Prostate-Specific Antigen and Pain Surrogacy Analysis in Metastatic Hormone-Refractory Prostate Cancer

Armstrong, Andrew J.; Garrett‐Mayer, Elizabeth; Yang, Yi; Carducci, Michael A.; Tannock, Ian F.; Wit, Ronald de; Eisenberger, Mario A.

doi:10.1200/jco.2007.11.4769

Cited by 257 publications

(163 citation statements)

References 18 publications

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“…Visceral metastasis, performance status, pain, and hemoglobin and alkaline phosphatase levels were proposed as prognostic parameters for overall survival in the TAX327 study. 25,26 We demonstrated that the presence of intraductal carcinoma of the prostate on needle biopsy was the strongest prognostic parameter for cancer-specific survival and overall survival among previously reported parameters, including clinical parameters, in patients with distant metastasis at initial diagnosis.…”

Section: Discussionmentioning

confidence: 76%

The presence of intraductal carcinoma of the prostate in needle biopsy is a significant prognostic factor for prostate cancer patients with distant metastasis at initial presentation

et al. 2016

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Intraductal carcinoma of the prostate is an adverse prognostic factor in localized prostate cancer patients. However, whether it influences outcome of those patients with distant metastases discovered at initial diagnosis is unclear. Here, we evaluated whether the presence of intraductal carcinoma of the prostate in prostate needle biopsies is an adverse prognostic factor for cancer-specific survival and overall survival in such prostate cancer patients. We retrospectively enrolled 150 eligible patients. All patients received androgen-deprivation therapy and/or chemotherapy. Their age, performance status, pain, metastatic sites, clinical T stage, serum prostatespecific antigen, alkaline phosphatase, hemoglobin, Gleason score, and the presence of Gleason pattern 5 were analyzed. Primary end point was cancer-specific survival; secondary end points included prostate-specific antigen progression-free survival and overall survival. Fine and Gray's model and the Cox proportional hazards model were used as statistical tests. Intraductal carcinoma of the prostate was detected in 100 (67%) patients. At a median follow-up of 38 months, 79 patients (53%) had died of the disease and nine (6%) had died of other causes. The average time interval to cancer-related death was 28 months. On multivariate analysis, only intraductal carcinoma of the prostate was significantly associated with cancer-specific survival (P = 0.018) and overall survival (P = 0.001), and only the presence of Gleason pattern 5 was significantly associated with prostate-specific antigen progression-free survival (P = 0.026). The presence of intraductal carcinoma of the prostate was the only significant prognostic parameter for cancer-specific survival and overall survival in prostate cancer patients with distant metastasis at presentation. These results may prove useful in planning future treatments.

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Section: Discussionmentioning

confidence: 76%

The presence of intraductal carcinoma of the prostate in needle biopsy is a significant prognostic factor for prostate cancer patients with distant metastasis at initial presentation

et al. 2016

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“…1 Survival of men with castrationresistant metastatic prostate cancer (CRPC) can range from several months to several years. 2,3 However, current prognostic models in CRPC only account for approximately 70% of the explained variability in survival outcomes and natural history of this disease, indicating that additional prognostic factors are likely implicated in prostate cancer outcomes. [3][4][5] There is a growing prevalence of obesity in the United States and worldwide.…”

Section: Introductionmentioning

confidence: 99%

The relationship of body mass index and serum testosterone with disease outcomes in men with castration-resistant metastatic prostate cancer

Armstrong

Halabi

Wit

et al. 2008

Prostate Cancer Prostatic Dis

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The purpose of this study was to evaluate the relationship of baseline body mass index (BMI) and serum testosterone level with prostate cancer outcomes in men with castration-resistant metastatic prostate cancer (CRPC). BMI and testosterone levels were evaluated for their ability to predict overall survival (OS) and prostate-specific antigen (PSA) declines in the TAX327 clinical trial, an international phase III randomized trial of one of the two schedules of docetaxel and prednisone compared with mitoxantrone and prednisone. In this study of 1006 men with CRPC, the median serum testosterone level was 14.5 ng per 100 ml (range 0-270), the median BMI was 27 kg m À2 (range 15.7-46.5), and 26% of men were obese or morbidly obese (BMIX30). Obesity was associated with younger age, lower PSA and alkaline phosphatase levels, and higher performance status, primary Gleason sum, testosterone and hemoglobin compared to absence of obesity. In multivariate analysis, neither BMI, presence of obesity, nor baseline testosterone was significantly associated with OS or PSA declines. Higher testosterone levels among obese men suggest incomplete gonadal suppression with current therapies, but these differences may not be clinically relevant in men with CRPC. There was evidence of potential hemodilution of PSA and alkaline phosphatase levels in obese men.

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“…21 The authors showed that the more criteria that were met for progression, the lower the rate of post-progression survival. A survival advantage to continuing chemotherapy was suggested for those men who had pain progression only.…”

Section: Progression-free Survival and Time To Progressionmentioning

confidence: 99%

Measuring therapeutic efficacy in the changing paradigm of castrate-resistant prostate cancer

Mulders

Schalken

2009

Prostate Cancer Prostatic Dis

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One of the current challenges in the evaluation of novel agents for the treatment of advanced prostate cancer is the identification of a surrogate end point for overall survival (OS). Prostatespecific antigen (PSA) levels have been used as a screening tool and a biomarker of response to both hormonal and cytotoxic agents. However, PSA levels do not seem to be a suitable surrogate end point for OS in trials of targeted agents for castrate-resistant prostate cancer (CRPC). These findings suggest the need for adopting measures of efficacy that more accurately reflect the mechanisms of action of these agents in phase II trials, in order to realize improvements in OS in the phase III setting. The Prostate Cancer Clinical Trials Working Group (PCWG2) have recently made recommendations for the design of future trials and advised that PSA levels should not be the sole criterion on which to base clinical decisions. Here, we appraise the end points that have been used in phase II and III trials in patients with CRPC, and highlight the need for the adoption of the PCWG2 guidelines, the recommendations of which include radiographic imaging, in addition to bone scintigraphy, and symptomatic or radiographic disease progression criteria.

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Prostate-Specific Antigen and Pain Surrogacy Analysis in Metastatic Hormone-Refractory Prostate Cancer

Cited by 257 publications

References 18 publications

The presence of intraductal carcinoma of the prostate in needle biopsy is a significant prognostic factor for prostate cancer patients with distant metastasis at initial presentation

The presence of intraductal carcinoma of the prostate in needle biopsy is a significant prognostic factor for prostate cancer patients with distant metastasis at initial presentation

The relationship of body mass index and serum testosterone with disease outcomes in men with castration-resistant metastatic prostate cancer

Measuring therapeutic efficacy in the changing paradigm of castrate-resistant prostate cancer

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