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尼妥珠单抗可延长恶性胶质瘤患者的生存期:一项关于尼妥珠单抗联合或不联合放疗化疗的I/II期临床研究。

Nimotuzumab prolongs survival in patients with malignant gliomas: A phase I/II clinical study of concomitant radiochemotherapy with or without nimotuzumab.

作者信息

Hong Jidong, Peng Yuping, Liao Yuping, Jiang Wuzhong, Wei Rui, Huo Lei, Han Zaide, Duan Chaojun, Zhong Meizuo

机构信息

Departments of Oncology.

出版信息

Exp Ther Med. 2012 Jul;4(1):151-157. doi: 10.3892/etm.2012.555. Epub 2012 Apr 19.

DOI:10.3892/etm.2012.555
PMID:23060940
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3460247/
Abstract

The present study aimed to determine whether nimotuzumab enhances the effect of radiochemotherapy in malignant gliomas. Patients (n=41) with malignant gliomas were divided into 20 cases (treatment group) in which nimotuzumab plus radiochemotherapy were offered and 21 cases (control group) in which placebo and radiochemotherapy were administered to the patients. The response to treatment was evaluated according to the Response Evaluation Criteria in Solid Tumors, the Kaplan-Meier method was used to calculate the mean and median survival times and 1-year survival rate, and the log-rank test and the Chi-square test were used to analyze the difference in the survival and response rate between the treatment and control groups. The mean survival times of the treatment and control groups were 14.3 and 10.4 months and the median survival times of the treatment and control groups were 16.5 and 10.5 months, respectively. The 1-year survival rates of the treatment and control groups were 81.3 and 69.1%, respectively, with no significant difference (P>0.05). The objective response rates of the treatment and control groups were 70.0 and 52.4%, respectively, with no significant difference (P>0.05). In conclusion, there was a trend towards improved treatment efficacy of radiochemotherapy combined with nimotuzumab against malignant gliomas. This study demonstrated that the use of nimotuzumab combined with radiotherapy and concomitant temozolomide chemotherapy is effective for malignant gliomas.

摘要

本研究旨在确定尼妥珠单抗是否能增强放化疗对恶性胶质瘤的疗效。41例恶性胶质瘤患者被分为两组,20例(治疗组)接受尼妥珠单抗联合放化疗,21例(对照组)接受安慰剂联合放化疗。根据实体瘤疗效评价标准评估治疗反应,采用Kaplan-Meier法计算平均生存时间、中位生存时间和1年生存率,并采用对数秩检验和卡方检验分析治疗组与对照组在生存率和反应率方面的差异。治疗组和对照组的平均生存时间分别为14.3个月和10.4个月,中位生存时间分别为16.5个月和10.5个月。治疗组和对照组的1年生存率分别为81.3%和69.1%,差异无统计学意义(P>0.05)。治疗组和对照组的客观反应率分别为70.0%和52.4%,差异无统计学意义(P>0.05)。综上所述,尼妥珠单抗联合放化疗治疗恶性胶质瘤有提高疗效的趋势。本研究表明,尼妥珠单抗联合放疗及同步替莫唑胺化疗对恶性胶质瘤有效。

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