(HealthDay News) -- Ovarian cancer has long had a reputation as a silent killer, because many people believed it gave no warning signs until far advanced.
But women suffering from the disease knew differently. They knew they had certain symptoms that were common from patient to patient.
"Survivors for years have said there are symptoms for the disease, but no one listened to them," said Jane Langridge, chief executive officer for the National Ovarian Cancer Coalition.
Now, doctors have agreed with them.
A screening test has been developed that, in one study, accurately detected early stage ovarian cancer 57 percent of the time.
Based on that and similar studies, experts from the American Cancer Society, the Gynecologic Cancer Foundation and the Society of Gynecologic Oncologists have agreed on a set of symptoms that can be signs of early ovarian cancer.
"We want people to know it's not the silent killer. There are symptoms women can bring to their doctors that are important to pay attention to," said Dr. Linda Duska, a member of the National Ovarian Cancer Coalition's medical advisory board and a gynecologic oncologist at Massachusetts General Hospital Cancer Center, in Boston.
"This agreement is significant in the fact that, maybe if we pay more attention to symptoms, we can catch them sooner and have more success in treating them," she continued.
Early detection of ovarian cancer is crucial.
More than 22,000 U.S. women will be diagnosed with the disease this year, and three-fourths of them -- more than 15,000 -- will die from it, according to the National Cancer Institute.
If caught in the early stages, the five-year survival rate for ovarian cancer is 90 percent. But 75 percent of women are still diagnosed in the advanced stages, when the prognosis is poor.
Ovarian cancer is the eighth most common cancer among American women, not including skin cancer, according to the American Cancer Society. An estimated two-thirds of women with ovarian cancer are 55 or older.
"It is a disease that is detected in stage 3 and above, and that is unacceptable," said Sherry Salway Black, executive director of the Ovarian Cancer National Alliance and a survivor of the disease. "Our mortality figures are unacceptable."
The symptoms of ovarian cancer can be subtle and hard to assess, because they often mimic common digestive and gastrointestinal disorders. They include persistent swelling, bloating, pressure or pain in the abdomen, gastrointestinal upset, difficulty eating or feeling full quickly, and the frequent or urgent need to urinate.
Because these symptoms are so common, women should be careful not to assume the worst, Duska said.
"The goal of this is not to make everyone think they have ovarian cancer," she said. "If women have these symptoms, and they persist over time, they should have them investigated.
Everyone with bloating does not have ovarian cancer."
Typically, two or more symptoms occur simultaneously and increase in severity over time, according to the National Ovarian Cancer Coalition.
The screening test developed late last year involves an extensive checklist of symptoms and their frequency. It picked up early stage ovarian cancer 56.7 percent of the time, and late stage ovarian cancer 80 percent of the time. The test also produced "false-positive" findings 10 percent to 13 percent of the time.
The test searches for many of the symptoms agreed upon by cancer experts as indicative of ovarian cancer.
"When women go to their doctors and have had some of these symptoms, and they are new and have persisted for two or more weeks, perhaps a doctor now would be willing to perform some pretty simple tests to rule out ovarian cancer," Langridge said.
Women who have a family history of breast or ovarian cancer are at increased risk and should pay particular attention to the symptoms, Duska said.
Treatment of ovarian cancer usually involves a combination of surgery and chemotherapy.
Advances in chemotherapy have made the late-stage disease more survivable, Duska said.
In a more intensive regimen recently shown to improve survival, standard intravenous chemotherapy is combined with chemotherapy injected directly into the abdominal cavity. The abdominal injection exposes hard-to-reach cancer cells to higher levels of chemotherapy than can be reached intravenously.
"That was a breakthrough, I think," Duska said.
Other treatments being explored include new chemotherapy drugs, vaccines, gene therapy and immunotherapy, which boosts the body's own immune system to help combat cancer, according to the Mayo Clinic.
More information
To learn more about ovarian cancer, visit the U.S. National Library of Medicine.
Senin, 29 Oktober 2007
Kamis, 25 Oktober 2007
FDA to Review Clotting Drug After Trial Suggests Death Risk
(HealthDay News) -- The U.S. Food and Drug Administration said Thursday that it will review the safety of the clotting drug aprotinin (Trasylol), after a major Canadian trial was stopped early due to an increase in deaths for cardiac surgery patients placed on the drug.
Trasylol, first approved by the FDA in 1993, is typically used to limit blood loss in patients undergoing cardiac surgery.
While less bleeding was noted in the aprotinin group versus patients assigned one of two other drugs, "a trend toward increased mortality in the aprotinin group had been observed throughout the study," the FDA noted in a statement released Thursday.
