临床神经外科杂志2019,Vol.16Issue(1):6-10,16,6.DOI:10.3969/j.issn.1672-7770.2019.01.002
顺铂联合替莫唑胺放化疗治疗MGMT启动子未甲基化胶质母细胞瘤的初步研究
Randomized controlled trial design and analysis of preliminary result on cisplatin combined with radiotherapy and concurrent chemotherapy of Temozolomide in MGMT unmethylated glioblastomas
摘要
Abstract
Objective To investigate the efficacy and safety of cisplatin combined with radiotherapy and concurrent chemotherapy of temozolomide in glioblastomas (GBM) of MGMT unmethylated and trial design. Methods The random clinical study with comparative method was used. The patients were divided into control group and test group. From Jun 2016 to Aug 2017, 50 patients were enrolled, 24 in control group and 26 in test group. The control group was treated with temozolomide and radiotherapy. The test group was treated with cisplatin combined with temozolomide and radiotherapy. Adverse reactions and survival time were documented in both groups. Results The most commonly adverse events include bone marrow inhibition, nausea and vomiting, loss of appetite, constipation, fatigue. Control group had 2 cases of bone marrow inhibition, and test group had 12 cases. The difference in the bone marrow inhibition of the two groups was prominent (P = 0. 002). 42%-50% of test group patients sufferd nausea and vomiting, loss of appetite, constipation and 25%-33% in control group, but both groups had no statistically significant difference. Control group had 5 cases of fatigue, and test group had 8 cases, the difference is not significiant. No patients had liver or kieney dysfunction, and no patients had hearing impairment. The difference in quality of life scores was not significant. Both groups were tolerated. No patients withdrew from the study. By the time to 29 th Feb 2018, patients had recurrence (15 cases in the control group and 14 cases in the test group). 13 patients died (7 cases in the control group and 6 cases in the test group). The differences in OS and PFS were not statistically significant (all P> 0. 05). Conclusion All patients have good tolerance. Cisplatin combined with temozolomide and radiotherapy may increase bone marrow inhibition, but it can be relieved after treatment and no patients withdrew from the study. The two groups are similar in efficacy. Further study should be conducted upon larger samples.关键词
胶质母细胞瘤/顺铂/放射治疗Key words
glioblastomas/cisplatin/radiotherapy分类
医药卫生引用本文复制引用
倪春霞,王宝红,吴学勇,张玺炜,汪洋,盛晓芳,高洪元,殷晓锋,陈淑,孟歌,胡莉..顺铂联合替莫唑胺放化疗治疗MGMT启动子未甲基化胶质母细胞瘤的初步研究[J].临床神经外科杂志,2019,16(1):6-10,16,6.基金项目
上海市科学技术委员会医学引导类西医科技支撑项目 (16411972300) (16411972300)