Adjuvant leuprolide with or without docetaxel in patients with high-risk prostate cancer after radical prostatectomy (TAX-3501): Important lessons for future trials

Michael T. Schweizer, Peng Huang, Michael W. Kattan, Adam S. Kibel, Ronald De Wit, Cora N. Sternberg, Jonathan Ira Epstein, Mario Eisenberger

Research output: Contribution to journalArticle

Abstract

BACKGROUND The current trial evaluated 2 common therapies for patients with advanced prostate cancer, docetaxel and hormonal therapy (HT), in the surgical adjuvant setting. METHODS TAX-3501 was a randomized, phase 3, adjuvant study post-radical prostatectomy (RP) in high-risk patients with prostate cancer (n = 228) comparing 18 months of HT with (CHT) without docetaxel chemotherapy either immediately (I) or deferred (D). High-risk disease was defined as a 5-year freedom-from-disease-progression rate of ≤ 60% as predicted by a post-RP nomogram. Progression-free survival (PFS), including prostate-specific antigen disease recurrence, was the primary endpoint. The authors also assessed the accuracy of the nomogram and analyzed testosterone recovery in 108 patients treated with HT who had at least 1 posttreatment testosterone value. RESULTS Between December 2005 and September 2007, 228 patients were randomized between the treatment cohorts. TAX-3501 was terminated prematurely because of enrollment challenges, leaving it underpowered to detect differences in PFS. After a median follow-up of 3.4 years (interquartile range, 2.3-3.8 years), 39 of 228 patients (17%) demonstrated PSA disease progression, and metastatic disease progression occurred in 1 patient. The median time to baseline testosterone recovery after the completion of treatment was prolonged at 487 days (95% confidence interval, 457-546 days). The nomogram's predicted versus observed freedom from disease progression was significantly different for the combination D(HT) and D(CHT) group (P

Original languageEnglish (US)
Pages (from-to)3610-3618
Number of pages9
JournalCancer
Volume119
Issue number20
DOIs
StatePublished - Oct 15 2013

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docetaxel
Leuprolide
Prostatectomy
Prostatic Neoplasms
Nomograms
Disease Progression
Therapeutics
Disease-Free Survival
Testosterone
Prostate-Specific Antigen

Keywords

  • adjuvant therapy
  • docetaxel
  • leuprolide
  • prostate cancer
  • testosterone recovery

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Adjuvant leuprolide with or without docetaxel in patients with high-risk prostate cancer after radical prostatectomy (TAX-3501) : Important lessons for future trials. / Schweizer, Michael T.; Huang, Peng; Kattan, Michael W.; Kibel, Adam S.; De Wit, Ronald; Sternberg, Cora N.; Epstein, Jonathan Ira; Eisenberger, Mario.

In: Cancer, Vol. 119, No. 20, 15.10.2013, p. 3610-3618.

Research output: Contribution to journalArticle

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abstract = "BACKGROUND The current trial evaluated 2 common therapies for patients with advanced prostate cancer, docetaxel and hormonal therapy (HT), in the surgical adjuvant setting. METHODS TAX-3501 was a randomized, phase 3, adjuvant study post-radical prostatectomy (RP) in high-risk patients with prostate cancer (n = 228) comparing 18 months of HT with (CHT) without docetaxel chemotherapy either immediately (I) or deferred (D). High-risk disease was defined as a 5-year freedom-from-disease-progression rate of ≤ 60{\%} as predicted by a post-RP nomogram. Progression-free survival (PFS), including prostate-specific antigen disease recurrence, was the primary endpoint. The authors also assessed the accuracy of the nomogram and analyzed testosterone recovery in 108 patients treated with HT who had at least 1 posttreatment testosterone value. RESULTS Between December 2005 and September 2007, 228 patients were randomized between the treatment cohorts. TAX-3501 was terminated prematurely because of enrollment challenges, leaving it underpowered to detect differences in PFS. After a median follow-up of 3.4 years (interquartile range, 2.3-3.8 years), 39 of 228 patients (17{\%}) demonstrated PSA disease progression, and metastatic disease progression occurred in 1 patient. The median time to baseline testosterone recovery after the completion of treatment was prolonged at 487 days (95{\%} confidence interval, 457-546 days). The nomogram's predicted versus observed freedom from disease progression was significantly different for the combination D(HT) and D(CHT) group (P",
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