caa a22 4500 605491798 CHVBK 20210128100511.0 cr unu---uuuuu 210128e20150401xx s 000 0 eng 10.1007/s10147-014-0705-3 doi (NATIONALLICENCE)springer-10.1007/s10147-014-0705-3 A phase I trial of preoperative S-1 in combination with oxaliplatin and pelvic radiation for lower rectal cancer with T4 and lateral pelvic lymph node metastasis [Elektronische Daten] [Masayuki Ohue, Tetsuya Hamaguchi, Yoshinori Ito, Daisuke Sakai, Shingo Noura, Yusuke Kinugasa, Shin Fujita, Yasuhiro Shimada, Norio Saito, Yoshihiro Moriya] Background: The purpose of this phase I study of the dose escalation of oxaliplatin in combination with oral S-1 and pelvic radiation preoperatively for poor-risk lower rectal cancer was to determine the dose-limiting toxicity (DLT) and recommended dose of oxaliplatin. Methods: Patients with cT4 and lateral pelvic lymph node metastasis, and without distant metastasis (cM0), were treated with weekly oxaliplatin, oral S-1 40mg/m2 twice daily for 5days a week, and radiation. A total of 5 weekly doses of oxaliplatin were planned. RT was administered to a total dose of 50.4Gy in 28 fractions. Results: We enrolled 11 patients between December 2009 and January 2012. DLTs were observed at dose level 1 (50mg/m2) in two patients, one of whom experienced grade 3 aspartate aminotransferase elevation and a grade 3 alanine aminotransferase increase, and the other developed grade 4 hypokalemia and a grade 3 alanine aminotransferase increase. Five patients at dose level 2 (60mg/m2) showed no DLTs. The hematological toxicities in all patients were mild and reversible. One patient showed distant metastasis after chemoradiation. Ten of the 11 patients achieved R0 resection by mesorectal resection and lateral lymph node dissection; three of the 10 underwent combined resection of the other organs. Conclusion: This phase I trial of preoperative S-1 in combination with oxaliplatin and radiation for lower rectal cancer with T4 and lateral pelvic lymph node metastasis revealed that the recommended dose of oxaliplatin was 60mg/m2 weekly. Japan Society of Clinical Oncology, 2014 Lower rectal cancer nationallicence T4 nationallicence Lateral pelvic lymph node metastasis nationallicence S-1 nationallicence Oxaliplatin nationallicence Preoperative chemoradiation nationallicence Ohue Masayuki Division of Colon and Rectal Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, 537-8511, Osaka, Japan aut Hamaguchi Tetsuya Division of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, Japan aut Ito Yoshinori Division of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan aut Sakai Daisuke Department of Frontier Science for Cancer and Chemotherapy, Graduate School of Medicine, Osaka University, Suita, Japan aut Noura Shingo Division of Colon and Rectal Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, 537-8511, Osaka, Japan aut Kinugasa Yusuke Division of Colon and Rectal Surgery, Shizuoka Cancer Center Hospital, Shizuoka, Japan aut Fujita Shin Department of Surgery, Tochigi Cancer Center Hospital, Utsunomiya, Japan aut Shimada Yasuhiro Division of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, Japan aut Saito Norio Colorectal and Pelvic Surgery Division, National Cancer Center Hospital East, Kashiwa, Japan aut Moriya Yoshihiro Colorectal Surgery Division, Japanese Red Cross Medical Center, Tokyo, Japan aut International Journal of Clinical Oncology Springer Japan 20/2(2015-04-01), 338-344 1341-9625 20:2<338 2015 20 10147 https://doi.org/10.1007/s10147-014-0705-3 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10147-014-0705-3 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Ohue Masayuki Division of Colon and Rectal Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, 537-8511, Osaka, Japan aut NATIONALLICENCE 700 1- Hamaguchi Tetsuya Division of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, Japan aut NATIONALLICENCE 700 1- Ito Yoshinori Division of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan aut NATIONALLICENCE 700 1- Sakai Daisuke Department of Frontier Science for Cancer and Chemotherapy, Graduate School of Medicine, Osaka University, Suita, Japan aut NATIONALLICENCE 700 1- Noura Shingo Division of Colon and Rectal Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, 537-8511, Osaka, Japan aut NATIONALLICENCE 700 1- Kinugasa Yusuke Division of Colon and Rectal Surgery, Shizuoka Cancer Center Hospital, Shizuoka, Japan aut NATIONALLICENCE 700 1- Fujita Shin Department of Surgery, Tochigi Cancer Center Hospital, Utsunomiya, Japan aut NATIONALLICENCE 700 1- Shimada Yasuhiro Division of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, Japan aut NATIONALLICENCE 700 1- Saito Norio Colorectal and Pelvic Surgery Division, National Cancer Center Hospital East, Kashiwa, Japan aut NATIONALLICENCE 700 1- Moriya Yoshihiro Colorectal Surgery Division, Japanese Red Cross Medical Center, Tokyo, Japan aut NATIONALLICENCE 773 0- International Journal of Clinical Oncology Springer Japan 20/2(2015-04-01), 338-344 1341-9625 20:2<338 2015 20 10147