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Annals of Oncology 6:847-849, 1995
© 1995 European Society for Medical Oncology

research-article

Phase II study of topotecan (NSC 609 699) in patients with recurrent or metastatic soft tissue sarcoma

V. H. C. Bramwell1,, E. A. Eisenhauer2, M. Blackstein3, G. Boos4, M. Knowling5, J. Jolivet6 and W. Bogues2

1London Regional Cancer Centre London, Ontario
2National Cancer Institute of Canada Clinical Trials Group Kingston
3Mount Sinai Hospital Toronto, Ontario
4McGill University, Montreal Quebec
5British Columbia Cancer Agency, Vancouver British Columbia
6'Hospital Notre-Dame, Montreal Quebec, Canada

Correspondence to: Dr. Vivien Bramwell London Regional Cancer Centre 790 Commissioners Road East London, Ontario N6A, 4L6 Canada

Background: New drugs are needed for treatment of un-resectable 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

soft tissue sarcoma, advanced disease, new drugs, topotecan


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