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

Abstract

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. Key words: Esophageal neoplasms; Radiotherapy; Drug therapy; Radiation tolerance; Raltitrexed