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Using surrogate biomarkers to predict clinical benefit in men with castration-resistant prostate cancer: an update and review of the literature.

Publication ,  Journal Article
Armstrong, AJ; Febbo, PG
Published in: Oncologist
August 2009

Recurrent prostate cancer has a complex molecular etiology and a prolonged disease course. Although initially responsive to androgen ablation, many men eventually become castration resistant, develop skeletal metastases, and are palliatively treated with docetaxel-based chemotherapy, radiation therapy, bisphosphonates, and best supportive care. Given the modest success rates of the current standard of care, clinical trial enrollment is encouraged. Castration-resistant prostate cancer (CRPC) is a heterogeneous disease, both in clinical manifestations and outcomes, requiring an individualized approach to both patient care and trial design. Herein, we review surrogate markers of disease progression and treatment efficacy in advanced prostate cancer in light of recently published guidelines that have redefined eligibility, response criteria, and suitable endpoints in prostate cancer drug development. The guidelines have refined outcome measures to potentially better capture clinical benefit and the ability of novel targeted molecular and biologic agents to impact favorably on this disease. We consider prostate-specific antigen changes, circulating tumor cells, bone scan alterations, markers of bone metabolism (urinary N-telopeptide and bone-specific alkaline phosphatase), pain improvements, and progression-free survival. To illustrate the role and challenges of these potential biomarkers and endpoints in drug development, we discuss a class of novel molecularly targeted agents, the src kinase inhibitors. Given that there are currently no validated surrogate markers of overall survival for assessing early clinical benefit from systemic therapy in metastatic CRPC, incorporation of relevant biomarkers into all phases of clinical development is essential to accelerate drug development in this field.

Duke Scholars

Published In

Oncologist

DOI

EISSN

1549-490X

Publication Date

August 2009

Volume

14

Issue

8

Start / End Page

816 / 827

Location

England

Related Subject Headings

  • Prostatic Neoplasms
  • Prostate-Specific Antigen
  • Orchiectomy
  • Oncology & Carcinogenesis
  • Neoplasms, Hormone-Dependent
  • Male
  • Humans
  • Disease-Free Survival
  • Biomarkers, Tumor
  • 3211 Oncology and carcinogenesis
 

Citation

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Armstrong, A. J., & Febbo, P. G. (2009). Using surrogate biomarkers to predict clinical benefit in men with castration-resistant prostate cancer: an update and review of the literature. Oncologist, 14(8), 816–827. https://doi.org/10.1634/theoncologist.2009-0043
Armstrong, Andrew J., and Phillip G. Febbo. “Using surrogate biomarkers to predict clinical benefit in men with castration-resistant prostate cancer: an update and review of the literature.Oncologist 14, no. 8 (August 2009): 816–27. https://doi.org/10.1634/theoncologist.2009-0043.
Armstrong, Andrew J., and Phillip G. Febbo. “Using surrogate biomarkers to predict clinical benefit in men with castration-resistant prostate cancer: an update and review of the literature.Oncologist, vol. 14, no. 8, Aug. 2009, pp. 816–27. Pubmed, doi:10.1634/theoncologist.2009-0043.

Published In

Oncologist

DOI

EISSN

1549-490X

Publication Date

August 2009

Volume

14

Issue

8

Start / End Page

816 / 827

Location

England

Related Subject Headings

  • Prostatic Neoplasms
  • Prostate-Specific Antigen
  • Orchiectomy
  • Oncology & Carcinogenesis
  • Neoplasms, Hormone-Dependent
  • Male
  • Humans
  • Disease-Free Survival
  • Biomarkers, Tumor
  • 3211 Oncology and carcinogenesis