局部晚期胃癌术后卡培他滨同期调强放疗的I期临床研究  

Phase I trial of postoperative concurrent capecitabine and intensity-modulated radiotherapy for locally advanced gastric cancer

作　　者：王鑫[1] 金晶[1] 李晔雄[1] 王淑莲[1] 刘跃平[1] 王维虎[1] 房辉[1] 任骅[1] 宋永文[1] 刘新帆[1] 余子豪[1] 

机构地区：[1]北京协和医学院中国医学科学院肿瘤医院放疗科,100021

出　　处：《中华放射肿瘤学杂志》2013年第5期343-346,共4页Chinese Journal of Radiation Oncology

摘　　要：目的观察局部晚期胃癌术后卡培他滨同期调强放疗（IMRT）中，卡培他滨的最大耐受剂量（MTD）和剂量限制性毒性（DLT）。方法人组标准为接受根治术（R0切除）或非根治术（R1、R2切除），术后病理证实为TxN（＋）M0期的近端或远端胃癌患者。共18例患者人组，其中R0术12例、R1术2例、R2术4例。放疗采用IMRT技术，R0术后总剂量45Gy，1．8Gy／次，5次／周。R1或R2术后，对有肉眼或镜下肿瘤残存部位进行局部加量10．8Gy分6次。卡培他滨剂量水平分5级，分别为625mg／m^2（I级）、700mg／m^2（Ⅱ级）、800mg／m^2（Ⅲ级）、900mg／m^2（Ⅳ级）、1000mg／m^2（V级），口服2次／d。结果最常见1—3级的不良反应为白细胞减少（89％）、食欲下降（83％）和恶心（83％）。I级中1例出现3级食欲下降、恶心和4级呕吐。Ⅱ级中1例出现3级食欲下降和恶心。Ⅲ级时2例分别出现4级中性粒细胞减少和3级放射性食管炎。结论局部晚期胃癌术后卡培他滨同期IMRT的MTD为800mg／m2，2次／d，DLT为恶心、呕吐、食欲下降、中性粒细胞减少和放射性食管炎。Objective To determine the maximum-tolerated dose （MTD） and dose-limiting toxicities （DLTs） of capecitabine during postoperative concurrent capecitabine and intensity-modulated radiotherapy （IMRT） for locally advanced gastric cancer. Methods The patients, who had T,N （ ＋ ） M0 gastroesophageal or gastric adenocarcinoma after radical surgery with negative margins （ R0 ） or non-radical surgery with microscopically positive margins （ R1 ） or macroscopically positive margins （ R2 ） , were included in the study. A total of 18 patients （R0 12;R1 2;R2 4） were recruited. IMRT （45 Gy at 1.8 Gy/fraction） was delivered to the tumor bed （T4b only） , anastomosis site, duodenal stump, and regional lymph nodes days per week for 5 weeks. Patients with R1 or R2 resection received additional radiation （ 10. 8 Gy/6 fractions） to the microscopically or macroscopically positive margins. During IMRT, capecitabine was orally administered twice daily at a dose of 625 mg/m2 （ level I, n = 6） , 700 mg/m2 （ level II , n = 6 ） , 800 mg/m2 （ level m , n = 6） , 900 mg/m2 （ level IV, n = 0） , and 1000 mg/m2 （ level V, n = 0）. DLT was defined as grade 3 or 4 hematologic and non-hematologic toxicities. Results Grade 1-3 leukopenia （89%） , anorexia （83%） , and nausea （83%） were the most common toxicities. Grade 3 anorexia/nausea and grade 4 vomiting occurred in one patient at dose level I. Grade 3 anorexia and nausea occurred in one patient at dose level ]I. One patient at dose level ]~ developed grade 4 neutropenia, while another patient at dose level III developed grade 3 radiation esophagitis. Conclusions During postoperative concurrent capecitabine and IMRT for locally advanced gastric cancer, the MTD of capeeitabine is 800 mg/m2 twice daily, and the DLTs are nausea, vomiting, anorexia, neutropenia, and radiation esophagitis.

关 键 词：卡培他滨 最大耐受剂量 剂量限制性毒性 胃肿瘤 M期化放疗法 放射疗法 调强 

分 类 号：R735.2[医药卫生—肿瘤]