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Zoladex treatment of symptomatic prostatic carcinoma
B-064 ; ‘x~l?j;i~ __c_ _~~~~~~_~~i.~~I~~~~_~~~~~_~_~~~ _I ti_i:a !!i_~[ I t_,F i_! Fm&Lt_:I I-iJL .LG.ilUE. R.H.,Edwards L.,Schally FI.U. and Lightman S.L. Pat-mar H. , Phillips CHFIRING CROSS & WESTMINSTER riEoIcft SCHOOL, WESTMINSTER HOSPITRL, LONDON RN0 TULANE UNIVERSITY SCHOOL OF MEDICINE, NEW ORLEANSa 118 Patients were 62 patients were entered intu randomized. the long acting Cl-Trp-6-LHRH (OECRPEPTYL j group and 56 patients into the orchiectomy group. Qll patient characteristics examined were similar and testosterone levels were in the castrate range in both groups at 1 month or later. The mean time to castrate leuels of testosterone in the Cl-Trp-b-LHRH group was 17 days. SO patients (80%) in the 0-Trp-6-LHRH and 44 patients (78%) in the group orchiectomy group had partial remission or stable disease at 3 months. 10 patients in the 0-Trp-6-LHRH group and 9 patients in the orchiectomy group have died. The mean survival was 15 months in the O-Trp-6-LHRH group and 13 months in the orchiectomy group. There was no significant difference between the groups for response or survival. 3 patients in the D-Trp-6-LHRH group had a disease “flare” in the first 10 days of t.reatment. The flare symptoms in all patie&S rE!SOllJed end of by the 8 weeks. The incidence of flushing, decreased libido and impotence crlas similar in both groups. Psychological indicated tests that there was slightly decreased morbidity in the O-Trp-6-LHRH group. This difference was not statistically significant. The the diagnosis of cancer seemed to over-ride the psychological impact of the surgical orchiectomy. Uur results indicate that medical orchiectomy offers a safe and highly effective alternatiue to surgical orchiectomy. B-065 A COUPARISON BETWEEN SURGICAL ORCRIDECTOWY AND THE LHRH AGONIST 'ZOLADEX' (ICI 118,630) IN THE TREATMENT OF METASTATIC PROSTATIC CARCINOMA Peeling W.B.. Buck C. and Turkes A. on behalf of the Multicentre Study Group
359 patients were entered into this open randomized clinical trial in order to compare the efficacy and safety of surgical orchidectomy and 'Zoladex' in the treatment of histologically proven metastatic prostatic cancer. Patients were recruited from sixteen centres in the U.K. and the Republic of Ireland between October 1983 and January 1986. Patients were randomized to receive either surgical orchidectomy (total or subcapsular) or the LHRH agonist 'Zoladex', which was given in a biodegradable depot formulation injected subcutaneously every 28 days. Efficacy was determined by subjective measurements of urine flow, pain, analgesic requirements and activity, and by objective measurements of the primary tumour and metastases. Interim analyses on 240 patients ('Zoladex' = 128; Orchidectomy = 112) at a minimum follow-up of 3 months showed no differences in either subjective response rates ('Zoladex' = 80%; Orchidectomy = 72%) or objective response rates -CR+PR+NC ('Zoladex' = 66%; Orchidectomy = 70%). Both treatments were well tolerated. The current analyses, based on a minimum follow-up of 6 months for all patients for response and time to disease progression and minimum of 12 months follow-up for survival, are not indicating significant differences between the treatments. It is concluded that treatment with the LHRH agonist 'Zoladex' provides a real alternative to surgical castration in this group of patients with advanced prostatic cancer. B-066
ZOLADmTm'IMEMTOFS
YMPTWATIC PROSTATIC CARCINOMA.
