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.

Autor: Kellokumpu-Lehtinen PL; Tampere University Hospital, Tampere, Finland. Electronic address: pirkko-liisa.kellokumpu-lehtinen@tuni.fi., Hjälm-Eriksson M; Department of Surgery, Capio S.t Görans Hospital, Stockholm, Sweden; Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden., Thellenberg-Karlsson C; Department of Radiation Sciences, Oncology, Umeå University Hospital, Umeå, Sweden., Åström L; Uppsala University Hospital, Uppsala, Sweden., Franzen L; Sundsvall University Hospital, Sundsvall, Sweden., Fransson AS; Gävle Central Hospital, Gävle, Sweden., Leskinen MJ; Seinäjoki Central Hospital, Seinäjoki, Finland., Zeke M; Växjö Central Hospital, Växjö, Sweden., Huttunen T; 4Pharma, Turku, Finland., Ginman C; Karlstad Central Hospital, Karlstad, Sweden.
Jazyk: angličtina
Zdroj: European urology [Eur Urol] 2019 Dec; Vol. 76 (6), pp. 823-830. Date of Electronic Publication: 2019 Aug 20.
DOI: 10.1016/j.eururo.2019.08.010
Abstrakt: 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.
(Copyright © 2019 European Association of Urology. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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