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21. |
Phase I Clinical Trial of Lobaplatin (D-19466) after Intravenous Bolus Injection |
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Onkologie,
Volume 17,
Issue 2,
1994,
Page 142-148
H.H. Fiebig,
H. Henß,
K. Mross,
F. Meyberg,
P. Aulenbacher,
K. Burk,
W. Queißer,
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摘要:
Backgrund: Lobaplatin, D-19466, l,2-diamminomethyl-cyclobutane-platinum-(II)-lactate, is a new watersoluble platin complex which showed a better therapeutic index than cisplatin or carboplatin in murine and human tumor models. Preclinical toxicology studies showed myelosuppression with predominant thrombocytopenia as the dose-limiting toxicity in rodents. Materials and Methods: The phase I study group of the AIO performed the phase I study with Lobaplatin administered as an intravenous bolus injection repeated every 4 weeks without hydration. Results: The maximum tolerated dose was 60 mg/m2, thrombocytopenia was the dose-limiting toxicity. The nadir occurred after 2 weeks with recovery within a week. Mild anemia and leukopenia were found with a nadir after 3 weeks. Nausea and vomiting occurred in half of the patients, however, they were well controlled by antiemetics. No alopecia, renal, CNS or ototoxicity were observed. Overall, Lobaplatin is well tolerated. The intravenous bolus injection without the need for hydration makes this therapy suitable for outpatient therapy. One partial remission was observed in a patient with an adenocarcinoma of the lung. Conclusion: The recommended dose for phase II studies is 50 mg/m2 every 3-4 weeks in good-risk patients with a normal kidney function.
ISSN:0378-584X
DOI:10.1159/000218399
出版商:S. Karger GmbH
年代:1994
数据来源: Karger
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22. |
Abstracts (Part 17 of 19) |
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Onkologie,
Volume 17,
Issue 2,
1994,
Page 145-153
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ISSN:0378-584X
DOI:10.1159/000317657
出版商:S. Karger GmbH
年代:1994
数据来源: Karger
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23. |
Incomplete Conization for Carcinoma in situ of the Uterine Cervix |
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Onkologie,
Volume 17,
Issue 2,
1994,
Page 150-153
M. Lahousen,
G. Jäger,
F. Girardi,
H. Pickel,
W.D. Schneeweiß,
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摘要:
Background: Cold-knife conization of the uterine cervix is a diagnostic and often curative procedure in patients with intraepithelial neoplasia of the uterine cervix. Patients in whom conization has not removed the lesion completely may require further treatment. Patients and Methods: Between 1970 and 1990 3,663 patients with carcinoma in situ of the cervix underwent cold-knife conization. In 669 patients (18%) histology showed that the lesion extended to the margins of the conization specimen. 441 of these patients, especially younger ones who wished to preserve their fertility, were followed up observantly and 228 patients underwent hysterectomy. Results: After incomplete conization a total of 6 out of 669 patients (0.1%) developed recurrent disease. Four patients (1.8%) developed grade 3 vaginal intraepithelial neoplasia after hysterectomy and 2 patients (0.5%) who were followed up observantly showed persisting carcinoma in situ. Of the 228 uteri extirpated immediately after incomplete conization, only 69 (30%) showed residual disease. No patient developed invasive disease. Conclusions: The results suggest that patients with incomplete conization for carcinoma in situ of the cervix can be followed up observantly with little risk of recurrence.
ISSN:0378-584X
DOI:10.1159/000218400
出版商:S. Karger GmbH
年代:1994
数据来源: Karger
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24. |
Phase II Study with Folinic Acid, Etoposide, 5-Fluorouracil and Cisplatin (FLEP) for Advanced Gastric Cancer |
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Onkologie,
Volume 17,
Issue 2,
1994,
Page 154-157
H. Wilke,
P. Preusser,
M. Stahl,
H.J. Meyer,
U. Fink,
W. Achterrath,
P. Busche,
J. Meyer,
A. Harstrick,
H.-J. Schmoll,
S. Seeber,
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摘要:
Background: Cisplatin is an active drug in advanced gastric cancer and acts synergis-tically with etoposide and 5-fluorouracil (5-FU). These were the reasons for adding cisplatin (P) to the combination of folinic acid, etoposide, and 5-FU (ELF), which is one of the newer and active regimens for the treatment of advanced gastric cancer. Patients and Methods: 29 patients with advanced gastric cancer were treated with folinic acid (300 mg/m2), etoposide (100 mg/m2), 5-FU (500 mg/m2), and cisplatin (30 mg/m2) intravenously on days 1, 2, and 3. Cycles were repeated on days 22-28. Results: 2 (7%) complete and 9 (31%) partial remissions were achieved. The medium remission duration was 6 months and the median survival time was 7 months. The main toxicity of FLEP was severe myelosuppression of WHO grades 3 and 4 leucocytopenia in 38 and 21 % of the patients. Conclusions: FLEP is an active regimen for gastric cancer with respect to remission induction. However, because of the marked objective and subjective side effects, and a response rate which was not different from ELF alone, the further evaluation of this combination is not meaningful in this tumor.
