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Old 10-16-2003, 06:35 PM   #1
urafreak
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letrozole...

thought this was an intersting article. found in my local paper.

Breast-cancer drug trial hailed
Deaths halved for older survivors
Positive results end study early


ELAINE CAREY
MEDICAL REPORTER

Jubilant Canadian researchers have announced a major breakthrough in the treatment of breast cancer in post-menopausal women.

The results of a large international trial released yesterday found that a drug called letrozole virtually cut in half the risk of disease recurrence and death in female breast-cancer survivors who had first taken the drug tamoxifen for five years.

The findings were so dramatic that the Canadian-led international trial was halted early so more women could benefit immediately. Half of the more than 5,000 women worldwide — 1,404 of them in Canada — taking part in the trial had, until now, been given a placebo. Neither they nor their doctors knew for the past 2 1/2 years whether they were taking the drug or a placebo.

The study was published yesterday in an advance on-line edition of The New England Journal of Medicine.

"I think this is a sea change in treatment, this is a new discussion that is going to take place now," said Dr. Paul Goss, director of breast-cancer research at Princess Margaret Hospital who conceived and chaired the international trial.

"Literally hundreds of thousands of women will be affected by this," Dr. James Ingle of the Mayo Clinic in Rochester, Minn., told a news conference at Toronto's Intercontinental Hotel.

Tamoxifen, developed more than 20 years ago, is used widely to treat breast cancer in early and advanced stages. The drug blocks the effects of estrogen, a female hormone that contributes to the growth of breast cancer. Letrozole, which also leads to the reduction of estrogen in the body, is used to treat breast cancer in post-menopausal women.

Until now, there has been no effective treatment for post-menopausal women after they have taken tamoxifen for five years to prevent recurrence.

At that point, tamoxifen stops being effective for these women because, researchers believe, tumours become resistant to it and it can actually cause more cancer.

The study was designed to see if letrozole could pick up where tamoxifen left off.

More than half of women who have a recurrence of breast cancer do so more than five years after their initial diagnosis, Goss said.

"This is a dark cloud that hangs over our patients and their families," he said. "Our study ushers in a new era of hope by cutting these ongoing recurrences and deaths from breast cancer after tamoxifen by almost one-half."

More than 21,000 women in Canada will be diagnosed with breast cancer this year and more than half of them may be eligible for the new treatment.

One of those patients is 50-year-old Kathy Anderson, who was diagnosed with breast cancer 8 1/2 years ago. She had two surgeries, radiation and chemotherapy and found out this week that she had been taking letrozole and not the placebo for the past 2 1/2 years of the trial.

She had taken tamoxifen for five years and "it's scary when you think you have nothing to move on to," she said at the news conference. "Knowing this drug has cut the recurrence rate in half is very important. It does relieve one's mind."

Anderson said she only learned the study results two days ago and until now hasn't told anyone except her husband.

"We celebrated that night with a special glass of wine," Anderson said. "The results are so important, the word has to get out. Women need to know they can go to their doctor because there is a drug."

Over-all, letrozole reduced the risk of cancer recurring by 43 per cent. After four years of the trial, 13 per cent of the women on the placebo, but only 7 per cent of those on letrozole, had a recurrence.

Seventeen women taking the placebo died of breast cancer during the trial, compared to nine taking letrozole.

In the study, one in 100 women benefited from letrozole — a figure that rose to six in 100 after four years.

"It's a bit like watching Tiger Woods hit a golf ball — it looks good at first, but it gets better as it goes along," Goss said.

The findings were even more "remarkable" because many anticipated that the benefits of letrozole would be modest, John Bryant and Dr. Norman Wolmark, two independent experts, said in an editorial in The New England Journal of Medicine.

But because the study was stopped early, many questions have been left unanswered, such as how long women should take letrozole and what the long-term side effects might be.

During the trial, the drug produced relatively minor side effects, including increased bone loss, hot flashes, sweating, sore muscles and fatigue.

The trial was to run for five years, but when an independent safety and monitoring committee saw the first dramatic results after just under 2 1/2 years, it recommended the trial be stopped so women on the placebo could be offered the drug.

