| 孙志强,于静萍,王坚,汪建林,倪新初,孟庆红,胡莉钧,李栋庆,李毅,孙苏平.沙利度胺联合放化疗治疗食管癌随机对照研究[J].中华放射医学与防护杂志,2016,36(11):815-821 |
| 沙利度胺联合放化疗治疗食管癌随机对照研究 |
| A randomized controlled study of thalidomide combined with radiochemotherapy in treating esophageal cancer |
| 投稿时间：2016-08-18 |
| DOI：10.3760/cma.j.issn.0254-5098.2016.11.004 |
| 中文关键词: 食管肿瘤 放射疗法 沙利度胺 血管内皮生长因子 预后 |
| 英文关键词:Esophageal neoplasms Radiotherapy Thalidomide Vascular endothelial growth factor Prognosis |
| 基金项目: |
| 作者 | 单位 | E-mail | | 孙志强 | 213003 常州, 江苏省常州市第二人民医院放疗科 | | | 于静萍 | 213003 常州, 江苏省常州市第二人民医院放疗科 | yujingping700420@sina.com | | 王坚 | 213003 常州, 江苏省常州市第二人民医院放疗科 | | | 汪建林 | 213003 常州, 江苏省常州市第二人民医院放疗科 | | | 倪新初 | 213003 常州, 江苏省常州市第二人民医院放疗科 | | | 孟庆红 | 213003 常州, 江苏省常州市第二人民医院放疗科 | | | 胡莉钧 | 213003 常州, 江苏省常州市第二人民医院放疗科 | | | 李栋庆 | 213003 常州, 江苏省常州市第二人民医院放疗科 | | | 李毅 | 213003 常州, 江苏省常州市第二人民医院放疗科 | | | 孙苏平 | 213003 常州, 江苏省常州市第二人民医院放疗科 | |
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| 中文摘要: |
| 目的 评价沙利度胺联合放化疗治疗食管癌的安全性及疗效。方法 对102例食管鳞癌患者进行放化疗。放疗前1周内、放疗第2~3周、放疗结束后1周测定患者血清血管内皮生长因子（VEGF）水平。放疗中较放疗前血清VEGF水平不降低的患者随机抛硬币法分为沙利度胺组和对照组；另将血清VEGF下降患者设为阴性对照（VEGF降低组）。沙利度胺组放化疗过程中给予沙利度胺治疗，对照组和VEGF降低组行常规放化疗。结果 95例患者完成治疗且随访资料齐全，其中沙利度胺组24例，对照组24例，VEGF降低组47例。沙利度胺不良反应主要表现为不同程度嗜睡。全组1、3年生存率分别为68.4%、22.3%，1、3年无进展生存率分别为56.8%、19.5%，1、3年局部控制率分别为83.6%、51.6%；中位生存期和中位无进展生存期分别为18.2和15.8个月。对照组、沙利度胺组、VEGF降低组患者生存曲线、无进展生存曲线比较，差异均无统计学意义（P>0.05）。局部晚期患者（Ⅱ、Ⅲ期）亚组分析显示，对照组、沙利度胺组、VEGF降低组患者3年生存率和3年无进展生存率分别为0、31.3%、20.0%和0、31.3%、16.7%，沙利度胺组均高于对照组，差异均有统计学意义（P均<0.05）。放疗后与放疗中血清VEGF水平比较，沙利度胺组和对照组降低、稳定、升高的病例数分别为13、11、0例和4、15、5例，差异有统计学意义（P<0.05）。沙利度胺组放疗后血清VEGF降低与稳定的患者1年生存率、1年无进展生存率分别为92.3%、84.6%和45.5%、27.3%，3年生存率、3年无进展生存率和3年局部控制率分别为55.6%、55.6%、100%和0.0%、0.0%、0.0%，VEGF降低的患者均高于VEGF稳定的患者，差异有统计学意义（P均<0.05）。多因素分析显示，与Ⅰ期患者相比，Ⅲ期患者死亡风险明显上升，差异有统计学意义（RR=4.868，P<0.05）；放疗后有病灶残留的患者死亡风险明显增加，差异有统计学意义（RR=1.731，P<0.05）。结论 沙利度胺可能改善放疗中血清VEGF水平不降低的局部晚期食管癌患者预后，其治疗不良反应可耐受。 |
| 英文摘要: |
| 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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