Studies: Avastin may fight early breast cancers

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Surprising results from two new studies may reopen debate about the value of Avastin for breast cancer. The drug helped make tumors disappear in certain women with early-stage disease, researchers found.

Avastin recently lost approval for treating advanced breast cancer, but the new studies suggest it might help women whose disease has not spread so widely. These were the first big tests of the drug for early breast cancer, and doctors were cautiously excited that it showed potential to help.

In one study, just over one third of women given Avastin plus chemotherapy for a few months before surgery had no sign of cancer in their breasts when doctors went to operate, versus 28 percent of women given chemo alone. In the other study, more than 18 percent on Avastin plus chemo had no cancer in their breasts or lymph nodes at surgery versus 15 percent of those on chemo alone.

A big caveat, though: The true test is whether Avastin improves survival, and it's too soon to know that — both studies are still tracking the women's health. The drug also has serious side effects.

"I don't think it's clear yet whether this is going to be a winner," Dr. Harry Bear of Virginia Commonwealth University said of Avastin. But he added, "I don't think we're done with it."

Bear led one study, in the United States. Dr. Gunter von Minckwitz of the University of Frankfurt led the other in Germany. Results are in Thursday's New England Journal of Medicine.

Avastin (uh-VAS'-tihn) is still on the market for some colon, lung, kidney and brain tumors. In 2008, it won conditional U.S. approval for advanced breast cancer because it seemed to slow the disease. Further research showed it didn't meaningfully extend life and could cause heart problems, bleeding and other problems. The government revoked its approval for breast cancer in November.

Now doctors can prescribe Avastin for breast cancer but insurers may not pay. Treatment can cost $10,000 a month. The drug is made by California-based Genentech, part of the Swiss company Roche. It is still approved for treating advanced breast cancer in Europe and Japan.

The new studies tested it in a relatively novel way — before surgery. This is sometimes done to shrink tumors that seem inoperable, or to enable women to have just a lump removed instead of the whole breast.

The women in the studies had tumors that were large enough to warrant treatment besides surgery. Their cancers were not the type that can be treated by Herceptin, another widely used drug.

In the U.S. study, 1,200 women were given chemo or chemo plus infusions of Avastin. By the time of their surgery, no cancer could be found in the breasts of more than 34 percent of those given Avastin versus 28 percent of the others. (Surgeons still have to operate because they don't know the tumor is gone until they check tissue samples.)

The German study involved 1,900 women including some with larger tumors. It used a stricter definition of cancer-free at surgery: no sign of disease in the breast or lymph nodes rather than just the breast. No cancer was seen in 18 percent of women on Avastin versus 15 percent of those given only chemo. Different chemo drugs were used — a factor that might change Avastin's effectiveness.

The U.S. study was paid for by the National Cancer Institute with some support from drug companies. The German study was sponsored by drug companies. Some researchers consult for Genentech or other makers of cancer drugs.

If even one of these studies shows a survival advantage for Avastin "that would be a game changer" although side effects remain a concern, said Dr. Gary Lyman. He is a Duke University researcher who was on the federal advisory panel that recommended revoking Avastin's approval.

However, von Minckwitz said side effects are more justifiable in early breast cancer patients because "the intention is cure" rather than in late-stage disease where cure isn't usually possible.

Of the more than 200,000 women in the U.S. diagnosed each year with breast cancer, about 30,000 are like those in the new studies, Lyman estimated.

But the studies' impact could be far greater: The participants' tissue samples are being analyzed for genes and biomarkers to predict which women are most likely to respond to Avastin. That could lead to a relook of using the drug for certain women with advanced disease, too.

Three other studies are under way testing Avastin in early breast cancer; one is expected to have results by the end of this year, said Dr. Sandra Horning, global development chief of cancer drugs for Roche and Genentech. The company does not plan to seek any change in Avastin's use until more results are available, she said.

___

Online:

Studies: http://www.nejm.org

Avastin: http://www.avastin.com

___

Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP

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When breast cancer tests get it wrong

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Kathleen Maxian says her cancer could have been prevented, and now she's angry. Myriad Genetics owns the patent on breast cancer genesMyriad offers one test that catches most abnormalities, then charges $700 for secondCompany defends BART test, based on separate technology

(CNN) -- Imagine going in for a cancer screening, and the technician turns to you and says, "We're finished, but if I push this button over here, the machine can detect even smaller cancers. But here's the hitch: You have to pay $700 if you want me to push this button."

