, 45 percent responded to the drug.
"It's exciting to be able to identify a group of patients who are likely to do well," Garon said.
After about a year of follow-up, most of the study patients with high PD-L1 levels were still alive, Garon said.
The researchers are still tracking what the typical survival might be. They're also continuing to study Keytruda's potential benefits for patients with lower amounts of PD-L1 in their tumor cells.
The most common side effects were fatigue, skin rash and appetite loss. But about 10 percent of patients had more severe side effects, Garon said. Nine developed serious cases of lung inflammation, including one who died.
Although Keytruda is on the market, it is not specifically approved for lung cancer yet. And the PD-L1 test is not commercially available, Garon said.
For people with lung cancer, Garon and Creelan pointed to the bigger picture: New approaches to battling the disease are under development and starting to come to the market.
"I think we're going to be seeing more options opening up for these patients," Garon said.
The U.S. National Cancer Institute has more on lung cancer treatment (http://www.cancer.gov/cancertopics/treatment/lung ).
SOURCES: Edward Garon, M.D., associate professor, medicine, David Geffen School of Medicine, University of California, Los Angeles; Benjamin Creelan, M.D., assistant member, thoracic oncology program, Moffitt Cancer Center, Tampa, Fla.; April 19, 2015 presentation, American Association for Cancer Research annual meeting, Philadelphia, Pa.; April 19, 2015 New England Journal of Medicine, online
FDA Warns of Bogus Botox
Doctors should closely examine wrinkle-reliever packaging
MONDAY, April 20, 2015 (HealthDay News) -- Counterfeit Botox may have been distributed to doctors' offices and medical clinics across the United States, the U.S. Food and Drug Administration warns.
The bogus Botox -- which is considered unsafe and should not be used -- was sold by an unlicensed supplier not authorized to ship or distribute drug products in the United States, the FDA said in a news release.
Packaging similarities between the fakes and the FDA-approved Botox, which is made by Allergan (100 units/vial), could cause health care professionals to mistake one for the other.
Approved Botox displays the active ingredient as "OnabotulinumtoxinA" on the outer carton and vial, the FDA said.
The outer carton of the counterfeit version says the active ingredient is "Botulinum Toxin Type A" instead of "OnabotulinumtoxinA," according to the agency.
The FDA said the counterfeit product also can be identified in other ways. For instance, the vial is missing the lot number.
Injections of Botox -- a toxin produced by the bacterium Clostridium botulinum -- temporarily smooth facial wrinkles and frown lines. Botox is also used to treat severe underarm sweating, uncontrolled blinking and chronic migraine, according to the U.S. National Institutes of Health.
Health care professionals should check with Allergan to confirm that the distributor that provided the Botox is authorized to sell the product, the FDA said. Allergan's website lists authorized Botox suppliers.
Suspected counterfeit Botox products should be reported to the FDA.
There are no known cases of people harmed by the counterfeit version of Botox, the FDA noted. The approved product by Allergan is considered safe.
The U.S. Food and Drug Administration has more about counterfeit medicine (http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htm ).
SOURCE: U.S. Food and Drug Administration, news release, April 20, 2015
'Tamper-Proof' Narcotic Painkiller May Be Curbing Abuse: Study
Number of prescriptions, overdoses dropped, but heroin overdoses went up
MONDAY, April 20, 2015 (HealthDay News) -- Narcotic painkillers that have features that make them hard to abuse may be linked to a drop in both the number of prescriptions and overdoses of these drugs, a new study finds.
After a tamper-resistant form of OxyContin was introduced in 2010, prescriptions dropped 19 percent and the rate of overdoses dropped 20 percent across the United States. However, the rate of heroin overdose increased by 23 percent during the same period, the researchers added.
"This is the first time in the last two decades that narcotic prescribing had dropped, rather than continued to increase," said lead researcher Dr. Marc Larochelle, an instructor at Boston University School of Medicine.
And painkiller overdoses also decreased, he added. "Some were skeptical that simply decreasing supply would lead to a decrease in overdoses, but we did find that," Larochelle said.
However, since heroin overdoses increased, the overall rate of overdoses from narcotics didn't decline, he explained.
"Reducing supply may have led some people who are abusing these drugs to substitute an illicit narcotic like heroin, and it may partially explain why we have seen an explosion in heroin use across the country," Larochelle said.