That elevated 30-day and overall death risk caused the Canadian study's Data Safety Monitoring Board (DSMB) to recommend stopping patient enrollment in the so-called BART trial. The trial was set to recruit about 3,000 adults who were candidates for a variety of cardiac surgeries and were at high risk of bleeding.
"The DSMB concluded that continued enrollment of patients into the aprotinin group was unlikely to significantly change the study findings," the FDA said.
Trasylol's maker, Bayer, also issued a new "guidance" to doctors on Thursday. The German company advises "that physicians use Trasylol only in accordance with approved product labeling." Bayer said it believes the drug "remains a safe and effective treatment option for physicians," but it is working with the FDA and international health authorities to see if any label changes might become necessary as new data emerges.
Trasylol has had a checkered history since it was first approved by the FDA in 1993.
On Sept. 12, a U.S. Food and Drug Administration advisory panel recommended that aprotinin remain on the market, despite evidence that it might have serious side effects.
In February, a study published in the Journal of the American Medical Association found patients on the drug were at greater risk of dying over the next five years than those given two other medications. The same researchers linked aprotinin to an increased risk of kidney failure, heart failure and stroke in a study published in 2006.
"Our present findings deal with death," one of the JAMA study's authors, Dr. Dennis T. Mangano, said at the time. Mangano, director of the Ischemia Research and Education Foundation, a California-based nonprofit group, said that "the death rate for aprotinin patients far outstrips that for the other two drugs."
His team's study tracked the long-term survival of nearly 3,900 heart patients who underwent coronary artery bypass surgery at 62 medical centers worldwide. The researchers tabulated survival at six weeks, six months, and then annually for five years.
The five-year death rate for patients given aprotinin was 20.8 percent, compared to 15.8 percent for those given another drug, aminocaproic acid, and 14.7 percent for those given tranexamic acid. Both alternative drugs are available in generic versions.
After the 2006 report from Mangano's group, the FDA advised doctors to carefully monitor aprotinin patients for kidney, heart and brain damage -- an action taken after Bayer disclosed study data showing that it increased the risk of death, kidney damage, congestive heart failure and stroke.
The 2006 report led to a 37 percent reduction in surgeons' use of aprotinin, Mangano said. "Clinicians, more than anyone else, will decide whether this drug should be on the market or its use should be limited," he said.
Aprotinin does have its defenders.
Dr. T. Bruce Ferguson Jr., associate director of cardiothoracic and vascular surgery at East Carolina University, wrote an accompanying editorial to the JAMA study. He believes the study "was inadequate to address the question they were asking because of the way the database was designed."
"The most important factor they were unable to control was why patients got aprotinin," Ferguson said. "There were no data to address that issue, and therefore it cannot account for physician-related bias."
For example, the higher rate of death and other complications linked to the drug might be due to aprotinin being prescribed for "higher-risk patients who could be expected to have a worse outcome and higher mortality," Ferguson said. Other studies have shown that "in carefully selected patients, aprotinin is a good drug," he said.
The information used in the study was thorough and complete, Mangano countered. "In terms of the database, we had between 7,000 and 10,000 pieces of data per patient from 59 centers in 16 countries, including 23 of the 25 top cardiac centers in the United States."
"The findings speak for themselves," Mangano said. "I think they are as accurate as you can get."
He believes that aprotinin's use should be restricted to about 5 percent of patients in whom other drugs could not be used.
"And the surgeon would have to tell each patient before using this drug that there is literature out there showing that this drug is associated with renal [kidney] failure and death," Mangano said. "For the vast majority of patients, there are the two other alternatives."
More information
There's more on cardiac surgery at the U.S. National Library of Medicine.
Trasylol, first approved by the FDA in 1993, is typically used to limit blood loss in patients undergoing cardiac surgery.
While less bleeding was noted in the aprotinin group versus patients assigned one of two other drugs, "a trend toward increased mortality in the aprotinin group had been observed throughout the study," the FDA noted in a statement released Thursday.
That elevated 30-day and overall death risk caused the Canadian study's Data Safety Monitoring Board (DSMB) to recommend stopping patient enrollment in the so-called BART trial. The trial was set to recruit about 3,000 adults who were candidates for a variety of cardiac surgeries and were at high risk of bleeding.
"The DSMB concluded that continued enrollment of patients into the aprotinin group was unlikely to significantly change the study findings," the FDA said.
Trasylol's maker, Bayer, also issued a new "guidance" to doctors on Thursday. The German company advises "that physicians use Trasylol only in accordance with approved product labeling." Bayer said it believes the drug "remains a safe and effective treatment option for physicians," but it is working with the FDA and international health authorities to see if any label changes might become necessary as new data emerges.
Trasylol has had a checkered history since it was first approved by the FDA in 1993.
