摘要
目的评价尼妥珠单抗联合化疗治疗恶性胶质瘤的疗效及不良反应。方法尼妥珠单抗200mg/次,每周1次,连续8周后改为每2周1次;根据患者O^6-甲基鸟嘌呤-DNA甲基转移酶(MGMT)蛋白表达状况和既往化疗效果,采用个体化的化疗方案。结果14例恶性胶质瘤患者共接受尼妥珠单抗沪疗122次,中位治疗7.5次(2~20次)。联合的化疗方案中,替莫唑胺21d方案10例,替莫唑胺5d方案2例,替尼泊甙联合顺铂方案1例,替尼泊甙联合尼莫司汀方案1例。PR3例(21.4%),SD6例(42.9%),客观有效率为21.4%,疾病控制率(PR+SD)为64.3%。中位无进展生存期(PFS)为4个月(95%CI0.7~7.3),6个月的疾病无进展生存率为30.6%。主要的不良反应为Ⅰ-Ⅱ度的中性粒细胞下降(2例)、血小板下降(2例)、淋巴细胞下降(1例)、恶心呕吐(3例)和无症状的转氨升高(1例)。1例替尼泊甙联合顺铂方案化疗的患者发生Ⅳ度中性粒细胞下降和血小板下降。1例患者出现尼妥珠单抗治疗相关痤疮样皮疹。结论尼妥珠单抗联合化疗治疗恶性胶质瘤有一定疗效,患者耐受性好,值得进一步扩大病例数开展临床研究。
Objective Nimotuzumab is a humanized monoclonal antibody targeted against epidermal growth factor receptor (EGFR). Recent clinical studies show that patients with malignant gliomas could benefit from nimotuzumab treatment. The aim of the present study was to evaluate the efficacy and side effects of nimotuzumab in combination with chemotherapy for patients with malignant gliomas. Methods The patients received 200 mg of nimotuzumab infusion intravenously over 60 minutes once weekly for the first eight weeks and then once every two weeks until unacceptable toxicity or tumor progression occurred. Individualized chemotherapy was administered based on O^6-methylguanine-DNA methyhransferase (MGMT) expression and previous chemotherapy responses in combined with nimotuzumab. Results Fourteen patients received a total of 122 times of nimotuzumab ranging from 2 to 20 ( median 7. 5 times ). Combined chemotherapy regimens included : continuous 21 -day temozolomide ( 10 cases) , standard 5-day temozolomide (2 cases), teniposide plus cisplatin ( 1 case), and teniposide plus nimustine ( 1 case). Partial response (PR) and stable disease (SD) were found in 3 patients (21.4%)and 6 patients (42. 9% ), respectively. Disease control rate (PR + SD) was 64.3%. The median progression-free survival (PFS) was 4 months (95% CI:0. 7-7.3 ) and PFS at 6 months was 30.6%. The most common toxicities include grade Ⅰ -Ⅱ neutropenia (2 cases), thrombocytopenia ( 2 cases), lymphopenia ( 1 case), nausea and vomitting ( 3 case) and asymptomatic transaminase increase (1 case). One patient developed grade Ⅳ neutropenia and thrombocytopenia. One patient developed nimotuzumab-related acneiform rash. Conclusions Nimotuzumab in combination with chemotherapy has moderate activity in patients with malignant gliomas and the toxicities are well tolerable, therefore, worth further investigation.
出处
《中华肿瘤杂志》
CAS
CSCD
北大核心
2011年第3期232-235,共4页
Chinese Journal of Oncology