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

来源：

HEPATO-GASTROENTEROLOGY | 2012年 / 59卷 / 117期

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

页码：1428 / 1432

页数：5

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