"You'd be enraged," says Ellen Matloff, director of cancer genetic counseling at Yale University Cancer Center. "You'd want to know why you have to pay extra to push that button. Why didn't they just do it right the first time?"

Doctors and genetic counselors interviewed by CNN say that Myriad Genetics in Utah is doing something very similar with tests that determine if a woman has a potentially dangerous genetic abnormality linked to breast cancers.

Most breast cancers do not seem to be genetic. Instead, they're the result of cells gone wild for no apparent reason. However, some women get breast cancer because a bad gene runs in their families. When testing shows that a woman carries such a gene, she has a much higher chance of getting breast cancer. These women usually then get more frequent MRIs, ultrasounds and mammograms to detect a cancer, and sometimes even choose to remove their breasts to prevent a cancer from growing in the first place.

Myriad owns the patent on breast cancer genes and so is the only company that can test for them. It offers one test that catches most, but not all, abnormalities, and then charges nearly all patients $700 for a second test that catches the rest.

If a woman can't afford the $700 fee, she may miss an abnormality, which could mean the difference between life and death.

"What Myriad's doing -- charging extra for this test -- is really sleazy," Matloff says. "They're collecting blood money off my patients."

Myriad defends the $700 charge for its second test, called BART, even though many patients can't afford it and insurance won't pay for it.

"The BART test is based on different and separate technology," Rebecca Chambers, a Myriad spokeswoman, wrote in an e-mail to CNN. "[It's] based on a sophisticated new technology developed exclusively by Myriad."

She added that Myriad is trying to persuade insurance companies to pay for the test and that it offers financial assistance to patients who meet certain criteria, and monthly interest-free payments to those why do owe the $700 fee.

"Myriad's mission is to improve the patient's quality of life and to save lives," she added in the e-mail.

Understanding the furor

To understand the anger and bitterness that patients, doctors and genetic counselors harbor toward Myriad, it's important to know the basics of genetic testing.

In 1996, Myriad offered its first test for breast cancer genetic abnormalities. Known as the BRCA test, it's been revolutionary and has saved countless lives: If the test reveals that a woman has a genetic abnormality, it means she has a very high chance of getting breast cancer in the future, and some women then opt to remove their breasts as a pre-emptive strike against cancer.

Women who test positive for BRCA also sometimes opt to have their ovaries removed, since having a breast cancer gene abnormality gives them a higher-than-normal chance of getting ovarian cancer as well.

"Genetic testing has been a godsend for so many women," Matloff says.

Myriad calls its test the Comprehensive BRACAnalysis, but it soon became clear that it wasn't truly comprehensive. It did not catch all genetic abnormalities linked to cancer, and so in 2006, the company began selling BART, the newer test that catches genetic defects that the original test misses. Doctors and counselors expected Myriad to offer BART as part of its original test, but instead the company offers it separately and charges nearly everyone $700 to take it.

"This is so irresponsible of Myriad," says Molly Klein, director of genetic counseling at Piedmont Hospital in Atlanta.

She and other genetic counselors have been fighting to get Myriad to stop the $700 charge. They say they worry that women who tested negative under the first test feel assured that they don't have a bad gene when in fact they might, and wouldn't know they're at increased risk for getting breast cancer.

Klein and other genetic counselors say that when Myriad came up with an improvement in its colon cancer test, it wrapped it into its original screening at one price. The counselors say they think Myriad handled the breast cancer test differently, charging a separate fee, because it has no competition.

"From a business perspective, I guess I understand why Myriad is doing what they're doing, because this is a good chunk of money for them," says Kristen Shannon, the senior genetic counselor at the Massachusetts General Hospital Cancer Center. "But I feel really strongly that Myriad is doing the wrong thing."

"That accusation is incorrect," Chambers wrote in an e-mail to CNN.

"I'm so angry"

For Eileen Kelly and Kathleen Maxian, money wasn't the issue.

The two sisters were stunned three years ago when Kelly was diagnosed with breast cancer at age 40. They breathed a sigh of relief when Kelly tested negative for the BRCA gene using Myriad's original test. This meant Kelly's cancer was a fluke, and not something her sister or other relatives needed to worry about.

Then two years later, at the age of 47, Maxian found out she had ovarian cancer. Surgeons removed her ovaries and found the cancer had spread to her abdomen. After chemotherapy, the cancer came back a year later.