Larochelle pointed out that when the tamper-resistant form of OxyContin was released, the prescriptions for this drug dropped 40 percent. Larochelle speculates that this drastic drop in prescriptions could be the result of fewer people abusing OxyContin or more of it being sold on the street. "Up to 40 percent of the product may have been being abused or diverted to the street," he said.
The new abuse-deterrent OxyContin is resistant to crushing and dissolving, both ways to bypass the extended-release mechanism and get a quicker, more intense high, the researchers said.
"With the pill, you used to be able to crush it up and either snort it or dissolve it and inject it. Now if you try and crush it, it doesn't turn into a powder -- it just kind of balls up, and if you try and dissolve it, it turns into a goo," Larochelle explained.
Changing the formulation will not by itself solve the drug abuse problem, he said. "But it shows supply could be one part of the issue. Abuse-resistant formulations will not cure people who are addicted to narcotics. It could, however, prevent or slow down the number of new people who become addicted, because many people who use heroin may have started with pills," he said.
Larochelle believes better access to treatment is needed for those addicted to narcotics. "We still need to focus on identification, diagnosis and treatment of people who have an addiction, not only on the supply chain," he suggested.
The report was published online April 20 in the journal JAMA Internal Medicine.
Dr. Hillary Kunins, an assistant commissioner in the New York City Department of Health and Mental Hygiene and author of an accompanying journal editorial, said making these long-acting narcotic painkillers tamper-resistant reduces the dangers of these drugs.
"However, this is only part of the response we need to make to the problem of narcotic misuse and overdose," she said. One way to prevent addiction in the first place, Kunins said, is by prescribing narcotic painkillers judicially.
"We seek to reduce or prevent the unnecessary exposure to narcotics and that's got to be part of the solution so people don't end up trying other narcotics like heroin or other prescription painkillers," she said. "We encourage the public to use narcotic painkillers only when needed and only for as long as needed, and if there are extra pills dispose of them safely."
In addition, people already addicted to narcotics need to have effective treatments available, Kunins said.
Kunins said that although the rate of heroin overdoses increased, the increase was not significant. "We are not trading one problem for another," she added.
For the study, Larochelle and colleagues used data from a large health insurer with 31 million members. They looked at claims for narcotic painkillers from 2003 through 2012.
Visit the U.S. National Institute on Drug Abuse (http://easyread.drugabuse.gov/painkiller-abuse-facts.php ) for more on narcotic painkillers.
SOURCES: Marc Larochelle, M.D., M.P.H., instructor, Boston University School of Medicine; Hillary Kunins, M.D., M.P.H., assistant commissioner, New York City Department of Health and Mental Hygiene; April 20, 2015, JAMA Internal Medicine, online
Antibiotics May Be Overused in Many Neonatal ICUs, Study Finds
Big variation seen in prescribing rates, despite little difference in infection rates
MONDAY, April 20, 2015 (HealthDay News) -- Antibiotics appear to be overused in many neonatal intensive care units, new research suggests.
Just how overused these medications were varied widely, the study authors found. Some neonatal intensive care units (NICUs) gave antibiotics to newborns at a rate 40 times greater than rates at other NICUs, even when there was little difference in infection rates.
"The results of this study aren't surprising. We have reams of data showing that antibiotics are overused in multiple other settings," said Dr. Clay Jones, a pediatrician specializing in newborns at Newton-Wellesley Hospital in Massachusetts, who was not involved in the study. "The most striking finding is the degree of variance in the use of antibiotics between facilities."
The findings were published online April 20 in the journal Pediatrics.
In the study, California health officials analyzed the medical care of more than 52,000 infants in 127 neonatal intensive care units across the state in 2013.
Antibiotic use in these units ranged from 2.4 percent of patient-days to 97 percent of patient-days. These percentages represent the number of days out of 100 that a baby received at least one antibiotic or antifungal medication. Approximately half the neonatal intensive care units used antibiotics less than 25 percent of patient-days, and half used more.
However, antibiotic use in the NICUs did not correspond to the rates of infections, surgical cases, infant deaths or cases of necrotizing enterocolitis, a condition in which parts of the digestive system decay. So, the researchers concluded that many antibiotics are likely being used when they are not needed.
A major reason for the wide variation in antibiotic rates is that deciding to prescribe antibiotics depends largely on an individual doctor's ability to determine the likelihood that an infant has a life-threatening infection, Jones explained.
