Newswire (Published: Monday, March 13, 2017, 12:01:00 AM CDT, Received: Thursday, March 9, 2017, 4:34:03 PM CST)

Word Count: 535

Findings from University of Alabama at Birmingham Provides New Data on Prostate Cancer (Impact of single-agent daily prednisone on outcomes in men with metastatic castration-resistant prostate cancer)

By a News Reporter-Staff News Editor at Clinical Trials Week -- Investigators publish new report on Oncology - Prostate Cancer. According to news reporting originating from Birmingham, Alabama, by NewsRx correspondents, research stated, "Despite palliative benefits and PSA responses, the objective clinical impact of daily oral prednisone (P) for metastatic castration-resistant prostate cancer (mCRPC) is unknown. We performed a pooled analysis of control arms of randomized trials that either did or did not administer single-agent P to evaluate its impact on overall survival (OS) and toxicities."

Our news editors obtained a quote from the research from the University of Alabama at Birmingham, "Individual patient data from control arms of randomized trials of men with mCRPC who received placebo or P+placebo post docetaxel were eligible for analysis. The impact of P on OS and severe toxicities was investigated in Cox regression models adjusted for known prognostic factors. Statistical significance was defined as p<0.05 and all tests were two sided. Data from the control arms of two randomized phase III trials were available totaling 794 men: the COU-AA-301 trial (n=394) administered P plus placebo and the CA184-043 trial (n=400) administered placebo alone. P plus placebo was not significantly associated with OS compared with placebo in a multivariable analysis (hazard ratio=0.89 (95% confidence interval 0.72-1.10), p=0.27). Other factors associated with poor OS were Eastern Cooperative Oncology Group (ECOG)-performance status (PS) ⩾1, Gleason score ⩾8, liver metastasis, high PSA, hypoalbuminemia and elevated lactate dehydrogenase (LDH). Grade ⩾3 therapy-related toxicities were significantly increased with P plus placebo compared with placebo (hazard ratio=1.48 (95% confidence interval 1.03-2.13), p=0.034). Other baseline factors significantly associated with a higher risk of grade ⩾3 toxicities were ECOG-PS ⩾1, hypoalbuminemia and elevated LDH. Fatigue, asthenia, anorexia and pain were not different based on P administration. P plus placebo was associated with higher grade ⩾3 toxicities but not extension of OS compared with placebo alone in men with mCRPC who received prior docetaxel."

According to the news editors, the research concluded: "Except for the use of P with abiraterone to alleviate toxicities, the use of P should be questioned given its association with toxicities and resistance."

For more information on this research see: Impact of single-agent daily prednisone on outcomes in men with metastatic castration-resistant prostate cancer. Prostate Cancer and Prostatic Diseases, 2016;20(1):67-71. (Nature Publishing Group - www.nature.com/; Prostate Cancer and Prostatic Diseases - www.nature.com/pcan/)

The news editors report that additional information may be obtained by contacting G. Sonpavde, University of Alabama at Birmingham, Birmingham, AL, United States. Additional authors for this research include G.R. Pond, A.J. Templeton, E.D. Kwon and J.S De Bono (see also Oncology - Prostate Cancer).

Keywords for this news article include: Pharmaceuticals, Alabama, Hormones, Oncology, Placebos, Birmingham, United States, Glucocorticoids, Prostate Cancer, Clinical Research, Prednisone Therapy, Drugs and Therapies, Prostatic Neoplasms, North and Central America, Adrenal Cortical Steroids, Clinical Trials and Studies.

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