"I told my surgeon my sister had genetic testing, but it came back negative," Maxian says. "My surgeon just hung her head down and shook it back and forth. I was like, 'What? How weird is that?' "

The surgeon told Maxian that her sister's test might have been incomplete. She instructed Maxian to ask her sister, who lives in Atlanta, to find out if she'd received the second test, BART, in addition to the original breast cancer genetic test.

Kelly found out she had not had not received BART. She went back to Piedmont Hospital to have it done, and the test was positive. Maxian and her father then had BART, and it turns out that they, too, carry a genetic abnormality.

Women who have genetic abnormalities like Maxian's have a 50% to 85% chance of getting breast cancer, and a 10% to 40% chance of getting ovarian cancer. She says that if her sister had had BART from the beginning, she also would have taken the test, and the positive result would have made her remove her breasts and ovaries "in a minute."

"If BART had been done from the beginning, it could have saved Kathleen from getting ovarian cancer," says Dr. Nefertiti duPont, Maxian's surgeon at the Roswell Park Cancer Institute in Buffalo, New York.

"It could have prevented my cancer, or at least caught it early," Maxian adds. "Now my cancer is so advanced, I have only a 20% chance of being alive five years from now. I'm so angry."

Klein, the genetic counselor at Piedmont Hospital, says she never mentioned BART to Kelly, nor to most of the women who came in for testing at that time. She says information from Myriad led her to believe that BART mutations were extremely rare among women like Kelly without an extremely strong family history of breast or ovarian cancer. When some women do have a very strong family history, Myriad will do a BART analysis for free as part of its original test, and has spent $20 million on these tests.

"We were left with the impression that BART wasn't necessary for families like Eileen's," Klein says. "It just didn't seem urgent."

But over time, it's become clear that Myriad might have been wrong about who needs BART testing, counselors say. Several studies, such as one done by Shannon at the Massachusetts General Hospital Cancer Center, show that a substantial number of women had BART mutations even without a very strong family history. Now, Klein and others offer BART to all their patients, but many can't do it because of the cost.

"This is all really frustrating," Klein says. "We know we're missing women out there with BART mutations because they can't afford to pay. If you miss just one BART mutation, that woman could be in danger, and so could her mother, her sisters and her other relatives."

"It's heartbreaking," says Mollie Hutton, Maxian's genetic counselor at the Roswell Park Cancer Institute. "It's so sad that now Kathleen is fighting for her life when something could have been done to avoid it. It's just crappy."

Chambers, the Myriad spokeswoman, says studies show "less than one percent of all women tested" have a BART mutation.

What to do when you get breast cancer genetic testing

If you're about to get breast cancer genetic testing, specifically ask if you'll receive BART testing.

If you've had breast cancer genetic testing, don't assume you received the BART test.

Also, don't assume that the place where you had the testing will get back in touch with you to let you know about BART. CNN contacted four genetic testing centers, each of which did something different: One center quickly contacted all patients to tell them about BART; another contacted only patients they considered high risk; the third contacted patients three years after BART became available; and the fourth still hasn't contacted patients to tell them about BART.

Genetic counselors recommend that you call the place where you had testing every year or so to see if there have been any improvements in the test.

Most women will have to decide whether they want to spend $700 to get BART testing.

Eileen Kelly wishes she'd had the opportunity to spend that money.

"I'm so mad at Myriad. It's even hard just to talk about it," Kelly says, starting to cry. "A test could have put the information in our hands that could have prevented my sister's cancer. It's frustrating and really hard to comprehend."

Aaron Cooper contributed to this report.

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Men with breast cancer 'isolated'

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20 October 2011 Last updated at 09:34 GMT By Eleanor Bradford BBC Scotland Health Correspondent Bernard Greenan had surgery after being told the spot on his nipple was nothing to worry about Even the NHS is forgetting that men get breast cancer, according to some of those who have been diagnosed.

Only 1% of breast cancer cases are in men and research for a website suggests many of them feel isolated by a health service which is geared towards women.

Kate Hunt, from the Medical Research Council's public health sciences unit in Glasgow, spoke to 33 men diagnosed with breast cancer.

"Sometimes people are just a little bit thoughtless, so in a clinic setting a man might be called to his appointment being addressed as 'Mrs' rather than 'Mr'," she said.

"Similarly, going to get a prescription, they'll be told the drug isn't for men, it's only for women."

The research was carried out for the website www.healthtalkonline.org, which features real patients' stories to provide information and support for people with a variety of conditions.

Bernard Greenan had been told a spot on his nipple was nothing to worry about, but he decided to ask his local GP to take a second look after it started bleeding.

