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Development and validation of a prognostic model for overall survival in chemotherapy-naïve men with metastatic castration-resistant prostate cancer.

Publication ,  Journal Article
Armstrong, AJ; Lin, P; Higano, CS; Sternberg, CN; Sonpavde, G; Tombal, B; Templeton, AJ; Fizazi, K; Phung, D; Wong, EK; Krivoshik, A; Beer, TM
Published in: Ann Oncol
November 1, 2018

BACKGROUND: Prognostic models are needed that reflect contemporary practice for men with metastatic castration-resistant prostate cancer (mCRPC). We sought to identify predictive and prognostic variables for overall survival (OS) in chemotherapy-naïve men with mCRPC treated with enzalutamide. PATIENTS AND METHODS: Patients from the PREVAIL trial database (enzalutamide versus placebo) were randomly split 2 : 1 into training (n = 1159) and testing (n = 550) sets. Using the training set, 23 predefined variables were analyzed and a multivariable model predicting OS was developed and validated in an independent testing set. RESULTS: Patient characteristics and outcomes were well balanced between training and testing sets; median OS was 32.7 months in each. The final validated multivariable model included 11 independent prognostic variables. Median OS for low-, intermediate-, and high-risk groups (testing set) defined by prognostic risk tertiles were not yet reached (NYR) (95% CI NYR-NYR), 34.2 months (31.5-NYR), and 21.1 months (17.5-25.0), respectively. Hazard ratios (95% CI) for OS in the low- and intermediate-risk groups versus high-risk group were 0.20 (0.14-0.29) and 0.40 (0.30-0.53), respectively. Secondary outcomes of response and progression differed widely in model-defined risk groups. Enzalutamide improved outcomes in all prognostic risk groups. CONCLUSIONS: Our validated prognostic model incorporates variables routinely collected in chemotherapy-naïve men with mCRPC treated with enzalutamide, identifying subsets of patients with widely differing survival outcomes that provide useful information for external validation, patient care, and clinical trial design. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01212991.

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Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

November 1, 2018

Volume

29

Issue

11

Start / End Page

2200 / 2207

Location

England

Related Subject Headings

  • Prostatic Neoplasms, Castration-Resistant
  • Proportional Hazards Models
  • Progression-Free Survival
  • Prognosis
  • Phenylthiohydantoin
  • Oncology & Carcinogenesis
  • Nitriles
  • Models, Biological
  • Male
  • Humans
 

Citation

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Chicago
ICMJE
MLA
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Armstrong, A. J., Lin, P., Higano, C. S., Sternberg, C. N., Sonpavde, G., Tombal, B., … Beer, T. M. (2018). Development and validation of a prognostic model for overall survival in chemotherapy-naïve men with metastatic castration-resistant prostate cancer. Ann Oncol, 29(11), 2200–2207. https://doi.org/10.1093/annonc/mdy406
Armstrong, A. J., P. Lin, C. S. Higano, C. N. Sternberg, G. Sonpavde, B. Tombal, A. J. Templeton, et al. “Development and validation of a prognostic model for overall survival in chemotherapy-naïve men with metastatic castration-resistant prostate cancer.Ann Oncol 29, no. 11 (November 1, 2018): 2200–2207. https://doi.org/10.1093/annonc/mdy406.
Armstrong AJ, Lin P, Higano CS, Sternberg CN, Sonpavde G, Tombal B, et al. Development and validation of a prognostic model for overall survival in chemotherapy-naïve men with metastatic castration-resistant prostate cancer. Ann Oncol. 2018 Nov 1;29(11):2200–7.
Armstrong, A. J., et al. “Development and validation of a prognostic model for overall survival in chemotherapy-naïve men with metastatic castration-resistant prostate cancer.Ann Oncol, vol. 29, no. 11, Nov. 2018, pp. 2200–07. Pubmed, doi:10.1093/annonc/mdy406.
Armstrong AJ, Lin P, Higano CS, Sternberg CN, Sonpavde G, Tombal B, Templeton AJ, Fizazi K, Phung D, Wong EK, Krivoshik A, Beer TM. Development and validation of a prognostic model for overall survival in chemotherapy-naïve men with metastatic castration-resistant prostate cancer. Ann Oncol. 2018 Nov 1;29(11):2200–2207.
Journal cover image

Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

November 1, 2018

Volume

29

Issue

11

Start / End Page

2200 / 2207

Location

England

Related Subject Headings

  • Prostatic Neoplasms, Castration-Resistant
  • Proportional Hazards Models
  • Progression-Free Survival
  • Prognosis
  • Phenylthiohydantoin
  • Oncology & Carcinogenesis
  • Nitriles
  • Models, Biological
  • Male
  • Humans