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首页> 外文期刊>Cancer: A Journal of the American Cancer Society >Phase 1-2 trial of PTK787/ZK222584 combined with intravenous doxorubicin for treatment of patients with advanced hepatocellular carcinoma: implication for antiangiogenic approach to hepatocellular carcinoma.
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Phase 1-2 trial of PTK787/ZK222584 combined with intravenous doxorubicin for treatment of patients with advanced hepatocellular carcinoma: implication for antiangiogenic approach to hepatocellular carcinoma.

机译：PTK787 / ZK222584联合静脉注射阿霉素治疗晚期肝细胞癌的1-2期试验：对肝细胞癌的抗血管生成方法具有重要意义。

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BACKGROUND: This phase 1-2 trial assessed the efficacy and tolerability of an oral angiogenesis inhibitor-PTK787/ZK222584 (PTK)-in combination with intravenous doxorubicin for the treatment of advanced hepatocellular carcinoma (HCC) patients. METHODS: In phase 1, advanced HCC patients received PTK at escalating doses together with doxorubicin 60 mg/m2 given as an intravenous bolus every 3 weeks to establish the maximum tolerated dose (MTD). Subsequently, in phase 2, all patients received the same regimen with oral PTK at the MTD dose every 3 weeks for a maximum of 6 cycles. RESULTS: Nine patients were recruited in phase 1, with the MTD established as 750 mg daily. Overall, 27 patients received the regimen with PTK at 750 mg daily. The median age was 52 years (range, 23-73 years), and 63 percent of patients were chronic hepatitis B carriers. Notably, the majority of patients had Child-Pugh B cirrhosis. The overall response rate was 26.0%, with all the responding patients having partial response. Another 20% of patients achieved stable disease for at least 12 weeks. The median progression-free survival was 5.4 months (range, 0.27-23.6 months), and overall survival was 7.3 months (range, 0.8-23.6 months). The commonest grade 3 or 4 nonhematological toxicities were mucositis (11%) and alopecia (7%), respectively. Grade 3 or 4 neutropenia was observed in 7 (26%) patients; 2 had neutropenic sepsis. CONCLUSIONS: The combination of PTK with intravenous doxorubicin shows encouraging activity in treating advanced HCC patients.
机译：背景：这项1-2期临床试验评估了口服血管生成抑制剂-PTK787 / ZK222584（PTK）-与静脉注射阿霉素治疗晚期肝细胞癌（HCC）的疗效和耐受性。方法：在第1阶段，晚期HCC患者接受递增剂量的PTK并每3周静脉推注阿霉素60 mg / m2，以确定最大耐受剂量（MTD）。随后，在第2期中，所有患者每3周接受相同的方案，每3周以MTD剂量口服PTK，最多6个周期。结果：第一阶段招募了9名患者，MTD确定为每天750 mg。总体上，有27名患者接受了每天750 mg PTK的治疗方案。中位年龄为52岁（范围为23-73岁），并且63％的患者为慢性乙型肝炎携带者。值得注意的是，大多数患者患有Child-Pugh B肝硬化。总体缓解率为26.0％，所有缓解患者均出现部分缓解。另有20％的患者至少在12周内达到了稳定的疾病。中位无进展生存期为5.4个月（范围0.27-23.6个月），总生存期为7.3个月（范围0.8-23.6个月）。最常见的3或4级非血液学毒性分别是粘膜炎（11％）和脱发（7％）。在7名（26％）患者中观察到3或4级中性粒细胞减少症; 2例发生中性粒细胞减少症。结论：PTK与静脉注射阿霉素的组合显示出在治疗晚期HCC患者中令人鼓舞的活性。

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