A PHASE II TRIAL OF NEOADJUVANT PREOPERATIVE CHEMORADIOTHERAPY WITH S-1 PLUS IRINOTECAN AND RADIATION IN PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER: CLINICAL FEASIBILITY AND RESPONSE RATE
A PHASE II TRIAL OF NEOADJUVANT PREOPERATIVE CHEMORADIOTHERAPY WITH S-1 PLUS IRINOTECAN AND RADIATION IN PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER: CLINICAL FEASIBILITY AND RESPONSE RATE
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DOI：
10.1016/j.ijrobp.2009.11.007
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发表时间：
2011-03-01
影响因子：
7
通讯作者：
Watanabe, Masahiko
中科院分区：
文献类型：
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作者：
Sato, Takeo;Ozawa, Heita;Watanabe, Masahiko
目的：我们旨在验证我们的假设，即在单臂II期的情况下，术前采用S-1联合伊立替康的放化疗方案治疗局部晚期直肠癌是可行的、安全的和积极的。方法和材料：符合条件的患者既往未经治疗的局部晚期直肠癌。放射治疗分次进行，每次1.8Gyd，共25d。S-1于第1~5、8~12、22~26、29~33天口服，每日固定剂量为80 mg/m~2。分别于第1、8、22、29天静脉滴注伊立替康80 mg/m(2)。治疗结束后4周或更长时间，行全直肠系膜切除加侧向淋巴清扫。主要终点是可行性方面的治疗完成率。次要终点是应答率和安全性。结果：我们招募了43名男性和24名女性参与研究。完成治疗58例(86.6%)。总体而言，46名患者(68.7%)对治疗有反应，24名(34.7%)完全组织病理学反应。3例患者出现3级白细胞减少，3例患者出现3级中性粒细胞减少。腹泻是最常见的非血液毒性类型：3例患者出现3级腹泻。结论：S-1、伊立替康和直肠放射治疗的术前方案是可行的，在这种非随机化的第一阶段环境下似乎是安全有效的。不良事件发生率低，治疗完成率高，病理完全应答率极高。(C)2011年爱思唯尔公司。
Purpose: We aimed to validate our hypothesis that a preoperative chemoradiotherapy regimen with S-1 plus irinotecan is feasible, safe, and active for the management of locally advanced rectal cancer in a single-arm Phase II setting.Methods and Materials: Eligible patients had previously untreated, locally advanced rectal adenocarcinoma. Radiotherapy was administered in fractions of 1.8Gy/d for 25 days. S-1 was administered orally in a fixed daily dose of 80mg/m(2) on Days 1 to 5, 8 to 12, 22 to 26, and 29 to 33. Irinotecan (80mg/m(2)) was infused on Days 1, 8, 22, and 29. Four or more weeks after the completion of the treatment, total mesorectal excision with lateral lymph node dissection was performed. The primary endpoint was the rate of completing treatment in terms of feasibility. The secondary endpoints were the response rate and safety.Results: We enrolled 43 men and 24 women in the study. The number of patients who completed treatment was 58 (86.6%). Overall, 46 patients (68.7%) responded to treatment and 24 (34.7%) had a complete histopathologic response. Three patients had Grade 3 leukopenia, and another three patients had Grade 3 neutropenia. Diarrhea was the most common type of nonhematologic toxicity: 3 patients had Grade 3 diarrhea.Conclusions: A preoperative regimen of S-1, irinotecan, and radiotherapy to the rectum was feasible, and it appeared safe and effective in this nonrandomized Phase It setting. It exhibited a low incidence of adverse events, a high rate of completion of treatment, and an extremely high rate of pathologic complete response. (C) 2011 Elsevier Inc.