News on 5-ARI for newly diagnosed Low Risk Prostate Cancer

Interesting Study
Vasco,

Thanks for posting this interesting study. A couple of things I think ought to be noted in the context of this report.

First the study authors were paid consultants of Glaxo Smith Kline, a large drug manufacturer.

The study does not highlight any side effects or adverse reactions to taking the 5-ARI drugs and I had difficulty finding the dosage used in the study in the long report and the end state of the cohort was judged to be a validated cancer progression. Evidently, from the first link the dosage was 10mg per day.

I questioned the statement: "The traditional (Finasteride and Dutasteride) drugs are inexpensive, do not interact with other medication and have low (or zero) side effects."

The FDA has indicated that the most common side effects of these drugs include trouble getting or keeping an erection (impotence), decrease in sex drive, decreased volume of ejaculate, ejaculation disorders, enlarged or painful breast. Other allergic reactions, including rash, itching, hives, and swelling of the lips and face have been reported. In rare cases male breast cancer has been reported.

It should also be noted that women, particularly women of child bearing age, should avoid all contact with these drugs (even touching them) as it has potential to damage a male fetus.

For a 5 mg/day dosage, the common side effects of dutasteride, one of the 5-ARI drugs used in the study had the following side effects:

Erectile dysfunction (ED) or impotence -- in up to 18.5 percent of people
Decreased libido (sex drive) -- up to 10 percent
Abnormal ejaculation, including decreased ejaculate amount -- up to 7.2 percent
Breast enlargement -- up to 2.2 percent.

Since apparently, the dosage administered in the study was 10 mg/day I could only assume that the side effects would be more intense and affect a larger population, but this was not addressed in the results and I wonder if the consultants to Glaxo were motivated to report only the positive results -- the reduction in PCa progression in some patients -- rather than dwell on any adverse impact of the drug use.

Don't get me wrong, I think these studies are important and add to the body of knowledge we have about the complexities of prostate cancer. To me, at least, it seems that one of the reasons men choose AS to deal with their cancer is it's absence of side effects and men on AS who might be tempted to try such a treatment need to go into it with their eyes wide open and fully understand the potential for adversde side effects which are inherent in any medicines used to treat cancerous conditions.

Another thing about these studies, particularly those that are looking at only a single variable (such as the use of 5-ARI drugs) is that they do not address the underlying causes of the cancer but instead look at symptoms or rate of progression.

Best,

K

Kongo said:

Interesting Study
Vasco,

Thanks for posting this interesting study. A couple of things I think ought to be noted in the context of this report.

First the study authors were paid consultants of Glaxo Smith Kline, a large drug manufacturer.

The study does not highlight any side effects or adverse reactions to taking the 5-ARI drugs and I had difficulty finding the dosage used in the study in the long report and the end state of the cohort was judged to be a validated cancer progression. Evidently, from the first link the dosage was 10mg per day.

I questioned the statement: "The traditional (Finasteride and Dutasteride) drugs are inexpensive, do not interact with other medication and have low (or zero) side effects."

The FDA has indicated that the most common side effects of these drugs include trouble getting or keeping an erection (impotence), decrease in sex drive, decreased volume of ejaculate, ejaculation disorders, enlarged or painful breast. Other allergic reactions, including rash, itching, hives, and swelling of the lips and face have been reported. In rare cases male breast cancer has been reported.

It should also be noted that women, particularly women of child bearing age, should avoid all contact with these drugs (even touching them) as it has potential to damage a male fetus.

For a 5 mg/day dosage, the common side effects of dutasteride, one of the 5-ARI drugs used in the study had the following side effects:

Erectile dysfunction (ED) or impotence -- in up to 18.5 percent of people
Decreased libido (sex drive) -- up to 10 percent
Abnormal ejaculation, including decreased ejaculate amount -- up to 7.2 percent
Breast enlargement -- up to 2.2 percent.

Since apparently, the dosage administered in the study was 10 mg/day I could only assume that the side effects would be more intense and affect a larger population, but this was not addressed in the results and I wonder if the consultants to Glaxo were motivated to report only the positive results -- the reduction in PCa progression in some patients -- rather than dwell on any adverse impact of the drug use.

Don't get me wrong, I think these studies are important and add to the body of knowledge we have about the complexities of prostate cancer. To me, at least, it seems that one of the reasons men choose AS to deal with their cancer is it's absence of side effects and men on AS who might be tempted to try such a treatment need to go into it with their eyes wide open and fully understand the potential for adversde side effects which are inherent in any medicines used to treat cancerous conditions.

Another thing about these studies, particularly those that are looking at only a single variable (such as the use of 5-ARI drugs) is that they do not address the underlying causes of the cancer but instead look at symptoms or rate of progression.

