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

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.