多吉美联合特罗凯或键泽治疗非细胞肺癌的II期临川试验结果
多吉美联合特罗凯或键泽治疗非细胞肺癌的II期临川试验结果。结果证明特罗凯联用多吉美组的中为生存时间是多吉美联用键泽的中为生存时间的两倍。（12.6个月VS6.6个月）意大利人看来也为我们对非小细胞肺癌找到了一条“新思路”。不知这样的结果，是否也适用于中国人群。Sorafenib in combination with erlotinib or with gemcitabine in elderly patients with advanced non-small-cell lung cancer: a randomized phase II study.
Gridelli C, Morgillo F, Favaretto A, de Marinis F, Chella A, Cerea G, Mattioli R, Tortora G, Rossi A, Fasano M, Pasello G, Ricciardi S, Maione P, Di Maio M, Ciardiello F.
Division of Medical Oncology, S.G. Moscati Hospital, Avellino.
Abstract
BACKGROUND: Sorafenib is a small-molecule multitargeted kinase inhibitor that blocks the activation of C-RAF, B-RAF, c-KIT, FLT-3, RET, vascular endothelial growth factor receptor 2 (VEGFR-2), VEGFR-3 and platelet-derived growth factor receptor β. The aim of this multicenter, randomized phase II study was to evaluate clinical activity and safety of sorafenib in combination with erlotinib or gemcitabine in unselected untreated elderly patients with non-small-cell lung cancer (NSCLC).
METHODS: The trial was designed to select the most promising sorafenib-containing combination in previously untreated elderly (≥70 years) stage IIIB or IV NSCLC patients, with performance status of zero to two. Patients were randomly assigned to one of the following combinations: gemcitabine, 1200 mg/m(2) days 1 and 8, every 21 days, for a maximum of six cycles, plus sorafenib, 800 mg/day, until disease progression or unacceptable toxicity (arm 1); or erlotinib, 150 mg/day, plus sorafenib, 800 mg/day, until disease progression or unacceptable toxicity (arm 2). A selection design was applied with 1-year survival rate as the primary end point of the study, requiring 58 patients.
RESULTS: Sixty patients were randomly allocated to the study (31 patients in arm 1 and 29 patients in arm 2). After a median follow-up of 15 months, 10 patients in arm 1 and 13 patients (45%, 95% CI 27% to 63%) in arm 2 were alive at 1 year. Median overall survival was 6.6 and 12.6 months in arm 1 and arm 2, respectively. Observed toxic effects were consistent with the expected drug profiles.
CONCLUSIONS: The combination of erlotinib and sorafenib was feasible in elderly patients with advanced NSCLC and was associated with a higher 1-year survival rate than the other arm. According to the selection design, this combination warrants further investigation in phase III trials.
PMID: 21212155 这个实验都是大于70岁的老年晚期非小细胞肺癌患者参加的，一共60人，31人参加多吉美+健泽组，29人参加多吉美（800mg/天）+特罗凯（150mg/天）组，结果证实中位生存期分别为6.6个月和12.6个月。
参加的人不多，不知道这个实验严不严肃。不过多吉美和 特罗凯都是挺有名的药物，这样叠加起来，也未尝不可，多吉美的副作用不小，但是如果逼得没法，我也会考虑用这个方法的。谢谢laorensefz提供资料！ 这个实验设计有点问题
应该是多吉美联合特，和单药特来做比较或者单药多吉美
这样做毫无意义，
首先，靶向和化疗联合，已经证明没用
其次，两种靶向联合要做实验应该是跟单药靶向做比较
这个文章我看过，因为这些思路所以没转发出来
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