New research shows men diagnosed with breast cancer feel isolated by services geared up only for women

"It started getting very itchy so I went back to the doctors and it was a young locum who was in, and I said, 'Would you mind having a look at my chest?' and he said, 'Well, I'll send you for a biopsy straight away'.

"They told me not to worry about it, they were 99.9% positive there was nothing wrong with me. That was on the Tuesday and then on the Friday I got the phone call to come in and that was it.

Continue reading the main story

In the information pack that they sent, they said that for the operation I should bring a soft bra with me”

End Quote Ben Diagnosed with breast cancer "They operated on me the following week."

Like many with the condition, Bernard has never met another man with breast cancer.

Most are likely to be the only male patient in breast cancer clinics.

Other men interviewed for the website said they felt isolated by female-focused services.

One man, who only wanted to be identified as Ben, said: "In the information pack that they sent, they said that for the operation I should bring a soft bra with me.

"I realised then that it was geared for women."

One suggestion made to researchers is that the pink ribbon, which has become a symbol of breast cancer awareness month, should have a blue streak or spot as a reminder that men get breast cancer too.

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Antioxidants tied to mixed effects in breast cancer

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By Amy Norton

NEW YORK | Fri Oct 7, 2011 4:20pm EDT

NEW YORK (Reuters Health) - Breast cancer patients who take antioxidants may have an increased or decreased risk of death or recurrent cancer, depending on which vitamin they use, a new study suggests.

Researchers found that among nearly 2,300 women with early-stage breast cancer, those who regularly used either vitamins C or E had a lower risk of cancer recurrence over five years than those who didn't use the vitamins.

On the other hand, women who regularly took a mix of carotenoids had a higher risk of dying from breast cancer, or any other cause, than women who did not take them.

Carotenoids include nutrients like vitamin A, beta-carotene and lutein.

The findings, reported in the journal Cancer, do not prove that any of the antioxidants are the reason for the effects seen.

But they do add to concerns about the risks of high doses of carotenoids, according to lead researcher Heather Greenlee, an assistant professor of epidemiology at Columbia University in New York.

"In my opinion," she told Reuters Health in an email, "our paper adds to the growing body of literature suggesting that dietary supplements containing high doses carotenoids may be harmful, and people should think twice before taking them."

Studies have found, for example, that giving beta-carotene supplements to smokers may actually raise their risk of lung cancer.

As for other antioxidants, Greenlee noted that the American Cancer Society and the American Institute for Cancer Research say that there's not enough evidence to recommend any dietary supplement for preventing cancer, or a cancer recurrence.

There is also concern about patients taking high doses of any antioxidant while on chemotherapy or radiation.

Antioxidants protect body cells from so-called oxidative damage. Cancer drugs and radiation work in part by creating oxidative damage. So in theory, high-dose antioxidants could diminish the treatments' effectiveness.

Still, studies show that women with breast cancer commonly use antioxidant supplements of some kind.

The current findings are based on questionnaires and case data from 2,264 U.S. women diagnosed with early-stage breast cancer.

Overall, 81 percent said they'd used at least one supplement containing antioxidants -- either within multivitamins or in the form of single-vitamin supplements -- in the two years after being diagnosed.

Over the next five years, the study found, women who'd reported using single supplements of either vitamin C or vitamin E six to seven days a week had a lower risk of cancer recurrence.

Of 540 women who took vitamin C, 15 percent had a breast cancer recurrence. That compared with 19 percent of the 1,072 women who did not use vitamin C supplements.

The differences were about the same when the researchers looked at vitamin E.

On the other hand, women who used any combination of carotenoids had a higher risk of dying from breast cancer, or from any cause. Of 89 women who used carotenoids six to seven days per week, 18 percent died of breast cancer; that compared with just under seven percent of women who did not use carotenoid combinations.

According to Greenlee, much of the benefit associated with vitamins C and E could potentially be explained by a "healthy user bias" -- that is, women who use dietary supplements tend to have healthier habits in general.

And that, she and her colleagues write, makes the increased risk of death linked to carotenoid use "even more striking."

The reasons for the different breast cancer outcomes linked to different antioxidants are not known, and the findings need to be confirmed in further studies, Greenlee said.

The most important point this study raises, she added, is that "antioxidant dietary supplements should not be assumed to all act in a similar fashion, as is a common perception in the general public."

"They are made up of different molecules," Greenlee said, "and likely have different effects."

