Prostatic Neoplasms: Bianco F

Arlen PM, Bianco F, Dahut WL, D'Amico A, Figg WD, Freedland SJ, Gulley JL, Kantoff PW, Kattan MW, Lee A, Regan MM, Sartor O, Anonymous00032. · Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland 20892, USA. · J Urol. · Pubmed #18423743 links to  free full text

Abstract: PURPOSE: Prostate specific antigen is a glycoprotein found almost exclusively in normal and neoplastic prostate cells. Prostate specific antigen doubling time, or the change in prostate specific antigen over time, has emerged as a useful predictive marker for assessing disease outcome in patients with prostate cancer. It is important to agree on definitions and values for the calculation of prostate specific antigen doubling time, and to develop a common approach to outcome analysis and reporting. MATERIALS AND METHODS: In September 2006 a conference was held at the National Cancer Institute in Bethesda, Maryland to define these parameters and develop guidelines for their use. RESULTS: The Prostate Specific Antigen Working Group defined criteria regarding prostate specific antigen doubling time including the calculation of prostate specific antigen doubling time, evidence to support prostate specific antigen doubling time as a predictive factor in the setting of biochemical recurrence and the use of prostate specific antigen doubling time as a stratification factor in clinical trials. CONCLUSIONS: We propose that investigators calculate prostate specific antigen doubling time before enrolling patients in clinical studies and calculate it as an additional measurement of therapeutic activity. We believe we have developed practical guidelines for the calculation of prostate specific antigen doubling time and its use as a measurement of prognosis and outcome. Furthermore, the use of common standards for prostate specific antigen doubling time in clinical trials is important as we determine which treatments should progress to randomized trials in which "hard" end points such as survival will be used.

Beekman K, Morris M, Slovin S, Heller G, Wilton A, Bianco F, Scardino PT, Scher HI. · Department of Medicine, Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, New York, USA. · Urology. · Pubmed #15882729 No free full text.

Abstract: OBJECTIVES: To develop objective measures to select systemic therapies for study in large-scale trials for patients with lesser tumor burdens, we explored prostate-specific antigen (PSA) changes after androgen ablation in patients with disease progression after treatment of localized disease. Long-term follow-up of trials incorporating androgen-deprivation with local therapy have shown improved survival relative to local therapy alone. This suggests that the benchmark for treatment of minimal metastatic disease can be cure. METHODS: Patients with a rising PSA level with or without clinical metastases after local therapy who received androgen deprivation at Memorial Sloan-Kettering Cancer were identified from two institutional databases. The primary outcome was the proportion achieving an undetectable PSA level, and the pretreatment parameters associated with this endpoint were evaluated. RESULTS: A total of 130 patients who received androgen ablation and were followed up at Memorial Sloan-Kettering Cancer Center were identified. Overall, 31 (57%) of 54 (95% confidence interval 44% to 71%) patients with a rising PSA level alone and 28 (37%) of 76 (95% confidence interval 26% to 47%) patients with a rising PSA level and clinical metastases achieved an undetectable PSA level after androgen ablation (P = 0.02). The PSA level at the start of androgen ablation and the presence of metastases were the most significant predictive factors. CONCLUSIONS: The probability of achieving an undetectable PSA level varied inversely with the disease extent. Although achieving an undetectable PSA level does not mean that a patient has been cured, it does establish an endpoint that can be used to identify approaches worthy of study in the Phase III setting.

Banerjee M, Powell IJ, George J, Biswas D, Bianco F, Severson RK. · Center for Healthcare Effectiveness Research, Wayne State University, 121 Shiffman Library, 4325 Brush Avenue, Detroit, MI 48201, USA. · Cancer. · Pubmed #12173323 No free full text.

Abstract: BACKGROUND: It is well established that African-American men (AAM) have a worse mortality from prostate carcinoma (PC) than White men (WM). Outcome data for men treated with radical prostatectomy for clinically localized PC demonstrate more advanced tumors and higher biochemical recurrence rates among AAM compared with WM. The objective of the current study was to characterize the pattern of prostate specific antigen (PSA) progression by race in patients experiencing disease recurrence after undergoing radical prostatectomy. Racial differences in the pattern of rising PSA would warrant different intervention strategies for reducing the disproportionality in survival outcomes between the two racial groups. METHODS: Between 1991-1996, 1080 consecutive men underwent radical prostatectomy for clinically localized PC at Wayne State University-affiliated Harper Hospital. Two hundred forty-one patients developed a biochemical recurrence on or before January, 1, 1999. The median follow-up was 39 months. Longitudinal PSA profiles of 77 men who met the study inclusion criteria were analyzed. Average relative velocities of PSA were compared between AAM and WM. Linear mixed effects regression was used to test the hypothesis that, after adjusting for age, preoperative PSA, stage and grade of disease, PSA levels increase at a faster rate in AAM compared with WM. RESULTS: The mean average relative velocity for AAM and WM experiencing a disease recurrence was 0.25 ng/mL and 0.11 ng/mL per month, respectively (P = 0.21). The relative rate of PSA increase in patients who developed a disease recurrence after radical prostatectomy was 18.9% per month for AAM and 16.3% per month for WM (P = 0.73). CONCLUSIONS: AAM and WM appear to have similar rates of PSA progression after undergoing radical prostatectomy.