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

Josefsson, Andreas ; Jellvert, Åsa ; Holmberg, Erik ; Brasso, Klaus ; Meidahl Petersen, Peter ; Aaltomaa, Sirpa ; Luukkaa, Marjaana ; Verhagen, Paul ; de Wit, Ronald and Ahlgren, Göran LU , et al. (2023) In Acta Oncologica 62(4). p.372-380
Abstract

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... (More)

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.

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Contribution to journal
publication status
published
subject
keywords
bicalutamide, docetaxel, Prostate cancer, psa relapse, randomized clinical trial
in
Acta Oncologica
volume
62
issue
4
pages
9 pages
publisher
Taylor & Francis
external identifiers
  • pmid:37073813
  • scopus:85153790361
ISSN
0284-186X
DOI
10.1080/0284186X.2023.2199940
language
English
LU publication?
yes
id
4adfb698-860b-457d-a57c-3b6927141c5e
date added to LUP
2023-07-14 10:44:55
date last changed
2024-04-19 23:26:55
@article{4adfb698-860b-457d-a57c-3b6927141c5e,
  abstract     = {{<p>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/m<sup>2</sup>, 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.</p>}},
  author       = {{Josefsson, Andreas and Jellvert, Åsa and Holmberg, Erik and Brasso, Klaus and Meidahl Petersen, Peter and Aaltomaa, Sirpa and Luukkaa, Marjaana and Verhagen, Paul and de Wit, Ronald and Ahlgren, Göran and Andrén, Ove and Castellanos, Enrique and Seke, Mihalj and Widmark, Anders and Damber, Jan Erik}},
  issn         = {{0284-186X}},
  keywords     = {{bicalutamide; docetaxel; Prostate cancer; psa relapse; randomized clinical trial}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{372--380}},
  publisher    = {{Taylor & Francis}},
  series       = {{Acta Oncologica}},
  title        = {{Effect of docetaxel added to bicalutamide in Hormone-Naïve non-metastatic prostate cancer with rising PSA, a randomized clinical trial (SPCG-14)}},
  url          = {{http://dx.doi.org/10.1080/0284186X.2023.2199940}},
  doi          = {{10.1080/0284186X.2023.2199940}},
  volume       = {{62}},
  year         = {{2023}},
}