End points and outcomes in castration-resistant prostate cancer: From clinical trials to clinical practice Journal Article
| Authors: | Scher, H. I.; Morris, M. J.; Basch, E.; Heller, G. |
| Article Title: | End points and outcomes in castration-resistant prostate cancer: From clinical trials to clinical practice |
| Abstract: | New therapeutic approaches for castration-resistant prostate cancer (CRPC) introduce new treatment dilemmas: how best to sequence these options to maximally benefit patients, what tests to perform before and after treatment to assess disease status, and how to interpret the test results and use them to guide treatment. New and specific end points for different classes of drugs are needed to provide the information to guide these treatment decisions. In 2008, the Prostate Cancer Working Group 2 consensus criteria for early-phase clinical trials redefined clinical trial end points as first, to control, relieve, or eliminate disease manifestations present when treatment is started and second, to prevent or delay future disease manifestations. Disease manifestations include prostate-specific antigen (PSA), soft-tissue disease (nodes and/or viscera), bone disease (most common site of spread), and symptoms. Recent US Food and Drug Administration (FDA) approvals for CRPC therapies have been based on the prevent/delay end points that reflect unequivocal benefit to a patient: prolongation of life or reduction in skeletalrelated events (SREs). For the practicing oncologist, the control/relieve/eliminate outcomes should serve primarily to inform the decision of whether to continue therapy. In this review, we consider individual end points such as PSA, imaging, and patient-reported outcomes in the context of the control/relieve/eliminate and prevent/delay framework. We address the time-to-event end points of metastasis prevention, SRE, time to progression, and overall survival in the context of regulatory approvals. We also discuss circulating tumor cells measured with the CellSearch assay, recently cleared by the FDA for monitoring CRPC. © 2011 by American Society of Clinical Oncology. |
| Keywords: | cancer chemotherapy; cancer survival; treatment outcome; overall survival; review; clinical trials as topic; bone metastasis; nuclear magnetic resonance imaging; antineoplastic agent; clinical practice; medical decision making; prostate specific antigen; ipilimumab; metastasis; progression free survival; computer assisted tomography; distant metastasis; docetaxel; prostatic neoplasms; neoplastic cells, circulating; disease progression; mitoxantrone; neoplasm metastasis; clinical research; orchiectomy; provenge; soft tissue disease; circulating tumor cell; castration resistant prostate cancer; abiraterone; denosumab; 4 [3 [4 cyano 3 (trifluoromethyl)phenyl] 5,5 dimethyl 4 oxo 2 thioxo 1 imidazolidinyl] 2 fluoro n methylbenzamide; orteronel; cabazitaxel |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 29 |
| Issue: | 27 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2011-09-20 |
| Start Page: | 3695 |
| End Page: | 3704 |
| Language: | English |
| DOI: | 10.1200/jco.2011.35.8648 |
| PROVIDER: | scopus |
| PUBMED: | 21859988 |
| PMCID: | PMC3675708 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 1" - "Export Date: 2 November 2011" - "CODEN: JCOND" - "Source: Scopus" |
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