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Medical Forum / Diseases and Disorders / Prostate Cancer / August 2004

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Casodex 150mg, Question.

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nospa - 05 Aug 2004 03:30 GMT
August 04, 2004

Hello Everyone:

My father (back in Peru, South America) was diagnosed with Prostate cancer
about 2 months ago. He is 70 years old and he was prescribed Casodex 150mg
daily with good results according to the doctor.

I read that taking 150 mg instead of 50 mg/daily was part of a study that
showed higher link to dead on patients, and Canada stopped approving the
sale or production of it (150 mg).

Any comment in the subject would be highly appreciated.

Regards,

M.
spammaltpc@mindspring.com

Please remove spam to remove.
======================
Robert - 05 Aug 2004 17:00 GMT
After chemo, RRP and radiation treatmentI am on intermittent hormonal
therapy. Four years ago I went on Casodex 150 mg per day for one year. A
year after I got off Casodex, psa started climbing. At that time I went on
Lupron for a year.  Been off Lupron for 9 months and psa is still non
detectable, but I expect it to rise in about three months.

Side effects were a lot less of a problem than with Lupron.  I hope to go on
casodex 150 rather than lupron the next time.

I am not aware of any issues related to mortality related to Casodex.

Robert

> August 04, 2004
>
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> ======================
Alan Meyer - 05 Aug 2004 21:38 GMT
> After chemo, RRP and radiation treatmentI am on intermittent hormonal
> therapy. Four years ago I went on Casodex 150 mg per day for one year. A
[quoted text clipped - 8 lines]
>
> Robert

Robert,

I haven't got the book in front of me, but if I remember
correctly, Dr. Stephen Strum, in his book, says that
patients who get to a PSA below .05 on hormone
therapy are unusually responsive to it, i.e., their
cancer is more than usually hormone dependent.

Again, IIRC, he recommends a combination HT
therapy for such patients whom, he says, may live
many more years than average patients on HT.

You might want to have a look at his book. See:
http://prostate-cancer.org/resource/primer.html

I'll make another posting about Strum's approach
to hormone therapy.

  Alan
Robert - 06 Aug 2004 02:16 GMT
Thank you for this info. I hadn't heard this before. I will be sure to
discuss it with the oncologist next month when I see him.

By the way, when I was taking lupron, I was also taking 50mg daily of
casodex.  I did not recall that when I wrote my first note on this topic.
So, it could have been the combination of Lupron and casodex that caused the
increase in side effects, not just the lupron as I was suggesting.
In any event, I will try to get a copy of Strum's book.

A lot of the current information about efficacy of treatment with various
hormonal protocols is still somewhat anecdotal. But the research is starting
to come in.  The oncologist I see is very well versed on the various
treatment protocols...he does ask be to cite sources now when I tell him
about what I have heard or read.

Robert

> > After chemo, RRP and radiation treatmentI am on intermittent hormonal
> > therapy. Four years ago I went on Casodex 150 mg per day for one year. A
[quoted text clipped - 29 lines]
>
>    Alan
nospa - 06 Aug 2004 02:34 GMT
Hello Robert and Alan:

Thank you for your reply.

The 3 websites where I read the articles about Mortality with 150mg of
Casodex are below.
Again, Thank you.

1-) http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/casodex_prof_e.html
2-) http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/casodex_pub_e.html
3-)
http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/casodex_2
81003.htm


=================================================

> Thank you for this info. I hadn't heard this before. I will be sure to
> discuss it with the oncologist next month when I see him.
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> >
> >    Alan
ron - 06 Aug 2004 03:13 GMT
> August 04, 2004
>
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> ======================

Hello M...You are correct, about a year ago Casodex 150 was withdrawn
for treatment of early prostate cancer in Canada (and I believe
England too).  If I'm remembering correctly, I don't think the FDA has
approved use of the 150 mg regimen for treatment of early PCa in the
US, I think they requested additional data from AZ.  Here is an
article on the subject, as well as two relevant links...Best wishes
and good health, Ron

Health Advisory
Important Safety Information Regarding Casodex 150mg
Accelerated deaths in Localized Prostate Cancer Patients
Health Canada has withdrawn its approval for Casodex 150mg for
early(localized) prostate cancer.

August 19,2003
In consultation with Health Canada, Astra Zeneca Canada Inc. is
advising
health professionals and the public of important new safety
information
related to the drug Casodex 150mg for the treatment of early
(localized)
prostate cancer.

