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  • 1
    Electronic Resource
    Electronic Resource
    Ulcerative Breast Cancer: Case Report and Review of Management (2001)
    Boston, MA, USA : Blackwell Science Inc
    The @breast journal 7 (2001), S. 0 
    Details
    ISSN: 1524-4741
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: In the literature, there is an astonishingly small amount of information on specific treatment modalities of locally advanced, ulcerated breast cancer. Here we present a case report and a literature review on ulceration in breast cancer. An older, so far untreated woman with complete ulcerative destruction of her right breast was inoperable because of the extent of the tumor. Primary anthracycline-based chemotherapy and hormonal therapy led to major tumor shrinkage with complete ulcer healing, which was maintained for nearly 2 years. There is increasing evidence from the literature that primary chemotherapy may particularly benefit patients with inoperable ulceration, as also illustrated by our case.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1524-4741.2001.07608.x
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  • 2
    Electronic Resource
    Electronic Resource
    Pharmacokinetics of 4′-O-tetrahydropyranyladriamycin given on a weekly schedule in patients with advanced breast cancer (1995)
    Springer
    Cancer chemotherapy and pharmacology 37 (1995), S. 91-96 
    Details
    ISSN: 1432-0843
    Keywords: Key words THP-ADM ; Metabolism ; Breast cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract  Improved quality of life has gained importance over shortly lasting remissions in yet incurable metastatic breast cancer. Fractionation of drug administration is one of the possible approaches to reduce the concentration-dependent toxicity of anthracyclines. We evaluated the pharmacokinetics of 4′-O-tetrahydropyranyladriamycin (THP-ADM) under weekly administration in patients with advanced breast cancer (dose escalation, from 20 to 27 mg/m2 THP-ADM). The concentration-time curves of THP-ADM in plasma were best described by an open three-compartment model [half-life of the first disposition phase (t1/2α), 3.15 min; terminal elimination half-life (t 1/2γ), 13.9 h] with a mean area under the curve (AUC) of 12.2 ng h ml-1mg-1 m-2, resulting in a mean plasma clearance of 86.9 l h-1 m-2. Metabolism included the formation of Adriamycin (ADM), Adriamycinol (ADM-OH), 13-dihydro-4′-O-tetrahydropyranyladriamycin (THP-OH), 7-deoxyadriamycinone (7H-ADn), and 7-deoxy-13-dihydroadriamycinone (7H-ADn-OH), with maximal plasma concentrations ranging from 2.8 to 5.5 ng/ml. The mean total amount of cytotoxic anthracyclines excreted into urine, mainly as the parent drug, was 5% of the delivered dose. ADM and ADM-OH, but not the parent drug, were observed in urine at up to 4 weeks after the last therapeutic cycle. There was a significant correlation between the leukocyte nadir under therapy and the AUC of ADM-OH (r=0.800, P〈0.05). Since no shift in the plasma kinetics was observed from the first to the sixth cycle, the favorable ratio of the AUCs of THP-ADM and ADM after fractionation of THP-ADM suggests lower toxic side effects attributable to ADM. This hypothesis was confirmed in a clinical study, where no severe cardiotoxicity and only mild alopecia were observed in 19 patients. Thus, pharmacokinetics studies might be helpful in both individualization of therapy with THP-ADM and optimization of the administration schedule.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002800050372
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  • 3
    Electronic Resource
    Electronic Resource
    Instability of the anticancer agent etoposide under in vitro culture conditions (1991)
    Springer
    Cancer chemotherapy and pharmacology 27 (1991), S. 354-360 
    Details
    ISSN: 1432-0843
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Degradation of etoposide is rapid under in vitro culture conditions. At pH 7.4 and 37°C, the isomerisation of trans-etoposide to the inactive compound cis-etoposide has a half-life of 2 days in Dulbecco's modified Eagle's medium and results in the loss of 90% of the active drug within 1 week. As a consequence, prolonged incubations with etoposide in in vitro assays may lead to erroneous interpretations ignoring the real in vitro situation. The degradation is not influenced by organic compounds such as bovine serum albumin or amino acids but depends strongly on the pH value and, to a lesser degree, on the ionic strength of the medium. Therefore, we propose a mathematical correction based on the pH value so as to obtain the real exposure of cells to trans-etoposide during in vitro assays.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00688857
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  • 4
    Electronic Resource
    Electronic Resource
