Phase I/II study of oxaliplatin with oral S-1 as first-line therapy for patients with metastatic colorectal cancer.
Phase I/II study of oxaliplatin with oral S-1 as first-line therapy for patients with metastatic colorectal cancer.
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DOI：
10.1038/sj.bjc.6604271
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发表时间：
2008-03-25
影响因子：
8.8
通讯作者：
Tanigawara, Y.
中科院分区：
文献类型：
--
作者：
Yamada, Y.;Tahara, M.;Miya, T.;Satoh, T.;Shirao, K.;Shimada, Y.;Ohtsu, A.;Sasaki, Y.;Tanigawara, Y.
两项S-1单药治疗的II期研究显示，在未经治疗的转移性结直肠癌患者中，有希望的缓解率（RR）为35-40%，耐受性良好。为了研究S-1+奥沙利铂（SOX）作为输注5-氟尿嘧啶/亚叶酸+奥沙利铂的替代方案的有效性，确定了SOX的推荐剂量（RD），并在I/II期研究中评价了其安全性和初步疗效。奥沙利铂在第1天以100 mg m−2（水平1）或130 mg m−2（水平2）的剂量给药，S-1（80-120）每日两次给药，持续2周，随后停药1周。每3周重复该时间表。2级被确定为RD。接受RD的28例患者中，中位疗程为6.5个周期（2-14），RR为50%（1例CR和13例PR：95%CI 31-69%），中位无进展生存期为196天。1年生存率为79%。在所有患者中均观察到周围神经病变，但无功能障碍。RD时的主要3级或4级不良反应为血小板减少（14%）、血小板减少（28%）和腹泻（3%）。SOX方案是有效的，易于管理，无需中心静脉通路。
Two phase II studies of S-1 monotherapy have shown promising response rates (RR) of 35–40% with good tolerability in patients with untreated metastatic colorectal cancer. To investigate the usefulness of S-1 plus oxaliplatin (SOX) as an alternative to infusional 5-fluorouracil/leucovorin plus oxaliplatin, the recommended dose (RD) of SOX was determined, and its safety and preliminary efficacy were evaluated in a phase I/II study. Oxaliplatin was administered at a dose of 100 mg m−2 (level 1) or 130 mg m−2 (level 2) on day 1, and S-1 (80–120) was given twice daily for 2 weeks followed by a 1-week rest. This schedule was repeated every 3 weeks. Level 2 was determined to be the RD. For the 28 patients who received the RD, the median treatment course was 6.5 cycles (2–14), RR of 50% (1 CR and 13 PR: 95% CI 31–69%), with a median progression-free survival of 196 days. Survival rate (1 year) was 79%. Peripheral neuropathy was observed in all patients but with no functional disorders. Major grade 3 or 4 adverse reactions at the RD were neutropaenia (14%), thrombocytopaenia (28%), and diarrhoea (3%). SOX regimen is effective and easily manageable without central vein access.
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影响因子：
50.5
作者：
Díaz-Rubio, E;Evans, TRJ;Baselga, J
通讯作者：
Baselga, J
影响因子：
2.4
作者：
Boku, Narikazu;Ohtsu, Atsushi;Tanigawara, Yusuke
通讯作者：
Tanigawara, Yusuke
影响因子：
8.8
作者：
通讯作者：
--
影响因子：
45.3
作者：
Goldberg, RM;Sargent, DJ;Alberts, SR
通讯作者：
Alberts, SR
影响因子：
45.3
作者：
Porschen, Rainer;Arkenau, Hendrik-Tobias;Schmoll, Hans-Joachim
通讯作者：
Schmoll, Hans-Joachim