Matsusaka Satoshi, Ishihara Soichiro, Kondo Keisaku, Horie Hisanaga, Uehara Keisuke, Oguchi Masahiko, Murofushi Keiko, Ueno Masashi, Mizunuma Nobuyuki, Shimbo Taiju, Kato Daiki, Okuda Junji, Hashiguchi Yojiro, Nakazawa Masanori, Sunami Eiji, Kawai Kazushige, Yamashita Hideomi, Okada Tohru, Ishikawa Yuichi, Nakajima Toshifusa, Watanabe Toshiaki
Department of Gastroenterology, Cancer Institute Hospital, Koto-ku, Japan.
Department of Surgical Oncology, University of Tokyo, Bunkyo-ku, Japan.
Radiother Oncol. 2015 Aug;116(2):209-13. doi: 10.1016/j.radonc.2015.08.002. Epub 2015 Aug 31.
This study was designed to evaluate the safety and efficacy of adding oxaliplatin to preoperative chemoradiotherapy (CRT) with S-1 in patients with locally advanced rectal carcinoma (LARC).
This was a multicenter phase II study in patients with histologically proven clinical stage T3 or T4 (any N, M0) LARC. Patients preoperatively received oral S-1 (80 mg/m(2)/day on days 1-5, 8-12, 22-27, and 29-33) and infusional oxaliplatin (60 mg/m(2) days on 1, 8, 22, and 29) plus radiotherapy (50.4 Gy), with a chemotherapy gap in the third week of radiotherapy. Pathological complete response (pCR) was the primary endpoint. Secondary endpoints included toxicity, compliance, R0 resection rate, and downstaging rate.
A total of 45 patients were enrolled at six centers in Japan. All 45 patients received CRT, and 44 underwent operation. A pCR was achieved in 12 (27.3%) of the 44 patients who underwent surgery. Near-total tumor regression was confirmed in 47.7%. There were no grade 4 adverse events, and 11.1% of the patients had grade 3 adverse events. R0 resection was achieved in 95.5% of the patients.
Preoperative CRT with S-1 plus oxaliplatin had a high pCR rate and a favorable toxicity profile.
本研究旨在评估在局部晚期直肠癌（LARC）患者中，术前同步放化疗（CRT）联合S-1方案加用奥沙利铂的安全性和有效性。
这是一项针对组织学确诊为临床分期T3或T4（任何N，M0）的LARC患者的多中心II期研究。患者术前接受口服S-1（第1 - 5天、8 - 12天、22 - 27天和29 - 33天，80 mg/m²/天）、静脉滴注奥沙利铂（第1、8、22和29天，60 mg/m²）以及放疗（50.4 Gy），放疗第三周有化疗间歇期。病理完全缓解（pCR）是主要终点。次要终点包括毒性、依从性、R0切除率和降期率。
日本六个中心共纳入45例患者。所有45例患者均接受了CRT，44例接受了手术。44例接受手术的患者中有12例（27.3%）达到pCR。47.7%的患者确认肿瘤接近完全消退。无4级不良事件发生，11.1%的患者发生3级不良事件。95.5%的患者实现了R0切除。
术前CRT联合S-1加奥沙利铂具有较高的pCR率和良好的毒性特征。
