Abstract | OBJECTIVE: MATERIAL AND METHODS: In total, 910 eligible patients with T0-4, NX, M1, G1-3 prostate cancer with an Eastern Cooperative Oncology Group performance status of 0-2 were randomized to treatment with either PEP 240 mg i.m. twice a month for 2 months and thereafter monthly, or flutamide ( Eulexin) 250 mg t.i.d. per os in combination with either triptorelin ( Decapeptyl) 3.75 mg i.m. per month or on an optional basis bilateral orchidectomy. RESULTS: At this final evaluation of the trial 855 of the 910 patients were dead. There was no difference between the treatment groups in terms of biochemical or clinical progression-free survival or in overall or disease-specific survival. There was no difference in cardiovascular mortality, but a significant increase in non-fatal cardiovascular events in the PEP arm (p<0.05) predominantly caused by an increase in ischemic heart and heart decompensation events. There were 18 grave skeletal events in the CAD group but none in the PEP group (p=0.001). CONCLUSIONS: PEP has an anticancer efficacy equal to CAD and does not increase cardiovascular mortality in metastasized patients, but carries a significant risk of non-fatal cardiovascular events, which should be balanced against the skeletal complications in the CAD group. It is feasible to use Estradurin in the primary or secondary endocrine treatment of metastasized patients without prominent cardiac risk factors and especially those with osteoporosis.
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Authors | Per Olov Hedlund, Jan-Erik Damber, Inger Hagerman, Svein Haukaas, Peter Henriksson, Peter Iversen, Robert Johansson, Peter Klarskov, Finn Lundbeck, Finn Rasmussen, Eberhard Varenhorst, Jouko Viitanen, SPCG-5 Study Group |
Journal | Scandinavian journal of urology and nephrology
(Scand J Urol Nephrol)
Vol. 42
Issue 3
Pg. 220-9
( 2008)
ISSN: 0036-5599 [Print] England |
PMID | 18432528
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Androgen Antagonists
- Estrogens
- Estradiol
- Flutamide
- polyestradiol phosphate
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Topics |
- Aged
- Aged, 80 and over
- Androgen Antagonists
(administration & dosage)
- Bone Neoplasms
(secondary)
- Cause of Death
- Estradiol
(administration & dosage, analogs & derivatives)
- Estrogens
(administration & dosage)
- Flutamide
(administration & dosage)
- Humans
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Prostatic Neoplasms
(drug therapy, mortality, pathology)
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