On Sept. 12, a U.S. Food and Drug Administration advisory panel recommended that aprotinin remain on the market, despite evidence that it might have serious side effects.
In February, a study published in the Journal of the American Medical Association found patients on the drug were at greater risk of dying over the next five years than those given two other medications. The same researchers linked aprotinin to an increased risk of kidney failure, heart failure and stroke in a study published in 2006.
"Our present findings deal with death," one of the JAMA study's authors, Dr. Dennis T. Mangano, said at the time. Mangano, director of the Ischemia Research and Education Foundation, a California-based nonprofit group, said that "the death rate for aprotinin patients far outstrips that for the other two drugs."
His team's study tracked the long-term survival of nearly 3,900 heart patients who underwent coronary artery bypass surgery at 62 medical centers worldwide. The researchers tabulated survival at six weeks, six months, and then annually for five years.
The five-year death rate for patients given aprotinin was 20.8 percent, compared to 15.8 percent for those given another drug, aminocaproic acid, and 14.7 percent for those given tranexamic acid. Both alternative drugs are available in generic versions.
After the 2006 report from Mangano's group, the FDA advised doctors to carefully monitor aprotinin patients for kidney, heart and brain damage -- an action taken after Bayer disclosed study data showing that it increased the risk of death, kidney damage, congestive heart failure and stroke.
The 2006 report led to a 37 percent reduction in surgeons' use of aprotinin, Mangano said. "Clinicians, more than anyone else, will decide whether this drug should be on the market or its use should be limited," he said.
Aprotinin does have its defenders.
Dr. T. Bruce Ferguson Jr., associate director of cardiothoracic and vascular surgery at East Carolina University, wrote an accompanying editorial to the JAMA study. He believes the study "was inadequate to address the question they were asking because of the way the database was designed."
"The most important factor they were unable to control was why patients got aprotinin," Ferguson said. "There were no data to address that issue, and therefore it cannot account for physician-related bias."
For example, the higher rate of death and other complications linked to the drug might be due to aprotinin being prescribed for "higher-risk patients who could be expected to have a worse outcome and higher mortality," Ferguson said. Other studies have shown that "in carefully selected patients, aprotinin is a good drug," he said.
The information used in the study was thorough and complete, Mangano countered. "In terms of the database, we had between 7,000 and 10,000 pieces of data per patient from 59 centers in 16 countries, including 23 of the 25 top cardiac centers in the United States."
"The findings speak for themselves," Mangano said. "I think they are as accurate as you can get."
He believes that aprotinin's use should be restricted to about 5 percent of patients in whom other drugs could not be used.
"And the surgeon would have to tell each patient before using this drug that there is literature out there showing that this drug is associated with renal [kidney] failure and death," Mangano said. "For the vast majority of patients, there are the two other alternatives."
More information
There's more on cardiac surgery at the U.S. National Library of Medicine.
Senin, 22 Oktober 2007
Whole Grains Do a Heart Good
(HealthDay News) -- Diets rich in whole grains, fruits, vegetables and even a little alcohol may help ward off heart woes, new studies show.
In one study, regular consumption of whole-grain breakfast cereal cut the risk of heart failure for male American physicians.
Another study, this time from Sweden, touted the benefits of fruits, veggies and the occasional drink in helping women beat heart attack.
The American study analyzed the association between breakfast cereal intake and new cases of heart failure, in which the heart progressively loses its ability to pump blood.
The study included data on more than 21,000 participants in the Physicians' Health Study who were followed for almost 20 years.
Compared to those who ate no whole-grain cereal, men who consumed 2 to 6 servings per week saw their risk of heart failure fall by 21 percent, while those who ate 7 or more servings per week reaped a 29 percent reduction in risk, the researchers reported in the Oct. 22 issue of the Archives of Internal Medicine.
That effect is due, in part, to the high levels of magnesium, potassium and fiber in those breakfast cereals, said study co-author Dr. Luc Djousse, an associate in epidemiology at Brigham and Women's Hospital in Boston.
"Our recommendation is that a lay person consuming breakfast cereal should look at fiber," Djousse said. "At least four grams of fiber [per serving], that should be sufficient."
Fiber increases cells' sensitivity to insulin, thus reducing the risk of diabetes, while potassium and magnesium lower blood pressure, he explained.
Breakfast cereal is best taken with skim milk, Djousse said, "and if you want to add to it, a piece or half-piece of fruit would be good."
While the study included only men, there is "no reason at all" why the results shouldn't apply to women, he said.
The Swedish study, done at the Karolinska Institute, Stockholm, took a much broader approach to the food intake of more than 24,000 postmenopausal women who supplied information on how often they ate 96 common foods.