    Pharmacokinetics of 4′-O-tetrahydropyranyladriamycin given on a weekly schedule in patients with advanced breast cancer (1995)
    Springer
    Cancer chemotherapy and pharmacology 37 (1995), S. 91-96 
    Details
    ISSN: 1432-0843
    Keywords: THP-ADM ; Metabolism ; Breast cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Improved quality of life has gained importance over shortly lasting remissions in yet incurable metastatic breast cancer. Fractionation of drug administration is one of the possible approaches to reduce the concentration-dependent toxicity of anthracyclines. We evaluated the pharmacokinetics of 4′-O-tetrahydropyranyladriamycin (THP-ADM) under weekly administration in patients with advanced breast cancer (dose escalation, from 20 to 27 mg/m2 THP-ADM). The concentration-time curves of THP-ADM in plasma were best described by an open three-compartment model [half-life of the first disposition phase (t1/2α), 3.15 min; terminal elimination half-life (t 1/2γ), 13.9 h] with a mean area under the curve (AUC) of 12.2 ng h ml−1mg−1m−2, resulting in a mean plasma clearance of 86.91 h−1m−2. Metabolism included the formation of Adriamycin (ADM), Adriamycinol (ADM-OH), 13-dihydro-4′-O-tetrahydropyranyladriamycin (THP-OH), 7-deoxyadriamycinone (7H-ADn), and 7-deoxy-13-dihydroadrimycinone (7H-ADn-OH), with maximal plasma concentrations ranging from 2.8 to 5.5 ng/ml. The mean total amount of cytotoxic anthracyclines excreted into urine, mainly as the parent drug, was 5% of the delivered dose. ADM and ADM-OH, but not the parent drug, were observed in urine at up to 4 weeks after the last therapeutic cycle. There was a significant correlation between the leukocyte nadir under therapy and the AUC of ADM-OH (r=0.800,P〈0.05). Since no shift in the plasma kinetics was observed from the first to the sixth cycle, the favorable ratio of the AUCs of THP-ADM and ADM after fractionation of THP-ADM suggests lower toxic side effects attributable to ADM. This hypothesis was confirmed in a clinical study, where no severe cardiotoxicity and only mild alopecia were observed in 19 patients. Thus, pharmacokinetics studies might be helpful in both individualization of therapy with THP-ADM and optimization of the administration schedule.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00685634
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  • 5
    Electronic Resource
    Electronic Resource
    Sequential administration of interferon γ and interleukin-2 in metastatic renal cell carcinoma: results of a phase II trial (2000)
    Springer
    Cancer immunology immunotherapy 49 (2000), S. 395-400 
    Details
    ISSN: 1432-0851
    Keywords: Key words Renal cell cancer ; Cytokines ; Interferon γ ; Interleukin-2 ; Metastatic RCC
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: Because of the known efficacy of several cytokines in the treatment of advanced renal cell cancer (RCC), we have conducted a phase II trial of the efficacy and toxicity of subcutaneous interferon γ (IFNγ) and interleukin-2 (IL-2). Methods: 63 patients with progressive metastatic RCC were treated with 100 μg recombinant IFNγ1b administered three times weekly during weeks 1 and 2 and with 4.5 MU recombinant IL-2 administered on 4 consecutive days during weeks 3 and 4, every 6 weeks. Results: 11% of patients had an objective response (CR: 3%, PR: 8%), 33% had SD. Toxicity was generally mild. The median duration of remissions (CR + PR) was 9.6 months; the median duration of SD 8 months. A significant survival benefit was evident at a median observation time of 51 months for patients (44%) responding to therapy (P 〈 0.0001). Conclusions: we conclude that sequential treatment with IFNγ and IL-2 may prolong survival in patients with metastatic RCC responding to therapy.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002620000128
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  • 6
    Electronic Resource
    Electronic Resource
    The in vitro effects of interleukin-12 upon tumor-infiltrating lymphocytes derived from renal cell carcinoma (1997)
    Springer
    Journal of cancer research and clinical oncology 123 (1997), S. 317-324 
    Details
    ISSN: 1432-1335
