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Phase I trial of dihydrolenperone in lung cancer patients: A novel compound within vitro activity against lung cancer (1993)

Johnson, Bruce E. ; Parker, Robert ; Tsai, C. M. ; [et al.]

Springer

Investigational new drugs 11 (1993), S. 29-37

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ISSN: 1573-0646

Keywords: dihydrolenperone ; drug evaluation ; drug screening assays ; antitumor ; carcinoma ; non-small cell lung carcinoma ; oat cell

Source: Springer Online Journal Archives 1860-2000

Topics: Chemistry and Pharmacology , Medicine

Notes: Summary Antitumor activity of the butyrophenone dihydrolenperone in non-small cell lung cancer was initially suggested byin vitro screening against tumor cells derived from fresh surgical samples using the human tumor colony-forming assay. We have completed a directed phase I trial in patients with lung cancer. Thirty-two patients with lung cancer have completed 25 courses of therapy at doses of 10 to 60 mg/square meter orally on a twice daily schedule. Twenty-three men and 9 women with a median age of 55 (range 24–69) were entered. Twenty-four were performance status 0 or 1 and 8 were 2. The maximum tolerated dose was 50 mg/square meter orally twice daily and the dose limiting toxicity was somnolence. Of the 32 patients, 18 developed symptomatic hypotension (grade 1 or 2). There was no significant hematologic, renal, or hepatic toxicity.In vitro drug testing using the MTT [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl-tetrazolium bromide (thiazolyl blue)] assay confirmed 50% inhibition of non-small cell and small cell lung cancer cell line growth at 70–450 micromolar concentrations. Plasma dihydrolenperone levels were at least 75-fold less than levels at whichin vitro activity was observed. We conclude: 1) the maximum tolerated dose in our study is 50 mg/square meter orally twice daily, 2) the dose-limiting side effect of dihydrolenperone is somnolence, and 3) the concentrations of dihydrolenperone observed in plasma are significantly lower than those associated within vitro activity.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1007/BF00873907

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Correlation of in vitro drug sensitivity testing results with response to chemotherapy and survival: Comparison of non-small cell lung cancer and small cell lung cancer (1996)

Shaw, Gail L. ; Gazdar, Adi F. ; Phelps, Ruby ; [et al.]

New York, N.Y. : Wiley-Blackwell

Journal of Cellular Biochemistry 63 (1996), S. 173-185

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ISSN: 0730-2312

Keywords: non-small cell lung cancer ; small cell lung cancer ; drug resistance ; cell survival ; Life Sciences ; Molecular Cell Biology

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Biology , Chemistry and Pharmacology , Medicine

Notes: Clinical protocols for small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) were devised to prospectively select individualized chemotherapy based on in vitro drug sensitivity testing (DST) of cell lines derived from the patient's SCLC tumor cell lines or the patient's fresh NSCLC tumor. DST data derived from SCLC tumor cell lines were available for 33/115 (29%) patients. The DST-selected chemotherapy regimen was administered to 21 (18%) patients, or 64% of patients with DST. In SCLC, the DST-selected chemotherapy was administered either during weeks 13-24 following 12 weeks of etoposide/cisplatin, or at relapse after complete response to etoposide/cisplatin. Several parameters of in vitro drug sensitivity were significantly associated (two-sided P 〈 0.05) with clinical response to primary therapy and also with response to the DST-selected chemotherapy regimen, but were not associated with survival (P = 0.24). Five patients treated with their DST-selected chemotherapy attained a complete or partial response, compared to 5 of 68 who received an empiric regimen (P = 0.057). A total of 36/165 (22%) NSCLC patients had DST successfully completed. These results directed management for 21/96 (22%) patients who eventually received chemotherapy, or 58% of patients with DST. Response to chemotherapy for the patients treated prospectively with their DST-selected chemotherapy regimen (2/21; 9%) was not significantly different than the response rate for patients treated empirically with etoposide/cisplatin (10/69; 14%) in the absence of in vitro results to direct chemotherapy (P = 0.73). There was no difference in survival by treatment group for the NSCLC patients. The correlation between in vitro and clinical response was not significant for any individual drug or for all drugs considered together, illustrating the poor predictive value of in vitro testing with currently available chemotherapy in NSCLC. © 1996 Wiley-Liss, Inc.

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