Servicio de Oncología Médica, Hospital Universitario Virgen de la Victoria, Málaga, España.
Oncology. 2010;79(1-2):98-104. doi: 10.1159/000320602. Epub 2010 Nov 15.
AIM: To retrospectively assess the efficacy and safety of bevacizumab plus low-dose metronomic oral cyclophosphamide in heavily pretreated patients with recurrent ovarian cancer. PATIENTS AND METHODS: Patients with recurrent ovarian cancer and prior treatment with platinum- and taxane-based chemotherapy were included. Treatment consisted of bevacizumab 10 mg/kg intravenously every 2 weeks plus oral cyclophosphamide 50 mg daily until disease progression or unacceptable toxicity. Response rates (RR) were determined according to RECIST criteria and by monitoring the CA 125 serum tumor marker according to Rustin's criteria. The endpoints were progression-free survival (PFS), RR, overall survival (OS), and safety. RESULTS: Thirty-eight patients were treated; 79% were platinum resistant and 21% were platinum sensitive. The median number of previous treatments was 4 (range 1-8). Seventy-nine percent of patients had received more than 2 previous lines of treatment. Eighty-one percent of patients had received gemcitabine, 76% liposomal doxorubicin, and 50% topotecan. A median of 8 (range 1-70) cycles of bevacizumab were administered. The overall RR was a complete response (CR) in 3 patients (8.1%), a partial response (PR) in 12 (32.4%), and stable disease (SD) ≥6 months in 3 (8.1%). The median PFS and OS were 4.5 and 10.7 months, respectively. Thirty-nine percent of patients were progression free for at least 6 months. In an exploratory analysis there was a significant relation of prior platinum response and performance status with the risk of progression. Grade 3-4 toxicities included anemia (1), hypertension (2), hematuria (1), arterial thrombosis in the leg (1), dyspnea (1), and intestinal fistulae (1). There were no cases of gastrointestinal perforation (GIP) or treatment-related deaths. CONCLUSION: The combination of bevacizumab and metronomic cyclophosphamide was active and well-tolerated in heavily pretreated patients with recurrent ovarian cancer.
目的:回顾性评估贝伐珠单抗联合低剂量节拍式环磷酰胺治疗复发性卵巢癌的疗效和安全性。
患者和方法:纳入铂类和紫杉烷类化疗药物治疗后复发的卵巢癌患者。治疗方案为贝伐珠单抗 10mg/kg 静脉注射,每 2 周 1 次,同时口服环磷酰胺 50mg,每日 1 次,直至疾病进展或出现不可接受的毒性。根据 RECIST 标准和 Rustin 标准监测血清 CA125 肿瘤标志物确定缓解率(RR)。主要终点为无进展生存期(PFS)、RR、总生存期(OS)和安全性。
结果:共 38 例患者接受治疗,79%的患者对铂类耐药,21%的患者对铂类敏感。中位治疗线数为 4 线(范围 1-8 线)。79%的患者接受了超过 2 种的先前治疗方案。81%的患者接受了吉西他滨,76%的患者接受了脂质体多柔比星,50%的患者接受了拓扑替康。中位贝伐珠单抗治疗周期数为 8 个周期(范围 1-70 个周期)。总体 RR 为完全缓解(CR)3 例(8.1%),部分缓解(PR)12 例(32.4%),稳定疾病(SD)≥6 个月 3 例(8.1%)。中位 PFS 和 OS 分别为 4.5 个月和 10.7 个月。39%的患者无进展生存期至少为 6 个月。探索性分析显示,先前的铂类治疗反应和体力状态与进展风险显著相关。3-4 级毒性包括贫血(1 例)、高血压(2 例)、血尿(1 例)、下肢动脉血栓形成(1 例)、呼吸困难(1 例)和肠瘘(1 例)。无胃肠道穿孔(GIP)或治疗相关死亡病例。
结论:贝伐珠单抗联合低剂量节拍式环磷酰胺治疗复发性卵巢癌在铂类药物预处理的患者中具有较好的疗效和耐受性。
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