Phase II study of oxaliplatin plus S-1 as first-line treatment for advanced gastric cancer (G-SOX study)

Phase II study of oxaliplatin plus S-1 as first-line treatment for advanced gastric cancer (G-SOX study)
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DOI:
10.1093/annonc/mdp464
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发表时间:
2010-05-01
期刊:
影响因子:
50.5
通讯作者:
Tsuburaya, A.
Tsuburaya, A.
中科院分区:
医学1区
文献类型:
--
作者:
Koizumi, W.;Takiuchi, H.;Tsuburaya, A.

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患者和方法:静脉注射奥沙利铂。 (100 mg/m(2)) 第 1 天,而 S-1 口服给药 (80 mg/m(2)/天,b.i.d.) 14 天,然后休息 7 天。该时间表每 3 周重复一次。 结果:在 55 名入组患者中,一名患者在另一项研究中接受奥沙利铂治疗,另外三名患者被认为不适合纳入标准。因此,对 51 名患者的疗效进行了评估。有效率59%,疾病控制率84%。中位无进展生存时间为6.5个月,1年生存率为71%,中位生存时间为16.5个月。在 54 名接受安全性评估的患者中,主要的 3/4 级毒性反应为中性粒细胞减少 (22%)、血小板减少 (13%)、贫血 (9%)、厌食 (6%)、疲劳 (6%) 和感觉神经病变 (4%)。 结论:这些研究结果表明,奥沙利铂剂量 100 mg/m(2) 的 SOX 方案是可行的,并且对晚期胃癌显示出良好的疗效。
Patients and methods: Oxaliplatin was administered i.v. (100 mg/m(2)) on day 1, while S-1 was administered orally (80 mg/m(2)/day, b.i.d.) for 14 days followed by a 7-day rest. This schedule was repeated every 3 weeks.Results: Among 55 patients enrolled, one patient received oxaliplatin for the other study, and three patients were considered unsuitable against the inclusion criteria. Accordingly, 51 patients were assessable for efficacy. The response rate was 59%, and the disease control rate was 84%. The median progression-free survival time was 6.5 months, the 1-year survival rate was 71%, and the median survival time was 16.5 months. In 54 patients assessed for safety, the major grade 3/4 toxic effects were neutropenia (22%), thrombocytopenia (13%), anemia (9%), anorexia (6%), fatigue (6%), and sensory neuropathy (4%).Conclusion: These findings indicate that SOX regimen with oxaliplatin at a dose of 100 mg/m(2) is feasible and shows promising efficacy against advanced gastric cancer.