Prostate cancer: evaluation of response to treatment, response criteria, and the need for standardization of the reporting of results.
(1988)
Journal - European journal of cancer & clinical oncology (ENGLAND )
Abstract :
Response criteria and the reporting of results in clinical trials on drug therapy of stage D prostate cancer were evaluated by examination of studies listed in the Index Medicus 1980-1984. During this 5-year period, 70 studies (51 phase II and 16 phase III) were listed, comprising 3184 evaluable patients. Among 346 patients reported as having evaluable disease according to the WHO criteria, 198 had well-defined evaluable disease. A variety of response criteria were used, the NPCP criteria being the most frequent. Only three studies included solely patients with evaluable disease according to the WHO criteria. Reporting of results was often inadequate. The value of the most frequently used response parameters such as acid phosphatase, bone scan, per-rectal ultrasound, CT scan, bone pain and performance status is discussed. A system to standardise the reporting of results is proposed.
| ISSN : | 0277-5379 |
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| Mesh Heading : | Acid Phosphatase Bone Neoplasms Clinical Trials as Topic Drug Evaluation Humans Liver Neoplasms Male Pain Prognosis Prostatic Neoplasms Soft Tissue Neoplasms blood radiography radionuclide imaging secondary secondary therapy enzymology secondary |
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| Mesh Heading Relevant : | drug therapy |
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High-dose ketoconazole to untreated stage D prostate cancer.
(1988)
Journal - European journal of cancer & clinical oncology (ENGLAND )
Abstract :
Eleven previously untreated patients with stage D prostate cancer were treated with ketoconazole in a dosage of 400 mg p.o. every 8 h. s-Testosterone was used as a measure of antiandrogen effect. Nine patients had a reduction in s-testosterone to castrate levels (less than 2.9 nmol/l) within 3 days. In the remaining two patients, dose escalation of ketoconazole to 400 mg every 6 h did not lead to sufficient reduction in s-testosterone. Two patients had a complete response and four patients had a partial response of 6/11. Additionally, two patients had bone pain relief without normalization of acid phosphatase. Side-effects and adverse reactions were prominent, causing discontinuation of the treatment in nine patients. It is concluded that high-dose ketoconazole is effective in disseminated prostate cancer, but the high frequency of side-effects makes it less attractive than conventional hormone manipulations like castration or estrogens.
| ISSN : | 0277-5379 |
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| Mesh Heading : | Acid Phosphatase Adult Aged Humans Hydrocortisone Ketoconazole Male Middle Aged Prostatic Neoplasms Testosterone Tomography, X-Ray Computed blood blood adverse effects therapeutic use blood radiography blood |
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| Mesh Heading Relevant : | administration & dosage drug therapy |
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