The results of a large on-going early prostate cancer study with
Casodex
150 have shown that in a subgroup of 1627 patients with early prostate
cancer there is an increase in the number of deaths (196 versus 174)
in
the Casodex 150mg treated patients compared to those receiving no
active
treatment(placebo).

Based on this data, it is recommended Casodex 150mg not be
administered
to patients in the early phase of prostate cancer. Patients currently
undergoing Casodex 150 therapy for early prostate cancer should
consult
their physician immediately and discontinuation of Casodex sholud be
discussed. It should be noted that metasatic prostate cancer patients
taking Casodex 50 mg per day are not affected by this new information.

In Nov. 2002 Health Canada issued a conditional approval for Casodex
150mg under a policy called the "Notice of compliance with conditions"
This approval reflects the promising nature of the first results of
the
on-going studies in patients with this serious disease, but are yet to
be confirmed. Approval was based on studt results which showed that in
patients who would otherwise undergo watchful waiting(whereby the
patient is monitored and treatment is only started when there are
signs
that the fisease is getting worse), the immediate use of Casodex 150mg
delayed the spread of prostate cancer when compared with watchful
waiting alone. Casodex 150mg was approved in Canada for some patients
unsuitable for surgery or radiotherapy that are at high risk of the
disease spreading.
Further analysis however, has shown that there is evidence of
accelarated deaths in patients with localized prostate cancer
undergoing
watchful waiting and Casodex 150mg therapy. These deaths are unrelated
to prostate cancer, however association With Casodex 150mg therapy
cannot be ruled out

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/casodex_pub_e.html
http://www.astrazeneca.com/pressrelease/464.aspx
Les Bradbury - 08 Aug 2004 11:38 GMT
As someone who is taking 150mg of Casodex a day as an adjuvant to external
beam radiation therapy, I too am concerned about the withdrawal of the
approval of Casodex for early stage prostate cancer treatment in both the UK
and England. The basis for the concern seems to be the results reported in
the 8000 patient trial that was reported in the Journal of Urology vol.168,
pges 429-435, August 2002. The results of this trial were broken down into
three groups broken. Trial 23 consisted of 3293 patient with an initial
avaerage psa of 7.1. Trial 24 consisted of 3603 pateinets with an average
starting psa of 11.7 and trail 25 had 1218 patients with an average starting
psa f 16.2. Thus, the groups correspond to low, medium and high risk cases
of prostate cancer. In each group, roughly half were given 150mg of Casodex
per day and the other half were given  a placebo. The background treatments
were either radical prostatectomy, external beam radiation or watchful
waiting. To illustrate the problem, I will give the results only for the
intermediate risk group (trial 24). At the end of about three years, 181
patients in the Casodex group showed evidence of clinical progression.
However, clinical progression includes deaths although not necessarily from
prostate cancer. In this group of 181 progressions, there were 85
progressions and 96 deaths. By contrast, the placebo group had a
significantly higher rate of progression of 293 patients. Of these, there
were 201 with clinical progressions and 92 were deaths. The other groups had
roughly similar outcomes. The odd thing is that the Casodex group have
certainly an improved rate of clinical progression but that there seems to
be a slightly higher death rate in the Casodex group. Without having more
data, it is difficult to know if the difference is of high statistical
significant but my instinct is that it is not. Nevertheless, my impression
is that it is these figures that have made the medical authorities uneasy
about the approval of Casodex for early stage cancers. However, so far as I
know, there is no obvious cause for the increase in deaths although the
paper seems to suggest that there is a small increase in abnormal liver
function in the Casodex group.

I have been tasking Casodex for a year following radiation therapy and, as I
reported in an earlier posting to this group, things seem to be progressing
well with not too serious side effects. My inclination is to continue taking
the Casodex for another year or maybe two because there is quite a lot of
evidence (although not indisputable) that the long term disease free
survival rates are significantly improved by the adjuvant use of drug
therapies with radiotherapy. In the case of your father with Casodex being
prescribed as the only treatment, it is a difficult decision but you should
certainly put it in the context of his psa history and Gleason scores. I
think deciding what to do when you are diagnosed with prostate cancer at a
reasonably early stage but when you are of reasonably advanced years (i.e.
65 plus) is a very tricky decision and is influenced by what your general
health is like and whether or not you are still having an active sex life
and so on. One of the advantages of Casodex compared to other hormone
therapies like Zoladex and Lupron is that its side effects are not generally
as severe but they are not negligible either.

I should stress that I am not a medical practitioner but you might like to
quizz your father's consultant a bit more on his reasons for suggesting the
150mg Casodex treatment as the primary treatment. Best wishes.
Les Bradbury
 
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