Cisplatin as single-agent chemotherapy in patients with liver dysfunction due to metastases.

BACKGROUND: Chemotherapeutic options are often limited for patients with hepatic dysfunction induced by advanced metastases. The toxicity and efficacy of cytotoxic drugs are often unpredictable due to altered drug activation or inactivation and excretion. Therefore, numerous chemotherapeutic agents should not be administered to patients with liver failure. PATIENTS AND METHODS: We retrospectively analysed 14 patients with solid tumours presenting with liver dysfunction induced by metastasis who were treated with cisplatin single-agent chemotherapy. RESULTS: Tolerance of therapy was acceptable with 1 grade I and 1 grade II renal toxicity. 6 patients experienced grade III haematological toxicity. Partial remission of the disease was observed in 6 cases, and 6 patients could receive combination chemotherapy after improvement of liver function. The median overall survival of the patient cohort was 4.8 months. CONCLUSION: Cisplatin monotherapy may thus be considered as a treatment option for patients with liver dysfunction induced by different solid tumours.

Prospective randomized study comparing docetaxel, estramustine, and prednisone with docetaxel and prednisone in metastatic hormone-refractory prostate cancer.

PURPOSE: To assess the efficacy and toxicity of the addition of estramustine to docetaxel (D) for the treatment of metastatic hormone-refractory prostate cancer. PATIENTS AND METHODS: One hundred fifty patients were randomly assigned to D alone (35 mg/m(2) on days 2 and 9, every 3 weeks) or D in combination with estramustine (D/E; 280 mg orally three times a day on days 1 to 5 and 8 to 12, every 3 weeks). All patients received prednisone (10 mg/d). The primary end point was prostate-specific antigen (PSA) response rate, which was defined as a decrease in PSA > or = 50% from baseline. The study was powered to test the hypothesis that D/E would improve the PSA response rate by 25%. RESULTS: The PSA response rate was not statistically different between the two groups. PSA of less than 4 ng/mL occurred in 29 (41%) of 71 patients receiving D/E and in 17 (25%) of 69 patients receiving D (P = .05). No significant differences were found for median time to PSA progression (D/E, 6.9 months; D, 7.3 months) or median overall survival time (D/E, 19.3 months; D, 21 months). More patients had at least one grade 3 or 4 toxicity with D/E (45%) compared with D (21%; P = .005), mainly as a result of grade 3 or 4 GI toxicity (P = .05). Serious adverse events were more frequent with D/E (n = 20) than with D (n = 9; P = .04). CONCLUSION: The addition of estramustine to weekly D does not provide any clinically relevant advantage. Both regimens are well tolerated, although the toxicity profile favors D without estramustine.