Kollmannsberger C, Brugger W, Hartmann J T, Maurer F, Böhm P, Kanz L, Bokemeyer C
Department of Internal Medicine, University of Tübingen Medical School, Germany.
Anticancer Drugs. 1999 Jun;10(5):453-6. doi: 10.1097/00001813-199906000-00004.
This phase II study investigated the activity of continuously administered oral trofosfamide in chemotherapy-pretreated patients with metastatic soft-tissue sarcoma (STS). Trosfosfamide is an oxazaphosphorine with ifosfamide as the predominant metabolite. Eighteen patients with a median age of 60 years were treated with trofosfamide given as continuous oral treatment. Starting dose was 300 mg/day for 7 days and subsequently 150 mg/day. All patients had previously received at least one chemotherapy regimen including doxorubicin and ifosfamide. Three patients achieved partial responses (18%) and nine a disease stabilization (53%) for an overall response rate of 18% (95% CI: 0.5-35%). Median progression-free interval was 4 months (0-17 months) and median overall survival was 10 months (4-39+) months. Toxicity was generally mild. Only one WHO grade III nausea, but no other non-hematologic WHO grade III/IV toxicity occurred. Leukopenia WHO grade III/IV was observed in four patients (22%). No thrombocytopenia <50,000/microl and no neutropenic infection was seen. Continuously administered oral trofosfamide is a well-tolerated palliative treatment in anthracycline/oxazaphosphorin-pretreated patients with advanced STS achieving responses and/or disease stabilization in up to 70% of patients.
这项II期研究调查了持续口服曲磷胺对接受过化疗的转移性软组织肉瘤（STS）患者的疗效。曲磷胺是一种恶唑磷类药物，其主要代谢产物为异环磷酰胺。18名中位年龄为60岁的患者接受了曲磷胺持续口服治疗。起始剂量为300mg/天，持续7天，随后为150mg/天。所有患者此前均接受过至少一种化疗方案，包括阿霉素和异环磷酰胺。3名患者获得部分缓解（18%），9名患者病情稳定（53%），总缓解率为18%（95%CI：0.5-35%）。中位无进展生存期为4个月（0-17个月），中位总生存期为10个月（4-39+个月）。毒性一般较轻。仅出现1例WHO III级恶心，但未出现其他非血液学WHO III/IV级毒性。4名患者（22%）出现WHO III/IV级白细胞减少。未观察到血小板减少<50,000/微升，也未出现中性粒细胞减少感染。持续口服曲磷胺对接受过蒽环类/恶唑磷类药物预处理的晚期STS患者是一种耐受性良好的姑息治疗方法，高达70%的患者可实现缓解和/或病情稳定。
