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Docetaxel Versus Surveillance After Radical Radiotherapy for Intermediate- or High-risk Prostate Cancer-Results from the Prospective, Randomised, Open-label Phase III SPCG-13 Trial

Kellokumpu-Lehtinen, Pirkko-Liisa (författare)
Tampere Univ Hosp, POB 2000, Tampere 33521, Finland
Hjälm-Eriksson, Marie (författare)
Capio St Gorans Hosp, Dept Surg, Stockholm, Sweden;Karolinska Inst, Dept Oncol & Pathol, Stockholm, Sweden
Thellenberg-Karlsson, Camilla (författare)
Umeå Univ Hosp, Dept Radiat Sci, Oncol, Umeå, Sweden
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Åström, Lennart (författare)
Uppsala universitet,Experimentell och klinisk onkologi
Franzen, Lars (författare)
Sundsvall Univ Hosp, Sundsvall, Sweden
Fransson, Ann-Sofie (författare)
Gävle Cent Hosp, Gävle, Sweden
Leskinen, Markku J. (författare)
Seinajoki Cent Hosp, Seinajoki, Finland
Zeke, Mihalj (författare)
Växjö Cent Hosp, Växjö, Sweden
Huttunen, Teppo (författare)
4Pharma, Turku, Finland
Ginman, Claes (författare)
Karlstad Cent Hosp, Karlstad, Sweden
Leskinen, MJ (författare)
Kellokumpu-Lehtinen, PL (författare)
Thellenberg-Karlsson, C (författare)
Ginman, C (författare)
Huttunen, T (författare)
Franzen, L (författare)
Hjalm-Eriksson, M (författare)
Fransson, AS (författare)
Zeke, M (författare)
Astrom, L (författare)
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Elsevier, 2019
Ingår i: European Urology. - : Elsevier. - 0302-2838 .- 1873-7560. ; 76:6, s. 823-830
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
  • Background: Docetaxel combined with androgen deprivation therapy (ADT) has improved patient survival for advanced prostate cancer (PCa). Objective: This randomised trial aimed to evaluate whether six courses of docetaxel improved biochemical disease-free survival (BDFS) after radical radiotherapy (RT) for intermediate- or high-risk PCa patients. Design, setting, and participants: A total of 376 patients were randomised in this multinational phase III study, and received either six cycles of adjuvant docetaxel 75 mg/m(2) every 3 wk without continuous prednisone (arm A, n =188) or surveillance (arm B, n = 188) after RT (NTC006653848). Neoadjuvant/adjuvant ADT was mandatory for all the patients. The primary endpoint was rising prostate-specific antigen (PSA) >= 2 ng/ml above the nadir PSA value. Intermediate- or high-risk PCa was defined as T2 with a Gleason score (GS) of 4 +3, PSA > 10; T2, GS 8-10, <= 70 ng/ml; or any T3. The patients were followed for 5 yr by assessing PSA levels every 3 mo for 2 yr and every 6 mo thereafter. Outcome measurements and statistical analysis: The study power was 89% to detect a difference in BDFS between groups, and the sample size calculation accounted for the T2/T3 distribution, where a 12%/15% difference in BDFS was assumed for the T2/T3 patients. Results and limitations: All six cycles were completed in 147 (78%) of the patients in arm A. The median age was 67 yr in both treatment groups, 75% had T3 disease, and 47% had GS 8-10. The median follow-up was 59 mo (range 1-111 mo). The primary endpoint was observed for 58 patients in arm A (docetaxel) and for 57 patients in arm B (surveillance). The Kaplan-Meier analysis showed no difference in the BDFS curves (p = 0.6) between the treatment groups. The 5-yr estimated biochemical progression rates were 31% for arm A and 28% for arm B. Febrile neutropenia occurred in 16% of the docetaxel patients.No deaths were related to the docetaxel treatment. There were 43 deaths during the trial, including 20 in arm A and 23 in arm B, of which nine and seven, respectively, were due to PCa. The hazard ratio from Cox multivariate analysis for PSA progression of arm A (docetaxel) versus arm B (surveillance) was 1.14 (95% confidence interval 0.79-1.64, p = 0.5). Conclusions: Adjuvant docetaxel without prednisone did not improve BDFS after radical RT with ADT for intermediate- or high-risk PCa. Patient summary: We compared six cycles of adjuvant docetaxel given after radical external radiotherapy plus androgen deprivation therapy to surveillance in intermediate- and high-risk localised prostate cancer. We found no overall benefit in this setting. (C) 2019 European Association of Urology. Published by Elsevier B.V. All rights reserved.


MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine (hsv//eng)


Prostate cancer
Randomised trial
Radical radiotherapy

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