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Updated: Aug 30, 2026
A Mouse Model of Incompletely Resected Soft Tissue Sarcoma for Testing (Neo)adjuvant Therapies
Published on: July 28, 2020
An open label, non-comparative phase II study of topotecan as salvage treatment for patients with soft tissue sarcoma
Peter Reichardt1, Karin Oechsle, Daniel Pink
1Medizinische Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie, Robert-Roessle-Klinik, Helios-Klinikum Berlin, Universitätsklinikum Charité, Berlin, Germany.
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/m(2) 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.
Insights
Topotecan showed good tolerability in patients with metastatic soft tissue sarcoma (STS) resistant to anthracyclines. However, this study found no objective response to topotecan in this patient group.
Area of Science:
- Medical Oncology
- Pharmacology
Background:
- Metastatic soft tissue sarcoma (STS) has limited effective cytotoxic treatment options, particularly after anthracycline failure.
- Developing novel therapeutic strategies for advanced STS is crucial.
Purpose of the Study:
- To evaluate the efficacy and safety of topotecan in patients with metastatic STS who progressed on first-line anthracycline-based chemotherapy.
Main Methods:
- An open-label, noncomparative study included 16 patients with STS.
- Topotecan was administered at 1.5 mg/m(2) for 5 consecutive days every 3 weeks.
- All patients had prior anthracycline or ifosfamide chemotherapy.
Main Results:
- No objective response was observed in any of the 16 patients.
- Six patients (38%) achieved stable disease, with four lasting over 6 weeks.
- Median time to progression was 79 days; 62% experienced progressive disease.
- Topotecan was generally well tolerated, with grade III/IV anemia and thrombocytopenia in 25% and severe neutropenia in 69%.
Conclusions:
- Topotecan is well tolerated in anthracycline-resistant metastatic STS patients.
- No objective responses were achieved with topotecan in this trial, indicating limited efficacy in this setting.