Best,

K

Avodart study results
Kongo,

I read a news report today (Feb 15) that reviewed the outcome of a new study that tested Avodart, not to prevent cancer, but to prevent the progression of it. Dr. Maha Hussain, a University of Michigan cancer specialist chaired a cancer conference in Florida where the study will be presented later this week. Is this the same drug and study you are referring to?

About 300 men in the United States and Canada with low-risk cancer that was confirmed by biopsy enrolled in the study. They were given daily Avodart or dummy pills and had biopsies 1 1/2 and three years later. Prostate cancer got worse in 38 percent of men taking Avodart and 49 percent of those on dummy pills. Final biopsies showed no signs of cancer in 36 percent of men on Avodart versus 23 percent of those on dummy pills.

Most amazingly, a third of those on the pill and a quarter on placebo showed no sign of cancer after previously being diagnosed only 3 years earlier! Moreover, from the numbers, it would it appear that 28%, (100-49)-23, of placebo takers' cancers remained stable. Significantly too, half of placebo takers' (watcher and waiters?) cancers got worse. One wonders by how much.

One immediately wonders also, what the cancer free %age would have been (after 3 years) if radiation had been incorporated into the study. And if you're like me, one wonders yet again what the effect of the drug would be on slowing/stopping PSA rise following RP.

sbj

Kongo said:

sbj
I too read that news report yesterday. I believe it is a complementary report to the one Vasco highlighted that gave similar results. As I recall, the news story also did not go into potential side effects of using one of the two drugs...perhaps when the paper is actually presented there will be more details forthcoming.

Like the report Vasco referred to, this one does not appear to address any underlying causes of cancer in the first place but it is interesting, as you point out, that fairly high percentages of men who were on the placebo apparently saw their cancer remain steady or even decrease. Although since these results evidently were based on biopsy results, it's certainly possible that follow-on biopsies simply missed an indolent cancer or that in the cases where progression is shown, happened to hit a spot that was overlooked before.

K

Didn't see the article,
.....can you direct me to the source.

hopeful and optimistic said:

Didn't see the article,
.....can you direct me to the source.

hopeful
The article was an AP piece in yesterday's Yahoo News. Here's a full copy of it:


By MARILYNN MARCHIONE, AP Medical Writer – Wed Feb 16, 6:30 am ET
A new study suggests a way to help men with early, low-risk prostate cancer avoid being overtreated for a disease that in most cases will never threaten their lives. It found that a drug can slow the growth of these tumors in men who opt to be monitored instead of having treatment right away.
This is the first time that a drug for treating enlarged prostates also has been shown to help treat prostate cancer in a rigorous study. It may persuade more men to choose active surveillance, or "watchful waiting," instead of rushing to have treatments that can leave them with urinary or sexual problems, doctors say.
However, the results also show that most of these men do very well with no treatment at all.
"We're identifying men who are not likely to need even a pill," said Dr. Maha Hussain, a University of Michigan cancer specialist. But Americans fear cancer so much that they want some kind of treatment and underestimate the financial and medical risks of treating low-risk cases, she added.
She is program chair of a cancer conference in Florida where the study will be presented later this week. Results were released Tuesday in a telephone news conference sponsored by the American Society for Clinical Oncology.
Roughly half of the 218,000 men diagnosed each year in the United States with prostate cancer have low-risk disease — PSA blood levels under 10 and low tumor aggressiveness scores.
"The American view of cancer" is that it's always best to treat, so about 80 percent of these men choose to have that right away, said Dr. Otis Brawley, a prostate cancer expert who is chief medical officer of the American Cancer Society.
In Europe, though, most choose watchful waiting — close monitoring and treatment only if the cancer progresses or causes pain or other problems.
Doctors know that drugs that shrink the prostate — GlaxoSmithKline PLC's Avodart and Merck & Co.'s Proscar — can help prevent prostate cancer. But federal health advisers recently recommended against taking them for this purpose because of potential risks.
The new study tested Avodart "not to prevent cancer, but to prevent the progression" of it in men who already have the disease, which may be a much better use of such drugs, said the study's leader, Dr. Neil Fleshner of University Health Network and Princess Margaret Hospital in Toronto.
"We know the vast majority of these men are not destined to die from that cancer," and wanted to see if Avodart could make "watchful waiting" safer, Fleshner said.
The study enrolled about 300 men in the United States and Canada with low-risk cancer that was confirmed by a biopsy. They were given daily Avodart or dummy pills and new biopsies 1 1/2 and three years later.
Prostate cancer got worse in 38 percent of men taking Avodart and 49 percent of those on dummy pills. Final biopsies showed no signs of cancer in 36 percent of men on Avodart versus 23 percent of those on dummy pills. Doctors say this last result shows how tiny many of these cancers were to start with, that they couldn't even be found when new biopsies were done.
Doctors don't think Avodart can cure cancers, but it seems to suppress it, said Dr. Howard Sandler, a prostate cancer specialist at Cedars-Sinai Medical Center in Los Angeles. He had no role in the study but is involved with the cancer conference.
Researchers gave no details on Avodart's side effects, but said no new ones appeared in the study. Avodart and Proscar are known to cause sexual problems for some men, but many men over 50 have this anyway and only about 5 percent more do when taking these drugs, said Brawley, who helped test Avodart for cancer prevention.
The new study was sponsored by Avodart's maker, GlaxoSmithKline. Avodart and Proscar cost about $4 a pill; generic versions of Proscar are available for about $2. Proscar is similar to Avodart but has not been tested for treating early cancer as this study did.
Sandler said Avodart might relieve some men's anxiety about monitoring their disease and may make them more comfortable not having immediate treatment.
"If it was me, I'd choose active surveillance," he said. Avodart "has the potential to be an important help."

