Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
Chin Med J (Engl). 2011 Dec;124(24):4299-303.
Antiangiogenesis is a promising field of cancer therapy. Endostar, a novel recombinant human endostatin, is one of the few approved drugs acting as angiogenesis inhibitors of cancer in China. However, there are few clinical studies about Endostar in gastrointestinal cancer. This pilot study aimed to evaluate the efficacy and safety of the combination of Endostar and chemotherapy in patients with metastatic colorectal and gastric cancers.
From March 2007 to October 2009, 23 patients were enrolled. Patients received Endostar intravenously at a dose of 15 mg daily from day 1 to 14 and day 1 to 7 when combined with 3- and 2-week chemotherapy regimens, respectively, which were determined according to patients' previous chemotherapy history. Treatment was repeated until disease progression, unacceptable toxicity or patients' refusal.
Seven, six and ten patients received Endostar as first-, second- and third-line therapy, respectively. A total of 75 cycles were administered. Twenty-one patients were assessable for responses. The overall response rate and disease control rate were 19.0% and 47.6%, respectively. All the four partial responses were among patients receiving Endostar as first-line therapy, whose response rate was 57.1%. The median time to progression and overall survival were 2.6 months (95%CI, 2.0 - 3.2 months) and 10.3 months (95%CI, 3.9 - 16.7 months), respectively. Toxicity was tolerable, with grade 3-4 toxicities observed for leucopenia (30.4%), neutropenia (34.8%), thrombocytopenia (17.4%) and anemia (13.0%). Three patients (13.0%) encountered transient sinus bradycardia with spontaneous remission.
Endostar combined with chemotherapy is well-tolerated in patients with metastatic colorectal and gastric cancers, and it is relatively effective as a first-line therapy.
抗血管生成是癌症治疗的一个很有前途的领域。恩度，一种新型的重组人血管内皮抑制素，是中国批准的少数几种作为癌症血管生成抑制剂的药物之一。然而，关于恩度在胃肠癌中的临床研究较少。本初步研究旨在评估恩度联合化疗治疗转移性结直肠癌和胃癌患者的疗效和安全性。
从 2007 年 3 月至 2009 年 10 月，共纳入 23 例患者。根据患者以往的化疗史，患者分别接受恩度静脉滴注，剂量为 15mg/天，第 1 天至第 14 天和第 1 天至第 7 天，与 3 周和 2 周化疗方案联合使用。治疗重复进行，直至疾病进展、无法耐受的毒性或患者拒绝。
7、6 和 10 例患者分别接受恩度一线、二线和三线治疗。共进行了 75 个周期的治疗。21 例患者可评估疗效。总缓解率和疾病控制率分别为 19.0%和 47.6%。所有 4 例部分缓解均发生在接受恩度一线治疗的患者中，其缓解率为 57.1%。中位无进展生存期和总生存期分别为 2.6 个月（95%CI，2.0-3.2 个月）和 10.3 个月（95%CI，3.9-16.7 个月）。毒性可耐受，3-4 级毒性主要为白细胞减少（30.4%）、中性粒细胞减少（34.8%）、血小板减少（17.4%）和贫血（13.0%）。3 例患者（13.0%）出现短暂性窦性心动过缓，自发缓解。
恩度联合化疗治疗转移性结直肠癌和胃癌患者耐受性良好，作为一线治疗相对有效。
