Clinical Trials Study
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World J Gastroenterol. May 7, 2014; 20(17): 5098-5103
Published online May 7, 2014. doi: 10.3748/wjg.v20.i17.5098
Clinical trial of thalidomide combined with radiotherapy in patients with esophageal cancer
Jing-Ping Yu, Su-Ping Sun, Zhi-Qiang Sun, Xin-Chu Ni, Jian Wang, Yi Li, Li-Jun Hu, Dong-Qing Li
Jing-Ping Yu, Su-Ping Sun, Zhi-Qiang Sun, Xin-Chu Ni, Jian Wang, Yi Li, Li-Jun Hu, Dong-Qing Li, Department of Radiation Oncology, Changzhou Second People’s Hospital, Affiliated to Nanjing Medical University, Changzhou 213003, Jiangsu Province, China
Author contributions: Yu JP and Sun ZQ wrote the manuscript; Yu JP and Sun SP revised the manuscript; Yu JP, Sun SP, Sun ZQ, Ni XC, Wang J, Li Y, Hu LJ and Li DQ contributed to the provision of study materials and patients.
Supported by Leading Scientific Research Project of the Health Department of Jiangsu Province, China, No. Z201220; Major Project of the Health Department of Changzhou, China, No. ZD201105; and Changzhou Sci-Tech Support Project for Social Development, No. CE20125021
Correspondence to: Su-Ping Sun, PhD, Department of Radiation Oncology, Changzhou Second People’s Hospital, Affiliated to Nanjing Medical University, Labor Lane, Changzhou 213003, Jiangsu Province, China. ssp56@126.com
Telephone: + 86-519-88118723 Fax: + 86-519-88115560
Received: November 25, 2013
Revised: February 25, 2014
Accepted: March 4, 2014
Published online: May 7, 2014
Processing time: 163 Days and 0.6 Hours
Abstract

AIM: To investigate the short-term efficacy and tolerability of radiotherapy plus thalidomide in patients with esophageal cancer (EC).

METHODS: Serum samples from 86 EC patients were collected before, during, and after radiotherapy, and the vascular endothelial growth factor (VEGF) level was examined by ELISA. According to the change in serum VEGF level during radiotherapy, the patients were divided into two groups: in the drug group, VEGF level was increased or remained unchanged, and thalidomide was administered up to the end of radiotherapy; in the non-drug group, VEGF level was decreased and radiotherapy was given alone. Thirty healthy volunteers served as controls. The efficacy and safety of radiotherapy plus thalidomide therapy were investigated.

RESULTS: The 86 EC patients had a significantly higher level of VEGF compared with the 30 healthy controls before radiotherapy (P < 0.01), and the VEGF level was significantly correlated with primary tumor size, lymph node metastasis, histopathologic type, and clinical stage (P < 0.01). Of 83 evaluable cases, VEGF level was significantly decreased after radiotherapy in 32 patients in the drug group (P < 0.05), with an effective rate of 71.88%. The incidence of dizziness and/or burnout in the drug group and non-drug group was 62.50% and 15.69%, respectively (P = 0.000), and the incidence of somnolence was 12.50% and 0%, respectively (P = 0.019). No significant differences were observed.

CONCLUSION: Thalidomide can down-regulate serum VEGF level in EC patients, and combined with radiotherapy may improve treatment outcome. Thalidomide was well tolerated by EC patients.

Keywords: Thalidomide, Radiotherapy, Esophageal cancer, Vascular endothelial growth factor

Core tip: Vascular endothelial growth factor (VEGF)-based individualized radiotherapy for esophageal cancer (EC) was achieved in this clinical study. EC patients undergoing radiation treatment may receive different protocols: thalidomide combined with radiation or radiation alone, according to their VEGF level. This study was designed to set appropriate radiotherapy regimens for different patients, improve sensitivity, and decrease resistance in radiation oncology.