Drug Can Reduce Risk of Breast Cancer, Study Says

Two drugs, tamoxifen and raloxifene, are already approved to prevent breast cancer but both are rarely used for that purpose, in part because they can have serious side effects like blood clots. The researchers said the new option, exemestane, does not have those side effects and might be more acceptable.

“There’s a very safe therapy that looks highly effective in preventing breast cancer,” Dr. Paul E. Goss, professor of medicine at Harvard and Massachusetts General Hospital, said at a news conference at the annual meeting of the American Society of Clinical Oncology. He was the lead investigator in the study, which was presented at the conference and published online by the New England Journal of Medicine.

Exemestane, also known by the brand name Aromasin, is one of a class of compounds known as aromatase inhibitors. These drugs stop the production of estrogen, which fuels tumor growth. They have proven superior to tamoxifen in preventing recurrence of cancer after a breast tumor is removed.

So researchers have long suspected that aromatase inhibitors would also reduce the risk of an initial occurrence of breast cancer, though this is the first big randomized study to demonstrate that.

The trial involved 4,560 post-menopausal women in the United States, Canada, France and Spain who were considered to be at a higher than normal risk of developing breast cancer either because of being over at least 60 or other factors. After a follow-up of about three years, 11 women getting the drug had developed invasive breast cancer compared with 32 of the women receiving a placebo. That is a reduction in risk of 65 percent.

But in absolute terms, 1.4 percent of women in the placebo group developed cancer compared with about one-half of 1 percent of women taking the drug.

About 94 women would have to be treated for three years to prevent one case of breast cancer, Dr. Goss said. In the trial, exemestane side effects were acceptable, he said. But women who took exemestane had more hot flashes and arthritis than those who had the placebo.

Still, whether exemestane will catch on where the other drugs have not remains to be seen.

Some doctors and patient advocates said that aromatase inhibitors had known side effects like bone pain and joint pain that caused many women who already had had cancer to stop taking them. For healthy women, that would be an even harder sell.

“People are going to think very, very hard about it before they are going to take an aromatase inhibitor in this setting,” said Dr. Eric Winer, a breast cancer specialist at the Dana-Farber Cancer Institute in Boston. He noted the study was not designed to show whether women who took exemestane lived longer.

Diana Zuckerman, president of the Cancer Prevention and Treatment Fund, a patient education group, said that the results were promising but that women in the study were followed for only three years, too short a period to judge long-term effects from taking the drug.

Dr. J. Leonard Lichtenfeld, deputy medical director of the American Cancer Society, said the drugs would be more accepted if there were a way to better predict who was truly at risk of getting breast cancer.

Another factor working against broad use is that aromatase inhibitors are now prescribed by oncologists. But for prevention, “They would have to be prescribed by gynecologists and family doctors,” said Dr. George W. Sledge Jr., a breast cancer specialist at Indiana University. “These doctors are not comfortable with these drugs.”

Patent protection on the drug expired in April. Generic versions will mean lower prices.

But generic competition also means that Pfizer, which sells Aromasin, has little incentive to seek regulatory approval for the drug for preventing breast cancer. The drug could still be available to women off label, but insurers might be reluctant to pay.

Pfizer declined to comment on whether it would seek such approval. Pfizer helped pay for the study, and Dr. Goss has received honorariums from the company.

Two other studies presented at the conference show that the widely used cancer drug Avastin is effective in delaying the progression of ovarian cancer. But both studies so far have narrowly missed showing that the drug can prolong lives, the ultimate test of a cancer drug. That threatens to embroil the use of Avastin for ovarian cancer in a debate similar to the one surrounding its use in breast cancer.

The drug’s manufacturer, Roche, has filed for approval in Europe to market the drug as a treatment for ovarian cancer. But its American subsidiary, Genentech, is still in discussions with the Food and Drug Administration about whether there is enough evidence for an approval. One question is whether it will be necessary to show that the drug prolongs lives, said Dr. Sandra Horning, who runs cancer clinical trials for Genentech. The F.D.A. is now moving to revoke the approval of Avastin for use in treating breast cancer in part because the drug has not prolonged lives in clinical trials. The F.D.A. will hold a hearing on this issue soon.

One study presented here involved 484 women whose ovarian cancer had recurred after an initial drug treatment. All received two standard drugs, and half of them also received Avastin.

The median time that women lived before their cancer worsened was 12.4 months for those who got Avastin compared with 8.4 months for those who received only the two other drugs.

