EORTC Early Clinical Studies Group early phase II trial of S-1 in patients with advanced or metastatic colorectal cancer.
EORTC Early Clinical Studies Group early phase II trial of S-1 in patients with advanced or metastatic colorectal cancer.
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EORTC早期临床研究小组S-1早期II期试验在晚期或转移性结直肠癌患者中。
DOI：
10.1038/sj.bjc.6600781
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发表时间：
2003-03-10
影响因子：
8.8
通讯作者：
Fumoleau, P
中科院分区：
文献类型：
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作者：
Van den Brande, J;Schoffski, P;Schellens, J H M;Roth, A D;Duffaud, F;Weigang-Kohler, K;Reinke, F;Wanders, J;de Boer, R F;Vermorken, J B;Fumoleau, P
结肠癌和直肠癌是美国和欧洲最常见的恶性肿瘤之一。标准的姑息治疗是基于5-氟尿嘧啶/亚叶酸组合，有或没有奥沙利铂或伊立替康，静脉给药。口服药物具有更大的患者便利性和接受度以及潜在的成本节约的优点。S-1是一种新型口服含氟嘧啶衍生物。在一项非随机化II期研究中，晚期/转移性结直肠癌患者接受S-1 40 mg m−2 b.i.d.治疗。连续28天，每5周重复一次，但由于严重药物不良反应的数量高于预期，因此在研究期间将剂量修订为35 mg m-2。共纳入47例结直肠癌患者。在37例可评价患者中，9例部分缓解（24%），17例疾病稳定（46%），11例疾病进展（30%）。腹泻经常发生，而且往往很严重：在40和35 mg m−2组中，分别有38%和35%的患者发生3-4级腹泻。其他毒性是有限和可控的。S-1在晚期结直肠癌中具有活性，但为了确定更安全的剂量，应进行进一步的研究。
Cancer of the colon and rectum is one of the most frequent malignancies both in the US and Europe. Standard palliative therapy is based on 5-fluorouracil/folinic acid combinations, with or without oxaliplatin or irinotecan, given intravenously. Oral medication has the advantage of greater patient convenience and acceptance and potential cost savings. S-1 is a new oral fluorinated pyrimidine derivative. In a nonrandomised phase II study, patients with advanced/metastatic colorectal cancer were treated with S-1 at 40 mg m−2 b.i.d. for 28 consecutive days, repeated every 5 weeks, but by amendment the dose was reduced to 35 mg m−2 during the study because of a higher than expected number of severe adverse drug reactions. In total 47 patients with colorectal cancer were included. In the 37 evaluable patients there were nine partial responses (24%), 17 stable diseases (46%) and 11 patients had progressive disease (30%). Diarrhoea occurred frequently and was often severe: in the 40 and 35 mg m−2 group, respectively, 38 and 35% of the patients experienced grade 3–4 diarrhoea. The other toxicities were limited and manageable. S-1 is active in advanced colorectal cancer, but in order to establish a safer dose the drug should be subject to further investigations.