| Sun Zhiqiang,Yu Jingping,Wang Jian,Wang Jianlin,Ni Xinchu,Meng Qinghong,Hu Lijun,Li Dongqing,Li Yi,Sun Suping.A randomized controlled study of thalidomide combined with radiochemotherapy in treating esophageal cancer[J].Chinese Journal of Radiological Medicine and Protection,2016,36(11):815-821 |
| A randomized controlled study of thalidomide combined with radiochemotherapy in treating esophageal cancer |
| Received:August 18, 2016 |
| DOI：10.3760/cma.j.issn.0254-5098.2016.11.004 |
| KeyWords:Esophageal neoplasms Radiotherapy Thalidomide Vascular endothelial growth factor Prognosis |
| FundProject: |
| Author Name | Affiliation | E-mail | | Sun Zhiqiang | Department of Radiotherapy, the Changzhou Second People's Hospital, Affiliated Hospital of Nanjing Medical University, Changzhou 213003, China | | | Yu Jingping | Department of Radiotherapy, the Changzhou Second People's Hospital, Affiliated Hospital of Nanjing Medical University, Changzhou 213003, China | yujingping700420@sina.com | | Wang Jian | Department of Radiotherapy, the Changzhou Second People's Hospital, Affiliated Hospital of Nanjing Medical University, Changzhou 213003, China | | | Wang Jianlin | Department of Radiotherapy, the Changzhou Second People's Hospital, Affiliated Hospital of Nanjing Medical University, Changzhou 213003, China | | | Ni Xinchu | Department of Radiotherapy, the Changzhou Second People's Hospital, Affiliated Hospital of Nanjing Medical University, Changzhou 213003, China | | | Meng Qinghong | Department of Radiotherapy, the Changzhou Second People's Hospital, Affiliated Hospital of Nanjing Medical University, Changzhou 213003, China | | | Hu Lijun | Department of Radiotherapy, the Changzhou Second People's Hospital, Affiliated Hospital of Nanjing Medical University, Changzhou 213003, China | | | Li Dongqing | Department of Radiotherapy, the Changzhou Second People's Hospital, Affiliated Hospital of Nanjing Medical University, Changzhou 213003, China | | | Li Yi | Department of Radiotherapy, the Changzhou Second People's Hospital, Affiliated Hospital of Nanjing Medical University, Changzhou 213003, China | | | Sun Suping | Department of Radiotherapy, the Changzhou Second People's Hospital, Affiliated Hospital of Nanjing Medical University, Changzhou 213003, China | |
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| Abstract:: |
| Objective To evaluate the safety and efficacy of using thalidomide combined with radiochemotherapy for the treatment of esophageal cancer. Methods A total of 102 patients with esophageal squamous cell carcinoma were treated with radiochemotherapy. The level of serum vascular endothelial growth factor (VEGF) was evaluated at 1 week before radiotherapy, 2-3weeks since the beginning of radiotherapy, and 1 week after radiotherapy completed. Patients who showed no change in the level of serum VEGF during radiotherapy, when compared with pre-radiotherapy, were randomly divided into two groups:control group and thalidomide group. Meanwhile, patients with reduced serum VEGF were assigned to the negative control group (reduced VEGF group). Thalidomide group patients were treated with thalidomide during radiochemotherapy, while those from the control group and reduced VEGF group were underwent regular radiochemotherapy. Results A total of 95 patients finished the treatment regimen with complete follow-up data (24 in thalidomide group, 24 in control group and 47 in reduced VEGF group). The main adverse reaction of thalidomide is varing degrees of lethargy. The 1-year and 3-year survival rates of all groups were 68.4% and 51.6%, progression-free survival time were 56.8% and 19.5%, local control rates were 83.6% and 21.3%, and median survival and progression-free survival time were 18.2 and 15.8 months, respectively. No significant differences were found in the survival and progression-free survival curramong control, thalidomide and reduced VEGF groups (P>0.05). Analysis of the locally advanced (stage II and III) patient subgroup showed that the 3-year survival rates of control, thalidomide and reduced VEGF groups were 0.0%, 31.3%, 20.0%, respectively; the 3-year progression-free survival rates were 0.0%, 31.3%, 16.7% respectively. Both two survival rates were significantly higher in the thalidomide group compared to the control group (P<0.05). The level of serum VEGF in all patients of control group and thalidomide group was measured after and during radiotherapy, and significant diffdfences were found between the two groups(P<0.05), which serum VEGF level reduced stable and rising cases were 13, 11, 0 and 4, 15, 5 in control groups and thalidomide group respectiveoy. The 1-year survival rate, 1-year progression-free survival rate of thalidomide group patients who seserum VEGF level was reduced and stable after radiotherapy were 92.3%, 84.6% and 45.5%, 27.3% respectively. The 3-year survival rate, 3-year progression-free survival rate and 3-year local control rate of thalidomide group patients who seserum VEGF showed reduced and unchanged after radiotherapy were 55.6%, 55.6%, 100% and 0, 0, 0 respectively. The survival and local control rates of patients with reduced serum VEGF were significantly higher than those with stable serum VEGF (P<0.05). Multivariate analysis showed that the death risk of stage III patients raise obviously compared to stage Ⅰ patients(RR=4.868, P<0.05). Residual disease after radiotherapy is another death risk in esophageal cancer patients(RR=1.731, P<0.05). Conclusions Thalidomide may improve the prognosis of patients with locally advanced esophageal cancer who seserum VEGF level showed no change during radiotherapy, and its adverse reactions can be tolerated. |
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