ISSN:0378-584X
DOI:10.1159/000218401
出版商:S. Karger GmbH
年代:1994
数据来源: Karger
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25. |
Pulmonary Toxicity of Highland Intermediate-Dose Cytosine Arabinoside Therapy: A Retrospective Analysis |
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Onkologie,
Volume 17,
Issue 2,
1994,
Page 158-164
J. Dierlamm,
B. Haubold-Reuter,
H.J. Weh,
H. Schäfer,
D.K. Hossfeld,
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摘要:
Background: Subacute noncardiogenic pulmonary edema is known to be a side effect of high- or intermediate-dose cytosine arabinoside (Ara-C) therapy. This often fatal complication seems to be underestimated, since only few publications concerning this subject are available and clinical and radiographic findings are nonspecific. Patients and Methods 15 g/m2/course) or intermediate-dose (6-15 g/m2/course) Ara-C. Therapy was administered in combination with mitoxantrone (108/115), etoposide (4/115) or daunorubicin (3/115) for treatment of acute myelogenous leukemia (62), acute lymphoblastic leukemia (19), blast crises of chronic myelogenous leukemia (3), or high-grade non-Hodgkin’s lymphoma (5). Results: Pulmonary toxicity attributable to Ara-C therapy was observed in 7 of 115 courses (6%) and appeared 2-18 (median: 10) days after the start of treatment. Three of the affected patients died as a result of respiratory failure and 4 recovered completely. In contrast to the patients who had a lethal course, all patients who recovered had received intravenous corticosteroids at an early stage. Additionally, patients presenting with drug-induced pulmonary toxicity showed considerably more cutaneous reactions related to Ara-C administration (3/7 patients) than the patients without pulmonary toxicity (7/82 patients). Other predisposing factors for the development of pulmonary toxicity were not evaluable. Conclusion: Patients with a history of cutaneous reactions related to Ara-C therapy should be monitored carefully for drug-induced pulmonary toxicity after high-or intermediate-dose Ara-C treatment. If drug-induced pulmonary toxicity is suspected, and other possible underlying causes of the pulmonary changes are excluded, corticosteroid treatment should be started immediatel
ISSN:0378-584X
DOI:10.1159/000218402
出版商:S. Karger GmbH
年代:1994
数据来源: Karger
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26. |
Abstracts (Part 19 of 19) |
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Onkologie,
Volume 17,
Issue 2,
1994,
Page 163-172
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ISSN:0378-584X
DOI:10.1159/000317659
出版商:S. Karger GmbH
年代:1994
数据来源: Karger
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27. |
Combination of Grading and New Biological Factors (S-Phase Fraction and Epidermal Growth Factor Receptor) Can Predict Relapse and Survival in Patients with Node-Negative Primary Breast Cancer |
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Onkologie,
Volume 17,
Issue 2,
1994,
Page 166-172
M. Kaufmann,
G.v. Minckwitz,
H.P. Finn,
H. Schmid,
K. Goerttler,
G. Bastert,
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摘要:
Background: In most cases of node-negative breast cancer, clinical outcome is relatively good after surgical treatment. It is necessary, however, to determine prognostic factors for the identification of high- and low-risk subgroups concerning recurrence and death, because only patients with excellent prognosis require no further treatment. The objective of the study was to select a few potential factors for a prognostic index that can be used in clinical practice. Patients and Methods: In 108 patients with primary node-negative breast cancer we examined simultaneously the impact of new prognosticators on disease-free survival (DFS) and overall survival (OAS): DNA ploidy, S-phase fraction (SPF), cycling index encoded by Ki 67, estrogen and progesterone receptor status, epidermal growth factor receptor (EGF-R), Her 2b/neu oncoprotein, and GP170 glycoprotein. Only fresh-frozen tissue was used. Median time of follow-up was 42 months. Results 5% of the tumor had a significantly shorter DFS (p = 0.01) and OAS (p = 0.01) than patients with a SPF 15 fmol/mg versus < 15 fmol/mg (p = 0.05) and tumors of grade III versus grade I/II (p = 0.03). A low progesterone receptor level ( < 20 fmol/mg) indicated a short DFS (p = 0.06) but was of no prognostic value for OAS. Using a combination of SPF and EGF-R, a group of patients with extremely good prognosis (no patients have died) could be identified, if at least one factor was favorably expressed. If both factors were elevated clinical outcome was poor (DFS: p = 0.003; OAS: p = 0.002). By including histological grading in the analysis, a prognostic index could be described when discriminated patients with good, medium, and high risk for relapse and survival (DFS: p = 0.009; OAS: p = 0.001). Conclusions: Out of 11 parameters, grading, SPF, and EGF-R have been selected for a prognostic index. This prognostic index can be used to classify patients with node-negative primary tumors in different risk categories, so that an individual and risk-adapted adjuvant systemic therapy becomes possible, according to the treatment recommendations outside clinical trials.