I.M. Holdaway, H.K. Ibbertson, M.S. Croxson, V. Harvey, J. Moulton, and B. Knox. Auckland and National Wcmens Hospitals, Auckland, New Zealand. The depot LRH analogue Zoladex has been used to treat 24 patients with symptcaMtic metastatic 21 patients had bone Etastases and 3 had advanced soft tissue disease. prostatic carcinm. Patients have been followed for 6-18 months on treatint (man 12 months). Using the NFCP criteria to assess response, 4% of patients wzre in complete remission (CR) after 3 months treatment, 44% wzre in partial remission (PR), 36% were stable (S) and 16% showed no response. After 12 months of therapy the figures were 7% (CR) 33% (PR) 20% (S), and 40% wze dead or had progressive disease. Subjective irr+?rovant was seen in 21 patients although initial tLrnour flare occur& in 4 subjects (17%). Peak urine flow rates improved by 52% at 6 months of treatnrmt, and maanfSD prostatic volm decreased fran 37f2Chnlto 14+7ml. Serum acid phosphatase concentrations fell from 11.4f14 to 0.9+0.9u/l (N = O-0.6) and serm osteocalcin levels increased frcm 13_3+10ng/ml to 24f15ng/ml at 6 mnths of treatment. Serum LH and FSH levels decreased from 14.8?7.8iu/lto 5.8+3.5iu/l and frcm ll.lk9.3 to 6.6+3.3iu/l resoectivelv. and total sennn testosterone and derived free testosterone levels fell frcm 9-l+ 6.
359 patients were entered into this open randomized clinical trial in order to compare the efficacy and safety of surgical orchidectomy and 'Zoladex' in the treatment of histologically proven metastatic prostatic cancer. Patients were recruited from sixteen centres in the U.K. and the Republic of Ireland between October 1983 and January 1986. Patients were randomized to receive either surgical orchidectomy (total or subcapsular) or the LHRH agonist 'Zoladex', which was given in a biodegradable depot formulation injected subcutaneously every 28 days. Efficacy was determined by subjective measurements of urine flow, pain, analgesic requirements and activity, and by objective measurements of the primary tumour and metastases. Interim analyses on 240 patients ('Zoladex' = 128; Orchidectomy = 112) at a minimum follow-up of 3 months showed no differences in either subjective response rates ('Zoladex' = 80%; Orchidectomy = 72%) or objective response rates -CR+PR+NC ('Zoladex' = 66%; Orchidectomy = 70%). Both treatments were well tolerated. The current analyses, based on a minimum follow-up of 6 months for all patients for response and time to disease progression and minimum of 12 months follow-up for survival, are not indicating significant differences between the treatments. It is concluded that treatment with the LHRH agonist 'Zoladex' provides a real alternative to surgical castration in this group of patients with advanced prostatic cancer. B-066
ZOLADmTm'IMEMTOFS
YMPTWATIC PROSTATIC CARCINOMA.
I.M. Holdaway, H.K. Ibbertson, M.S. Croxson, V. Harvey, J. Moulton, and B. Knox. Auckland and National Wcmens Hospitals, Auckland, New Zealand. The depot LRH analogue Zoladex has been used to treat 24 patients with symptcaMtic metastatic 21 patients had bone Etastases and 3 had advanced soft tissue disease. prostatic carcinm. Patients have been followed for 6-18 months on treatint (man 12 months). Using the NFCP criteria to assess response, 4% of patients wzre in complete remission (CR) after 3 months treatment, 44% wzre in partial remission (PR), 36% were stable (S) and 16% showed no response. After 12 months of therapy the figures were 7% (CR) 33% (PR) 20% (S), and 40% wze dead or had progressive disease. Subjective irr+?rovant was seen in 21 patients although initial tLrnour flare occur& in 4 subjects (17%). Peak urine flow rates improved by 52% at 6 months of treatnrmt, and maanfSD prostatic volm decreased fran 37f2Chnlto 14+7ml. Serum acid phosphatase concentrations fell from 11.4f14 to 0.9+0.9u/l (N = O-0.6) and serm osteocalcin levels increased frcm 13_3+10ng/ml to 24f15ng/ml at 6 mnths of treatment. Serum LH and FSH levels decreased from 14.8?7.8iu/lto 5.8+3.5iu/l and frcm ll.lk9.3 to 6.6+3.3iu/l resoectivelv. and total sennn testosterone and derived free testosterone levels fell frcm 9-l+ 6.