转移性乳腺癌患者中口服抗血管生成药物TSU-68的循环血浆生物标志物
Circulating Plasma Biomarkers for TSU-68, an Oral Antiangiogenic Agent, in Patients with Metastatic Breast Cancer.
作者信息
Yoo Changhoon, Kim Sung-Bae, Ro Jungsil, Im Seock-Ah, Im Young-Hyuck, Kim Jee Hyun, Ahn Jin-Hee, Jung Kyung Hae, Song Hong Suk, Kang Seok Yun, Park Hee Sook, Chung Hyun-Cheol
机构信息
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Center for Breast Cancer, National Cancer Center, Goyang, Korea.
出版信息
Cancer Res Treat. 2016 Apr;48(2):499-507. doi: 10.4143/crt.2015.089. Epub 2015 Jul 14.
PURPOSE
This study analyzed the role of plasma biomarkers for TSU-68 in a previous phase II trial comparing TSU-68 plus docetaxel and docetaxel alone in patients with metastatic breast cancer.
MATERIALS AND METHODS
A total of 77 patients were eligible for this study (38 in the TSU-68 plus docetaxel arm and 39 in the docetaxel alone arm). Blood samples were collected prior to the start of each cycle, and vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF)-AA, -AB, -BB, fibroblast growth factor, M30, C-reactive protein (CRP), and interleukin 6 (IL-6) levels were measured using enzyme linked immunosorbent assay. The primary endpoint was progression-free survival (PFS).
RESULTS
In patients with baseline PDGF-AA ≥ median, median PFS was significantly worse in the TSU-68 plus docetaxel group than in the docetaxel alone group (5.4 months vs. 13.7 months, p=0.049), while a trend toward a PFS benefit was observed in those with baseline PDGF-AA < median (9.7 months vs. 4.0 months, p=0.18; p for interaction=0.03). In the TSU-68 plus docetaxel group, PFS showed significant association with fold changes in CRP (p=0.001), IL-6 (p < .001), PDGF-BB (p=0.02), and VEGF (p=0.047) following the first treatment cycle.
CONCLUSION
Baseline PDGF-AA levels and dynamics of VEGF, PDGF-BB, CRP, and IL-6 levels were predictive for the efficacy of TSU-68.
目的
本研究在先前的一项II期试验中分析了血浆生物标志物TSU-68的作用，该试验比较了TSU-68联合多西他赛与单纯多西他赛治疗转移性乳腺癌患者的疗效。
材料与方法
共有77例患者符合本研究条件（TSU-68联合多西他赛组38例，单纯多西他赛组39例）。在每个周期开始前采集血样，采用酶联免疫吸附测定法检测血管内皮生长因子（VEGF）、血小板衍生生长因子（PDGF）-AA、-AB、-BB、成纤维细胞生长因子、M30、C反应蛋白（CRP）和白细胞介素6（IL-6）水平。主要终点为无进展生存期（PFS）。
结果
在基线PDGF-AA≥中位数的患者中，TSU-68联合多西他赛组的中位PFS显著低于单纯多西他赛组（5.4个月对13.7个月，p=0.049），而在基线PDGF-AA<中位数的患者中观察到PFS获益的趋势（9.7个月对4.0个月，p=0.18；交互作用p=0.03）。在TSU-68联合多西他赛组中，PFS与第一个治疗周期后CRP（p=0.001）、IL-6（p<.001）、PDGF-BB（p=0.02）和VEGF（p=0.047）的变化倍数显著相关。
结论
基线PDGF-AA水平以及VEGF、PDGF-BB、CRP和IL-6水平的动态变化可预测TSU-68的疗效。
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