厄洛替尼联合放疗治疗老年食管癌的Ⅱ期临床观察

Phase Ⅱ study of radiotherapy plus erlotinib for elder patients with esophageal carcinoma

目的探讨厄洛替尼联合放疗治疗老年食管癌的疗效和安全性。方法2007年12月26日至2011年2月14日温州医学院附属第一医院符合条件的老年食管癌患者给予60Gy／30F放疗并同步厄洛替尼150mg／d。观察生存情况和毒性反应，用SPSS17．0统计软件包分析结果。结果33例患者入组。1、2年生存率分别为66．3％、49．7％，中位生存期（16．3±8．6）个月（95％C10．0～33．3），中位无疾病进展时间（16．7±7．1）个月（95％CI2．9—30．5）。1、2年局部控制率为73．3％、54．9％。治疗主要毒性反应为放射性食管炎，肺炎，皮疹，多为1～2级。结论老年食管癌患者厄洛替尼联合化疗方案治疗显示了满意的疗效，安全可行。此Ⅱ期临床研究结果尚需更大样本的临床研究证实。

Objective To evaluate the safety and efficacy of radiation plus erlotinib in patients with esophageal cancer older than 70 years. Methods Radiotherapy was prescribed at a daily fraction of 2. 0 Gy up to a total dose of 60 Gy over 6 weeks. Concurrent edotinib was administrated at a dose of 150 mg daily at days 1 - 42. Acute toxicities were assessed by the criteria of Radiation Therapy Oncology Group （RTOG） and National Cancer Institute （NCI）. The results were analyzed by the software SPSS 17.0. Results A total of 33 patients were enrolled. The median survival time was 16. 3 ± 8. 6 months（95% CI 0. 0 -33.3 ）and the 1-and 2-year overall survival rates were 66. 3% and 49.7% respectively. The media progression-free survival was 16.7 ±7.1 months（95% CI 2.9 - 30. 5 ） and the 1-and 2-year local control rates 73.3% and 54.9% respectively. Most toxicities were of grade 1-2 and manageable. Conclusion The combined regimen of radiation and erlotinib is effective and safe in elder patients aged 〉 70 years with esophageal cancer. However the results of our study should be confirmed in randomized controlled trials of a larger sample size.