"In all areas of medicine, treatment decisions come down to an assessment of risks versus benefits, and often there is a subjective component to this assessment," Jones said. "Most instances where antibiotics are used in newborns, we don't know what we are treating, but something has led us to have concern that the child is infected."
Doctors rely on their training and experience, but their emotions and thinking biases may lead them to make different decisions from one another, Jones said. Blood tests can also have false negatives, where the lab work shows no infection but there really is one.
When a baby has a major infection, it can be "catastrophic," Jones said, so doctors may also err on the side of caution by giving antibiotics. However, that cautionary treatment also has risks.
"Many of the potential adverse outcomes of antibiotics are not immediate, so the prescribing physicians in these facilities may not be exposed to them frequently," Jones said. "Thus, there may be a false perception regarding the risk of unnecessary antibiotic use."
Giving antibiotics to newborns may actually increase the risk of infection, death and necrotizing enterocolitis, the study authors explained. Antibiotic use is also linked to a higher risk of asthma later in life, can affect the balance of bacteria in the digestive tract, and contributes to the rise of antibiotic-resistant bacteria.
"These so-called multidrug-resistant pathogens are themselves associated with increased illness, deaths, cost of care and length of hospital stay," said study author Dr. Joseph Schulman, director of NICU quality measurement and improvement for California Department of Health Care Services. "There are benefits and harms when treating suspected but unproven infection, and these may vary among different newborns."
More research could help reveal how doctors are making their decisions, but solving the problem is not so simple, Jones said.
"Unfortunately, this isn't a situation where firm recommendations are possible," Jones said. "These aren't well toddlers with the sniffles. With current technology, it is difficult to see how the subjective component of decision-making can be taken out of the equation."
Parents should always speak up to ask why antibiotics are being used, if they are needed and if they can be stopped, Jones suggested. But that usually is a lot to ask of anxious, exhausted parents with a child in NICU, he said.
"The responsibility of curbing excessive use of antibiotics falls on the physicians," Jones said. "Research such as this, even if not surprising, is still beneficial. We need to be made aware of our shortcomings in order to focus on improving them."
To learn more about antibiotic use, go to the American Academy of Family Physicians (http://familydoctor.org/familydoctor/en/drugs-procedures-devices/prescription-medicines/antibiotics-when-they-can-and-cant-help.printerview.all.html ).
SOURCES: Clay Jones, M.D., neonatal hospitalist, Newton-Wellesley Hospital, Newton, Mass.; Joseph Schulman, M.D., director, NICU quality measurement and improvement, California Children's Services/Systems of Care, California Department of Health Care Services, Sacramento, Calif.; April 20, 2015, Pediatrics, online
Income May Affect Survival After Lung Cancer Surgery
Study also finds education level, hospital linked to odds of death in month after operation
MONDAY, April 20, 2015 (HealthDay News) -- Lung cancer patients with less income and education are more likely to die within 30 days of cancer surgery than those with more education and money, a new study finds.
The type of hospital where the surgery occurs also matters, said researchers who examined results of more than 215,000 lung cancer surgeries performed in the United States between 2003 and 2011.
The findings are published in the April 20 issue of the Journal of the American College of Surgeons.
"Clearly, our results show that patients who come from less educated and less wealthy communities are at risk for mortality with the lung cancer operation," said study co-author Dr. Felix Fernandez, an assistant professor of surgery at Emory University School of Medicine in Atlanta.
"In order to get uniform superior outcomes for our patients, we need to identify the patients who are at risk for worse outcomes. This is the first step in describing where those disparities exist," he added in a journal news release.
As in previous studies, this one found that the risk of death within 30 days of surgery was higher among patients who were men, older, had other health problems, had late-stage cancer and had larger tumors.
But after accounting for these factors, the researchers also found that lower income and education levels were independently associated with an increased risk of death. However, the study did not show a cause-and-effect link.
Patients who lived in communities with a median annual household income of less than $30,000 were 25 percent more likely to die within 30 days of lung cancer surgery than those who lived in communities with a median annual household income of more than $46,000. Median is the midpoint, not the average.
Patients in communities with lower levels of education were 16 percent more likely to die within 30 days of lung cancer surgery than those in communities with higher levels of education, according to the study.
Compared to those who had surgery at an academic medical center, the risk of death within 30 days was 34 percent higher among patients who had surgery at a community hospital and 22 percent higher among those who had surgery at a comprehensive center.
In the United States, lung cancer is the leading cause of cancer death, according to the U.S. Centers for Disease Control and Prevention.
