Phase II/III Trial of Etoposide and High-Dose Ifosfamide in Newly Diagnosed Metastatic Osteosarcoma: A Pediatric Oncology Group Trial
| Autor: | Allen M, Goorin, Michael B, Harris, Mark, Bernstein, William, Ferguson, Meenakshi, Devidas, Gene P, Siegal, Mark C, Gebhardt, Cindy L, Schwartz, Michael, Link, Holcombe E, Grier |
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| Rok vydání: | 2002 |
| Předmět: |
Adult
Male Osteosarcoma Cancer Research Neutropenia Adolescent Bone Neoplasms Thrombocytopenia Disease-Free Survival Treatment Outcome Oncology Antineoplastic Combined Chemotherapy Protocols Granulocyte Colony-Stimulating Factor Humans Female Ifosfamide Neoplasm Metastasis Child Infusions Intravenous Etoposide |
| Zdroj: | Journal of Clinical Oncology. 20:426-433 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2002.20.2.426 |
| Popis: | PURPOSE: The objectives of this trial were to estimate the response rate, progression-free survival, and overall survival of patients who received therapy with etoposide and high-dose ifosfamide, and to define the toxicity of this combination when provided with standard chemotherapy in patients with newly diagnosed metastatic osteosarcoma. PATIENTS AND METHODS: Eligible patients received infusions of 100 mg/m2 per day of etoposide and 3.5 g/m2 per day of ifosfamide for 5 days. Therapy with granulocyte colony-stimulating factor was begun on day 6. This was repeated 3 weeks after therapy was begun. Response was determined at week 6 by both standard World Health Organization response criteria and by pathologic determination of tumor necrosis of the primary tumor. RESULTS: Forty-three patients were registered; 39 were assessable for response and 41 for toxicity and survival. Twenty-eight (68%) of 41 had metastatic sites only in the lung; 12 (29%) had metastatic sites in other bones with or without lung involvement. Four patients (10%) experienced complete response, and 19 patients (49%) experienced partial response, for an overall response rate of 59% ± 8%. The projected 2-year progression-free survival (PFS) for the 28 patients with metastases to lungs was 39% ± 11%. The projected 2-year PFS for the 12 patients with metastases to other bones (with or without pulmonary metastases) was 58% ± 17%. Two patients died as a result of therapy toxicity. Eighty-three percent of patients had grade 4 neutropenia, and 29% had grade 4 thrombocytopenia. Ten patients (24%) had sepsis. Fanconi’s syndrome was observed in five patients. CONCLUSION: The combination of etoposide and high-dose ifosfamide is effective induction chemotherapy for patients with metastatic osteosarcoma, despite significant associated myelosuppression sometimes complicated by infection and renal toxicity. |
| Databáze: | OpenAIRE |
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