    Keywords: Key words Interleukin-12  ;  Tumor-infiltrating lymphocytes  ;  Renal cell cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Clinical trials utilising interleukin (IL)-2 with tumor-infiltrating lymphocytes (TIL) have demonstrated efficacy in the treatment of metastatic renal cell carcinoma (RCC). Several cytokines, as well as growth factors have demonstrated modulatory effects upon the biological properties of TIL from RCC, suggesting a potentially important role for cytokines other than IL-2 in the development of active and tumor-specific TIL. IL-12 was recently characterized as a natural-killer-cell-stimulatory factor or cytotoxic-T-cell-maturation factor. These properties of IL-12 prompted us to investigate the impact of this cytokine upon the activation of TIL from human RCC. In an attempt to enhance the in vitro growth and activity of renal TIL, we have grown eight renal TIL cultures in varying concentrations of IL-2 (8, 40, 80, 400 U/ml) and IL-12 (200 U/ml). In addition, IL-12 (200 U/ml) was added to TIL cultures pre-activated with IL-2 (400 U/ml). Growth, cell expansion, and the ability of TIL to release certain cytokines upon tumor stimulation were determined. Proliferation assays, phenotypic analysis, and cytotoxicity assays were performed at an early and a late culture stage. IL-12, alone and when added to suboptimal concentrations of IL-2, failed to induce TIL growth. While the addition of IL-12 to optimal doses of IL-2 suppressed TIL culture expansion, sequential culture exposure first to IL-2 and then to IL-2+IL-12 increased the number of cells expressing CD3+/CD56+ and these cultures demonstrated enhanced in vitro lysis of autologous tumor. IL-12 clearly demonstrated a sequence-dependent impact of the biological behaviour of TIL from RCC. The optimal use of IL-12 in the in vitro expansion of renal TIL may result in cells with an enhanced specific anti-tumor effect.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01438307
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  • 7
    Electronic Resource
    Electronic Resource
    Double modulation of 5-fluorouracil by high-dose leucovorin and interferonα2b in advanced colorectal cancer (1994)
    Springer
    Journal of cancer research and clinical oncology 120 (1994), S. 314-318 
    Details
    ISSN: 1432-1335
    Keywords: Colorectal cancer ; 5-Fluorouracil ; Interferon α ; Leucovorin ; Phase I trial ; Phase II trial
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract In an attempt to evaluate the feasibility of 5-fluorouracil (FU) treatment modulated by (R,S)-leucovorin (LV) and interferonα (IFNα) in patients with advanced colorectal cancer, we conducted a phase I trial with increasing doses of subcutaneous IFNα (3×1×106 U, 3×3×106 U, 3×3×106 U, 3×5×106 U and 3×10×106 U/week) and 500 mg/m2 LV i.v. as a 2-h infusion with 600 mg/m2 FU i.v. as a midpoint injection. Unacceptable side-effects occurred in all 3 patients at the highest dose level of IFNα, while toxicity was tolerable at 3×5×5106 U IFNα/week. Thus, this dose was defined as the maximal tolerable dose for IFNα in combination with FU and LV. In a subsequent phase II study a total of 83 treatment courses (median: 2.8, range: 2–10) were administered to 30 evaluable patients. Side-effects were acceptable with no WHO grade IV toxicities. Grade III toxicities consited in thrombopenia (2/30), stomatitis (2/30), diarrhoea (3/30) and nausea/vomiting (4/30). After a median observation time of 17 months (range: 8–22 months), no complete remission was observed and 9 patients experienced a partial response lasting for a median of 6.6 months (range: 3–13+ months), for an overall response rate of 30% (95% confidence interval: 15%–49%). These results show that the described regiment of FU doubly modulated by LV and IFNα is active in colorectal cancer and can be safely administered in an out patient setting with acceptable toxicity. Thus, this regimen is suitable to be used for further evaluation in clinical trials.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01236390
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  • 8
    Electronic Resource
    Electronic Resource
    The in vitro effects of interleukin-12 upon tumor-infiltrating lymphocytes derived from renal cell carcinoma (1997)
    Springer
    Journal of cancer research and clinical oncology 123 (1997), S. 317-324 
    Details
    ISSN: 1432-1335
    Keywords: Interleukin-12 ; Tumor-infiltrating lymphocytes ; Renal cell cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Clinical trials utilising interleukin (IL)-2 with tumor-infiltrating lymphocytes (TIL) have demonstrated efficacy in the treatment of metastatic renal cell carcinoma (RCC). Several cytokines, as well as growth factors have demonstrated modulatory effects upon the biological properties of TIL from RCC, suggesting a potentially important role for cytokines other than IL-2 in the development of active and tumor-specific TIL. IL-12 was recently characterized as a natural-killer-cellstimulatory factor or cytotoxic-T-cell-maturation factor. These properties of IL-12 prompted us to investigate the impact of this cytokine upon the activation of TIL from human RCC. In an attempt to enhance the in vitro growth and activity of renal TIL, we have grown eight renal TIL cultures in varying concentrations of IL-2 (8, 40, 80, 400 U/ml) and IL-12 (200 U/ml). In addition, IL-12 (200 U/ml) was added to TIL cultures pre-activated with IL-2 (400 U/ml). Growth, cell expansion, and the ability of TIL to release certain cytokines upon tumor