Divisions of New Drug Development, European Institute of Oncology, Milan, Italy.
Chemotherapy. 2011;57(3):217-24. doi: 10.1159/000326466. Epub 2011 May 18.
Ifosfamide and doxorubicin combination is an active regimen for patients with advanced soft tissue sarcomas (STS) but is burdened by high toxicity. A phase II trial was designed to assess the activity of continuous infusion ifosfamide and doxorubicin combination.
Thirty-four chemotherapy-naive patients with advanced STS were treated with ifosfamide (13 g/m(2)/12 days as continuous infusion) and doxorubicin (75 mg/m(2) on day 8) every 28 days with granulocyte colony-stimulating factor.
The major toxicity was hematological: grade 3/4 neutropenia, anemia and thrombocytopenia occurred in 63, 30 and 12% of patients, respectively. The disease control rate was 68% and the median time to progression was 7.1 months. Among leiomyosarcomas, 2 partial responses and 4 stable diseases were observed.
Our study confirms that the ifosfamide and doxorubicin combination has a very low non-hematological toxicity profile. This regimen attained a high disease control rate with moderate activity. Further investigation into leiomyosarcoma is warranted.
异环磷酰胺和阿霉素联合治疗晚期软组织肉瘤（STS）具有较好的疗效，但毒性较大。本研究旨在评估连续输注异环磷酰胺和阿霉素联合方案的疗效。
34 例初治晚期 STS 患者接受异环磷酰胺（13 g/m2/12 天连续输注）和阿霉素（75 mg/m2，第 8 天）治疗，每 28 天 1 次，同时应用粒细胞集落刺激因子。
主要毒性为血液学毒性：中性粒细胞减少症、贫血和血小板减少症的发生率分别为 63%、30%和 12%，其中 3/4 级毒性发生率分别为 47%、24%和 12%。疾病控制率为 68%，中位无进展生存期为 7.1 个月。平滑肌肉瘤患者中，2 例获得部分缓解，4 例病情稳定。
本研究证实异环磷酰胺和阿霉素联合方案具有较好的血液学毒性特征，而非血液学毒性较小。该方案疗效确切，为治疗晚期软组织肉瘤提供了新的选择。