ISSN:0378-584X
DOI:10.1159/000218403
出版商:S. Karger GmbH
年代:1994
数据来源: Karger
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28. |
Hinweise tür Autoren – Instructions to Authors |
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Onkologie,
Volume 17,
Issue 2,
1994,
Page 173-174
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ISSN:0378-584X
DOI:10.1159/000218516
出版商:S. Karger GmbH
年代:1994
数据来源: Karger
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29. |
The Blood Circulation of Malignant and Benign Tumours of the Genital Interior as a Diagnostic Tool |
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Onkologie,
Volume 17,
Issue 2,
1994,
Page 174-178
Ch. Sohn,
E.M. Grischke,
M. Kaufmann,
G. Bastert,
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摘要:
Background: Malignant tumours usually display a blood circulation different from that of benign ones. This fact can be used in sonographic dignity diagnostics. A prerequisite is a technology capable of detecting this difference which becomes evident in the smallest blood vessels, where flow is extremely slow. Patients and Method: The Sonolayer SSH 140A (Toshiba) and the Quantum 2000 (Siemens) devices were used. These systems are in a position to detect slow blood flow in the tissue tested. We examined the very small vessels in the tumour which cannot be identified by black and white ultrasound image but only with the colour Doppler. The colour pixels which we found in or around the tumour in the colour mode were examined with the pulsed Doppler in order to quantify the blood flow. The resistance index (RI) was calculated from systole and diastole. The lowest RI was used for the evaluation. 51 female patients with ovarian tumours (29 malignant, 22 benign), 41 patients with transmutations of the endometrium (25 malignant, 16 benign), 3 patients with sarcoma, 12 patients with myoma and 39 patients with transmutations of the cervix (24 malignant, 15 benign) were preoperatively examined and the result was correlated with the dignity. None of the patients was treated with hormones. Results: The following RI values were measured: ovarian tumours: malignant 41%, benign 77% (premenopause: 45%); endometrial findings: malignant 49%, benign 66% (premenopause: 51%); sarcoma/myoma uteri: sarcoma 33%, myoma 35% (premenopause: 34%); cervical findings: malignant 51%, benign 78% (premenopause: 52%). According to these results the division into premenopause and postmenopause is decisive. As our results demonstrate, differentiation before the menopause is barely possible due to the blood circulation pattern present at this stage, whilst in the postmenopausal status the distinction between benign and malignant tumours becomes highly significant. Conclusion: The organs of the genital interior have physiologically a high circulation of blood in the premenopause. Therefore, the difference between benign and malignant transmutations is low. Thus we can see a significant difference between the blood flow in benign and malignant tumours of the uterus and ovary in the postmenopausal women but no significant difference in the premenopausal woman. The colour Doppler examination is able to improve the dignity diagnostics in postmenopausal women. We could not verify a differentiation between sarcoma and myoma by Doppler examination. If all the restrictions listed are taken into consideration, the blood circulation diagnostics of transmutations of the genital interior in the postmenopause will be able to make an important contribution to dignity diagnostics.
ISSN:0378-584X
DOI:10.1159/000218404
出版商:S. Karger GmbH
年代:1994
数据来源: Karger
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30. |
Meningeal Involvement in Acute Leukaemia and High-Grade Non-Hodgkin’s Lymphoma is Associated with Elevated Activities of Galactosyltransferases in the Cerebrospinal Fluid |
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Onkologie,
Volume 17,
Issue 2,
1994,
Page 180-183
H. Ottinger,
C. Cyrus,
C. Belka,
S. Leuner,
M. Engelhard,
W. Augener,
G. Brittinger,
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摘要:
Background: Galactosyltransferases (Gal-T) are intracellular and cell surface enzymes involved in the biosynthesis of glycoconjugates. Gal-T were suggested to be implicated in oncogenesis, since their levels are elevated in various body fluids of patients with different types of malignoma; the invasiveness of certain neoplastic cell lines is correlated with their cell surface Gal-T activities, and cancer-associated Gal-T-isoforms were identified. Material and Methods: Gal-T activities in the cerebrospinal fluid (CSF) of patients with meningeal involvement in acute leukaemia or high-grade lymphoma (n = 8), normal controls (n = 54), patients with acute viral meningitis/encephalitis (n = 8) and multiple sclerosis (n = 10) were compared. CSF Gal-T activities were measured with uridine diphosphate-14C-galactose as substrate after isolation of the enzymatically transferred 14C-galactose by high-voltage electrophoresis. Simultaneously, the permeability of the blood-CSF barrier was analysed by the Q-albumin method. Results: In case of an intact blood-CSF barrier, Gal-T activities were elevated exclusively in patients with meningeal involvement in malignancies, but declined rapidly during intrathecal polychemotherapy. Conclusions: CSF Gal-T activities might prove to be a marker for early or residual involvement of the central nervous system in acute leukaemia or high-grade lymphoma.
ISSN:0378-584X
DOI:10.1159/000218405
出版商:S. Karger GmbH
年代:1994
数据来源: Karger
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