Objectives: To investigate the safety and efficacy in terms of PSA response of a low-dose oral combination of estramustine phosphate (EMP) and etoposide (VP16) in hormone- refractory prostate cancer (HRPC) patients. Well-tolerated outpatient chemotherapy regimens for patients unfit and/or unwilling to be admitted to hospital are needed. Methods: Fifty-six HRPC patients with metastatic disease (median age 75 years) were randomized between arm A (daily oral EMP 10 mg/kg, in 3 doses) and arm B (28-day cycle with low-dose EMP 3 mg/kg once daily plus VP16 25 mg/m2 once daily on days 1 through 14). Baseline characteristics between the two groups were similar. LHRH therapy was maintained. Anti- androgen was stopped 1 month before entry. Results: The low-dose combination was better tolerated, with a significant advantage in terms of time to treatment interruption for any reason (p = 0.01) or toxicity (6 vs. 12 months, p = 0.02). A trend in favour of arm B was evident in terms of PSA reduction (41.4 vs. 15%), performance status and pain improvement. Hospital admission due to toxicity was never required for arm B patients and there were no treatment-related deaths. Conclusions: Low-dose oral combination of EMP and VP16 might represent a treatment option for patients unfit for i.v. chemotherapy. This regimen requires minimal toxicity monitoring when administered at home for prolonged periods.
Estradiol, progesterone, 17-hydroxyprogesterone, androstenedione and CA125 were assayed in 25 women (12 oophorectomized before entering the study) with ovarian carcinoma. The data from patients were ordered according to the presence or absence of the gonads. The patients with ovaries (Group A) showed significantly higher levels of estradiol (p less than 0.01), progesterone (p less than 0.01) and 17-hydroxyprogesterone (p less than 0.01) than controls. This difference was not observed between oophorectomized patients (Group B) and controls. CA125 levels were significantly higher in patients that in controls (p less than 0.001) irrespective of the ovarian status of the patients. Eleven patients were followed during chemotherapy. Significant reductions of estradiol (p less than 0.01) and CA125 (p less than 0.001) levels after three courses of chemotherapy were observed. These data confirm that women with ovarian carcinoma produce an abnormal amount of steroids. Nevertheless, a marked difference between patients with and without ovaries was observed, suggesting that reported data might be biased by the presence of gonadal tissue. Thus the clinical application of steroids as tumor markers in unselected patients is limited.
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