On the other hand, the researchers found no evidence that breast cancer recurrence or deaths were linked to antioxidants taken within multivitamins -- which generally have more moderate doses of individual nutrients.

SOURCE: bit.ly/rkf6uw Cancer, online September 27, 2011.

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Stem-cell breast ops warning

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30 September 2011 Last updated at 06:46 GMT By Neil Bowdler Health reporter, BBC News The procedure involves grafting fat harvested from the patient by liposuction Senior plastic surgeons have issued a warning over a breast enlargement procedure being offered by private UK clinics.

The British Association of Aesthetic Plastic Surgeons (BAAPS) say "stem-cell breast augmentations" are unproven and should not be offered commercially.

The warning came at the group's annual conference in Birmingham.

One Harley Street clinic offering the surgery responded by saying they were "confident" the treatment was safe.

Research 'hijacked'

The surgery involves using fat harvested from the patient's stomach or thighs via liposuction and using it to build up the breast.

Prior to transplantation, around half of of the fat is processed to enrich the stem-cell content - naturally occurring regenerative cells found within the fat.

The hope is that this enrichment process can improve the prospects for the fat graft.

The same technology is being used in reconstructive surgery where "cell-enriched fat grafting" is now being offered in several centres around the world to reconstruct breasts following cancer surgery.

Trials are currently under way at NHS centres in London, Glasgow, Swansea, Norwich and North Tyneside.

But BAAPS believes more clinical testing needs to be done to establish its safety before it is used commercially on healthy women.

Continue reading the main story

We have to make sure whatever treatment we offer for breast augmentation is safe in the long-term”

End Quote Eva Weiler-Mithoff Consultant plastic surgeon "To think that this unproven research is hijacked and used in the commercial sector is really an appalling thought," former BAAPS president and consultant plastic surgeon Adam Searle told the BBC. "Not least when it's being utilised by inadequately trained practitioners."

Private London clinics, The Harley Street Skin Clinic and The Private Clinic of Harley Street, have been advertising stem-cell breast augmentations for some time. The latter says they will have treated some 200 patients by the end of this year.

In a statement, Dr Valentina Petrone of the The Private Clinic, said the views of BAAPS were welcome, but insisted the surgery was safe and every precaution was taken.

"The Private Clinic, is confident in respect to the safety of this treatment. Furthermore ongoing studies reassures us even more. We have strict patient selection criteria and clinical protocols in place.

"We, of course, look forward to completion of studies and any other findings as they become available over time and will, if necessary, adapt our protocols accordingly."

Cancer concern

The BAAPS warning came the same week new clinical data on cell-enriched fat grafting was presented to an conference in Nottingham.

Eva Weiler-Mithoff, a consultant surgeon at Canniesburn Plastic Surgery Unit in Glasgow, presented details of a 12-month trial to a meeting of the Oncoplastic Reconstructive Breast Surgery group.

The trial involved around 70 patients in seven centres in four countries. The data is yet to undergo peer review and was sponsored by Cytori Therapeutics, the US makers of a machine which can enrich the fat.

Consultant plastic surgeon Eva Weiler-Mithoff discusses the findings of a 12-month clinical trial

Ms Weiler-Mithoff told the BBC the procedure appears to be effective in cancer patients in filling in defects in the breast and in improving the appearance and feel of the breast. Nor were there any serious side-effects or recurrence of breast cancer to date.

"Traditional fat-grafting (in breast reconstructive surgery) does not work terribly well because there is not enough circulation to support the survival of the fat graft," she said.

"We know if we augment the fat graft with the naturally occurring regenerative cells in fat tissues we can improve the circulation around the fat graft and the survival of the fat graft."

But she said longer-term results were needed - at least five to10 years of data - before the technique could be deemed safe for use in cosmetic surgery.

"We still don't have enough long-term outcome data to say it's safe in the sense that it doesn't encourage the cancer to come back or new breast cancer to develop," she said.

"Because breast cancer is such a common disease we have to make sure whatever treatment we offer for breast augmentation is safe in the long-term."

A previous Japanese study involving 40 Japanese women undergoing cosmetic stem-cell breast augmentation also deemed the procedure to be effective, but also called for additional study.

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Stem-cell breast ops warning

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30 September 2011 Last updated at 06:46 GMT By Neil Bowdler Health reporter, BBC News The procedure involves grafting fat harvested from the patient by liposuction Senior plastic surgeons have issued a warning over a breast enlargement procedure being offered by private UK clinics.

