Efficacy of S-1 and concurrent intensity-modulated radiotherapy for locally advanced gastric cancer:an interim study of phase Ⅱ clinical trial / 中华放射肿瘤学杂志

ABSTRACT

Objective To observe the incidence of adverse reactions and short-term efficacy of S-1 and concurrent intensity-modulated radiotherapy ( IMRT) for locally advanced gastric cancer in a phase Ⅱclinical trial based on the phase I clinical trial.Methods Patients pathologically diagnosed with stage TN (+) gastric adenocarcinoma with local or distal metastasis after R0 resection were enrolled as subjects.IMRT was delivered 5 times per week with a total dose of 45 Gy in 25 fractions.S-1 was orally administered on the day of radiotherapy at a dose of 80 mg/m2 .Results A total of 40 patients, consisting of 6 patients from the phase I trial and 34 patients from the phaseⅡtrial, were enrolled in this study.In those patients, the age ranged between 27 and 73 years ( median age 50 years) and the male-to-female ratio was 3:1.Thirty-nine ( 98%) out of the forty patients completed radiotherapy and thirty-five ( 88%) completed concurrent chemotherapy.The most common grade 3-4 adverse reactions were nausea/anorexia ( 13%) , leukopenia ( 10%) , vomiting ( 8%) , radiation esophagitis ( 5%) , and neutropenia ( 5%) .There was no perioperative death.The 2-year overall survival and disease-free survival rates were 74% and 77%, respectively. Conclusions Postoperative S-1 and concurrent IMRT achieve satisfactory outcomes and tolerable toxicity in patients with locally advanced gastric cancer.