After two years, more women given Avastin were alive, but the difference was not quite statistically significant. Too few women had died to draw conclusions.

“It really is not appropriate statistically to say we really know anything about overall survival here,” said Dr. Carol Aghajanian of the Memorial Sloan-Kettering Cancer Center, the lead investigator. The trial was sponsored by Genentech.

The other trial, partly paid for by Roche, involved adding Avastin to the standard drugs used as initial therapy. There were 178 deaths in the Avastin arm and 200 among those who got the standard drugs, a finding that narrowly missed statistical significance. However, in a subset of patients considered to be at higher risk of recurrence, there was a statistically significant improvement in survival.

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Audit Finds Long Waits for Breast Exams

The audit examined waiting times at nine health care facilities in the 2009 fiscal year and found that the worst were at Elmhurst Hospital Center in Queens, where women had to wait 148 calendar days for routine screening mammograms and 50 working days for diagnostic mammograms, when cancer is suspected.

John C. Liu, the city comptroller, said in a statement accompanying the audit that the long waiting times “placed women in jeopardy” and violated the city’s policies, which recommend waits of no more than two weeks for routine screening.

He said women who had to wait long times for appointments were more likely to miss them.

Ana Marengo, a spokeswoman for the city’s Health and Hospitals Corporation, which runs the public health system, said that the comptroller’s data was outdated and that high-risk patients at its hospitals received mammograms within 24 to 72 hours.

“If there is a lump, if there is a family history, if there is a high-risk individual that had cancer before, all those are considered urgent,” and the patient would be seen within 72 hours, Ms. Marengo said. She conceded that “two years ago, the wait time was longer,” and that even now, in cases in which the risk of cancer was considered lower, the wait could still be longer.

At Elmhurst, she said, the wait as of December 2010 was 20 days for screening and 23 days for a general diagnostic test, as opposed to an urgent one.

At Queens Hospital Center, the wait for a screening test was 56 days in December, Ms. Marengo said. “It’s due to volume and higher demand,” she said. “We only have a certain amount of resources.”

The audit found that the longest waits for diagnostic tests were at Bellevue Hospital Center, with 17 working days; Gouverneur Healthcare Services, with 20; Kings County Hospital Center, with 21; Woodhull Medical Center, with 28; and Elmhurst, with 50.

For screening tests, the longest waits were 41 calendar days at Woodhull in Brooklyn, 49 days at Queens, and 148 days at Elmhurst.

Elmhurst Hospital conducted the most mammograms, 11,425, and Queens was second, with 10,544, the comptroller said.

Last year, public hospitals performed 100,000 mammograms systemwide, up from about 92,000 in 2009, Ms. Marengo said.

View the original article here

Audit Finds Long Waits for Breast Exams

The audit examined waiting times at nine health care facilities in the 2009 fiscal year and found that the worst were at Elmhurst Hospital Center in Queens, where women had to wait 148 calendar days for routine screening mammograms and 50 working days for diagnostic mammograms, when cancer is suspected.

John C. Liu, the city comptroller, said in a statement accompanying the audit that the long waiting times “placed women in jeopardy” and violated the city’s policies, which recommend waits of no more than two weeks for routine screening.

He said women who had to wait long times for appointments were more likely to miss them.

Ana Marengo, a spokeswoman for the city’s Health and Hospitals Corporation, which runs the public health system, said that the comptroller’s data was outdated and that high-risk patients at its hospitals received mammograms within 24 to 72 hours.

“If there is a lump, if there is a family history, if there is a high-risk individual that had cancer before, all those are considered urgent,” and the patient would be seen within 72 hours, Ms. Marengo said. She conceded that “two years ago, the wait time was longer,” and that even now, in cases in which the risk of cancer was considered lower, the wait could still be longer.

At Elmhurst, she said, the wait as of December 2010 was 20 days for screening and 23 days for a general diagnostic test, as opposed to an urgent one.

At Queens Hospital Center, the wait for a screening test was 56 days in December, Ms. Marengo said. “It’s due to volume and higher demand,” she said. “We only have a certain amount of resources.”

The audit found that the longest waits for diagnostic tests were at Bellevue Hospital Center, with 17 working days; Gouverneur Healthcare Services, with 20; Kings County Hospital Center, with 21; Woodhull Medical Center, with 28; and Elmhurst, with 50.

For screening tests, the longest waits were 41 calendar days at Woodhull in Brooklyn, 49 days at Queens, and 148 days at Elmhurst.

Elmhurst Hospital conducted the most mammograms, 11,425, and Queens was second, with 10,544, the comptroller said.

