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An open label, non-comparative phase II study of gemcitabine as salvage treatment for patients with pretreated adult type soft tissue sarcoma

  • Phase II Studies
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Summary

Background: The number of effective cytotoxic agents for the treatment of patients with metastatic adult type soft tissue sarcoma (STS) is limited, when patients have failed anthracyline-based chemotherapy. The aim of this trial was to evaluate the efficacy of gemcitabine in this setting. Methods: Between August 2001 and March 2003 19 patients were eligible to enter. Gemcitabine was administered as a 30-minutes infusion at a dosage of 1 g/m2 on day 1, 8 and 15 every 4 weeks. All patients had progressive disease during (n = 12) or shortly after an anthracycline-based regimen (n = 3). Results: Four of 19 patients did not start study treatment because of fulminant progression. Fifteen patients with a median age 47 years (32–72) were assessable. All patients had received at least one prior treatment regimen (range, 1–6) for metastatic disease containing anthracyclines (n = 15) and ifosfamide (n = 11). To date, a total of 72+ cycles have been applied (median; 3, 1–28+). Seven patients (47%) had progressive disease after completion of two cycles at the first response assessment. One patient (6%) attained a partial remission, and 7 patients (47%) achieved disease stabilisations. One patient is still on treatment after more than 2.5 years. The calculated progression-free rate at 3 and 6 months was 46.7% (CI95%, 21.4–71.9) and 13.3% (CI95%, (0–30.5). 95% of the cycles have been applied without any dose modification or treatment delay. Conclusions: Considering response and progression-free rate as the primary endpoints for phase II trials in pretreated STS, gemcitabine has moderate efficacy.

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Authors and Affiliations

  1. Department of Medical Oncology, Hematology, Immunology, Rheumatology, Pneumology, Eberhard-Karls-University, Tuebingen

    J. T. Hartmann, K. Oechsle, L. Kanz & C. Bokemeyer

  2. Interdisciplinary Sarcoma Center, South West German Cancer Center, Eberhard-Karls-University, Tuebingen

    J. T. Hartmann & M. Horger

  3. Department of Gynaecology and Obstretics, Eberhard-Karls-University, Tuebingen

    J. Huober

  4. Klinikum, Offenburg

    A. Jakob

  5. Klinik Tumorbiologie, Freiburg

    M. Azemar

  6. Department of Radiology, Eberhard-Karls-University, Tuebingen

    M. Horger

Authors
  1. J. T. Hartmann
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  2. K. Oechsle
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  3. J. Huober
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  4. A. Jakob
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  5. M. Azemar
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  7. L. Kanz
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  8. C. Bokemeyer
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Correspondence to J. T. Hartmann.

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Hartmann, J.T., Oechsle, K., Huober, J. et al. An open label, non-comparative phase II study of gemcitabine as salvage treatment for patients with pretreated adult type soft tissue sarcoma. Invest New Drugs 24, 249–253 (2006). https://doi.org/10.1007/s10637-005-3537-1

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  • DOI: https://doi.org/10.1007/s10637-005-3537-1

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