Bisagni G, Boni C, Manenti A L, Moretti G, Rondini E, Sassi M, Zadro A, Savoldi L
Medical Oncology Service, General Hospital, Reggio Emilia, Italy.
Tumori. 1998 Nov-Dec;84(6):659-61. doi: 10.1177/030089169808400608.
A phase II study with ifosfamide in pretreated patients with advanced breast cancer was performed to determine the objective response rate, the toxicity and the feasibility of the regimen.
METHODS & STUDY DESIGN: Patients enrolled had advanced breast cancer pretreated with at least one previous regimen of chemotherapy for advanced disease. Treatment consisted of ifosfamide infused at a dose of 2 g/m2 iv in 4 hrs followed by ifosfamide, 8 g/m2 iv in 120 hrs in ambulatory treatment, using a portable external pump system. The total dose of ifosfamide was 10 g/m2; mesna (4 g/m2 iv) was administered mixed with ifosfamide in 120 hrs Cycles were repeated every 3 weeks. Three patients were pretreated with neoadjuvant and 15 with adjuvant chemotherapy. All patients were treated for advanced disease (median number of regimens, 1; range, 1-3): 21 with the cyclophosphamide-containing regimen and 15 with adryamicin. Sixteen patients received one or more lines of endocrine therapy. Fifteen patients had dominant site in viscera, 6 in bone, and only one in soft tissue; 17 patients had more than one site of disease.
Twenty-two patients were enrolled and all were assessable for response and toxicity. A partial response was reached in 5 patients (23%; 95% confidence limits 5% to 60%). Hematologic toxicity was the dose-limiting side effect; grade 4 leukopenia occurred in 10 patients (46%).
Considering the response rate obtained in our series of intensively pretreated patients, the results seem to indicate that the regimen is active and could be included among the possible options in the treatment of patients with refractory, poor-prognosis, advanced breast carcinoma.
开展一项关于异环磷酰胺治疗晚期乳腺癌经治患者的II期研究，以确定该方案的客观缓解率、毒性及可行性。
入组患者为晚期乳腺癌患者，此前至少接受过一种晚期疾病化疗方案的治疗。治疗方案为：异环磷酰胺2 g/m²静脉滴注4小时，随后使用便携式外置泵系统进行门诊治疗，异环磷酰胺8 g/m²静脉滴注120小时。异环磷酰胺总剂量为10 g/m²；美司钠（4 g/m²静脉滴注）在120小时内与异环磷酰胺混合给药。每3周重复一个周期。3例患者接受过新辅助治疗，15例接受过辅助化疗。所有患者均接受晚期疾病治疗（化疗方案中位数为1；范围为1 - 3）：21例接受含环磷酰胺方案，15例接受阿霉素方案。16例患者接受过一线或多线内分泌治疗。15例患者主要病变位于内脏，6例位于骨骼，仅1例位于软组织；17例患者有不止一个病灶部位。
22例患者入组，所有患者均可评估疗效和毒性。5例患者达到部分缓解（23%；95%置信区间为5%至60%）。血液学毒性是剂量限制性副作用；10例患者（46%）出现4级白细胞减少。
考虑到我们这组经过强化预处理患者所获得的缓解率，结果似乎表明该方案具有活性，可作为难治性、预后不良的晚期乳腺癌患者治疗的可能选择之一。