The U.S. National Cancer Institute has more about lung cancer (http://www.cancer.gov/publications/patient-education/wyntk-lung-cancer ).
SOURCE: Journal of the American College of Surgeons, news release, April 16, 2015
Aspirin May Help Ward Off Gastro Cancers, Study Finds
But experts caution against starting to take it every day in hopes of preventing disease
SUNDAY, April 19, 2015 (HealthDay News) -- Taking aspirin regularly over several years may help prevent gastrointestinal cancers, a new study suggests.
There was a 20 percent lower risk of cancers of the gastrointestinal tract, especially in the colon and rectum, among people taking aspirin, said lead researcher Yin Cao, a postdoctoral research fellow at the Harvard School of Public Health in Boston.
But Cao doesn't think people should start taking aspirin to prevent cancer until more research is done. "The results of ongoing research to develop more tailored treatment based upon a personalized assessment of risks and benefits is critical before recommending aspirin for preventing cancer," she said.
Moreover, patients and their doctors need to consider the potential risks of taking aspirin, including stomach bleeding, Cao said.
However, "if considered alongside the known benefits of aspirin in the prevention of heart attacks and strokes, our data suggest the possibility that long-term regular aspirin use may have a significant benefit in prevention of the two leading causes of sickness and death in the U.S. and much of the world," she said.
The results of the study were to be presented Sunday at an American Association for Cancer Research meeting in Philadelphia. The data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.
For the study, Cao and her colleagues collected data on 82,600 women enrolled in the Nurses' Health Study in 1980 and 47,650 men enrolled in the Health Professionals Follow-up Study in 1986. The researchers collected data on aspirin use, risk factors for cancer and diagnoses of cancer.
After up to 32 years of follow-up, about 20,400 women and 7,570 men developed cancer, the investigators found. Among men, prostate cancer was excluded.
Cao's team found that men and women who took a regular dose of aspirin (325 milligrams) two times a week or more had a lower risk of cancer overall than people who did not regularly take aspirin. The reduced risk was largely due to fewer cases of gastrointestinal cancers, including colon cancer, rectal cancer and esophageal cancer.
Regular aspirin use was not associated with a reduced risk of other cancers. Specifically, no link was found between aspirin use and a lower risk of breast cancer, advanced prostate cancer or lung cancer, the researchers said.
Moreover, the benefit of aspirin in reducing overall cancer risk appeared to depend on how much one took. So the more aspirin taken, the more the risk was reduced. Amounts ranged from less than one aspirin a week to 15 or more, the researchers said.
Getting the biggest benefit from aspirin required taking it for at least 16 years. The benefit was no longer seen within four years of stopping it, the researchers found. And the study only showed an association between aspirin use and gastrointestinal cancer risk, not a cause-and-effect relationship.
The association of aspirin with reduced cancer risk was the same for women and men regardless of race, history of diabetes, family history of cancer, weight, smoking, regular use of other painkillers or taking multivitamins, the study authors added.
Eric Jacobs, strategic director of pharmacoepidemiology at the American Cancer Society, said the new study "confirms the now well-established link between regular aspirin use and lower risk of developing certain cancers of the gastrointestinal tract -- cancers of the colon, rectum and esophagus."
Some, though not all, previous studies have indicated that aspirin might slightly lower risk of certain other cancers, including breast cancer, prostate cancer and lung cancer, he added.
"Although aspirin is recommended for most people who have had a heart attack, and has some benefits for cancer risk as well, at this point the American Cancer Society does not recommend that people use aspirin specifically to prevent cancer because it is not clear that the benefits with respect to cancer outweigh the risks," Jacobs said.
While not common, aspirin can cause serious, even occasionally fatal, stomach bleeding, even at low doses, he said.
"People who are uncertain about whether they should be using aspirin should talk to their health care provider, who knows their personal medical history and can help weigh their individual risks and benefits," Jacobs said.
Visit the U.S. National Cancer Institute (http://www.cancer.gov/cancertopics/research-updates/2014/aspirin ) for more on aspirin and cancer risk.
SOURCES: Yin Cao, postdoctoral research fellow, Harvard School of Public Health, Boston; Eric Jacobs, Ph.D., strategic director, pharmacoepidemiology, American Cancer Society; April 19, 2015, presentation, American Association for Cancer Research meeting, Philadelphia
Health Tip: Prevent Toenail Fungus
Keep feet clean and dry
(HealthDay News) -- Fungi are everywhere, and can easily sneak beneath your toenails and cause an unpleasant infection.
