Biomedical subjects
Publications and source records attributed to K Burk.
1. A weekly fractionation of EPIRUBICIN at an unchanged dose intensity leads to a significant decrease in toxicity. 2. The weekly administration of 25 mg/m2 EPIRUBICIN is effective in treating hormone refractory prostate carcinoma and completely fulfills the requirements for palliation.
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Liver biopsies from patients with alcoholic hepatitis, chemical hepatitis, or viral hepatitis types A, B, or non-A, non-B were examined by electron microscopy. Circular, fused, cytoplasmic membranes were observed in hepatocytes of 17% of patients with hepatitis type B and 92% of patients with hepatitis type non-A, non-B. The membrane alterations were not observed in hepatocytes of patients with the other types of hepatitis. The greater frequency of altered cytoplasmic membranes in hepatocytes of patients with non-A, non-B hepatitis was shown to be statistically significant (p less than 0.05) when compared to that in patients with viral hepatitis type B.
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In summary, only a chromosome analysis of directly extracted tumour tissue seems to be of prognostic value, because this allows one to exclude alterations that are conditioned by cultures. The number of chromosomes does not give an indication of the malignancy and invasiveness of the tumour. The presence of marker chromosomes in superficial bladder carcinoma seems to worsen the prognosis of those patients significantly. Further observation of the previously investigated patients and new studies are aimed at determining whether the reported tendency proves to be valid. If the presence of marker chromosomes really enables us to predict an unfavourable prognosis, a timely cystectomy, i.e. cystectomy in the preinvasive stage, should decisively ameliorate the poor prognosis of these patients.
We report the results of 2 randomized cooperative studies. The aim of the first study was to find the optimal instillation interval for recurrence prophylactic treatment of superficial bladder tumors using Adriamycin. For this purpose the patients were randomized into 3 groups, with different instillation intervals of 1, 2 and 4 weeks. All patients had 12 instillations with 50 mg Adriamycin in 30 ml saline. Summarizing the results of the 3 groups, it was possible to reduce the number of recurrences to 36% in the 1st year after TUR and 46% after 2 years. Three years after TUR 52% of the patients had a recurrence. Differences between the groups existed in the percentage of recurrences after completion of the instillation therapy and furthermore in the incidence of chemocystitis. Admitted to this first study were 197 patients from July 1979 to December 1980. We started a second study in January 1981, in which we combined the first tested instillation intervals. All patients had now 3 instillations at 1 week intervals followed by 6 instillations at 2 weeks intervals thereafter they had 8 instillations, at 4 weeks intervals. With this combination the number of recurrences could be reduced even further. One year after TUR recurrence was found in 11.4% of the patients and 2 years after TUR in 21.9%. In a median follow-up time of 17 months we found 24% recurrences. Admitted to the second study were 214 patients from January 1981 to May 1983.
Logothetis and von Eschenbach first 1981 reported encouraging preliminary results of the DMF regimen (Doxorubicine = Adriamycin, Mitomycin, 5 Fluorouracil) in hormone refractory adenocarcinoma of the prostate. 60% out of 62 patients had an objective remission over a mean period of 27 weeks. At the beginning of this year together with 5 other hospitals we started our study based on the results of Logothetis. In difference to his study all of our patients had prior therapy with Estracyt and patients with extrapelvic radiation were excluded. It is too early to present our results but we believe that this regimen is an advancement in the therapy of terminal prostatic carcinoma.
BACKGROUND: NK611 is a novel podophyllotoxin derivative. Compared with etoposide, NK611 carries a dimethylamino group at the D-glucose moiety. The antitumor activity of NK611 showed to be equal or superior to etoposide in a variety of in vitro and in vivo tumor models. The aim of our present study was to determine the maximum tolerated dose and the dose-limiting toxicities of NK611 administered as intravenous infusion over 30 min every 28 days. PATIENTS AND METHODS: 45 patients (7 female, 38 male; median age 54 [range 37-73]) were enrolled. In a first stage, NK611 was administered without hematopoietic growth factor support; in a second stage, G-CSF was used for further dose escalation. Toxicities were assessed using WHO-criteria. RESULTS: Initially, the dose was escalated from 60 mg/m2 to 120 mg/m2. In a second patient cohort, doses were further escalated with G-CSF support with doses ranging from 140 mg/m2 to 250 mg/m2. Dose-limiting toxicities were granulocytopenia and thrombocytopenia. Non-hematologic toxicities consisted of alopecia, mild nausea, and infection. Four partial responses were observed: two at 200 mg/m2 (pleural mesothelioma, response duration 7 months, and non-small cell lung cancer, response duration 13 months), and two at 250 mg/m2 (hepatocellular carcinoma, response duration 7 months, and non-small cell lung cancer, response duration 2 months). Pharmacokinetic analyses were performed in all patients. Using an open 3-compartment model, the terminal half-life (t1/2gamma) was 14.7 +/- 3.7 h. The AUC at 250 mg/m2 was determined to be 330 +/- 147 microg/mlh, the plasma clearance of NK611 was 16.2 +/- 8.2 ml/min x m2 and the V(ss) was 16.8 +/- 3.3 l/m2. Protein binding of NK611 was 98.7%. CONCLUSION: the recommended dose for clinical Phase II studies is 120 mg/m2 without G-CSF support and 200 mg/m2 with G-CSF support.