Phase I/II trial of gemcitabine plus oral TS-1 in elderly patients with advanced non-small cell lung cancer: Thoracic oncology research group study 0502
Phase I/II trial of gemcitabine plus oral TS-1 in elderly patients with advanced non-small cell lung cancer: Thoracic oncology research group study 0502
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吉西他滨联合口服 TS-1 治疗老年晚期非小细胞肺癌的 I/II 期试验：胸部肿瘤学研究组研究 0502
DOI：
10.1016/j.lungcan.2009.10.017
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发表时间：
2010
期刊：
影响因子：
5.3
通讯作者：
et al
中科院分区：
文献类型：
--
作者：
Seto T;Yamanaka T;Wasada I;Seki N;Okamoto H;Ogura T;Shibuya M;Takiguchi Y;Shinkai T;Masuda N;et al
本研究设计了一项TS-1联合吉西他滨治疗老年晚期非小细胞肺癌（NSCLC）的I/II期临床试验，旨在确定最大耐受剂量（MTD）和推荐剂量（RD），并评价其疗效和毒性。年龄大于70岁的患者接受TS-1口服，每日两次。第1-14天静脉注射吉西他滨，第8和15天静脉注射吉西他滨，每4周一次。在I期（n=22）中，每个队列接受递增剂量的TS-1（30- 40 mg/m2 b.i.d.）和吉西他滨（800- 1000 mg/m2）; MTD为40 mg/m2每日两次TS-1和吉西他滨1000 mg/m2; RD为30 mg/m2 b.i.d.。TS-1和1000 mg/m2吉西他滨。剂量限制性毒性包括3级感染、皮肤毒性和口腔炎。在II期（n=37）中，总缓解率为27%（90%置信区间（CI）：15-42%），中位至进展时间和总生存期分别为4.2个月（90% CI：3.2-5.7）和12.9个月（90% CI：10.4-14.7）。最常见的3级或以上毒性为中性粒细胞减少症（45.9%），13.5%的患者观察到血小板减少症。观察到3级肺炎和皮肤毒性各2例，但非血液学毒性的发生频率通常较低。TS-1联合吉西他滨是治疗老年晚期NSCLC患者的一种有前景的双联方案，毒性可接受。
A phase I/II trial of TS-1 combined with gemcitabine was designed to determine the maximum tolerated dose (MTD) and recommended dose (RD) and to evaluate the efficacy and toxicity in elderly patients with advanced non-small cell lung cancer (NSCLC). Patients older than 70 years of age received TS-1 orally b.i.d. on days 1–14 and gemcitabine intravenously on days 8 and 15 every 4 weeks. In phase I (n=22), each cohort received escalating doses of TS-1 (30–40mg/m2b.i.d.) and gemcitabine (800–1000mg/m2); MTD was 40mg/m2b.i.d. TS-1 and 1000mg/m2gemcitabine; RD was 30mg/m2b.i.d. TS-1 and 1000mg/m2gemcitabine. Dose-limiting toxicities included a grade 3 infection, skin toxicity, and stomatitis. In phase II (n=37), the overall response rate was 27% (90% confidence interval (CI): 15–42%) and the median time to progression and overall survival were 4.2 months (90% CI: 3.2–5.7) and 12.9 months (90% CI: 10.4–14.7), respectively. The most common grade 3 or higher toxicity was neutropenia (45.9%), and thrombocytopenia was observed in 13.5% of patients. Two cases each of grade 3 pneumonitis and skin toxicity were observed, but nonhematological toxicities occurred at generally low frequencies. TS-1 with gemcitabine is a promising doublet regimen in elderly patients with advanced NSCLC with acceptable toxicities.