The study, published in the same issue of the journal, identified four major dietary patterns: healthy (vegetables, fruits and legumes); Western/Swedish (red meat, processed meat, poultry, rice, pasta, eggs, fried potatoes, fish); alcohol (wine, liquor, beer and some snacks); and sweets (sweet baked goods, candy, chocolate, jam and ice cream).
In an average 6.2-year follow-up period, 308 of the women had heart attacks. However, two dietary patterns, healthy and alcohol, were associated with a reduced risk of heart attack, the researchers said.
A low-risk diet is characterized by a high intake of whole grains, fish, vegetables, fruit and legumes, moderate alcohol consumption, along with not smoking and being physically active and relatively thin, the researchers concluded. "This combination of healthy behaviors -- present in 5 percent [of those studied] -- may prevent 77 percent of myocardial infarctions [heart attacks] in the study population," the team wrote.
The study was called "empowering" by Dr. Suzanne Steinbaum, director of women and heart disease at Lenox Hill Hospital in New York, because "it demonstrates that people have control over their health and can take control, eat properly and exercise and prevent onset of disease."
"This study clearly demonstrates that it is within an individual's control to change destiny and the ability to control his or her health," Steinbaum said.
"What's amazing is that a study of 24,000 women shows that a reduction of 77 percent is possible," she said. "What could be more empowering than that?"
The issue is muddied by a plethora of books urging different diets, she acknowledged. But the real road to long-term health "is not so much going on a diet as adopting a healthy lifestyle," Steinbaum said.
More information
There's more on heart-healthy lifestyles at the American Heart Association.
In one study, regular consumption of whole-grain breakfast cereal cut the risk of heart failure for male American physicians.
Another study, this time from Sweden, touted the benefits of fruits, veggies and the occasional drink in helping women beat heart attack.
The American study analyzed the association between breakfast cereal intake and new cases of heart failure, in which the heart progressively loses its ability to pump blood.
The study included data on more than 21,000 participants in the Physicians' Health Study who were followed for almost 20 years.
Compared to those who ate no whole-grain cereal, men who consumed 2 to 6 servings per week saw their risk of heart failure fall by 21 percent, while those who ate 7 or more servings per week reaped a 29 percent reduction in risk, the researchers reported in the Oct. 22 issue of the Archives of Internal Medicine.
That effect is due, in part, to the high levels of magnesium, potassium and fiber in those breakfast cereals, said study co-author Dr. Luc Djousse, an associate in epidemiology at Brigham and Women's Hospital in Boston.
"Our recommendation is that a lay person consuming breakfast cereal should look at fiber," Djousse said. "At least four grams of fiber [per serving], that should be sufficient."
Fiber increases cells' sensitivity to insulin, thus reducing the risk of diabetes, while potassium and magnesium lower blood pressure, he explained.
Breakfast cereal is best taken with skim milk, Djousse said, "and if you want to add to it, a piece or half-piece of fruit would be good."
While the study included only men, there is "no reason at all" why the results shouldn't apply to women, he said.
The Swedish study, done at the Karolinska Institute, Stockholm, took a much broader approach to the food intake of more than 24,000 postmenopausal women who supplied information on how often they ate 96 common foods.
The study, published in the same issue of the journal, identified four major dietary patterns: healthy (vegetables, fruits and legumes); Western/Swedish (red meat, processed meat, poultry, rice, pasta, eggs, fried potatoes, fish); alcohol (wine, liquor, beer and some snacks); and sweets (sweet baked goods, candy, chocolate, jam and ice cream).
In an average 6.2-year follow-up period, 308 of the women had heart attacks. However, two dietary patterns, healthy and alcohol, were associated with a reduced risk of heart attack, the researchers said.
A low-risk diet is characterized by a high intake of whole grains, fish, vegetables, fruit and legumes, moderate alcohol consumption, along with not smoking and being physically active and relatively thin, the researchers concluded. "This combination of healthy behaviors -- present in 5 percent [of those studied] -- may prevent 77 percent of myocardial infarctions [heart attacks] in the study population," the team wrote.
The study was called "empowering" by Dr. Suzanne Steinbaum, director of women and heart disease at Lenox Hill Hospital in New York, because "it demonstrates that people have control over their health and can take control, eat properly and exercise and prevent onset of disease."
"This study clearly demonstrates that it is within an individual's control to change destiny and the ability to control his or her health," Steinbaum said.
"What's amazing is that a study of 24,000 women shows that a reduction of 77 percent is possible," she said. "What could be more empowering than that?"
The issue is muddied by a plethora of books urging different diets, she acknowledged. But the real road to long-term health "is not so much going on a diet as adopting a healthy lifestyle," Steinbaum said.
More information
There's more on heart-healthy lifestyles at the American Heart Association.
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