"The estimated magnitude of the benefit ... was substantially greater than expected," Bryant and Wolmark wrote in the journal editorial.

Patients in any drug trial sign a consent form and this one specified, "If new side effects or information about my disease or treatment are discovered during the study, I will be told."

That's normally built in for the safety of the patients in case the drug has adverse effects, said Dr. Lois Shepherd, trial co-ordinator of the study for the National Cancer Institute of Canada clinical trials group.

But in this case, the benefits of the drug were "so extreme," the independent monitoring group decided the trial should be halted so more women could benefit.

"That doesn't happen very often," she said.

The journal editorial commends the study as a "well-conceived and well-conducted clinical trial," and concedes "perhaps reluctantly" that the recommendation to halt the study was justified.

But many things were lost because the study was stopped, the editorial adds.

The trial was to determine the effect of taking letrozole for five years, yet none of the women took it that long.

As well, concerns about the long-term side effects of the drug remain, including a possible increased risk of osteoporosis and cardiovascular disease.

"It would have been of great value to have been able to follow the women over a period of years in comparison with a blinded placebo group," the editorial says.

Moreover, other long-term trials involving aromatase inhibitors like "are virtually certain to be modified or terminated" because of the early release of the study results.

That includes a trial Bryant and Wolmark are involved in that "is in peril" because of these results, they say.

But after asking rhetorically what they would have done in the same situation, they conclude they would have "disclosed the data in exactly the same manner."

"An inescapable truism of randomized trials is that we are condemned to bear the burden and limitations of our incremental successes," the editorial says.

Shepherd said the investigators plan to keep the women in the study on letrozole for five years and will follow them afterwards to see the long-term effects.

"We just won't have a placebo group to compare them to any more," she said. "The issue is we have lost a little bit of information."

Most studies take the full five years to produce the results researchers are looking for, Shepherd said.

"No one really expected the results to be this dramatically different at such an early time point. It was really exciting," she said.

"You conduct these trials and you put these studies together in the hopes you will advance knowledge and help people with cancer," Shepherd said. "It's such a lot of work, a lot of people power — a lot of patients and organizational effort goes into these studies.

"To have such a positive result that will potentially affect so many women is a pretty wonderful feeling."

"This drug in my opinion is far more effective than it could possibly be dangerous," Goss said.

"This is very rewarding," he said. "It makes me go to the clinic tomorrow with a lighter step."

The study was conducted by researchers from the Canadian Cancer Society, Princess Margaret, the U.S. National Cancer Institute, the Mayo Clinic and the National Cancer Institute of Canada's clinical trial group at Queen's University in Kingston.
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Old 12-17-2003, 01:40 PM   #2
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Great read. A word of caution to bodybuilders, letrozole has a greater negative impact on blood lipids than either arimidex or nolvadex. Many users also complain of stiff, sore and dry joints while on letrozole.
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Old 04-26-2016, 08:37 AM   #3
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A word of caution to bodybuilders, letrozole has a greater negative impact on blood lipids than either arimidex or nolvadex. Many users also complain of stiff, sore and dry joints while on letrozole.
What is the minimum dose of letrozole to use to reduce bloat but avoid the negative lipid / dry joint sides?

I was thinking 1.25mg / ew, split up into 2 doses.... M / TH
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Old 04-27-2016, 09:48 AM   #4
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Old 04-27-2016, 05:59 PM   #5
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What is the minimum dose of letrozole to use to reduce bloat but avoid the negative lipid / dry joint sides?

I was thinking 1.25mg / ew, split up into 2 doses.... M / TH
It varies from person to person. I have used 1.25 mgs eod w/o problems. This thread is about 12 years old when letro first came out in our community.
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Old 04-28-2016, 07:03 AM   #6
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yes sir but has the science behind it or the chemical structure changed in that time frame?

I was always an arimidex guy but have femara laying around
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Old 04-29-2016, 10:14 PM   #7
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yes sir but has the science behind it or the chemical structure changed in that time frame?

I was always an arimidex guy but have femara laying around
if its 2.5 split it in half the stuff is super strong you don't need much
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