stimulation were determined. Proliferation assays, phenotypic analysis, and cytotoxicity assays were performed at an early and a late culture stage. IL-12, alone and when added to suboptimal concentrations of IL-2, failed to induce TIL growth. While the addition of IL-12 to optimal doses of IL-2 suppressed TIL culture expansion, sequential culture exposure first to IL-2 and then to IL-2+IL-12 increased the number of cells expressing CD3+/CD56+ and these cultures demonstrated enhanced in vitro lysis of autologous tumor. IL-12 clearly demonstrated a sequence-dependent impact of the biological behaviour of TIL from RCC. The optimal use of IL-12 in the in vitro expansion of renal TIL may result in cells with an enhanced specific anti-tumor effect.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01438307
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  • 9
    Electronic Resource
    Electronic Resource
    Cutaneous side effects in breast cancer patients treated with cytostatic polychemotherapy and rh GM-CSF: Immune phenomena or drug toxicity? (1995)
    Springer
    Breast cancer research and treatment 34 (1995), S. 213-219 
    Details
    ISSN: 1573-7217
    Keywords: GM-CSF ; cutaneous reactions ; immune phenomena ; breast cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary The application of recombinant colony stimulating factors for chemotherapy induced granulocytopenia is becoming common in clinical oncology. Here we report on localized cutaneous side effects after subcutaneous administration of recombinant human granulocyte-macrophage colony-stimulating factor (rh GM-CSF) in 11 patients with breast cancer receiving cytostatic treatment. Seven patients suffering from inflammatory breast cancer received cytostatic chemotherapy with mitoxantrone/cyclophosphamide, whereas four patients suffering from noninflammatory breast cancer received high-dose epirubicin/cyclophosphamide, respectively. rh GM-CSF was applicated subcutaneously in a dose of 5 µg/kg/d for at least ten days. In all patients, sharply demarked, maculous itching and burning erythemas restricted to the injection sites occured after three to four injections of rh GM-CSF. These eruptions cleared within 2 to 3 weeks, but reappeared after reexposure to rh GM-CSF. In contrast to previous sporadic reports, no generalized erythemas were observed. Because of this unexpected and subjectively intolerable side effect, rh GM-CSF administration had to be interrupted in all patients. Histopathological findings revealed skin infiltration with lymphocytes, monocytes/macrophages, neutrophils, and occasionally eosinophils, respectively. Since GM-CSF is known to alter immune functions, it seems likely that the eruptions were at least in part due to local immune reactions.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00689712
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  • 10
    Electronic Resource
    Electronic Resource
    Relationship between in vivo drug exposure of the tumor interstitium and inhibition of tumor cell growth in vitro: a study in breast cancer patients (2000)
    Springer
    Breast cancer research and treatment 60 (2000), S. 211-217 
    Details
    ISSN: 1573-7217
    Keywords: breast cancer ; 5-fluorouracil ; methotrexate ; pharmacodynamics ; pharmacokinetics
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract A novel approach is described to simulate effect site pharmacodynamics of anticancer drugs. This approach is based on (i) the in vivo measurement of unbound, interstitial drug pharmacokinetics (PK) in solid tumor lesions in patients and (ii) a subsequent pharmacodynamic (PD) simulation of the time versus drug concentration profile in an in vitro setting. For this purpose, breast cancer cells (MCF-7) were exposed in vitro to the time versus interstitial tumor concentration profiles of 5-fluorouracil (5-FU) and methotrexate (MTX) from primary breast cancer lesions in patients. This led to a maximal reduction in the viable cell count of 69 on day 4, and of 71 on day 7 for 5-FU and MTX, respectively. This effect was dependent on the initial cell count and was characterized by a high interindividual variability. For 5-FU there was a significant correlation between the maximum antitumor effect and the intratumoral AUC (r = 0.82, p = 0.0005), whereas no correlation could be shown for MTX (r = 0.05, p = 0.88). We conclude, that the in-vivo-PK / in-vitro-PD model presented in this study may provide a rational approach for describing and predicting pharmacodynamics of cytotoxic drugs at the target site. Data derived from this approach support the concept that tumor penetration of 5-FU may be a response-limiting event, while the response to MTX may be determined by events beyond interstitial fluid kinetics.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1006497202341
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