A pilot study of bevacizumab and interferon-α2b in ocular melanoma.
A pilot study of bevacizumab and interferon-α2b in ocular melanoma.
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DOI：
10.1097/coc.0b013e3181d2ed67
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发表时间：
2011-02
期刊：
影响因子：
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通讯作者：
Carson WE 3rd
中科院分区：
文献类型：
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作者：
Guenterberg KD;Grignol VP;Relekar KV;Varker KA;Chen HX;Kendra KL;Olencki TE;Carson WE 3rd
我们假设贝伐单抗（一种中和血管内皮生长因子的单克隆抗体）联合大剂量干扰素-α2b（一种碱性成纤维细胞生长因子抑制剂）对转移性眼黑色素瘤患者具有临床活性。转移性眼黑色素瘤患者接受贝伐单抗（15 mg/kg，每2周静脉注射）加IFN-α2b （5 MU/m2皮下注射，每周3次，持续2周，随后皮下注射10 MU/m2）。表现出临床反应或疾病稳定的患者接受治疗直至疾病进展。在这项初步研究中，5例患者接受治疗（3男2女），平均年龄63.8岁（范围53-71岁）。总体而言，该方案耐受性良好。记录了以下不良事件：3级呼吸困难（2例），3级和4级疲劳（2例），3级肌肉无力（1例），3级厌食（1例），1级和2级蛋白尿（2例），3级腹泻（1例）。所有不良事件均在治疗期或减量后消失。根据实体瘤标准中的反应评价标准，1例患者的肿瘤负担减轻了23%，2例患者的疾病稳定持续时间分别为28周和36周。2例患者在治疗6周和7周后没有反应并进展。贝伐单抗和IFN-α2b在该患者群体中耐受性良好，并观察到临床活性。在这种情况下，高剂量IFN-α2b联合贝伐单抗的进一步研究是必要的。
We hypothesized that administration of bevacizumab, a monoclonal antibody that neutralizes vascular endothelial growth factor, in combination with high-dose interferon-alpha2b (IFN-α2b), an inhibitor of basic fibroblast growth factor, would have clinical activity in patients with metastatic ocular melanoma. Patients with metastatic ocular melanoma received bevacizumab (15 mg/kg intravenously every 2 weeks) plus IFN-α2b (5 MU/m2 subcutaneously 3 times weekly for 2 weeks followed by a dose of 10 MU/m2 subcutaneously thereafter). Patients exhibiting a clinical response or stabilization of disease were treated until disease progression. In this pilot study, 5 patients were treated (3 men, 2 women) with a mean age of 63.8 years (range, 53–71 years). Overall, the regimen was well-tolerated. The following adverse events were noted: grade 3 dyspnea (2 patients), grade 3 and 4 fatigue (2), grade 3 muscle weakness (1), grade 3 anorexia (1), grade 1 and 2 proteinuria (2), and grade 3 diarrhea (1). All adverse events resolved with a treatment holiday or dose reduction. One patient had reduction in tumor burden of 23% by Response Evaluation Criteria in Solid Tumors criteria and 2 patients had stabilization of disease lasting 28 and 36 weeks, respectively. Two patients failed to respond and progressed after 6 and 7 weeks of therapy. Bevacizumab and IFN-α2b were well tolerated in this patient population, and clinical activity was observed. Further study of high-dose IFN-α2b in combination with bevacizumab in this setting is warranted.