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Parenteral Estrogen Versus Combined Androgen Deprivation in the Treatment of Metastatic Prostatic Cancer - Scandinavian Prostatic Cancer Group (SPCG) Study No

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Parenteral Estrogen Versus Combined Androgen Deprivation in the Treatment of Metastatic Prostatic Cancer - Scandinavian Prostatic Cancer Group (SPCG) Study No Scandinavian Journal of Urology and Nephrology ISSN: 0036-5599 (Print) 1651-2065 (Online) Journal homepage: https://www.tandfonline.com/loi/isju19 Parenteral Estrogen versus Combined Androgen Deprivation in the Treatment of Metastatic Prostatic Cancer - Scandinavian Prostatic Cancer Group (SPCG) Study No. 5 Per Olov Hedlund, Martti Ala-Opas, Einar Brekkan, Jan Erik Damber, Lena Damber, Inger Hagerman, Svein Haukaas, Peter Henriksson, Peter Iversen, Åke Pousette, Finn Rasmussen, Jaakko Salo, Sigmund Vaage & Eberhard Varenhorst To cite this article: Per Olov Hedlund, Martti Ala-Opas, Einar Brekkan, Jan Erik Damber, Lena Damber, Inger Hagerman, Svein Haukaas, Peter Henriksson, Peter Iversen, Åke Pousette, Finn Rasmussen, Jaakko Salo, Sigmund Vaage & Eberhard Varenhorst (2002) Parenteral Estrogen versus Combined Androgen Deprivation in the Treatment of Metastatic Prostatic Cancer - Scandinavian Prostatic Cancer Group (SPCG) Study No. 5, Scandinavian Journal of Urology and Nephrology, 36:6, 405-413, DOI: 10.1080/003655902762467549 To link to this article: https://doi.org/10.1080/003655902762467549 Published online: 09 Jul 2009. Submit your article to this journal Article views: 72 Citing articles: 33 View citing articles Full Terms & Conditions of access and use can be found at https://www.tandfonline.com/action/journalInformation?journalCode=isju20 ORIGINAL ARTICLE Parenteral Estrogen versus Combined Androgen Deprivation in the Treatment of Metastatic Prostatic Cancer ScandinavianProstatic Cancer Group(SPCG) Study No. 5 Per Olov Hedlund, 1 Martti Ala-Opas, 2 Einar Brekkan, 3 Jan Erik Damber, 4 Lena Damber, 5 Inger Hagerman, 6 Svein Haukaas, 7 Peter Henriksson, 8 Peter Iversen, 9 AÊ ke Pousette, 10 Finn Rasmussen, 11 Jaakko Salo, 12 Sigmund Vaage, 13 Eberhard Varenhorst 14 and the SPCG-5* Study Group Fromthe Departments of Urology, 1KarolinskaHospital, Stockholm, Sweden, 2KuopioUniversity Hospital,Kuopio, Finland, 3UppsalaAcademic Hospital, Uppsala, Sweden and 4SahlgrensUniversity Hospital,Gothenburg, Sweden, 5OncologicCenter, UmeaÊ University, UmeaÊ , Sweden, 6Departmentof Cardiology, Huddinge Hospital, Huddinge, Sweden, 7Diakonissehjemmet Hospital,Bergen, Norway, 8Departmentof Medicine,Huddinge Hospital, Huddinge, Sweden, 9Departmentof Urology, Rigshospitalet,Copenhagen, Denmark, 10ResearchLaboratory for ReproductiveHealth, Karolinska Hospital, Stockholm, Swedenand the Departments of Urology, 11HerlevUniversity Hospital,Herlev, Denmark, 12Helsinki University Hospital,Helsinki, Finland, 13StavangerHospital, Stavanger, Norway and 14Norrko¨pingHospital, Norrko ¨ping,Sweden (SubmittedFebruary 14, 2002. Accepted for publicationApril 24,2002) Scand JUrol Nephrol 36: 405–413, 2002 Objective: Inthe mid-1980s, interest in parenteral estrogen therapy for prostate cancerwas renewed when it wasfound that it inuenced liver metabolism only marginally and had very fewcardiovascular side-effects.In this study high-dose polyestradiol phosphate (PEP; Estradurin 1)wascompared to combined androgen deprivation (CAD)for the treatmentof patients with metastaticprostate cancer.The aimof the study wasto compareanticancer ef cacy and adverseevents, especially cardiovascular side-effects. Material and Methods: Atotal of 917 patients with T0–4, NX, M1, G1-3 prostate cancerand an Eastern Cooperative Oncology Group performance status of 0–2 wererandomized to treatmentwith either PEP 240 mgi.m. twicea month for 2 months and thereafteronce amonth or utamide (Eulexin 1)250 mg t.i.d. per os in combination with either triptorelin (Decapeptyl 1)3.75 mgper month i.m. or, on an optional basis, bilateral orchidectomy. Atotal of 556 patients had died atthe timeof this analysis. Results: There wasno differencebetween the treatmentarms in termsof timeto biochemical or clinical progression and overall or disease-specic survival. There wasno increasein cardiovascular mortality in the PEP arm.The PEP group had a higher prevalence of cardiovascular diseaseprior to the study and asignicantly higher incidence of non-fatal ischemicheart events and heart decompensation during the study. Conclusions: PEP has an equal anticanceref cacy to CADand does not increasecardiovascular mortality. Final evaluation of cardiovascular morbidity is awaiting further analysis and follow-up. PEP is considerably cheaperthan CAD. Key words: advanced disease,cardiovascular complications, combined androgen deprivation, hormone treatment, multicenter study, parenteral estrogen, prostate cancer. PerOlov Hedlund, Skogsstigen 22, SE-131 42 Nacka, Sweden. E-mail: [email protected] Oralestrogen treatment,once