S-1 单药治疗铂类耐药的晚期非小细胞肺癌的 II 期研究。
Phase II study of S-1 monotherapy in platinum-refractory, advanced non-small cell lung cancer.
机构信息
Department of Respiratory Medicine, Osaka Police Hospital, 10-31 Kitayama-chou, Tennoji-ku, Osaka 543-0035, Japan.
出版信息
Lung Cancer. 2011 Oct;74(1):85-8. doi: 10.1016/j.lungcan.2011.01.017. Epub 2011 Feb 20.
OBJECTIVE
The aim of this study was to evaluate the efficacy and toxicity of a novel oral 5-fluorouracil formulation (S-1) as second-line therapy after platinum agent chemotherapy for advanced non-small cell lung cancer (NSCLC).
METHODS
S-1 was administered orally at a dose of 80 mg/m(2) for 28 days, followed by 14 days of rest (1 cycle); treatment was repeated until disease progression, unacceptable toxicity, or patient refusal.
RESULTS
Of the 46 patients enrolled in this study, 44 were evaluable. Six patients (14%) exhibited a partial response and 28 (64%) showed stable disease. Disease-control rate was 77.3% (34/44) (95% CI, 64.9-89.7%). The overall response rate was 14% (6/44) (95% CI, 3.5-23.8%). Median progression-free survival was 4.2 months. The median survival time was 16.4 months, and the one-year survival rate 60.3%. Grade 3/4 hematological toxicities were minor. All of those adverse reactions were tolerable and reversible.
CONCLUSION
This study demonstrated the efficacy of S-1 monotherapy as second-line treatment for advanced NSCLC.
目的
本研究旨在评估新型口服 5-氟尿嘧啶制剂（S-1）作为铂类药物化疗后晚期非小细胞肺癌（NSCLC）二线治疗的疗效和毒性。
方法
S-1 口服剂量为 80mg/m²，28 天为 1 个周期，随后休息 14 天（1 个周期）；治疗重复进行，直至疾病进展、不可接受的毒性或患者拒绝。
结果
本研究共纳入 46 例患者，其中 44 例可评估。6 例患者（14%）出现部分缓解，28 例（64%）患者病情稳定。疾病控制率为 77.3%（34/44）（95%CI，64.9-89.7%）。总有效率为 14%（6/44）（95%CI，3.5-23.8%）。中位无进展生存期为 4.2 个月。中位总生存期为 16.4 个月，1 年生存率为 60.3%。3/4 级血液学毒性轻微。所有这些不良反应均可耐受且可逆。
结论
本研究表明 S-1 单药治疗晚期 NSCLC 的疗效。
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