sbj

sbj said:

hopeful
The article was an AP piece in yesterday's Yahoo News. Here's a full copy of it:


By MARILYNN MARCHIONE, AP Medical Writer – Wed Feb 16, 6:30 am ET
A new study suggests a way to help men with early, low-risk prostate cancer avoid being overtreated for a disease that in most cases will never threaten their lives. It found that a drug can slow the growth of these tumors in men who opt to be monitored instead of having treatment right away.
This is the first time that a drug for treating enlarged prostates also has been shown to help treat prostate cancer in a rigorous study. It may persuade more men to choose active surveillance, or "watchful waiting," instead of rushing to have treatments that can leave them with urinary or sexual problems, doctors say.
However, the results also show that most of these men do very well with no treatment at all.
"We're identifying men who are not likely to need even a pill," said Dr. Maha Hussain, a University of Michigan cancer specialist. But Americans fear cancer so much that they want some kind of treatment and underestimate the financial and medical risks of treating low-risk cases, she added.
She is program chair of a cancer conference in Florida where the study will be presented later this week. Results were released Tuesday in a telephone news conference sponsored by the American Society for Clinical Oncology.
Roughly half of the 218,000 men diagnosed each year in the United States with prostate cancer have low-risk disease — PSA blood levels under 10 and low tumor aggressiveness scores.
"The American view of cancer" is that it's always best to treat, so about 80 percent of these men choose to have that right away, said Dr. Otis Brawley, a prostate cancer expert who is chief medical officer of the American Cancer Society.
In Europe, though, most choose watchful waiting — close monitoring and treatment only if the cancer progresses or causes pain or other problems.
Doctors know that drugs that shrink the prostate — GlaxoSmithKline PLC's Avodart and Merck & Co.'s Proscar — can help prevent prostate cancer. But federal health advisers recently recommended against taking them for this purpose because of potential risks.
The new study tested Avodart "not to prevent cancer, but to prevent the progression" of it in men who already have the disease, which may be a much better use of such drugs, said the study's leader, Dr. Neil Fleshner of University Health Network and Princess Margaret Hospital in Toronto.
"We know the vast majority of these men are not destined to die from that cancer," and wanted to see if Avodart could make "watchful waiting" safer, Fleshner said.
The study enrolled about 300 men in the United States and Canada with low-risk cancer that was confirmed by a biopsy. They were given daily Avodart or dummy pills and new biopsies 1 1/2 and three years later.
Prostate cancer got worse in 38 percent of men taking Avodart and 49 percent of those on dummy pills. Final biopsies showed no signs of cancer in 36 percent of men on Avodart versus 23 percent of those on dummy pills. Doctors say this last result shows how tiny many of these cancers were to start with, that they couldn't even be found when new biopsies were done.
Doctors don't think Avodart can cure cancers, but it seems to suppress it, said Dr. Howard Sandler, a prostate cancer specialist at Cedars-Sinai Medical Center in Los Angeles. He had no role in the study but is involved with the cancer conference.
Researchers gave no details on Avodart's side effects, but said no new ones appeared in the study. Avodart and Proscar are known to cause sexual problems for some men, but many men over 50 have this anyway and only about 5 percent more do when taking these drugs, said Brawley, who helped test Avodart for cancer prevention.
The new study was sponsored by Avodart's maker, GlaxoSmithKline. Avodart and Proscar cost about $4 a pill; generic versions of Proscar are available for about $2. Proscar is similar to Avodart but has not been tested for treating early cancer as this study did.
Sandler said Avodart might relieve some men's anxiety about monitoring their disease and may make them more comfortable not having immediate treatment.
"If it was me, I'd choose active surveillance," he said. Avodart "has the potential to be an important help."

sbj

SBJ and Kongo
Thanks for the AP news release ........