Dreicer R, Lallas T A, Joyce J K, Anderson B, Sorosky J I, Buller R E
Department of Internal Medicine, University of Iowa College of Medicine, Iowa City, USA.
Am J Clin Oncol. 1998 Jun;21(3):287-90. doi: 10.1097/00000421-199806000-00017.
The authors performed a phase II trial of the VIG regimen (vinblastine, ifosfamide, and gallium nitrate) in patients who had advanced ovarian cancer who were refractory to cisplatin and/or carboplatin and whose disease had progressed after paclitaxel-based therapy. This was a heavily pretreated population, with five patients having received two to three prior chemotherapy regimens and six patients having received more than six prior chemotherapy regimens, with an average of 21 therapy cycles per patient. Fourteen patients were treated with vinblastine, 0.08 mg/kg intravenously on days 1 and 2; ifosfamide, 900 mg/m2 intravenously on days 1 through 5 with standard mesna uroprotection; and gallium nitrate administered as a continuous intravenous infusion at 225 mg/m2 per 24 hours x 120 hours. Granulocyte colony-stimulating factor (G-CSF) was administered subcutaneously at 5 microg/kg/day beginning on day 7 until day 13. Five of 14 patients achieved a partial response for an overall response rate of 36% (95% confidence interval, 14%-68%). The median response duration was 14 weeks. Toxicity was primarily hematologic, with anemia and leukopenia being most significant. There were no treatment-related deaths. Further evaluation of this regimen in a less heavily pretreated population is warranted.
作者对VIG方案(长春碱、异环磷酰胺和硝酸镓)进行了一项II期试验,受试患者为铂类难治性晚期卵巢癌患者,且其疾病在以紫杉醇为基础的治疗后出现进展。这是一个接受过大量治疗的人群,5例患者接受过两到三个先前的化疗方案,6例患者接受过超过六个先前的化疗方案,每位患者平均接受21个治疗周期。14例患者接受长春碱治疗,第1天和第2天静脉注射0.08mg/kg;异环磷酰胺,第1天至第5天静脉注射900mg/m²,同时给予标准美司钠尿路保护;硝酸镓以225mg/m²每24小时持续静脉输注120小时。从第7天开始至第13天,皮下注射粒细胞集落刺激因子(G-CSF),剂量为5μg/kg/天。14例患者中有5例获得部分缓解,总缓解率为36%(95%置信区间,14%-68%)。中位缓解持续时间为14周。毒性主要为血液学毒性,贫血和白细胞减少最为显著。无治疗相关死亡。有必要在预处理程度较低的人群中对该方案进行进一步评估。