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A phase II trial of docetaxel (Taxotere®) as second-line chemotherapy in patients with metastatic breast cancer

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Abstract

The efficacy and tolerability of docetaxel 100 mg/m² every 3 weeks as second-line chemotherapy in patients with metastatic breast cancer was investigated. In addition, the efficacy of a 3-day prophylaxis against cumulative dose-related fluid retention was examined with methylprednisolone 32 mg twice daily for 3 days starting 12 and 3 h before the docetaxel infusion together with oral cetirizine 10 mg 12 and 3 h before start of docetaxel for prevention of acute hypersensitivity reactions. According to the intent to treat-analysis 35% (95%CI: 25; 46) of the 94 patients entered responded to therapy. Their median survival was 12 months (range 0–20 months). The respective response rate for the 87 patients eligible for response evaluation was 37% (95%CI: 27; 48). Their median duration of response was 8 months (range 3–12 months), their median time to progression was 4 months (range 1–12 months). The corresponding response rate in the eligible patient cohort with anthracycline-resistant disease was 28% (95%CI: 15; 45) and increased to 44% (95%CI: 30; 59) in the cohort with non-anthracycline-resistant disease. Patients with visceral metastases responded in 36% and patients with ≥3 organs involved in 33%. In a retrospective analysis, the 3-day premedication of corticosteroids and antihistamines proved to be as effective as the established but more toxic 5-day regimen in delaying and preventing the occurrence of docetaxel derived toxicities especially the cumulative fluid retention. In conclusion, docetaxel represents one of the most active agents for second-line treatment of metastatic breast cancer, especially for anthracycline-resistant patients. Due to comparable effectiveness of the 5-day regimen which is widely used by others and the 3-day premedication tested in this trial the latter proved to be more favourable and was therefore recommended for future therapies.

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Authors and Affiliations

  1. Applied Cancer Research-Institution for Translational Research Vienna (ACR-ITR VIEnna), Vienna, Austria

    Martina Baur & Christian Dittrich

  2. Ludwig Boltzmann-Institute for Applied Cancer Research (LBI-ACR VIEnna), Vienna, Austria

    Martina Baur & Christian Dittrich

  3. 3rd Medical Department, Centre for Oncology and Haematology, Kaiser Franz Josef-Spital, Kundratstrasse 3, 1100, Vienna, Austria

    Martina Baur & Christian Dittrich

  4. Division of Medical Oncology and Radiotherapy, Universitaire Ziekenhuis Ku Leuven, Herestraat 49, 3000, Leuven, Belgium

    Allan T. van Oosterom

  5. Department of Medical Oncology, Institut Curie, 26, rue d′Ulm, 75231, Paris Cedex 05, France

    Véronique Diéras

  6. Centre René Huguenin, 35, rue Dailly, 92211, Saint-Cloud, France

    Michele Tubiana-Hulin

  7. Imperial College, Division of Surgery, Ccb Cancer Medicine, Ducane Road, London, W120NN, UK

    R. Charles Coombes

  8. Department of Oncology, Radiumhemmet, Karolinska University Hospital, 17176, Stockholm, Sweden

    Thomas Hatschek

  9. SanofiAventis, 46 Quai.de la Rapée, 75601, Paris Cedex 12, France

    Michael Murawsky & May Klink-Alakl

  10. Institute of Scientific Computing, University of Vienna, Universitätsstrasse 5, 1010, Vienna, Austria

    Marcus Hudec

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  1. Martina Baur
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  2. Allan T. van Oosterom
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  9. Christian Dittrich
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Baur, M., van Oosterom, A.T., Diéras, V. et al. A phase II trial of docetaxel (Taxotere®) as second-line chemotherapy in patients with metastatic breast cancer. J Cancer Res Clin Oncol 134, 125–135 (2008). https://doi.org/10.1007/s00432-007-0259-0

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  • DOI: https://doi.org/10.1007/s00432-007-0259-0

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