Phase I trial of neoadjuvant preoperative chemotherapy with S-1, oxaliplatin, and bevacizumab plus radiation in patients with locally advanced rectal cancer

Verfasser / Beitragende:
[Hirohiko Sato, Mitsuo Shimada, Nobuhiro Kurita, Takashi Iwata, Kozo Yoshikawa, Jun Higashigima, Motoya Chikakio, Hideya Kashihara, Chie Takasu, Noriko Matsumoto, Shozo Eto]
Ort, Verlag, Jahr:
2015
Enthalten in:
International Journal of Clinical Oncology, 20/3(2015-06-01), 543-548
Format:
Artikel (online)
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245 0 0 |a Phase I trial of neoadjuvant preoperative chemotherapy with S-1, oxaliplatin, and bevacizumab plus radiation in patients with locally advanced rectal cancer  |h [Elektronische Daten]  |c [Hirohiko Sato, Mitsuo Shimada, Nobuhiro Kurita, Takashi Iwata, Kozo Yoshikawa, Jun Higashigima, Motoya Chikakio, Hideya Kashihara, Chie Takasu, Noriko Matsumoto, Shozo Eto] 
520 3 |a Background: This phase I study was performed to determine the maximum tolerated dose (MTD), recommended dose (RD), and dose-limiting toxicities (DLTs) of oxaliplatin combined with preoperative chemoradiotherapy with S-1, oxaliplatin, and bevacizumab in locally advanced rectal cancer. Methods: Eligible patients had a newly diagnosed clinical stage T1-4 N0-3 M0 rectal adenocarcinoma within 12cm of the anal verge suitable for curative resection. Conformal radiation therapy was given (4 fields, 2Gy daily fractions, 5days/week, total dose 40Gy) with concurrent S-1 (80mg/m2/day orally, days 1-5, 8-12, 15-19, and 22-26), bevacizumab (90min continuous intravenous infusion at 5mg/kg, days 1 and 15), and oxaliplatin (120min continuous intravenous infusion, days 1, 8, 15, and 22). The initial oxaliplatin dose (40mg/m2/day) was gradually increased to determine the MTD and RD. Surgery was performed 6weeks after completion of preoperative chemoradiotherapy. Results: 11 patients were enrolled. The MTD of oxaliplatin was considered to be 60mg/m2, because three of five patients developed DLTs such as diarrhea and hives. The recommended dose of oxaliplatin was set at 50mg/m2. Of the patients who received oxaliplatin at≤RD, 5 (83.3%) had a clinical response [four pathological responses and one pathological complete response (Grade 3)]. Conclusions: With this new regimen, the MTD of oxaliplatin was 60mg/m2, and the RD for phase II studies was 50mg/m2. This new regimen appears to provide worthwhile outcomes for locally advanced rectal cancer and merits a phase II study. 
540 |a Japan Society of Clinical Oncology, 2014 
690 7 |a Bevacizumab  |2 nationallicence 
690 7 |a Neoadjuvant chemoradiotherapy  |2 nationallicence 
690 7 |a Oxaliplatin  |2 nationallicence 
690 7 |a Phase I study  |2 nationallicence 
690 7 |a Rectal cancer  |2 nationallicence 
690 7 |a S-1  |2 nationallicence 
700 1 |a Sato  |D Hirohiko  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
700 1 |a Shimada  |D Mitsuo  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
700 1 |a Kurita  |D Nobuhiro  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
700 1 |a Iwata  |D Takashi  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
700 1 |a Yoshikawa  |D Kozo  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
700 1 |a Higashigima  |D Jun  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
700 1 |a Chikakio  |D Motoya  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
700 1 |a Kashihara  |D Hideya  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
700 1 |a Takasu  |D Chie  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
700 1 |a Matsumoto  |D Noriko  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
700 1 |a Eto  |D Shozo  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
773 0 |t International Journal of Clinical Oncology  |d Springer Japan  |g 20/3(2015-06-01), 543-548  |x 1341-9625  |q 20:3<543  |1 2015  |2 20  |o 10147 
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900 7 |a Metadata rights reserved  |b Springer special CC-BY-NC licence  |2 nationallicence 
908 |D 1  |a research-article  |2 jats 
949 |B NATIONALLICENCE  |F NATIONALLICENCE  |b NL-springer 
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950 |B NATIONALLICENCE  |P 700  |E 1-  |a Sato  |D Hirohiko  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Shimada  |D Mitsuo  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Kurita  |D Nobuhiro  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Iwata  |D Takashi  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Yoshikawa  |D Kozo  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Higashigima  |D Jun  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Chikakio  |D Motoya  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Kashihara  |D Hideya  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Takasu  |D Chie  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Matsumoto  |D Noriko  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Eto  |D Shozo  |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 773  |E 0-  |t International Journal of Clinical Oncology  |d Springer Japan  |g 20/3(2015-06-01), 543-548  |x 1341-9625  |q 20:3<543  |1 2015  |2 20  |o 10147