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Phase II study of topotecan (NSC 609 699) in patients with recurrent or metastatic soft tissue sarcoma
V H Bramwell1, E A Eisenhauer, M Blackstein
1London Regional Cancer Centre, Ontario, Canada.
Background:
New drugs are needed for treatment of unresectable or metastatic soft tissue sarcoma. Topotecan, a semisynthetic derivative of the alkaloid, camptothecin, exerts its cytotoxic effect through inhibition of topoisomerase I.
Patients And Methods:
Thirty-two adult patients with locally advanced or metastatic soft tissue sarcoma entered this phase II study of topotecan, administered at 1.5 mg/m2/day IV x 5 days every 3 weeks. All had measurable disease and none had received previous chemotherapy.
Results:
There were 3 partial responses (10.3%; 95% CI 2.2-27.4%) in 29 evaluable patients. Grade 3 or 4 neutropenia occurred in 25 patients, and there was a 17% incidence of infection/neutropenic fever leading to one toxic death.
Conclusions:
Topotecan, in this dose and schedule, has low activity in adult soft tissue sarcoma.
Insights
Topotecan shows limited effectiveness for treating advanced soft tissue sarcoma. This study found low activity and significant toxicity, including neutropenia and infection, in patients receiving topotecan chemotherapy.
Area of Science:
- Oncology
- Pharmacology
Background:
- Soft tissue sarcoma requires novel therapeutic agents for unresectable or metastatic disease.
- Topotecan, a camptothecin derivative, functions by inhibiting topoisomerase I.
Purpose of the Study:
- To evaluate the efficacy and safety of topotecan in adult patients with advanced soft tissue sarcoma.
Main Methods:
- A phase II study administered topotecan at 1.5 mg/m2/day intravenously for 5 days every 3 weeks.
- Thirty-two adult patients with measurable, previously untreated soft tissue sarcoma were enrolled.
Main Results:
- Three partial responses (10.3%) were observed in 29 evaluable patients.
- Grade 3 or 4 neutropenia affected 25 patients, with a 17% incidence of infection/neutropenic fever.
- One toxic death occurred due to infection/neutropenic fever.
Conclusions:
- Topotecan demonstrated low clinical activity in this patient population at the tested dose and schedule.
- The observed toxicity profile, including severe neutropenia and infection, raises concerns for this regimen in soft tissue sarcoma.