Satoshi Matsusaka1, Soichiro Ishihara2, Keisaku Kondo3, Hisanaga Horie4, Keisuke Uehara5, Masahiko Oguchi6, Keiko Murofushi6, Masashi Ueno7, Nobuyuki Mizunuma1, Taiju Shimbo8, Daiki Kato9, Junji Okuda3, Yojiro Hashiguchi10, Masanori Nakazawa11, Eiji Sunami2, Kazushige Kawai2, Hideomi Yamashita12, Tohru Okada13, Yuichi Ishikawa14, Toshifusa Nakajima15, Toshiaki Watanabe16. 1. Department of Gastroenterology, Cancer Institute Hospital, Koto-ku, Japan. 2. Department of Surgical Oncology, University of Tokyo, Bunkyo-ku, Japan. 3. Department of General & Gastroenterological Surgery, Osaka Medical College, Takatsuki, Japan. 4. Department of Surgery, School of Medicine, Jichi Medical University, Shimotsuke, Japan. 5. Division of Surgical Oncology, Department of Surgery, Nagoya University, Japan. 6. Department of Radiation Oncology, Cancer Institute Hospital, Koto-ku, Japan. 7. Department of Gastroenterological Surgery, Cancer Institute Hospital, Koto-ku, Japan. 8. Department of Radiology, Osaka Medical College, Takatsuki, Japan. 9. Department of Radiology, Teikyo University, Itabashi-ku, Japan. 10. Department of Surgery, Teikyo University, Itabashi-ku, Japan. 11. Department of Radiology, School of Medicine, Jichi Medical University, Shimotsuke, Japan. 12. Department of Radiology, University of Tokyo, Bunkyo-ku, Japan. 13. Department of Radiology, Nagoya University, Japan. 14. Japanese Foundation for Cancer Research, Koto-ku, Japan. 15. Japan Clinical Cancer Research Organization, Chuo-ku, Japan. 16. Department of Surgical Oncology, University of Tokyo, Bunkyo-ku, Japan. Electronic address: toshwatanabe@yahoo.co.jp.
Abstract
PURPOSE: 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). PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSION: Preoperative CRT with S-1 plus oxaliplatin had a high pCR rate and a favorable toxicity profile.
PURPOSE: 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). PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSION: Preoperative CRT with S-1 plus oxaliplatin had a high pCR rate and a favorable toxicity profile.