The British Association of Aesthetic Plastic Surgeons (BAAPS) say "stem-cell breast augmentations" are unproven and should not be offered commercially.

The warning came at the group's annual conference in Birmingham.

One Harley Street clinic offering the surgery responded by saying they were "confident" the treatment was safe.

Research 'hijacked'

The surgery involves using fat harvested from the patient's stomach or thighs via liposuction and using it to build up the breast.

Prior to transplantation, around half of of the fat is processed to enrich the stem-cell content - naturally occurring regenerative cells found within the fat.

The hope is that this enrichment process can improve the prospects for the fat graft.

The same technology is being used in reconstructive surgery where "cell-enriched fat grafting" is now being offered in several centres around the world to reconstruct breasts following cancer surgery.

Trials are currently under way at NHS centres in London, Glasgow, Swansea, Norwich and North Tyneside.

But BAAPS believes more clinical testing needs to be done to establish its safety before it is used commercially on healthy women.

Continue reading the main story

We have to make sure whatever treatment we offer for breast augmentation is safe in the long-term”

End Quote Eva Weiler-Mithoff Consultant plastic surgeon "To think that this unproven research is hijacked and used in the commercial sector is really an appalling thought," former BAAPS president and consultant plastic surgeon Adam Searle told the BBC. "Not least when it's being utilised by inadequately trained practitioners."

Private London clinics, The Harley Street Skin Clinic and The Private Clinic of Harley Street, have been advertising stem-cell breast augmentations for some time. The latter says they will have treated some 200 patients by the end of this year.

In a statement, Dr Valentina Petrone of the The Private Clinic, said the views of BAAPS were welcome, but insisted the surgery was safe and every precaution was taken.

"The Private Clinic, is confident in respect to the safety of this treatment. Furthermore ongoing studies reassures us even more. We have strict patient selection criteria and clinical protocols in place.

"We, of course, look forward to completion of studies and any other findings as they become available over time and will, if necessary, adapt our protocols accordingly."

Cancer concern

The BAAPS warning came the same week new clinical data on cell-enriched fat grafting was presented to an conference in Nottingham.

Eva Weiler-Mithoff, a consultant surgeon at Canniesburn Plastic Surgery Unit in Glasgow, presented details of a 12-month trial to a meeting of the Oncoplastic Reconstructive Breast Surgery group.

The trial involved around 70 patients in seven centres in four countries. The data is yet to undergo peer review and was sponsored by Cytori Therapeutics, the US makers of a machine which can enrich the fat.

Consultant plastic surgeon Eva Weiler-Mithoff discusses the findings of a 12-month clinical trial

Ms Weiler-Mithoff told the BBC the procedure appears to be effective in cancer patients in filling in defects in the breast and in improving the appearance and feel of the breast. Nor were there any serious side-effects or recurrence of breast cancer to date.

"Traditional fat-grafting (in breast reconstructive surgery) does not work terribly well because there is not enough circulation to support the survival of the fat graft," she said.

"We know if we augment the fat graft with the naturally occurring regenerative cells in fat tissues we can improve the circulation around the fat graft and the survival of the fat graft."

But she said longer-term results were needed - at least five to10 years of data - before the technique could be deemed safe for use in cosmetic surgery.

"We still don't have enough long-term outcome data to say it's safe in the sense that it doesn't encourage the cancer to come back or new breast cancer to develop," she said.

"Because breast cancer is such a common disease we have to make sure whatever treatment we offer for breast augmentation is safe in the long-term."

A previous Japanese study involving 40 Japanese women undergoing cosmetic stem-cell breast augmentation also deemed the procedure to be effective, but also called for additional study.

View the original article here

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Novartis drug may help older breast cancer patients

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By Kate Kelland

STOCKHOLM | Sun Sep 25, 2011 11:20am EDT

STOCKHOLM (Reuters) - Novartis's bone drug Zometa extended survival in older breast cancer patients but failed to improve disease-free survival among younger women patients in a large-scale clinical trial, researchers said on Sunday.

Detailed data presented at the European Multidisciplinary Cancer Congress (EMCC) in Stockholm showed that Zometa, a bisphosphonate drug known generically as zoledronic acid, only improved overall survival rates in patients who had undergone the menopause at least five years earlier.

Researchers said the effect was likely to be linked to levels of reproductive hormones, which are lower in women who have been through the menopause.

"This is not a treatment for ever woman with breast cancer," said Robert Coleman of Britain's Sheffield University, who led the study. But for women with low levels of female hormones, either due to aging or specific treatments to induce menopause, Zometa "appears very promising."

