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

Verfasser / Beitragende:
[Masayuki Ohue, Tetsuya Hamaguchi, Yoshinori Ito, Daisuke Sakai, Shingo Noura, Yusuke Kinugasa, Shin Fujita, Yasuhiro Shimada, Norio Saito, Yoshihiro Moriya]
Ort, Verlag, Jahr:
2015
Enthalten in:
International Journal of Clinical Oncology, 20/2(2015-04-01), 338-344
Format:
Artikel (online)
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024 7 0 |a 10.1007/s10147-014-0705-3  |2 doi 
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245 0 2 |a 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  |h [Elektronische Daten]  |c [Masayuki Ohue, Tetsuya Hamaguchi, Yoshinori Ito, Daisuke Sakai, Shingo Noura, Yusuke Kinugasa, Shin Fujita, Yasuhiro Shimada, Norio Saito, Yoshihiro Moriya] 
520 3 |a 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. 
540 |a Japan Society of Clinical Oncology, 2014 
690 7 |a Lower rectal cancer  |2 nationallicence 
690 7 |a T4  |2 nationallicence 
690 7 |a Lateral pelvic lymph node metastasis  |2 nationallicence 
690 7 |a S-1  |2 nationallicence 
690 7 |a Oxaliplatin  |2 nationallicence 
690 7 |a Preoperative chemoradiation  |2 nationallicence 
700 1 |a Ohue  |D Masayuki  |u Division of Colon and Rectal Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, 537-8511, Osaka, Japan  |4 aut 
700 1 |a Hamaguchi  |D Tetsuya  |u Division of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, Japan  |4 aut 
700 1 |a Ito  |D Yoshinori  |u Division of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan  |4 aut 
700 1 |a Sakai  |D Daisuke  |u Department of Frontier Science for Cancer and Chemotherapy, Graduate School of Medicine, Osaka University, Suita, Japan  |4 aut 
700 1 |a Noura  |D Shingo  |u Division of Colon and Rectal Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, 537-8511, Osaka, Japan  |4 aut 
700 1 |a Kinugasa  |D Yusuke  |u Division of Colon and Rectal Surgery, Shizuoka Cancer Center Hospital, Shizuoka, Japan  |4 aut 
700 1 |a Fujita  |D Shin  |u Department of Surgery, Tochigi Cancer Center Hospital, Utsunomiya, Japan  |4 aut 
700 1 |a Shimada  |D Yasuhiro  |u Division of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, Japan  |4 aut 
700 1 |a Saito  |D Norio  |u Colorectal and Pelvic Surgery Division, National Cancer Center Hospital East, Kashiwa, Japan  |4 aut 
700 1 |a Moriya  |D Yoshihiro  |u Colorectal Surgery Division, Japanese Red Cross Medical Center, Tokyo, Japan  |4 aut 
773 0 |t International Journal of Clinical Oncology  |d Springer Japan  |g 20/2(2015-04-01), 338-344  |x 1341-9625  |q 20:2<338  |1 2015  |2 20  |o 10147 
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950 |B NATIONALLICENCE  |P 700  |E 1-  |a Ohue  |D Masayuki  |u Division of Colon and Rectal Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, 537-8511, Osaka, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Hamaguchi  |D Tetsuya  |u Division of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Ito  |D Yoshinori  |u Division of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Sakai  |D Daisuke  |u Department of Frontier Science for Cancer and Chemotherapy, Graduate School of Medicine, Osaka University, Suita, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Noura  |D Shingo  |u Division of Colon and Rectal Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, 537-8511, Osaka, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Kinugasa  |D Yusuke  |u Division of Colon and Rectal Surgery, Shizuoka Cancer Center Hospital, Shizuoka, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Fujita  |D Shin  |u Department of Surgery, Tochigi Cancer Center Hospital, Utsunomiya, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Shimada  |D Yasuhiro  |u Division of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Saito  |D Norio  |u Colorectal and Pelvic Surgery Division, National Cancer Center Hospital East, Kashiwa, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Moriya  |D Yoshihiro  |u Colorectal Surgery Division, Japanese Red Cross Medical Center, Tokyo, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 773  |E 0-  |t International Journal of Clinical Oncology  |d Springer Japan  |g 20/2(2015-04-01), 338-344  |x 1341-9625  |q 20:2<338  |1 2015  |2 20  |o 10147