OBJECTIVE: To evaluate the clinical efficacy and cardiovascular complications of orchidectomy or polyoestradiol phosphate (PEP) in the treatment of advanced prostatic cancer. PATIENTS AND METHODS: In a prospective, randomized study 444 patients (mean age 73 years, range 45-91) with T3-4 M0 or T1-4 M1 prostatic cancer were treated either by orchidectomy (group 1, n = 217) or parenteral PEP (group 2, n = 227; 240 mg/month). The patients were examined at 3 and 6 months after start of the therapy and thereafter every 6 months; they were also assessed whenever they had symptoms indicating progression. Possible cardiovascular complications included myocardial infarction, cerebrovascular accident, pulmonary embolism and deep vein thrombosis. RESULTS: After a follow-up of 2 years there was no statistically significant difference between the groups in progression-free time; 65 of 217 (30%) patients in group 1 showed evidence of progression, including seven (3%) who died from prostate cancer. In group 2, 64 of 227 (28%) patients showed progression and eight (3.5%) died from prostatic cancer. There were 10 (5%) cardiovascular complications in patients in group 1, including five (2%) cardiovascular deaths; in group 2 there were 24 (11%) and 14 (6%), respectively. During the first year of treatment there were three (1.4%) cardiovascular complications in group 1 and 14 (6%) in group 2 (P < 0.05), and during the second year, seven (4%) and 10 (6%), respectively. CONCLUSION:Parenteral PEP (240 mg/month) seems to be as efficient as orchidectomy in inhibiting disease in patients with advanced prostatic cancer (T3-4 M0 and T1-4 M1). There were more cardiovascular complications in patients treated with PEP than after orchidectomy; the difference was statistically significant during the first year of treatment.
RCT Entities:
OBJECTIVE: To evaluate the clinical efficacy and cardiovascular complications of orchidectomy or polyoestradiol phosphate (PEP) in the treatment of advanced prostatic cancer. PATIENTS AND METHODS: In a prospective, randomized study 444 patients (mean age 73 years, range 45-91) with T3-4 M0 or T1-4 M1 prostatic cancer were treated either by orchidectomy (group 1, n = 217) or parenteral PEP (group 2, n = 227; 240 mg/month). The patients were examined at 3 and 6 months after start of the therapy and thereafter every 6 months; they were also assessed whenever they had symptoms indicating progression. Possible cardiovascular complications included myocardial infarction, cerebrovascular accident, pulmonary embolism and deep vein thrombosis. RESULTS: After a follow-up of 2 years there was no statistically significant difference between the groups in progression-free time; 65 of 217 (30%) patients in group 1 showed evidence of progression, including seven (3%) who died from prostate cancer. In group 2, 64 of 227 (28%) patients showed progression and eight (3.5%) died from prostatic cancer. There were 10 (5%) cardiovascular complications in patients in group 1, including five (2%) cardiovascular deaths; in group 2 there were 24 (11%) and 14 (6%), respectively. During the first year of treatment there were three (1.4%) cardiovascular complications in group 1 and 14 (6%) in group 2 (P < 0.05), and during the second year, seven (4%) and 10 (6%), respectively. CONCLUSION: Parenteral PEP (240 mg/month) seems to be as efficient as orchidectomy in inhibiting disease in patients with advanced prostatic cancer (T3-4 M0 and T1-4 M1). There were more cardiovascular complications in patients treated with PEP than after orchidectomy; the difference was statistically significant during the first year of treatment.
Authors: G Norman; M E Dean; R E Langley; Z C Hodges; G Ritchie; M K B Parmar; M R Sydes; P Abel; A J Eastwood Journal: Br J Cancer Date: 2008-02-12 Impact factor: 7.640