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dc.contributor.authorAhlgren, Göran M.
dc.contributor.authorFlodgren, Per
dc.contributor.authorTammela, Teuvo L.J.
dc.contributor.authorKellokumpu-Lehtinen, Pirkko
dc.contributor.authorBorre, Michael
dc.contributor.authorAngelsen, Anders
dc.contributor.authorIversen, Jon Reidar
dc.contributor.authorSverrisdottir, Asgerdur
dc.contributor.authorJonsson, Eirikur
dc.contributor.authorSengelov, Lisa
dc.date.accessioned2018-06-15T15:03:07Z
dc.date.available2018-06-15T15:03:07Z
dc.date.issued2018-06
dc.date.submitted2018
dc.identifier.citationDocetaxel Versus Surveillance After Radical Prostatectomy for High-risk Prostate Cancer: Results from the Prospective Randomised, Open-label Phase 3 Scandinavian Prostate Cancer Group 12 Trial 2018, 73 (6):870 European Urologyen
dc.identifier.issn03022838
dc.identifier.doi10.1016/j.eururo.2018.01.012
dc.identifier.urihttp://hdl.handle.net/2336/620598
dc.descriptionTo access publisher's full text version of this article click on the hyperlink belowen
dc.description.abstractBACKGROUND: Adjuvant chemotherapy is standard treatment for other solid tumours, but to date has not proven effective in prostate cancer. OBJECTIVE: o evaluate whether six cycles of docetaxel alone improve biochemical disease-free survival after radical prostatectomy for high-risk prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: Open-label, randomised multinational phase 3 trial. Enrolment of 459 patients after prostatectomy. INCLUSION CRITERIA: high-risk pT2 margin positive or pT3a Gleason score ≥4+3, pT3b, or lymph node positive disease Gleason score ≥3+4. Patients assigned (1:1) to either six cycles of adjuvant docetaxel 75mg/m2 every 3 wk without daily prednisone (Arm A) or surveillance (Arm B) until endpoint was reached. Primary endpoint was prostate-specific antigen progression ≥0.5 ng/ml. INTERVENTION: Docetaxel treatment after prostatectomy. RESULTS AND LIMITATIONS: Median time to progression, death, or last follow-up was 56.8 mo. Primary endpoint was reached in 190/459 patients-the risk of progression at 5 yr being 41% (45% in Arm A and 38% in Arm B). There was evidence of nonproportional hazards in Kaplan-Meier analysis, so we used the difference in restricted mean survival time as the primary estimate of effect. Restricted mean survival time to endpoint was 43 mo in Arm A versus 46 mo in Arm B (p=0.06), a nonsignificant difference of 3.2 mo (95% confidence interval: 6.7 to -1.5 mo). A total of 116 serious adverse events were recorded in Arm A and 41 in Arm B with no treatment-related deaths. Not all patients received docetaxel by protocol. The endpoint is biochemical progression and some patients received radiation treatment before the endpoint. CONCLUSIONS: Docetaxel without hormonal therapy did not significantly improve biochemical disease-free survival after radical prostatectomy. PATIENT SUMMARY: In this randomised trial, we tested whether chemotherapy after surgery for high-risk prostate cancer decreases the risk of a rising prostate-specific antigen. We found no benefit from docetaxel given after radical prostatectomy.
dc.description.sponsorshipSanofien
dc.language.isoenen
dc.publisherElsevier Scienceen
dc.relation.urlhttp://linkinghub.elsevier.com/retrieve/pii/S0302283818300216en
dc.rightsArchived with thanks to European Urologyen
dc.subjectBlöðruhálskirtilskrabbameinen
dc.subjectLyfjameðferðen
dc.subjectChemotherapyen
dc.subjectSkurðlækningaren
dc.subjectBlöðruhálskirtillen
dc.subjectMAO12en
dc.subjectURS12en
dc.subject.meshAntineoplastic Agentsen
dc.subject.meshProstatic Neoplasmsen
dc.subject.meshProstatectomyen
dc.subject.meshDrug Therapyen
dc.titleDocetaxel Versus Surveillance After Radical Prostatectomy for High-risk Prostate Cancer: Results from the Prospective Randomised, Open-label Phase 3 Scandinavian Prostate Cancer Group 12 Trialen
dc.typeArticleen
dc.contributor.department1 ] Lund Univ, Skane Univ Hosp, Dept Urol, Jan Waldenstroms Gata 5, S-20502 Malmo, Sweden Show more [ 2 ] Lund Univ, Skane Univ Hosp, Dept Oncol, Malmo, Sweden Show more [ 3 ] Univ Tampere, Tampere Univ Hosp, Dept Urol, Tampere, Finland Show more [ 4 ] Univ Tampere, Tampere Univ Hosp, Dept Oncol, Tampere, Finland Show more [ 5 ] Aarhus Univ Hosp, Skejby Sygehus, Dept Urol, Aarhus, Denmark Show more [ 6 ] Norwegian Univ Sci & Technol, Dept Urol, Trondheim, Norway Show more [ 7 ] Oslo Univ Hosp, Dept Oncol, Oslo, Norway Show more [ 8 ] Landspitali Univ Hosp, Dept Oncol, Reykjavik, Iceland Show more [ 9 ] Landspitali Univ Hosp, Dept Urol, Reykjavik, Iceland [ 10 ] Herlev Gentofte Hosp, Dept Oncol, Herlev, Denmarken
dc.identifier.journalEuropean Urologyen
dc.rights.accessNational Consortium - Landsaðganguren
dc.departmentcodeMAO12, URS12
html.description.abstractBACKGROUND: Adjuvant chemotherapy is standard treatment for other solid tumours, but to date has not proven effective in prostate cancer. OBJECTIVE: o evaluate whether six cycles of docetaxel alone improve biochemical disease-free survival after radical prostatectomy for high-risk prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: Open-label, randomised multinational phase 3 trial. Enrolment of 459 patients after prostatectomy. INCLUSION CRITERIA: high-risk pT2 margin positive or pT3a Gleason score ≥4+3, pT3b, or lymph node positive disease Gleason score ≥3+4. Patients assigned (1:1) to either six cycles of adjuvant docetaxel 75mg/m2 every 3 wk without daily prednisone (Arm A) or surveillance (Arm B) until endpoint was reached. Primary endpoint was prostate-specific antigen progression ≥0.5 ng/ml. INTERVENTION: Docetaxel treatment after prostatectomy. RESULTS AND LIMITATIONS: Median time to progression, death, or last follow-up was 56.8 mo. Primary endpoint was reached in 190/459 patients-the risk of progression at 5 yr being 41% (45% in Arm A and 38% in Arm B). There was evidence of nonproportional hazards in Kaplan-Meier analysis, so we used the difference in restricted mean survival time as the primary estimate of effect. Restricted mean survival time to endpoint was 43 mo in Arm A versus 46 mo in Arm B (p=0.06), a nonsignificant difference of 3.2 mo (95% confidence interval: 6.7 to -1.5 mo). A total of 116 serious adverse events were recorded in Arm A and 41 in Arm B with no treatment-related deaths. Not all patients received docetaxel by protocol. The endpoint is biochemical progression and some patients received radiation treatment before the endpoint. CONCLUSIONS: Docetaxel without hormonal therapy did not significantly improve biochemical disease-free survival after radical prostatectomy. PATIENT SUMMARY: In this randomised trial, we tested whether chemotherapy after surgery for high-risk prostate cancer decreases the risk of a rising prostate-specific antigen. We found no benefit from docetaxel given after radical prostatectomy.


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