We are analyzing https://link.springer.com/article/10.1007/s10549-004-1720-2.

Title:
A multicentre phase II study on gefitinib in taxane- and anthracycline-pretreated metastatic breast cancer | Breast Cancer Research and Treatment
Description:
Background. Epidermal growth factor receptor (EGFR) is considered to be a viable drug target in a variety of solid tumors. The clinical benefit and safety of the EGFR tyrosine kinase inhibitor gefitinib (‘Iressa’)1 was evaluated in this Phase II, multicentre study of patients with taxane and anthracycline pretreated, metastatic breast cancer. Methods. Gefitinib (500 mg/day) was given to 58 patients until disease progression. Primary endpoint was the clinical response rate to the study treatment. Results. One patient (1.7%) had objective partial tumor response of her liver and pleural metastasis. Fifty-seven patients (98.3%) were non-responders with 52 patients (89.7%) having progressive disease and five patients (8.6%) were not evaluable. Two patients reported a significant improvement in pain at metastatic sites (1 liver, 1 bone). The median time to progression was 61 days (95% CI : 54–82 days) and the proportion of patients alive and progression free at 6 months at trial closure was 1.8% (95% CI : 0.0–5.2%). The median survival time was 357 days (95% CI : 257–441 days). Fifty-four patients (93.1%) discontinued study medication prematurely due to disease progression and three (5.2%) due to adverse events (diarrhea, pruritus, peripheral edema). Conclusions. Gefitinib monotherapy at 500 mg daily did not appear to be efficacious in the treatment of heavily pretreated metastatic breast cancer patients. It was well tolerated and the side effect profile was as expected from current knowledge of the drug. There was no correlation between EGFR expression and response in this study.
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cancer, breast, google, scholar, cas, pubmed, article, patients, metastatic, phase, study, gefitinib, oncol, treatment, clin, growth, factor, receptor, trial, minckwitz, epidermal, inhibitor, research, access, privacy, cookies, content, tyrosine, kinase, iressa, response, results, chemotherapy, therapy, publish, search, jonat, andreas, egfr, solid, safety, progression, days, advanced, doxorubicin, randomized, multicenter, lung, data, european,

Topics {✒️}

er/her2-positive breast cancer metastatic breast cancer-report month download article/chapter kaufmann hj luck cancer therapy-breast small-cell lung cancer small-cell lung cancer metastatic breast cancer cancer therapy scale andreas du bois related subjects gunter von minckwitz hans-joachim lück full article pdf metastatic cervical cancer neu-isenburg/frankfurt egfr inhibitor gefitinib fgfr inhibitor azd4547 privacy choices/manage cookies national cancer institute janicke dg kieback gynaekologische onkologie phase iii trial breast cancer anthracycline pretreated frauenklinik der mhh henriettenstiftung neu-bethesda european economic area kuhn ae schindler staedtisches klinikum magdeburg open-label s-phase fraction peter fasching oral capecitabine tumor pharmacodynamic study check access instant access jörn hilfrich side effect profile marty jl misset ochs pm lorusso baum gp magquire shaughnessy jl misset fehrenbacher dj slamon murphy wf novotny shak sj stewart additive antitumour effect horst-schmidt-kliniken line therapy conditions privacy policy

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LJ Fallowfield M Baum GP Magquire (1987) Do psychological studies upset patients?

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         headline:A multicentre phase II study on gefitinib in taxane- and anthracycline-pretreated metastatic breast cancer
         description:Background. Epidermal growth factor receptor (EGFR) is considered to be a viable drug target in a variety of solid tumors. The clinical benefit and safety of the EGFR tyrosine kinase inhibitor gefitinib (‘Iressa’)1 was evaluated in this Phase II, multicentre study of patients with taxane and anthracycline pretreated, metastatic breast cancer. Methods. Gefitinib (500 mg/day) was given to 58 patients until disease progression. Primary endpoint was the clinical response rate to the study treatment. Results. One patient (1.7%) had objective partial tumor response of her liver and pleural metastasis. Fifty-seven patients (98.3%) were non-responders with 52 patients (89.7%) having progressive disease and five patients (8.6%) were not evaluable. Two patients reported a significant improvement in pain at metastatic sites (1 liver, 1 bone). The median time to progression was 61 days (95% CI : 54–82 days) and the proportion of patients alive and progression free at 6 months at trial closure was 1.8% (95% CI : 0.0–5.2%). The median survival time was 357 days (95% CI : 257–441 days). Fifty-four patients (93.1%) discontinued study medication prematurely due to disease progression and three (5.2%) due to adverse events (diarrhea, pruritus, peripheral edema). Conclusions. Gefitinib monotherapy at 500 mg daily did not appear to be efficacious in the treatment of heavily pretreated metastatic breast cancer patients. It was well tolerated and the side effect profile was as expected from current knowledge of the drug. There was no correlation between EGFR expression and response in this study.
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            metastatic breast cancer
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      headline:A multicentre phase II study on gefitinib in taxane- and anthracycline-pretreated metastatic breast cancer
      description:Background. Epidermal growth factor receptor (EGFR) is considered to be a viable drug target in a variety of solid tumors. The clinical benefit and safety of the EGFR tyrosine kinase inhibitor gefitinib (‘Iressa’)1 was evaluated in this Phase II, multicentre study of patients with taxane and anthracycline pretreated, metastatic breast cancer. Methods. Gefitinib (500 mg/day) was given to 58 patients until disease progression. Primary endpoint was the clinical response rate to the study treatment. Results. One patient (1.7%) had objective partial tumor response of her liver and pleural metastasis. Fifty-seven patients (98.3%) were non-responders with 52 patients (89.7%) having progressive disease and five patients (8.6%) were not evaluable. Two patients reported a significant improvement in pain at metastatic sites (1 liver, 1 bone). The median time to progression was 61 days (95% CI : 54–82 days) and the proportion of patients alive and progression free at 6 months at trial closure was 1.8% (95% CI : 0.0–5.2%). The median survival time was 357 days (95% CI : 257–441 days). Fifty-four patients (93.1%) discontinued study medication prematurely due to disease progression and three (5.2%) due to adverse events (diarrhea, pruritus, peripheral edema). Conclusions. Gefitinib monotherapy at 500 mg daily did not appear to be efficacious in the treatment of heavily pretreated metastatic breast cancer patients. It was well tolerated and the side effect profile was as expected from current knowledge of the drug. There was no correlation between EGFR expression and response in this study.
      datePublished:
      dateModified:
      pageStart:165
      pageEnd:172
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         gefitinib
         metastatic breast cancer
         phase II
         taxane-pretreated
         Oncology
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      name:Klinik fuer Gynaekologie und Gynaekologische Onkologie, Dr.-Horst-Schmidt-Kliniken, Wiesbaden
      name:Haematologisch-onkologische Praxis Altona, Hamburg
      name:Abt. Gynaekologische Onkologie, Krankenhaus Oststadt, Frauenklinik der MHH, Hannover
      name:Haematologische Abteilung, Staedtisches Klinikum Magdeburg, Magdeburg
      name:Standort Kirchrode, Gynaekologie, Henriettenstiftung Neu-Bethesda, Hannover
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      name:AstraZeneca GmbH, Wedel
      name:Universitaetsklinikum Heidelberg, Frauenklinik, Heidelberg, Germany
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