The American Podiatric Medical Association suggests these preventive steps:
Treat feet to regular, careful washing with soap and water and a thorough drying.
In public places, wear flip flops or shower shoes.
Swap hosiery, socks and shoes more than once per day.
Keep toenails trimmed and cut in a straight line. Disinfect nail clippers and other tools used on nails.
Avoid tight hosiery, and stick to well-fitting shoes made of materials that breathe.
Opt for socks made of synthetic materials that keep away moisture from skin.
Don't attempt to cover up fungus discoloration with nail polish.
Immune-Focused Drugs Show Promise Against Melanoma
Keytruda, Yervoy and other medications harness immune cells to target cancers, experts say
MONDAY, April 20, 2015 (HealthDay News) -- Drugs that supercharge the body's immune system show promise in treating advanced melanoma, according to a pair of clinical trials.
The trials both involve drugs called immune checkpoint inhibitors, which essentially prod the immune system to attack and destroy cancer cells, said Dr. Suzanne Topalian, director of the Melanoma Program at Johns Hopkins' Sidney Kimmel Comprehensive Cancer Center in Baltimore.
In one trial, researchers found that an immune checkpoint inhibitor called Keytruda (pembrolizumab) outperformed the current frontline treatment for advanced melanoma, another immune-boosting drug called Yervoy (ipilimumab).
The other trial showed that patients responded better to a combination of two different types of immune checkpoint inhibitors than to Yervoy used on its own.
Both trials were slated for presentation Monday in Philadelphia at the annual meeting of the American Association for Cancer Research, and both were also simultaneously published in the New England Journal of Medicine.
The new drugs provide hope for patients with advanced melanoma, which up to now has proven a swift and fatal disease, said Dr. Gary Schwartz, chief of the division of Hematology/Oncology at Columbia University Medical Center in New York City.
"We were lucky if patients lived nine to 11 months," said Schwartz, who also is an expert for the American Society of Clinical Oncology. "Now we have patients living five or 10 years with metastatic disease, and that was unheard of in melanoma."
Schwartz said the immune-boosting drugs now being tested have the potential to help curb many other forms of cancer.
"The potential here is really limitless with immune activation. Now we can effectively turn on these immune switches and kill cancer cells," he said. "This is the beginning of a new age of oncology, and it is starting with melanoma."
The U.S. Food and Drug Administration approved Yervoy in 2011. The drug targets an immune system "switch" called CTLA4, which acts to rein in the body's immune cells so they don't run amok.
Cancers normally take advantage of controls like CTLA4 to avoid detection and destruction by the immune system. "It turns out these immune checkpoint molecules help the tumor create a shield around itself, preventing the immune cells from destroying it," Topalian said.
The FDA subsequently has approved a second-generation set of immune checkpoint inhibitors that target a more cancer-specific "switch" called PD1, Schwartz said. These drugs currently are used if patients do not respond to Yervoy.
One of the anti-PD1 drugs, Keytruda, showed better results with fewer side effects in a phase III trial that compared it against Yervoy, researchers reported Monday.
The trial involved 834 patients with advanced melanoma in 16 countries. Two-thirds received Keytruda, while the rest received the current front-line treatment.
At six months after treatment, progression-free survival -- meaning the cancer had not grown -- was about 46 percent for Keytruda and 26 percent for Yervoy. Overall survival rates after one year stood at 74 percent and 68 percent for Keytruda, depending on the dose patients received, compared with 58 percent for Yervoy.
About 33 percent of patients responded to treatment with Keytruda, compared with 12 percent for Yervoy, the study found.
Furthermore, only 12 percent of patients taking Keytruda suffered from side effects, compared with 20 percent in those who received Yervoy.
Keytruda performs better because it focuses on a switch involved in immune system cells that already have identified the cancer and are trying to attack it, said senior investigator Dr. Antoni Ribas, director of the Tumor Immunology Program Area at UCLA Jonsson Comprehensive Cancer Center.
The other clinical trial showed that combining two types of immune checkpoint inhibitors produced a good response in many more patients, even those with a genetic mutation that increases the ferocity of their melanoma.
However, the combination also greatly increased the risk of side effects, the researchers noted.