An analysis of the subset of older patients showed that at a the five-year follow-up, there was a 26 percent reduction in recurrence of tumors, Coleman said, as well as a 26 percent reduction in the risk of an early death.

These strong results could lead to "a major new treatment approach" for post-menopausal patients, he said.

Zometa, which generated sales of $2.1 billion for Novartis in 2010, is an intravenous drug from a widely used class of osteoporosis medicines called bisphosphonates.

It is increasingly being prescribed to help reduce or delay fractures and other skeletal complications in a variety of cancers that have spread to the bones. From 65 to 75 percent of breast cancer recurrences occur in the bones.

This trial, called AZURE and also published in the New England Journal of Medicine on Sunday, involved 3,360 women with early-stage breast cancer from 174 centers in Britain, Australia, Spain, Ireland, Portugal, Taiwan and Thailand.

Patients randomly allocated receive standard chemotherapy and/or hormone therapy, either with or without the addition of Zometa, a drug that works by inhibiting the cells that break down bone, called osteoclasts.

The results showed that looking across all trial participants, there was no significant difference in disease-free survival or overall survival between patients who received Zometa and those who didn't. But in a subset of older patients, the addition of the Novartis drug did bring clear benefits.

These women, who had at least five years since their last period, had an overall survival rate at five years of 85 percent on Zometa compared with 79 percent for those not on the drug. For all other patients, overall five-year survival was similar, at 86 percent in the Zometa group and 85 percent in the control group.

Investigators said that most surprising among the findings was the drug's effect on the rate at which the cancer recurred outside the bone. The relative risk for developing metastases, or secondary tumors, outside bone during treatment with Zometa was approximately halved in the postmenopausal women compared with the younger patients.

Coleman said the results shed new light on the role bones may play in the progress of the disease.

"The effects on metastasis and recurrence outside bone suggests that the bone marrow is an important sanctuary for tumor cells which can be activated after, sometimes, many years of dormancy," he said. "With help from bone marrow stem cells, they may then spread via the blood stream to set up metastases at other sites."

(Editing by Will Waterman)

View the original article here

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Novartis's Afinitor shows promise in breast cancer

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By Kate Kelland

STOCKHOLM | Sun Sep 25, 2011 6:03pm EDT

STOCKHOLM (Reuters) - C ombining two drugs from Novartis and Pfizer to treat post-menopausal women with a certain type of advanced breast cancer more than doubled the time they lived without their disease getting worse, study data showed on Monday.

Investigators conducting a clinical trial found that women treated with a combination of Novartis' Afinitor or everolimus, and Pfizer's oestrogen-blocker Aromasin, known generically as xemestane, had progression-free survival (PFS) of as much as seven months more than women treated with the Pfizer drug alone.

"This is a highly significant improvement in the time to disease progression. It's quite remarkable," said Jose Baselga of Massachusetts General Hospital and Harvard Medical School, who led the trial and presented the data at the European Multidisciplinary Cancer Congress (EMCC) in Stockholm.

He said side effects were consistent with those previously reported in trials of Afinitor and did not lead to a worse quality of life for patients on the drug.

Baselga's analysis of the data showed that PFS for women in the Afinitor group was 6.9 months versus 2.8 months for those not taking the Novartis drug -- a 57 percent improvement.

The trial was stopped early after a separate independent analysis by a central review committee showed that Afinitor extended PFS to 10.6 months compared to 4.1 months -- a 64 percent improvement.

"These results are impressive and, potentially, could represent a new therapeutic option," Baselga said.

Afinitor targets mTOR, a protein that acts as an important regulator of tumor cell division, blood vessel growth and cell metabolism. Novartis says there are around 220,000 newly diagnosed cases worldwide each year of the type of advanced breast cancer that could benefit from Afinitor.

Novartis has been upbeat about the prospects for the drug, which is already approved for other types of cancer, such as kidney and a rare type of pancreatic cancer.

The Swiss firm's CEO Joe Jimenez told Reuters in a recent interview it could generate an extra $1 billion or more in annual sales from its new use in breast cancer. [ID:nL5E7K227N]

Herve Hoppenot, president of Novartis's oncology division, said the magnitude of benefit seen in this trial showed that Afinitor is "a potential important new treatment approach".

The Swiss drugmaker is planning to file for regulatory approval of Afinitor in breast cancer by the end of this year.

