Medical Forum / Diseases and Disorders / Prostate Cancer / August 2004
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 > [quoted text clipped - 17 lines] > Please remove spam to remove. > ====================== 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
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> 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. [quoted text clipped - 48 lines] > > > > Alan ron - 06 Aug 2004 03:13 GMT > August 04, 2004 > [quoted text clipped - 17 lines] > Please remove spam to remove. > ====================== 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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