Investigational New Drugs

, Volume 21, Issue 4, pp 481–486

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

  • Peter Reichardt
  • Karin Oechsle
  • Daniel Pink
  • Carsten Bokemeyer
  • F. Schneller
  • Rolf Issels
  • Lothar Kanz
  • Jörg Thomas Hartmann


Background: The number of effective cytotoxic agents for the treatment of patients with metastatic soft tissue sarcoma (STS) is limited, especially when patients have failed anthracyline-based chemotherapy. Patients and methods: Between 1999 and 2000 a total of 16 patients with histologically proven STS progressing during or after first-line anthracycline-based chemotherapy were entered into this open-label, noncomparative study. Topotecan was administered as a 30-min infusion at a dosage of 1.5 mg/m2 on five consecutive days every 3 weeks. All patients had received an anthracycline- or ifosfamide-based first-line chemotherapy. Results: None of the 16 included patients achieved an objective response to topotecan. Six patients achieved stable disease (38%), lasting for at least 6 weeks in four patients (25%) and for less than 6 weeks in two patients (13%). Ten patients (62%) had progressive disease. The median time to progression was 79 days calculated from the start of topotecan therapy (range, 28–230). The treatment was well tolerated; however, both anemia and thrombopenia grade III/IV occurred in 25% of the patients as well as severe neutropenia in 69% of the patients. Nonhematologic toxicities grade III/IV such as diarrhea and severe bleeding occurred only in one patient each (6%). Discussion: Topotecan is well tolerated in anthracycline-resistant patients with metastatic STS, but no objective response has been observed in this trial.

advanced soft tissue sarcoma topotecan topoisomerase-I-inhibitor second-line chemotherapy 


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Copyright information

© Kluwer Academic Publishers 2003

Authors and Affiliations

  • Peter Reichardt
    • 1
  • Karin Oechsle
    • 2
  • Daniel Pink
    • 1
  • Carsten Bokemeyer
    • 2
  • F. Schneller
    • 3
  • Rolf Issels
    • 4
  • Lothar Kanz
    • 2
  • Jörg Thomas Hartmann
    • 2
  1. 1.Medizinische Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie, Robert-Roessle-Klinik, Helios-Klinikum BerlinUniversitätsklinikum CharitéeBerlinGermany
  2. 2.Medizinische Klinik IIUniversitätsklinikum, Eberhard-Karls-UniversityTuebingenGermany
  3. 3.Medizinische Klinik IIIKlinikum rechts der IsarMunichGermany
  4. 4.Medizinische Klinik IIILMU Grosshadern und GSF-Institut für Molekulare Immunologie, KKG HTMunichGermany

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