雷替曲塞联合放疗治疗老年食管癌的Ⅱ期前瞻性临床研究

A phase Ⅱ prospective study on raltitrexed combined with concurrent radiotherapy for elderly esophageal carcinoma

目的 探讨雷替曲塞联合放疗治疗老年食管癌的临床疗效及不良反应.方法 采用信封法随机将60例老年食管癌患者分成雷替曲塞同步放化疗组（试验组30例）与单纯放疗组（对照组30例）,采用常规分割方式,放疗剂量56~60 Gy/28~30 F,试验组放疗第1、22天给予雷替曲塞2.6 mg/m2单药增敏化疗,放疗期间连用2周期,观察两组患者的近期疗效、生存时间及不良反应发生情况.结果 试验组总有效率为93.3%,而对照组为73.3%,差异有统计学意义（χ2=4.320,P=0.038）.试验组及对照组中位生存时间分别为24.0个月、12.0个月,经Log-rank检验差异有统计学意义（χ2=6.048,P=0.014）.试验组和对照组患者常见的重度不良反应（3~4级）如放射性食管炎（10.0%∶3.3%;χ2=0.268,P=0.605）、白细胞减少（13.3%∶10.0%;χ2=0.000,P=1.000）、血小板减少（3.3%∶0;P=1.000）、恶心呕吐（6.7%∶0;χ2=0.517,P=0.472）发生率的差异均无统计学意义.结论 雷替曲塞联合放疗治疗老年食管癌可显著提高其近期疗效,延长生存期,且不良反应轻微,值得进一步临床研究.

Objective To evaluate the clinical effects and adverse reaction of raltitrexed combined with radiation for esophageal carcinoma in elderly patients.Methods Sixty patients were randomly divided into two groups by the envelope method, 30 patients in experimental group received raltitrexed combined with radiotherapy and 30 patients in control group received radiotherapy only.Patients in both groups received conventional radiotherapy with a total dose of 56-60 Gy/28-30 F.In experimental group, raltitrexed 2.6 mg/m2 was administered concurrently with the radiotherapy on d1 and d22.Two cycles of concurrent chemotherapy were administered during radiotherapy.The short-term effects, survival times and adverse reactions of the two groups were compared.Results The total effective rates of experimental group and control group were 93.3% and 73.3%, respectively, and there was statistically significant difference between the two groups （χ2=4.320, P=0.038）.The median survival times of experimental group and control group was 24.0 months and 12.0 months, respectively, and there was statistically significant difference by Log-rank test （χ2=6.048, P=0.014）.The major adverse reactions of grade 3-4 in experimental group and control group were radiation-induced esophagitis （10.0% vs.3.3%;χ2=0.268, P=0.605）, leukopenia （13.3% vs.10.0%;χ2=0.000, P=1.000）, thrombocytopenia （3.3% vs.0;P=1.000）, nausea and vomiting （6.7% vs.0;χ2=0.517, P=0.472）, and the differences were not statistically significant.Conclusion Raltitrexed combined with radiotherapy can enhance the short-term effect and prolong the survival time for the elderly esophageal carcinoma patients, and the adverse reactions are mild.It is worthy of further clinical study.