Long-term oncological outcomes of a phase II trial of neoadjuvant chemohormonal therapy followed by radical prostatectomy for patients with clinically localised, high-risk prostate cancer Journal Article


Authors: Silberstein, J. L.; Poon, S. A.; Sjoberg, D. D.; Maschino, A. C.; Vickers, A. J.; Bernie, A.; Konety, B. R.; Kevin Kelly, W.; Eastham, J. A.
Article Title: Long-term oncological outcomes of a phase II trial of neoadjuvant chemohormonal therapy followed by radical prostatectomy for patients with clinically localised, high-risk prostate cancer
Abstract: Objective To determine long-term oncological outcomes of radical prostatectomy (RP) after neoadjuvant chemohormonal therapy (CHT) for clinically localised, high-risk prostate cancer. Patients and Methods In this phase II multicentre trial of patients with high-risk prostate cancer (PSA level >20 ng/mL, Gleason ≥8, or clinical stage ≥T3), androgen-deprivation therapy (goserelin acetate depot) and paclitaxel, carboplatin and estramustine were administered before RP. We report the long-term oncological outcomes of these patients and compared them to a contemporary cohort who met oncological inclusion criteria but received RP only. Results In all, 34 patients were enrolled and followed for a median of 13.1 years. Within 10 years most patients had biochemical recurrence (BCR-free probability 22%; 95% confidence interval [CI] 10-37%). However, the probability of disease-specific survival at 10 years was 84% (95% CI 66-93%) and overall survival was 78% (95% CI 60-89%). The CHT group had higher-risk features than the comparison group (123 patients), with an almost doubled risk of calculated preoperative 5-year BCR (69% vs 36%, P < 0.01). After adjusting for these imbalances the CHT group had trends toward improvement in BCR (hazard ratio [HR] 0.76, 95% CI 0.43-1.34; P = 0.3) and metastasis-free survival (HR 0.55, 95% CI 0.24-1.29; P = 0.2) although these were not statistically significant. Conclusions Neoadjuvant CHT followed by RP was associated with lower rates of BCR and metastasis compared with the RP-only group; however, these results were not statistically significant. Because this treatment strategy has known harms and unproven benefit, this strategy should only be instituted in the setting of a clinical trial. © 2014 The Authors BJU International © 2014 BJU International Published by John Wiley & Sons Ltd.
Keywords: survival; adult; clinical article; controlled study; survival rate; overall survival; cancer risk; paclitaxel; cancer adjuvant therapy; chemotherapy; follow up; carboplatin; multiple cycle treatment; phase 2 clinical trial; cohort analysis; cancer hormone therapy; prostate cancer; goserelin; survival time; prostatectomy; multicenter study; radical prostatectomy; phase 1 clinical trial; androgen deprivation therapy; biochemical recurrence; disease specific survival; hormone therapy; neoadjuvant; prostate neoplasms; estramustine; metastasis free survival; human; male; priority journal; article; neoadjuvant chemohormonal therapy
Journal Title: BJU International
Volume: 116
Issue: 1
ISSN: 1464-4096
Publisher: Wiley Blackwell  
Date Published: 2015-07-01
Start Page: 50
End Page: 56
Language: English
DOI: 10.1111/bju.12676
PROVIDER: scopus
PMCID: PMC4219923
PUBMED: 24552276
DOI/URL:
Notes: Export Date: 3 August 2015 -- Source: Scopus
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  1. Andrew J Vickers
    880 Vickers
  2. Daniel D. Sjoberg
    234 Sjoberg
  3. James Eastham
    537 Eastham
  4. Aaron Michael Bernie
    2 Bernie