Ifosfamide plus doxorubicin in previously untreated patients with advanced soft tissue sarcoma |
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| Affiliation: | 1. Universitätsklinik Essen, West Germany;2. Finsen Institute, Copenhagen, Denmark;3. Christie Hospital, Manchester, U.K.;4. Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy;5. University Hospital, Leiden, The Netherlands;6. Universitaire Ziekenhuis, Antwerpen, Belgium;7. Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands;8. Queen Elizabeth Hospital, Birmingham, U.K.;9. Dr Daniel den Hoed Cancer Center, Rotterdam, The Netherlands;10. Herlev Hospital, Copenhagen, Denmark;11. EORTC Data Center, Brussels, Belgium;1. Center for Orthopedic and Trauma Surgery, University Medical Center, Cologne, Germany;2. Cologne Center for Musculoskeletal Biomechanics, Medical Faculty, University of Cologne, Cologne, Germany;3. Institute of Anatomy I, University of Cologne, Cologne, Germany;4. Institute of Biomechanics and Orthopaedics, German Sport University Cologne, Cologne, Germany;1. Rubin Institute for Advanced Orthopedics, Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore, Baltimore, Maryland;2. Department of Orthopaedic Surgery, SUNY Downstate Medical Center, Brooklyn, New York;3. Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio;1. Department of Tumor Cell Biology, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China;2. Department of Thoracic Oncology, Lung Cancer Diagnosis and Treatment Center, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China;3. National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin’s Clinical Research Center for Cancer, National Key Laboratory of Druggability Evaluation and Systematic Translational Medicine, Tianjin 300060, China;4. Department of Pathology, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China;5. Department of Oncology, Affiliated Hospital of Chifeng University, Chifeng, Inner Mongolia 024000, China;6. Department of Oncology, Inner Mongolia Autonomous Region People’s Hospital, Hohhot, Inner Mongolia 010000, China;1. Department of Neurosurgery, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710061, China;2. Department of Operation, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710061, China;3. Department of Anus and Intestine Surgery, ZiBo Central Hospital, Zibo 255036, China;1. Department of Chemistry, Saint Mary''s University, Halifax, NS, CA;2. University Health Network, University of Toronto, Toronto, ON, CA;3. University Hospitals Cleveland Medical Center, Cleveland, OH, US;4. Department of Pathology, Case Western Reserve University, Cleveland, OH, US;5. Princess Margaret Cancer Centre/University Health Network, Toronto, ON, CA;6. Department of Medical Biophysics, University of Toronto, Toronto, ON, CA;7. Department of Physics, University of Toronto, Toronto, ON, CA;8. Department of Chemical and Physical Sciences, University of Toronto Mississauga, Mississauga, ON, CA |
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| Abstract: | The objective of this phase II trial was to assess the therapeutic activity and toxicity of doxorubicin plus ifosfamide in previously untreated patients with advanced soft tissue sarcoma. Treatment was doxorubicin 50 mg/m2 followed by a 24 h infusion of ifosfamide 5 g/m2 plus mesna 2.5 g/m2 repeated every 3 weeks until disease progression or unacceptable toxicity occurred. Of 203 patients entered, 175 were evaluable for response. The response rate was 35% (95% CI 28–42%), with 9% of the patients achieving a complete remission and 26% a partial remission. The median time to progression was 29 weeks for all evaluable patients, and 67, 40 and 28 weeks for complete and partial responders and patients with stable disease, respectively. The median duration of survival was 58 weeks. Myelosuppression was the dose-limiting toxicity, resulting in leukopenia (WHO grade 3 and 4) in 73% of evaluable treatment courses. Other side-effects were rare and usually well manageable. |
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