The trial involved 142 patients with advanced melanoma. Two-thirds received the combo therapy, which included the anti-CTLA4 drug Yervoy and the anti-PD1 drug Opdivo (nivolumab). Another third of patients received Yervoy alone.
The study found that in patients without the dangerous mutation, 61 percent responded to the combo treatment versus just 11 percent who responded to treatment with Yervoy alone.
Patients with the dangerous mutation also responded well to the combination therapy, with 44 percent receiving some benefit.
"We now have a combination of medicines that seem to benefit more than half of patients with malignant melanoma, regardless of mutation status," said senior clinical trial investigator Dr. Jedd Wolchok, chief of Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center in New York City.
However, about half of the patients receiving the combination therapy did suffer from moderate to serious side effects, compared with just a quarter of patients treated with Yervoy alone, the team found.
By unleashing the immune system to attack cancer, doctors run the risk that the immune cells also will start targeting the major organs of the body, Schwartz said. This can cause temporary organ damage and, in extreme cases, organ failure.
"This is not penicillin," he said. "There are still times when the immune system will run amok, and you have to put it back in the box."
Topalian noted that researchers in the studies were able to control the side effects by suspending the drug therapy and treating patients with inflammation-dampening steroid medications.
But Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, said the seriousness of these side effects cannot be ignored.
"We understand better now how to manage some of those side effects, but the reality is they can be significant and they require a team of professionals working together to manage those side effects," Lichtenfeld said. "It is not a simple treatment."
The new cancer drugs are not cheap, either. Topalian said treatment with any of them will easily top $100,000 a year.
That said, both clinical trials represent significant advances in "a continuing evolution of our understanding how to treat patients with advanced melanoma," Lichtenfeld said.
"Before, we had virtually nothing for the vast majority of advanced melanoma patients that would allow them to live more months," Lichtenfeld said. "Now we have drugs where that is actually happening. For some patients, they've had responses where the disease has even stabilized or gone away, and they maintain those responses for a long period of time."
The Keytruda trial was funded by the drug company Merck, while the combination therapy trial was funded by Bristol-Myers Squibb.
For more on melanoma, visit the U.S. National Institutes of Health (http://www.nlm.nih.gov/medlineplus/melanoma.html ).
SOURCES: Suzanne Topalian, M.D., director, Melanoma Program, Johns Hopkins' Sidney Kimmel Comprehensive Cancer Center, Baltimore, Md.; Gary Schwartz, M.D., chief, division of Hematology/Oncology, Columbia University Medical Center, New York City; Jedd Wolchok, M.D., Ph.D., chief of Melanoma and Immunotherapeutics Service, Memorial Sloan Kettering Cancer Center, New York City; Len Lichtenfeld, M.D., deputy chief medical officer, American Cancer Society; Antoni Ribas, M.D., Ph.D., director, Tumor Immunology Program Area, UCLA Jonsson Comprehensive Cancer Center, Los Angeles, Calif.; presentations, April 20, 2015, annual meeting, American Association for Cancer Research; April 20, 2015, online, New England Journal of Medicine
Pets Can Spread Infections to People: Review
Vet offers tips on how to protect vulnerable household members
MONDAY, April 20, 2015 (HealthDay News) -- Pets can transfer infections to humans, especially young children, seniors, pregnant women and those with weakened immune systems, experts report.
Pet owners and health care providers need to be aware of this risk and take steps to protect vulnerable people, said the authors of a review published in the April 20 issue of the Canadian Medical Association Journal.
"Studies suggest physicians do not regularly ask about pet contact, nor do they discuss the risks of zoonotic diseases with patients, regardless of the patient's immune status," said Dr. Jason Stull in a journal news release. He is an assistant professor in the department of veterinary preventive medicine at Ohio State University.
A zoonotic disease is one that can be passed between animals and humans.
All pets can transmit diseases to people, including salmonella, drug-resistant bacteria, campylobacter, and parasitic diseases such as hookworm, roundworm and toxoplasmosis. The infections can be transmitted through bites, scratches, saliva and contact with feces. Reptiles and amphibians can transmit diseases indirectly, such as on contaminated surfaces.
"Reptiles and amphibians are estimated to be responsible for 11 percent of all sporadic salmonella infections among patients less than 21 years of age, and direct contact with such animals is not required for zoonotic transmission," the researchers noted.
"In one study, 31 percent of reptile-associated salmonellosis cases occurred in children less than 5 years of age and 17 percent occurred in children aged 1 year or younger; these findings highlight the heightened risk in children and the potential for reptile-associated salmonella to be transmitted without direct contact with the animal or its enclosure," they added.
