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Chinese Journal of Radiation Oncology  2013, Vol. 22 Issue (5): 343-346    DOI: 10.3760/cma.j.issn.1004-4221.2013.05.001
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Phase I trial of postoperative concurrent capecitabine and intensity-modulated radiotherapy for locally advanced gastric cancer
WANG Xin, JIN Jing, LI Ye-xiong, WANG Shu-lian, LIU Yue-ping, WANG Wei-hu, FANG Hui, REN Hua, SONG Yong-wen, LIU Xin-Fan, YU Zi-hao.
Department of Radiation Oncology, Cancer Hospital (Institute), Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100021, China
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Abstract  

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 TxN (+) 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 Ⅲ, 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 Ⅱ. One patient at dose level Ⅲ 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 capecitabine is 800 mg/m2 twice daily, and the DLTs are nausea, vomiting, anorexia, neutropenia, and radiation esophagitis.

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Articles by authors
WANG Xin
JIN Jing
LI Ye-xiong
WANG Shu-lian
LIU Yue-ping
WANG Wei-hu
FANG Hui
REN Hua
SONG Yong-wen
LIU Xin-Fan
YU Zi-hao.
Key wordsCapecitabine      Maximum tolerated dose      Dose-limiting toxicity      Gastric neoplasms/concurrent chemoradiotherapy      Radiotherapy, intensity-modulated     
Received: 24 April 2013     
Corresponding Authors: JIN Jing,Email:jingjin1025@163.com;LI Ye-xiong,Email:yexiong@yahoo.com   
Cite this article:   
WANG Xin,JIN Jing,LI Ye-xiong et al. Phase I trial of postoperative concurrent capecitabine and intensity-modulated radiotherapy for locally advanced gastric cancer[J]. Chinese Journal of Radiation Oncology, 2013, 22(5): 343-346.
WANG Xin,JIN Jing,LI Ye-xiong et al. Phase I trial of postoperative concurrent capecitabine and intensity-modulated radiotherapy for locally advanced gastric cancer[J]. Chinese Journal of Radiation Oncology, 2013, 22(5): 343-346.
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http://journal12.magtechjournal.com/Jweb_fszlx/EN/10.3760/cma.j.issn.1004-4221.2013.05.001     OR     http://journal12.magtechjournal.com/Jweb_fszlx/EN/Y2013/V22/I5/343
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