Last year, public hospitals performed 100,000 mammograms systemwide, up from about 92,000 in 2009, Ms. Marengo said.

 

Audit Finds Long Waits for Breast Exams

The audit examined waiting times at nine health care facilities in the 2009 fiscal year and found that the worst were at Elmhurst Hospital Center in Queens, where women had to wait 148 calendar days for routine screening mammograms and 50 working days for diagnostic mammograms, when cancer is suspected.

John C. Liu, the city comptroller, said in a statement accompanying the audit that the long waiting times “placed women in jeopardy” and violated the city’s policies, which recommend waits of no more than two weeks for routine screening.

He said women who had to wait long times for appointments were more likely to miss them.

Ana Marengo, a spokeswoman for the city’s Health and Hospitals Corporation, which runs the public health system, said that the comptroller’s data was outdated and that high-risk patients at its hospitals received mammograms within 24 to 72 hours.

“If there is a lump, if there is a family history, if there is a high-risk individual that had cancer before, all those are considered urgent,” and the patient would be seen within 72 hours, Ms. Marengo said. She conceded that “two years ago, the wait time was longer,” and that even now, in cases in which the risk of cancer was considered lower, the wait could still be longer.

At Elmhurst, she said, the wait as of December 2010 was 20 days for screening and 23 days for a general diagnostic test, as opposed to an urgent one.

At Queens Hospital Center, the wait for a screening test was 56 days in December, Ms. Marengo said. “It’s due to volume and higher demand,” she said. “We only have a certain amount of resources.”

The audit found that the longest waits for diagnostic tests were at Bellevue Hospital Center, with 17 working days; Gouverneur Healthcare Services, with 20; Kings County Hospital Center, with 21; Woodhull Medical Center, with 28; and Elmhurst, with 50.

For screening tests, the longest waits were 41 calendar days at Woodhull in Brooklyn, 49 days at Queens, and 148 days at Elmhurst.

Elmhurst Hospital conducted the most mammograms, 11,425, and Queens was second, with 10,544, the comptroller said.

Last year, public hospitals performed 100,000 mammograms systemwide, up from about 92,000 in 2009, Ms. Marengo said.

 

Breast Device Recall Made Most Severe

The recall of a medical device that left particles of tungsten in women’s breasts has been classified as the most serious type of recall, one involving “situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” the Food and Drug Administration said on Wednesday.

The device, the Axxent FlexiShield Mini, was a pad made of tungsten and silicone rubber that was temporarily placed inside breast incisions during an unusual procedure in which women were given an entire course of radiation treatment in one dose after undergoing a lumpectomy for cancer. The pads were used to help direct the radiation beam and shield healthy tissue. But the pads were flawed, and left the breast tissue and chest muscles riddled with hundreds of tungsten particles.

It is not known if tungsten is dangerous because relatively little research has been done on its long-term health effects in humans. But it shows up on mammograms and may make them difficult to read, especially troubling for women who have had breast cancer and worry about recurrences. The metal particles resemble calcium deposits, which can indicate cancer.

That the tungsten shows up on mammograms is what made the recall Class I, the most serious type, said Karen Riley, a spokeswoman for the Food and Drug Administration. She said the particles could interfere with diagnosis because they can be mistaken for cancerous calcifications or may hide real calcifications. Twenty-nine women are known to have been affected: 27 at Hoag Memorial Hospital Presbyterian in Newport Beach, Calif., and 2 at Karmanos-Crittenton Cancer Center in Rochester Hills, Mich. So far, 16 have had follow-up mammograms six months after their surgery, and all 16 were found to have tungsten particles.

Some of the women, concerned that the tungsten could be harmful, are considering having mastectomies to rid themselves of the particles. Seven are suing Hoag and the device manufacturer, according to Jeffrey Milman, a lawyer in Irvine, Calif., who is representing the women.

Mr. Milman said that for the purposes of the lawsuits, the government’s decision to classify the recall as serious was “icing on the cake.” The device was made by a company called Xoft, which was subsequently bought by another company, iCad.

The Axxent FlexiShield Mini had been cleared by the drug agency in June 2009 in an abbreviated process used for devices that are considered equivalent to products already on the market. That process, known as 510(k), takes less time than the procedure used to approve a new device, and it generally does not require tests on humans.

The shields, taken off the market in February, were cut to fit each patient, and Ms. Riley said the tungsten particles were shed after the cutting. But why that occurred is not clear, because the shields were meant to be cut and were made with that in mind.