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首页> 外文期刊>Lung cancer: Journal of the International Association for the Study of Lung Cancer >Randomized phase II study of gemcitabine plus cisplatin versus etoposide plus cisplatin for the treatment of locally advanced or metastatic non-small cell lung cancer: Korean Cancer Study Group experience.
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Randomized phase II study of gemcitabine plus cisplatin versus etoposide plus cisplatin for the treatment of locally advanced or metastatic non-small cell lung cancer: Korean Cancer Study Group experience.

机译:吉西他滨+随机二期研究顺铂和依托泊苷+顺铂的治疗的局部晚期或转移性非小细胞肺癌:韩国癌症研究组织经验。

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摘要

BACKGROUND: Several randomized trials have demonstrated superior response rates and survivals for new agent platinum doublets than for older platinum doublets in advanced non-small cell lung cancer (NSCLC), however, few trials have been performed in Asian populations. Thus, we conducted a randomized study to compare gemcitabine-cisplatin (GP) with etoposide-cisplatin (EP) in Korean patients with advanced NSCLC. METHODS: Patients with histologically confirmed, locally advanced or metastatic NSCLC were randomized to receive either gemcitabine 1250 mg/m2 on days 1 and 8 plus cisplatin 75 mg/m2 on day 1, or etoposide 100 mg/m2 on days 1-3 plus cisplatin 75 mg/m2 on day 1. Treatment was repeated every 21 days in both groups. The primary endpoint was response rate. RESULTS: Between May 2000 and December 2001, 83 patients at 9 Korean centers were enrolled in this study. The GP arm showed a significantly higher response rate (52.6% versus 19.4%; P = 0.002), a longer time to progression (4.3 months in both arms; P = 0.018) and a marginally significant prolongation of overall survival (18.3 months versus 10.9 months; P = 0.059) than the EP arm. Grades 3 and 4 thrombocytopenia (18% versus 0%) was more common in the GP arm whereas grades 3 and 4 neutropenia was more common in EP arm (48.7% versus 71.8%). Other toxicities were comparable in both arms. CONCLUSION: GP provided a significantly higher response rate and a longer time to progression than EP and should be considered a standard treatment in advanced NSCLC in Korean population.
机译:背景:一些随机试验优越的响应率和示威由新代理比铂对比对老年晚期非小中铂对比细胞性肺癌(NSCLC),然而,一些试验已经完成了亚洲人群。我们进行了一项随机研究比较gemcitabine-cisplatin (GP)etoposide-cisplatin (EP)患者在韩国晚期非小细胞肺癌。局部晚期或组织学证实转移性非小细胞肺癌随机吉西他滨1250 mg / m2在天1和8加顺铂75 mg / m2 1天,或者依托泊苷100 mg / m2在1 - 3天+顺铂75 mg / m2第一天。两组。率。2001年,83名患者在9个韩国中心参加本研究。显著提高反应率(52.6% vs19.4%;(4.3个月的双臂;近乎显著延长生存(18.3个月和10.9个月;0.059)比EP的手臂。血小板减少(18%比0%)更常见在医生的手臂而成绩3和4嗜中性白血球减少症在EP的手臂更常见(48.7%和71.8%)。其他毒性在双臂可比。结论:全科医生提供了显著提高响应速度和更长的时间发展比EP和应该考虑一个标准韩国人口的先进治疗非小细胞肺癌。

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