the commonest method changes in liver metabolism and grave deviations in forhormone manipulation of prostate cancerin the blood levels of coagulation factors seen afteroral Nordic countries, was largely abandoned in the 1970s therapy werereported to be absent or only marginally due its signicant cardiovascular toxicity. In the mid- present afterparenteral therapy (1). Two Finnish 1980s, interest in estrogen therapy was renewed when studies showed that polyestradiol phosphate (PEP; it was found that estrogen administered parenterally Estradurin1;PharmaciaAB, Sweden) given atadose did not induce these side-effects. The signicant of 160 mg i.m. per month did not lead to higher cardiovascular morbidity or mortality than bilateral *Acompletelist of themembers of theSPCG-5 studygroup is orchidectomy (2)or gonadotrophin-releasing hormone givenin theAppendix. analog therapy (3). This dose of PEPdid however have Ó 2002Taylor & Francis. ISSN0036– 5599 ScandJ UrolNephrol 36 406 P.O.Hedlund et al. inferior anticancer efcacy, measured in termsof about the study and gave their oral consent to progression-free survival. This may be explained by participate. the factthat 160 mg of PEPper month does not Patients werestrati ed according to country (with decrease serumtestosterone to castration levels (4). In Iceland being included in the Norwegian group), aSwedish pilot study it was found that PEPgiven ata ECOGperformance status 0–1 vs 2, alkaline phospha- dose of 240 mg per month decreased serumtestoster- tase level under or over 1.25 the upper limitof one to castration levels, and that this was most rapidly normal and whether or not they£ had aprevious or achieved by giving PEP240 mg every second week current history of cardiovascular disease. Randomiza- during the rst 2months (5). In an open study of 40 tion was done by the Oncologic Center of the prostate cancerpatients, no increase in cardiovascular Karolinska Hospital, Stockholm, atwhich the eligi- toxicity was noted during the rst 3years of this bility of the patients was initially checked. Patients therapy (6). wereallocated to treatmentaccording to their position The aimof the present study was to comparePEP on the stratication list. with combined androgen deprivation (CAD),with Polyestradiol phosphate (Estradurin) was given as overall survival as the primaryendpoint. Secondary i.m. injections of 240 mgtwicea month for2 months objectives wereto compare timeto biochemical and (total of ve doses), and thereafteronce every month. clinical progression, cancer-specic survival, cardio- CAD was given as utamide tablets (Eulexin 1; vascular toxicity, other adverse events and quality of Schering-Plough AB, Stockholm, Sweden), 250 mg life.Some data fromthe rst evaluation have pre- t.i.d., in combination with either triptorelin (Decapep- viously been published (7). The present paper gives a tyl1;Ferring AB, Malmo¨,Sweden), 3.75 mgi.m. per morecomprehensive presentation of the design and month, or, on an optional basis, bilateral orchidectomy. initial results. Flutamide treatmentwas started 1week before the rst triptorelin injection. Irradiation of the breasts prior to therapy was optional. MATERIALAND METHODS The patients werefollowed by visits to the trialist Between December1992 and June 1997, 917 men with 1, 3and 6months afterthe start of the study and hormone-naive, T0–4, NX, M1, G1–3 prostate cancer thereafterevery 6months until clinical progression was and anEastern Cooperative Oncology Group (ECOG) clearly established. Between these visits, prostate- performancestatus of 0–2 wererandomized to receive specic antigen (PSA)values weredetermined in treatmentwith either PEPor CAD. All patients had every patient, so that the PSA was measured every 3 skeletal metastases as evaluated frombone scans months. Ifrequired, patients could request more supplemented with X-rays when needed. The primary detailed examinations. At every visit patients were tumor was staged by means of digital rectalexamina- questioned and evaluated with regard tosymptoms or tion according tothe TNMclassi cation of 1987 and signs of disease progression and adverse events. Blood graded according to the World Health Organization pressure, body weight, performancestatus and pain and (WHO)system, either as aresult of ne-needle analgesic scores (seeTable II)were noted and levels of aspiration cytology (8)or histologically fromtrans- hemoglobin, creatinine, PSA and liver enzymes, urethral resection of the prostate specimens (9). The including alkaline phosphatase, weremeasured. Digital extent of bone disease was calculated frompretreat- rectalexamination, bone scan or X-rays werenot done ment bone scans according to amodied Soloway regularly and only ifconsidered necessary forevalua- score as follows: score 1, the total areaof hot spots is tion of the disease status. The evaluation of clinical less than three bodies of alumbar vertebra; score 2, the progression was based on clinical signs and
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