局部晚期胃癌术后S－1同期IMRT的Ⅱ期临床研究中期分析

Efficacy of S-1 and concurrent intensity-modulated radiotherapy for locally advanced gastric cancer：an interim study of phase Ⅱ clinical trial

目的：本研究为“局部晚期胃癌术后S－1同期调强放疗Ⅰ期临床研究”基础上的Ⅱ期研究，拟继续观察不良反应发生率和近期疗效。方法入组标准为接受R0切除，术后病理证实为任何TN （＋）期的近端或远端胃腺癌患者。放疗采用IMRT技术，总剂量45 Gy，1．8 Gy／次，5次／周。 S－1剂量每天80 mg／m2，于放疗日分2次口服。结果包括Ⅰ期研究最后1个剂量水平（80 mg／m2）中的6例及Ⅱ期入组的34例，共40例患者纳入分析。年龄27～73岁（中位数50岁），男女比例3：1。完成放疗39例（98％），完成同期化疗35例（88％）。最常见的3、4级不良反应为恶心或食欲下降（13％）、白细胞减少（10％）、呕吐（8％）、放射性食管炎（5％）和中性粒细胞减少（5％）。围术期无死亡病例。全组2年OS、DFS率为74％、77％。结论局部晚期胃癌术后S－1同期IMRT近期疗效较好，不良反应可耐受。

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.