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Docetaxel Versus Su...
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
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- Kellokumpu-Lehtinen, Pirkko-Liisa (author)
- Tampere Univ Hosp, POB 2000, Tampere 33521, Finland
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- Hjälm-Eriksson, Marie (author)
- Capio St Gorans Hosp, Dept Surg, Stockholm, Sweden;Karolinska Inst, Dept Oncol & Pathol, Stockholm, Sweden
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- Thellenberg-Karlsson, Camilla (author)
- Umeå Univ Hosp, Dept Radiat Sci, Oncol, Umeå, Sweden
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- Åström, Lennart (author)
- Uppsala universitet,Experimentell och klinisk onkologi
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- Franzen, Lars (author)
- Sundsvall Univ Hosp, Sundsvall, Sweden
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- Fransson, Ann-Sofie (author)
- Gävle Cent Hosp, Gävle, Sweden
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- Leskinen, Markku J. (author)
- Seinajoki Cent Hosp, Seinajoki, Finland
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- Zeke, Mihalj (author)
- Växjö Cent Hosp, Växjö, Sweden
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- Huttunen, Teppo (author)
- 4Pharma, Turku, Finland
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- Ginman, Claes (author)
- Karlstad Cent Hosp, Karlstad, Sweden
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(creator_code:org_t)
- Elsevier, 2019
- 2019
- English.
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In: European Urology. - : Elsevier. - 0302-2838 .- 1873-7560. ; 76:6, s. 823-830
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- Prostate cancer
- Adjuvant
- Docetaxel
- Randomised trial
- Radical radiotherapy
Publication and Content Type
- ref (subject category)
- art (subject category)
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