A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial).
A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial).
复制标题
Oxaliptin Plus口服S-1和骨盆辐射的I期剂量升级研究（Shogun试验）。
DOI：
10.1186/s13014-015-0333-8
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发表时间：
2015-01-23
期刊：
影响因子：
--
通讯作者：
Watanabe T
中科院分区：
文献类型：
--
作者：
Ishihara S;Matsusaka S;Kondo K;Horie H;Uehara K;Oguchi M;Murofushi K;Ueno M;Mizunuma N;Shinbo T;Kato D;Okuda J;Hashiguchi Y;Nakazawa M;Sunami E;Kawai K;Yamashita H;Okada T;Ishikawa Y;Nakajima T;Watanabe T
本研究的I期研究旨在确定S-1联合奥沙利铂治疗局部晚期直肠癌患者的术前放化疗最大耐受量和推荐剂量。患者接受放射治疗，总剂量为50.4Gy28次。同步化疗包括在第1-5、8-12、22-27、29-33天口服固定剂量的S-1(80 mg/m~2/d)，在第1、8、22、29天递增剂量的奥沙利铂静脉滴注。奥沙利铂最初给3名患者服用40 mg/m2/周。然后逐步增加剂量至50 mg/m2/周，最高剂量水平为60 mg/m2/周，直到达到MTD。13例患者入选，12例接受CRT治疗。剂量水平3的6名患者中有2名出现剂量限制性毒性(DLT)(持续性2级中性粒细胞减少，奥沙利铂治疗延迟3天以上)；没有3级或4级不良反应定义为DLT。奥沙利铂在第1、8、22、29天的Rd为60 mg/m~2/周。12名患者接受了组织学证实的R0切除，6名患者中有2名(33%)接受了3级剂量的病理完全反应。进一步研究的RD方案为：S-1 5天/周80 mg/m2，奥沙利铂60 mg/m2，分别于第1、8、22、29天和放疗同期进行。虽然我们的结果是初步的，但这种新的新辅助放化疗方案被认为是安全和有效的。这项试验在ClinicalTrials.gov注册(识别符：NCT01227239)。
The objective of this phase I study was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of preoperative chemoradiotherapy (CRT) with S-1 plus oxaliplatin in patients with locally advanced rectal cancer. Patients received radiotherapy in a total dose of 50.4 Gy in 28 fractions. Concurrent chemotherapy consisted of a fixed oral dose of S-1 (80 mg/m2/day) on days 1–5, 8–12, 22–27, and 29–33, plus escalated doses of oxaliplatin as an intravenous infusion on days 1, 8, 22, and 29. Oxaliplatin was initially given in a dose of 40 mg/m2/week to three patients. The dose was then increased in a stepwise fashion to 50 mg/m2/week and the highest dose level of 60 mg/m2/week until the MTD was attained. Thirteen patients were enrolled, and 12 received CRT. Dose-limiting toxicity (DLT) occurred in two of six patients (persistent grade 2 neutropenia, delaying oxaliplatin treatment by more than 3 days) at dose level 3; there were no grade 3 or 4 adverse events defined as DLT. The RD was 60 mg/m2/week of oxaliplatin on days 1, 8, 22, and 29. Twelve patients underwent histologically confirmed R0 resections, and two out of six patients (33%) given dose level 3 had pathological complete responses. The RD for further studies is 80 mg/m2 of S-1 5 days per week plus 60 mg/m2 of oxaliplatin on days 1, 8, 22, and 29 and concurrent radiotherapy. Although our results are preliminary, this new regimen for neoadjuvant chemoradiotherapy is considered safe and active. This trial was registered with Clinicaltrials.gov (identifier: NCT01227239).
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影响因子：
5.7
作者：
Bujko, K;Nowacki, MP;Kukolowicz, P
通讯作者：
Kukolowicz, P
DOI：
10.1016/s0360-3016(01)02792-4
发表时间：
2002-03-15
影响因子：
7
作者：
Cividalli, A;Ceciarelli, F;Danesi, DT
通讯作者：
Danesi, DT
影响因子：
158.5
作者：
Kapiteijn, E;Marijnen, CAM;van de Velde, CJH
通讯作者：
van de Velde, CJH
影响因子：
45.3
作者：
Kuebler, J. Philip;Wieand, H. Samuel;Wolmark, Norman
通讯作者：
Wolmark, Norman
影响因子：
4.2
作者：
Fukushima, Masakazu;Sakamoto, Kazuki;Sakata, Yu
通讯作者：
Sakata, Yu