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Volume 1, Issue 2, Pages 99-101

EORTC Group Phase II Study of Oral Etoposide for Pretreated Soft Tissue Sarcoma

1Leiden University Hospital, The Netherlands
2University of Manchester, UK
3Aarhus University Hospital, Denmark
4University Hospital of Antwerp, Belgium
5Madrid Hospital Universitario, Spain
6EORTC Data Center, Belgium
7Netherlands Cancer Institute, The Netherlands
8Institut Gustave-Roussy, France
9Leiden University Medical Center, Department of Clinical Oncology, PO Box 9600 (K1-P), RC Leiden NL-2300, The Netherlands

Copyright © 1997 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Purpose. This study investigates the efficacy and toxicity of daily oral etoposide in chemotherapy for non-heavily pretreated advanced and metastatic soft tissue sarcoma (STS).

Subjects. Twenty-seven patients with progressive and measurable disease were treated. Median age was 53 years (range 20–71 years) and performance status WHO 0 or 1. Histologies included mainly leiomyosarcoma (8), malignant fibrous histiocytoma (4), rhabdomyosarcoma (4), liposarcoma (2) and synovial sarcoma (2). Fifteen patients had received prior radiotherapy, of whom three included sites with haematopoiesis. All patients had received prior chemotherapy, including adjuvant therapy (7) and mostly consisted of one two-drug schedule (ifosfamide and doxorubicin) or two single-drug regimens.

Methods. Chemotherapy consisted of etoposide (VP16-213), 50 mg m2 day1 × 21 q 4 weeks. Blood cell counts were done weekly. Dose reductions and a maximum delay of 2 weeks was allowed depending on cell counts during treatment and at the start of a new 4-week treatment cycle.

Results. No objective response was observed. Progressive disease was observed after two treatment cycles in 17/27 patients (68%) and after three cycles in 22/27 patients (81%). The other patients received three to five cycles. Twenty-four patients went off study due to progressive disease. Grade 3 and 4 neutropenia was observed in eight and one patients, respectively. Thrombocytopenia grade 3 was seen in two patients. Non-haematological toxicity grade 3 (nausea, diarrhoea or alopecia) was observed in three patients, and grade 4 (dyspnea, hypotension or haemorrhage) in three patients.

Discussion. No objective response was obtained. Oral etoposide at a dose of 50 mg m2 day1 × 21 q 4 weeks is inactive in chemotherapy of pretreated STS. Disease progression occurred within three cycles in the majority (81%) of patients. Toxicity of this regimen in non-heavily pretreated patients is low.