Department of Epidemiology, Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy. gallus@marionegri.it

OBJECTIVES: To analyze the relationship between selected risk factors and prostate cancer risk in men younger than 60 years, using data from a large, multicenter, case-control study conducted in Italy. METHODS: Cases were 219 patients, aged 45 to 59 years, with histologically confirmed prostate cancer, and controls were 431 men of the same age group, admitted in hospital for acute, non-neoplastic diseases. RESULTS: A family history of prostate cancer (odds ratio [OR] = 5.5), brain cancer (OR = 3.7), and leukemia (OR = 6.2) were associated with prostate cancer risk. A significantly increased risk was found for high education level (OR = 3.3 for 12 or more years versus less than 7 years) and a decreased risk for physical activity (OR = 0.5 for active versus inactive). Coffee consumption was directly associated with risk of prostate cancer (OR = 1.9 for the third versus the first tertile). Bread consumption was directly related (OR = 1.6) and consumption of raw and total vegetables inversely related (OR = 0.6) to prostate cancer risk, although these associations were of borderline significance. No association emerged with marital status, body mass index, history of diabetes, alcohol drinking, and other considered foods. CONCLUSIONS: This study confirms that some recognized risk factors, including family history of prostate cancer, high level of education, and low physical activity, are associated with prostate cancer risk in middle-aged men.

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Department of Urology, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Kumamoto, 860-8556, Japan, pullpullachan326@bridge.ocn.ne.jp.

PURPOSE: Advanced prostate cancer, which is one of the most common cancers, usually progresses to hormone-refractory prostate cancer (HRPC). A recent randomized trial of treatment with docetaxel demonstrated improved survival for patients with HRPC. The combination of docetaxel and estramustine phosphate (estramustine) has been reported to be effective for HRPC. Low-dose estramustine suppresses the pituitary-gonadal axis. Docetaxel plus 5-fluoro-5′-deoxyuridine (5′-dFUrd) had supra-additive cytotoxic effects on HRPC cells consistent with the molecular mechanism. Therefore, we examined the efficacy of adding 5′-dFUrd on the chemotherapy regimen, which consist docetaxel and estramustine. METHODS: All of the HRPC patients were treated with estramustine 140 mg orally twice 5′-dFUrd 200 mg orally four times daily on days 1-21, and docetaxel 60 mg/m(2) was administered on day 1. We evaluated serum prostate-specific antigen (PSA) and measurable responses, the progression-free and overall survival, and the impact on adverse effects and the quality of life (QOL). RESULTS: Of 34 patients with a median age of 72.3 years, 73% showed PSA responses and 70% showed measurable responses. The median progression-free survival was 18.0 and 5.8 months for PSA responders and non-responders and the overall survival was 19.4 months, respectively. There were few serious adverse effects. Grade 3/4 neutropenia occurred in 32.4% of the patients, and was easily managed with granulocyte colony-stimulating factor (G-CSF) injection. There was no significant change in the overall QOL scores serially. CONCLUSIONS: This study shows that the combined regimen is tolerable and effective in Japanese HRPC patients.

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The objective of this study was to evaluate the efficacy and safety of atrasentan (Xinlay), a selective endothelin-A receptor antagonist, in patients with metastatic hormone-refractory prostate cancer (HRPC). METHODS.: This multinational, double-blind, placebo-controlled trial enrolled 809 men with metastatic HRPC. Patients were randomized 1:1 to receive either atrasentan 10 mg per day or placebo. The primary endpoint was time to disease progression (TTP), which was determined according to radiographic and clinical measures. Analyses of overall survival and changes in biomarkers also were performed. RESULTS.: Atrasentan did not reduce the risk of disease progression relative to placebo (hazards ratio, 0.89; 95% confidence interval, 0.76-1.04; P = .136). Most patients progressed radiographically at the first 12-week bone scan without concomitant clinical progression. In exploratory analyses, increases from baseline to final bone alkaline phosphatase (BAP) and prostate-specific antigen (PSA) levels were significantly lower with atrasentan treatment (P < .05 for each). The median time to BAP progression (>/=50% increase from nadir) was twice as long with atrasentan treatment (505 days vs 254 days; P < .01). The delay in time to PSA progression did not reach statistical significance. Atrasentan generally was tolerated well, and the most common adverse events associated with treatment were headache, rhinitis, and peripheral edema, reflecting the vasodilatory and fluid-retention properties of endothelin-A receptor antagonism. CONCLUSIONS.: Atrasentan did not delay disease progression in men with metastatic HRPC despite evidence of biologic effects on PSA and BAP as markers of disease burden. Cancer 2007. (c) 2007 American Cancer Society.
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