Phase II/III trial of etoposide and high-dose ifosfamide in newly diagnosed metastatic osteosarcoma: A Pediatric Oncology Group trial
Phase II/III trial of etoposide and high-dose ifosfamide in newly diagnosed metastatic osteosarcoma: A Pediatric Oncology Group trial
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DOI：
10.1200/jco.2002.20.2.426
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发表时间：
2002-01-15
影响因子：
45.3
通讯作者：
Grier, HE
中科院分区：
文献类型：
--
作者：
Goorin, AM;Harris, MB;Grier, HE
目的：本试验的目的是评估接受依托泊苷和大剂量异环磷酰胺治疗的患者的缓解率、无进展生存期和总生存期，并确定新诊断的转移性骨肉瘤患者接受标准化疗时该组合的毒性。患者和方法：符合条件的患者每天接受依托泊苷输注 100 mg/m(2) 和每天 3.5 g/m(2) 异环磷酰胺输注5天。在第6天开始用粒细胞集落刺激因子进行治疗。在治疗开始后3周重复该治疗。在第 6 周，通过标准世界卫生组织反应标准和原发性肿瘤的肿瘤坏死的病理学测定来确定反应。 结果：登记了 43 名患者； 39 例可评估反应，41 例可评估毒性和存活率。 41 例中的 28 例 (68%) 仅在肺部有转移部位； 12 例 (29%) 在其他骨骼中存在转移部位，伴或不伴肺部受累。 4 名患者 (10%) 出现完全缓解，19 名患者 (49%) 出现部分缓解，总缓解率为 59% +/- 8%。 28 名肺转移患者的预计 2 年无进展生存率 (PFS) 为 39% +/- 11%。 12 名转移至其他骨骼（伴或不伴肺转移）的患者的预计 2 年 PFS 为 58% +/- 17%。两名患者因治疗毒性而死亡。 83% 的患者患有 4 级中性粒细胞减少症，29% 患有 4 级血小板减少症。十名患者（24%）患有败血症。 5 例患者观察到 Fanconi 综合征。结论：依托泊苷和大剂量异环磷酰胺联合治疗转移性骨肉瘤患者是有效的诱导化疗，尽管有时会并发感染和肾毒性，但伴有显着的骨髓抑制。 (C) 2002 年，美国临床肿瘤学会。
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/m(2) per day of etoposide and 3.5 g/m(2) 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 osteasarcoma, despite significant associated myelosuppression sometimes complicated by infection and renal toxicity. (C) 2002 by American Society of Clinical Oncology.