The researchers said there are a number of simple ways to reduce the risk of pets infecting people. These include: wearing protective gloves to clean aquariums and cages and to remove feces; proper hand washing after contact with pets; discouraging pets from licking faces, and regular cleaning and disinfection of animal cages, feeding areas and bedding.
Other measures include: covering playground boxes when not in use; placing litter boxes away from areas where people eat and prepare food; avoiding contact with exotic animals; regular veterinary visits for all pets, and not getting a new pet until everyone's immune system is healthy.
The U.S. National Library of Medicine has more about pets and people with weakened immune systems (http://www.nlm.nih.gov/medlineplus/ency/article/003967.htm ).
SOURCE: Canadian Medical Association Journal, news release, April 20, 2015
Swallowing Pills? Children Can Learn How
Five strategies were identified that help get the medicine down
MONDAY, April 20, 2015 (HealthDay News) -- Children who have trouble swallowing needed pills aren't out of luck, according to a new study. At least five different strategies may help them swallow pills and capsules more easily, researchers found.
"Pill swallowing difficulty is not an uncommon problem, and there are resources that may be available to children based on their particular difficulty," said study co-author Dr. Kathleen Bradford, a pediatrician at North Carolina Children's Hospital in Chapel Hill. "Addressing this problem and researching more effective ways to implement these interventions can help improve medication administration and compliance in children."
The key, one expert said, is that children practice, especially when they are not sick, so they don't need to learn on the fly.
"I recommend practice, lots of water and start small," said Dr. Jaime Friedman, a pediatrician at Children's Primary Care Medical Group in San Diego. "My partner taught his son using Tic Tacs."
Starting "pill swallowing training" earlier rather than waiting till your child has had bad experiences is also helpful, Bradford's team reported.
The researchers looked for all studies from 1986 to 2013 that focused on improving difficulties with pill swallowing for children. They found five studies that identified a successful method to help kids swallow pills more easily.
The successful strategies included using flavored throat spray first, giving children verbal instructions, behavioral therapies, using a specialized pill cup and training children to use five different head postures.
The findings were published online April 20 in the journal Pediatrics.
An estimated 10 to 20 percent of children will have problems swallowing pills, Bradford said, though some studies noted in this paper showed even higher percentages.
Study co-author Dr. Ravi Jhaveri, also a pediatrician at North Carolina Children's Hospital, said there are many reasons children have problems with pill swallowing. "Some are behavioral, including anxiety, and others include problems with pill size, texture and taste, as well as the physical technique required to swallow a pill," he said.
For many medications, doctors can prescribe a liquid, but liquid is not always an option, said Friedman, who was not involved in the study.
"For some medications like most ADHD meds, there isn't a choice, so the kids have to learn," Friedman said. "I think children have trouble because it is a new sensation and they are afraid of gagging or choking or vomiting."
The methods described in the studies offer some helpful solutions, Friedman said.
"I think a combined method of behavioral interventions and teaching head positions seems most plausible," she said. "The paper was not specific about what the behavioral interventions were, but I think relaxation is key."
Modeling, or demonstrating, was also found helpful as a behavioral therapy.
Most of the studies reviewed in this paper involved small numbers of children, but they showed high levels of success with the various methods.
For example, one study teaching behavioral interventions enabled 17 of 29 children to take large capsules for at least six months. Another study with behavioral interventions had success with all but one of 23 children.
In another study involving 67 children who initially could not swallow pills, 47 learned to do so by following scripted instructions, and nine others learned with the script once they had a small pill cup.
The study with the flavored throat spray had just 11 children, seven of whom could swallow a small candy after using the throat spray.
Finally, all 33 children who were taught five different head positions and completed a two-week practice plan were able to swallow pills successfully after those two weeks.
The U.S. National Library of Medicine has tips on giving children's medications (http://www.nlm.nih.gov/medlineplus/medicinesandchildren.html ).
SOURCES: Kathleen Bradford, M.D., division of general pediatrics and adolescent medicine, North Carolina Children's Hospital, Chapel Hill, N.C.; Ravi Jhaveri, M.D., associate professor, pediatrics, division of infectious diseases, North Carolina Children's Hospital; Jaime Friedman, M.D., F.A.A.P., pediatrician, Children's Primary Care Medical Group, San Diego, Calif.; May 2015, Pediatrics