未经证实:临床前研究表明他汀类药物可能具有抗癌作用,但在乳腺癌患者中联合使用他汀类药物与标准化疗方案的协同作用尚未得到研究.
UNASSIGNED:本研究旨在评估乳腺癌患者与新辅助化疗方案同时使用匹伐他汀的疗效。
UNASSIGNED:本研究是一项随机对照临床试验。共有70例经病理证实的浸润性乳腺癌的成年女性患者被随机分配接受或不接受匹伐他汀(2mg)口服片剂,每天一次,并伴随标准的新辅助化疗方案,持续6个月。这项研究的主要结果是肿瘤大小的变化和Ki67指数的变化。此外,次要结局是cyclinD1和caspase-3血清水平的变化.本研究在ClinicalTrials.gov注册(标识符:NCT04705909)。
UNASSIGNED:与对照组[-5.0(-15.5,0.0)相比,匹伐他汀组患者的肿瘤大小中位数(IQR)减少幅度显著高于对照组[-19.8(-41.5,9.5)],p=0.0009]。Ki67从基线到治疗结束的变化在两组之间相似(p=0.12)。在治疗结束时,匹伐他汀组cyclinD1水平显著下降[中位数(IQR)变化-10.0(-20.2,-2.9)从基线],而对照组显示细胞周期蛋白D1水平升高[14.8(4.1,56.4)]。匹伐他汀组的中位数(IQR)caspase-3升高1.6(0.2,2.2),对照组下降(-0.2(-1.1,0.0),p=0.0002)。匹伐他汀组的亚组分析显示,人表皮生长受体2(HER2)阳性患者的Ki67减少中位数(IQR)[-35.0(-70.0,-12.5)]高于HER2阴性患者[2.5(-15.0,10.0),p=0.04]。所有获得完全病理应答的患者(n=9)在基线时表现出HER2-neu阳性受体。
UNASSIGNED:与标准新辅助化疗方案同时使用匹伐他汀可能会改善乳腺癌患者的新辅助化疗反应。
UNASSIGNED: Preclinical studies have demonstrated the possible anticancer effects of statins, but the synergistic effect of concomitant statin use with standard chemotherapy protocols in patients with breast cancer has not yet been investigated.
UNASSIGNED: The current
study aimed to evaluate the efficacy of concomitant pitavastatin use with neoadjuvant chemotherapy protocols in patients with breast cancer.
UNASSIGNED: This
study was a randomized controlled clinical
trial. A total of 70 adult female patients with pathologically-proven invasive breast cancer were randomized to receive or not receive pitavastatin (2 mg) oral tablets once daily concomitantly with standard neoadjuvant chemotherapy protocols for 6 months. The primary outcomes of this
study were changes in tumor size and changes to the Ki67 index. In addition, secondary outcomes were changes in cyclin D1 and cleaved caspase-3 serum levels. This
study was registered at ClinicalTrials.gov (Identifier: NCT04705909).
UNASSIGNED: Patients in the pitavastatin group showed significantly higher median (IQR) reductions in tumor size [-19.8 (-41.5, 9.5)] compared to those in the control group [-5.0 (-15.5, 0.0), p = 0.0009]. The change in Ki67 from baseline to the end of therapy was similar between the two groups (p = 0.12). By the end of therapy, the cyclin D1 levels in the pitavastatin group were significantly decreased [median (IQR) change of - 10.0 (-20.2, -2.9) from baseline], whereas the control group showed an increase in cyclin D1 levels [14.8 (4.1, 56.4)]. The median (IQR) caspase-3 was elevated in the pitavastatin group 1.6 (0.2, 2.2), and decreased in the control group (-0.2 (-1.1, 0.0), p = 0.0002).Subgroup analysis of the pitavastatin group revealed that patients with positive human epidermal growth receptor 2 (HER2) had higher median (IQR) reductions in Ki67 [-35.0 (-70.0, -12.5)] than those with negative HER2 [2.5 (-15.0, 10.0), p = 0.04]. All patients who achieved a complete pathological response (n = 9) exhibited an HER2-neu positive receptor at baseline.
UNASSIGNED: Concomitant use of pitavastatin with standard neoadjuvant chemotherapy protocols may improve neoadjuvant chemotherapy responses in patients with breast cancer.