Docetaxel 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) In European Urology 73(6). p.870-876- Abstract
Background: 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... (More)
Background: 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. In this randomised trial, docetaxel without hormonal therapy or continuous corticosteroids was given after radical prostatectomy for high-risk prostate cancer. We found no benefit from docetaxel alone given after radical prostatectomy.
(Less)
- author
- Ahlgren, Göran M. LU ; Flodgren, Per LU ; Tammela, Teuvo L.J. ; Kellokumpu-Lehtinen, Pirkko ; Borre, Michael ; Angelsen, Anders ; Iversen, Jon Reidar ; Sverrisdottir, Asgerdur ; Jonsson, Eirikur and Sengelov, Lisa
- organization
- publishing date
- 2018
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Adjuvant, Docetaxel, Prostate cancer, Radical prostatectomy, Randomised trial
- in
- European Urology
- volume
- 73
- issue
- 6
- pages
- 870 - 876
- publisher
- Elsevier
- external identifiers
-
- scopus:85041005496
- pmid:29395502
- ISSN
- 0302-2838
- DOI
- 10.1016/j.eururo.2018.01.012
- language
- English
- LU publication?
- yes
- id
- c4bfc8a3-9709-46f9-98c8-2e3fc5cdfc58
- date added to LUP
- 2018-02-05 12:34:18
- date last changed
- 2024-04-15 01:44:52
@article{c4bfc8a3-9709-46f9-98c8-2e3fc5cdfc58,
abstract = {{<p>Background: 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/m<sup>2</sup> 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. In this randomised trial, docetaxel without hormonal therapy or continuous corticosteroids was given after radical prostatectomy for high-risk prostate cancer. We found no benefit from docetaxel alone given after radical prostatectomy.</p>}},
author = {{Ahlgren, Göran M. and Flodgren, Per and Tammela, Teuvo L.J. and Kellokumpu-Lehtinen, Pirkko and Borre, Michael and Angelsen, Anders and Iversen, Jon Reidar and Sverrisdottir, Asgerdur and Jonsson, Eirikur and Sengelov, Lisa}},
issn = {{0302-2838}},
keywords = {{Adjuvant; Docetaxel; Prostate cancer; Radical prostatectomy; Randomised trial}},
language = {{eng}},
number = {{6}},
pages = {{870--876}},
publisher = {{Elsevier}},
series = {{European Urology}},
title = {{Docetaxel 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}},
url = {{http://dx.doi.org/10.1016/j.eururo.2018.01.012}},
doi = {{10.1016/j.eururo.2018.01.012}},
volume = {{73}},
year = {{2018}},
}