Preoperative Radiotherapy Combined with S-1 for Advanced Lower Rectal Cancer: Phase I Trial

被引:11
作者
Morimoto, Shinya [1 ]
Shimada, Mitsuo [1 ]
Kurita, Nobuhiro [1 ]
Sato, Hirohiko [1 ]
Iwata, Takashi [1 ]
Nishioka, Masanori [1 ]
Yoshikawa, Kozo [1 ]
Miyatani, Tomohiko [1 ]
Kashihara, Hideya [1 ]
Takasu, Chie [1 ]
Ikushima, Hitoshi
机构
[1] Tokushima Univ Hosp, Dept Surg & Transplantat, Tokushima 7708503, Japan
基金
日本学术振兴会;
关键词
Chemoradiation; S-1; Phase I study; Rectal cancer; GASTRIC-CANCER; 5-FLUOROURACIL; CAPECITABINE; CHEMORADIOTHERAPY; CHEMOTHERAPY; CHEMORADIATION; FLUOROURACIL; LEUCOVORIN; RADIATION; THERAPY;
D O I
10.5754/hge11699
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background/Aims: S-1 based chemoradiation is the recommended treatment for rectal cancer; however, the optimal scheduling and dosing are not yet established. A Phase I study was conducted to determine the maximum tolerated dose (MTD) of S-1 with radiotherapy (RT). Endpoints were the toxicity profile of this regimen and to determine the recommended dose (RD). Methodology: Conformal RT was given using 4 fields at daily fractions of 2Gy on 5 days per week to a total dose of 40Gy. Concurrently S-1 was given twice daily throughout RT. Eligible patients had a newly diagnosed clinical stage T3-4 N0-2 M0 rectal adenocarcinoma located within 12cm of the anal verge suitable for curative resection. Surgery was performed 6 weeks from completion of preoperative chemoradiotherapy. The dose escalating from S-1 80mg/m(2)/day (Level 1) to 100mg/m(2)/day (Level 2). Results: Nine patients were valid for safety. In all patients, S-1 was administered. There was no dose-limiting toxicity (DLT) in patients treated at dose Level 1. Six patients were enrolled in the dose-escalation phase. At dose Level 2, two patients developed DLT and this was considered the MTD. Objective response according to RECIST were observed in 5 of 9 patients who had measurable disease (56%). Conclusions: The RD of S-1 with concurrent RT was determined to be 80mg/m(2)/day. Preoperative RT combined with S-1 was feasible and well tolerated.
引用
收藏
页码:1428 / 1432
页数:5
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