Novartis reported Afinitor sales for cancer of $243 million in 2010 but analysts expect that number to balloon if the drug is licensed in breast cancer. Thomson Reuters Pharma data show analysts on average forecast sales of $1.53 billion by 2016.

The hormone oestrogen promotes the growth of about two thirds of breast cancers, and hormonal therapies such as Aromasin which block the effect of oestrogen or reduce its levels are used to treat these so-called hormone receptor-positive breast cancers.

But many breast cancer patients, and nearly all those with advanced forms of the disease where it has spread to other parts of the body, become resistant to hormonal therapy.

"When patients stop responding to hormonal therapy, the benefits from any secondary therapy are limited," Baselga said.

The Phase III clinical trial, known as BOLERO 2, was designed to test the efficacy of Afinitor in patients resistant to aromatase inhibitors - drugs that cut the amount of oestrogen produced and help to slow or reverse the growth of the cancer.

It was as conducted in 24 countries in 724 patients with an average age of 62. All patients had already been treated with the aromatase inhibitors anastrozole, sold by AstraZeneca as Arimidex, or the generic drug letrozole. Some had also been treated with tamoxifen, fulvestrant and chemotherapy.

Pfizer's Aromasin lost its patent in April and is now available in a cheaper generic version.

(Editing by Greg Mahlich)

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Breast cancer study shows benefits of double therapy

AppId is over the quota
AppId is over the quota

A woman undergoes a mammography exam, a special type of X-ray of the breasts, which is used to detect tumours as part of a regular cancer prevention medical check-up at a clinic in Nice, south eastern France January 4, 2008.

Credit: Reuters/Eric Gaillard

By Kate Kelland

STOCKHOLM | Sat Sep 24, 2011 6:04pm EDT

STOCKHOLM (Reuters) - Giving breast cancer patients radiotherapy and chemotherapy at the same time significantly cuts the risk their tumors will come back and should be considered as a new treatment approach across the world, cancer experts said on Sunday.

The double treatment, known as synchronous chemoradiation, could also save lives among people with breast cancer, a disease that currently kills 425,000 women a year worldwide, according to the British experts who conducted a major scientific study.

They said the synchronous treatment, which the study showed has limited side effects and does not harm patients' quality of life, should be considered for use by all breast cancer doctors.

"The results have implications worldwide," Indrajit Fernando, a consultant clinical oncologist at the University Hospitals Birmingham Trust, told reporters at the European Multidisciplinary Cancer Congress (EMCC) in Stockholm.

"Clinical practice needs to be reviewed."

Breast cancer is the most common cancer among women. A recent study by the Institute for Health Metrics and Evaluation in the United States found that in 2010 it killed around 425,000 people and was newly diagnosed in 1.6 million.

Radiotherapy and chemotherapy are usually given after breast cancer surgery to kill any remaining cancer cells in the breast, chest wall or underarm area, and to try to reduce the risk of a local cancer recurrence. The standard approach is to give chemotherapy first, followed by radiotherapy.

But the best timings for radiotherapy and chemotherapy have long been debated among cancer experts, so Fernando's team decided to study various schedules of radiotherapy with a type of chemotherapy called anthracycline-CMF chemotherapy in patients with early-stage breast cancer.

The study involved almost 2,300 women in Britain who had already undergone surgery to remove their tumors.

The results showed that compared with the standard approach, giving both treatments at the same time "reduces the risk of local cancer recurrence by 35 percent in women with early breast cancer," Fernando said.

After a follow-up of over eight years, the study found that only 41 patients in the synchronous chemoradiation group had suffered recurrence, compared with 63 patients in the group who had standard chemotherapy followed by radiation treatment.

At five years, tumors had recurred in only 2.8 percent of those who got both treatments at the same time, compared with 5.1 percent among those who received the therapies separately.

Although there were no differences in overall survival rates between the two groups after five years, Fernando said he would expect to see survival rates rise in larger groups of patients over a longer time period.

"Even a 2.3 percent reduction in local recurrence rates will have an impact worldwide when we consider that this is a very common cancer," he said, citing data showing that for every four local recurrences of the disease prevented, one death from breast cancer death can be avoided.

Fernando said he has already changed practice in his own clinic and will send his data to Britain's National Institute of Clinical Excellence, which advises on treatment guidelines.

Michael Baumann, president of the European Cancer Organization, said more follow up would be needed to assess potential longer-term side effects. "I am convinced this trial will spur a lot of discussion," he said.

(Editing by Ruth Pitchford)

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