放疗联合雷替曲塞奥沙利铂同步治疗中晚期食管癌的Ⅱ期临床研究

夏铀铀; 王磊; 宋大安; 黎世秋; 蒋晓东

doi:10.3969/j.issn.1000-8179.20140440

放疗联合雷替曲塞奥沙利铂同步治疗中晚期食管癌的Ⅱ期临床研究

Phase Ⅱ clinical trial of raltitrexed plus oxaliplatin combined with concurrent radiotherapy for advanced esophageal carcinoma

摘要

摘要:
目的初步评价中晚期食管癌患者应用雷替曲塞/奥沙利铂同步放疗的疗效、安全性。
方法 54例采用食管癌非手术分期的Ⅱ~Ⅲ期食管癌患者，应用雷替曲塞/奥沙利铂方案联合放疗进行治疗。放疗剂量60 Gy/30次。雷替曲塞剂量为2.6 mg/m²，奥沙利铂剂量为100 mg/m²，均于放疗d1、d22应用。放疗期间行2周期化疗。
结果全组共9例（16.7%）获得完全缓解，部分缓解37例（68.5%），无缓解或病情进展8例（14.8%），有效率85.2%。1、2年局部控制率分别为75.4%和57.3%，1、2年生存率分别为70. 4%（95%CI：0.6~0.8）、46.6%（95%CI：0.3~0.6）。患者的急性放射性食管炎、白细胞下降、急性腹泻、神经毒性发生率分别为100%、72.2%、16.7%、44.4%；不良反应≥3级分别为7.4%、7.4%、1.9%、0。
结论雷替曲塞联合奥沙利铂同步放疗对提高中晚期食管癌临床缓解率、生存率有一定意义，且不良反应轻，值得进一步大样本Ⅲ期临床研究。

Abstract:
Objective To evaluate the efficacy and safety of raltitrexed plus oxaliplatin combined with concurrent radiotherapy for advanced esophageal carcinoma.
Methods A total of 54 patients with stage Ⅱ/Ⅲ advanced esophageal carcinoma according to the clinical staging of esophageal carcinoma nonsurgical methods were treated with raltitrexed plus oxaliplatin combined with concurrent radiotherapy. The patients were irradiated with a dose of 60 Gy in 30 fractions. Two cycles of concurrent chemotherapy were administered during radiotherapy, with 100 mg/m² oxaliplatin and 2.6 mg/m² raltitrexed on d1 and d22.
Results The complete response rate was 16.7% (9/54), and the partial response rate was 68.5% (37/54). The total response rate was 85.2%. The no response and progression rate was 14.8% (8/54). The one- and two-year local control rates and overall survival rates were 75.4%, 57.3% and 70.4% (95% CI, 0.6-0.8), 46.6% (95% CI, 0.3-0.6), respectively. The incidence rates of radiation-induced esophagitis, leucopenia, acute diarrhea, neuro-toxicity were 100%, 72.2%, 16.7%, and 44.4%, of which 7.4%, 7.4%, 1.9%, and 0% were ≥grade 3, respectively.
Conclusions Raltitrexed plus oxaliplatin combined with concurrent radiotherapy can enhance the response rate and prolong the survival of patients with advanced esophageal carcinoma. The regime has mild toxicity and is worthy of further study in PhaseⅢ.

HTML全文

参考文献(16)

施引文献

资源附件(0)