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

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.

Figure 1.

The survival curves of the treatment and control groups.

Figure 2.

MRI from a case with grade III glioma in the control group. The lesion was located in the right temporal lobe and hippocampus and intruded suprasellar cistern with slight enhancement. The tumor size was 5×4 cm and the surrounding peritumor edema was mild. (A) Contrasted T1 image prior to surgery. (B) Contrasted T1 image following surgery shows residual lesion. (C) Contrasted T1 image following postoperative radiotherapy shows CR. (D) Contrasted T1 image three months after radiotherapy shows no recurrent lesion.

Figure 3.

MRI from a case with grade III–IV glioma in the treatment group. The lesion was located in the right frontal lobe with mild enhancement. Tumor size was 4x4 cm and the surrounding peritumor edema was not obvious. (A) Contrasted T1 image prior to surgery. (B) Contrasted T1 image following surgery shows total resection. (C) Contrasted T1 image following postoperative radiotherapy shows SD. (D) Contrasted T1 image one year following postoperative radiotherapy shows pseudoprogress.

Figure 4.

MRI from a case with grade III–IV glioma in the control group. The lesion was located in the left parietal lobe with mid-range enhancement. Tumor size was 6x5 cm and surrounding peri-tumor edema was marked. (A) Contrasted T1 image prior to surgery. (B) Contrasted T1 image following surgery shows total resection. (C) Contrasted T1 image following radiotherapy shows SD. (D) Contrasted T1 image 10 months after postoperative radiotherapy shows recurrent lesion.

Figure 5.

MRI from a case with grade IV glioma in the treatment group. The lesion was located in the body of the lateral cerebral ventricle. Tumor size was 5x4cm with uneven enhancement. Surrounding peri-tumor edema was not marked. (A) Contrasted T1 image prior to surgery (B) Contrasted T1 image following surgery shows total resection. (C) Contrasted T1 image following postoperative radiotherapy shows SD. (D) Contrasted T1 image seven months after postoperative radiotherapy shows no recurrent lesion.