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Investigational New Drugs

, Volume 24, Issue 3, pp 249–253 | Cite as

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

  • J. T. Hartmann
  • K. Oechsle
  • J. Huober
  • A. Jakob
  • M. Azemar
  • M. Horger
  • L. Kanz
  • C. Bokemeyer
Phase II Studies

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.

Key Words

advanced soft tissue sarcoma gemcitabine second-line chemotherapy refractory disease 

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Copyright information

© Springer Science + Business Media, LLC 2005

Authors and Affiliations

  • J. T. Hartmann
    • 1
    • 2
  • K. Oechsle
    • 1
  • J. Huober
    • 3
  • A. Jakob
    • 4
  • M. Azemar
    • 5
  • M. Horger
    • 2
    • 6
  • L. Kanz
    • 1
  • C. Bokemeyer
    • 1
  1. 1.Department of Medical Oncology, Hematology, Immunology, Rheumatology, PneumologyEberhard-Karls-UniversityTuebingen
  2. 2.Interdisciplinary Sarcoma Center, South West German Cancer CenterEberhard-Karls-UniversityTuebingen
  3. 3.Department of Gynaecology and ObstreticsEberhard-Karls-UniversityTuebingen
  4. 4.KlinikumOffenburg
  5. 5.Klinik TumorbiologieFreiburg
  6. 6.Department of RadiologyEberhard-Karls-UniversityTuebingen

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