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  • Josefsson, Andreas,1979-Umeå University,Umeå universitet,Wallenberg centrum för molekylär medicin vid Umeå universitet (WCMM),Urologi och andrologi,Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden (författare)

Effect of docetaxel added to bicalutamide in Hormone-Naïve non-metastatic prostate cancer with rising PSA, a randomized clinical trial (SPCG-14)

  • Artikel/kapitelEngelska2023

Förlag, utgivningsår, omfång ...

  • Taylor & Francis,2023
  • electronicrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:umu-207884
  • https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-207884URI
  • https://doi.org/10.1080/0284186X.2023.2199940DOI
  • https://lup.lub.lu.se/record/4adfb698-860b-457d-a57c-3b6927141c5eURI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Background: Historically, endocrine therapy was used in a range of scenarios in patients with rising PSA, both as a treatment for locally advanced non-metastatic prostate cancer and PSA recurrence following curative intended therapy. In the present study the objective was to investigate if chemotherapy added to endocrine therapy could improve progression-free survival (PFS).Materials and Methods: Patients with hormone-naïve, non-metastatic prostate cancer and rising prostate-specific antigen (PSA), enrolled from Sweden, Denmark, the Netherlands, and Finland, were randomized to long-term bicalutamide (150 mg daily) or plus docetaxel (75 mg/m2, q3w, 8–10 cycles) without prednisone, after stratification for the site, prior local therapy or not, and PSA doubling time. The primary endpoint was 5-year PFS analyzed with a stratified Cox proportional hazards regression model on intention to treat basis.Results: Between 2009 and 2018, a total of 348 patients were randomized; 315 patients had PSA relapse after radical treatment, 33 patients had no prior local therapy. Median follow-up was 4.9 years (IQR 4.0–5.1). Adding docetaxel improved PFS (HR 0.68, 95% CI 0.50–0.93; p = 0.015). Docetaxel showed an advantage for patients with PSA relapse after prior local therapy (HR 0.67, 95% CI 0.49–0.94; p = 0.019). One event of neutropenic infection/fever occurred in 27% of the patients receiving docetaxel. Limitations were slow recruitment, lack of enrolling patients without radical local treatment, and too short follow-up for evaluation of overall survival in patients with PSA relapse.Conclusion: Docetaxel improved PFS in patients starting bicalutamide due to PSA relapse after local therapy or localized disease without local therapy. Confirmatory studies of the efficacy of docetaxel in the setting of PSA-only relapse in addition to endocrine therapies may be justified if longer follow-up will show increased metastatic-free survival.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Jellvert, ÅsaDepartment of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, NU Hospital Group, Department of Surgery, Uddevalla, Sweden; Department of Oncology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden (författare)
  • Holmberg, ErikDepartment of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Regional Cancer Centre West, Gothenburg, Sweden,Regional Cancer Center Western Sweden (författare)
  • Brasso, KlausCopenhagen Prostate Cancer Center, Department of Urology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark,Copenhagen University Hospital (författare)
  • Meidahl Petersen, PeterDepartment of Oncology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark,Copenhagen University Hospital (författare)
  • Aaltomaa, SirpaDepartment of Urology, Kuopio University Hospital, Kuopio, Finland (författare)
  • Luukkaa, MarjaanaDepartment of Oncology, Turku University Hospital, Turku, Finland (författare)
  • Verhagen, PaulDepartment of Urology, Erasmus Medical Centre, Rotterdam, Netherlands,Erasmus University Medical Center (författare)
  • de Wit, RonaldDepartment of Medical Oncology, Erasmus University Medical Centre Cancer Institute, Rotterdam, Netherlands (författare)
  • Ahlgren, GöranLund University,Lunds universitet,Urologisk cancerforskning, Malmö,Forskargrupper vid Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Urological cancer, Malmö,Lund University Research Groups,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Skåne University Hospital(Swepub:lu)kir-gah (författare)
  • Andrén, OveÖrebro University (författare)
  • Castellanos, EnriqueDepartment of Oncology, Karolinska University Hospital, Stockholm, Sweden (författare)
  • Seke, MihaljCentrallasarettet Växjö, Växjö, Sweden (författare)
  • Widmark, AndersUmeå University,Umeå universitet,Institutionen för strålningsvetenskaper(Swepub:umu)anwi0004 (författare)
  • Damber, Jan-ErikDepartment of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden (författare)
  • Umeå universitetWallenberg centrum för molekylär medicin vid Umeå universitet (WCMM) (creator_code:org_t)
  • the SPCG14-investigators

Sammanhörande titlar

  • Ingår i:Acta Oncologica: Taylor & Francis62:4, s. 372-3800284-186X1651-226X

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