Clin Cancer Res:瑞博西尼(ribociclib)联合依西美坦+依维莫司治疗CDK4/6抑制剂治疗进展的HR+/HER2-晚期乳腺癌的疗效和安全性:I/II期TRINITI-1研究

2021-06-27 yd2015 MedSci原创

TRINITI-1研究表明,对于CDK4/6抑制剂(CDK4/6i)治疗后进展的内分泌耐药HR+/HER2-晚期乳腺癌患者,对CDK4/6和PI3K/AKT/mTOR通路的阻滞显示出抗肿瘤疗效和安全性

对于激素受体阳性(HR+)、HER2阴性(HER2-)的转移性乳腺癌,目前推荐的标准治疗为内分泌治疗(ET)联合CDK4/6抑制剂(CDK4/6i)。但是,对于CDK4/6i治疗后进展的最优治疗尚不清楚。来自美国研究团队开展了TRINITI-1临床研究,评估CDK4/6i治疗HR+/HER2-晚期乳腺癌患者后进展,使用瑞博西尼(ribociclib)联合依西美坦+依维莫司的疗效和安全性。相关成果发表在CLINICAL CANCER RESEARCH杂志上。

这是多中心、开放标签的I/II期临床研究。I期研究确定瑞博西尼(ribociclib)、依西美坦和依维莫司的最大耐受剂量(MTD),定义为<30%患者出现剂量限制性毒性。之后进行II期临床研究,评估疗效。主要研究终点为第24周的临床获益率(CBR),次要终点为PFS、OS、客观缓解率和安全性。

共纳入104例内分泌耐药患者(均为女性),其中25例为纳入I期研究,79例纳入II期研究。其中既往接受过CDK4/6i治疗的患者有96例,基线中位年龄为58岁,大部分患者为白种人(81.3%),ECOG PS 0 (57.3%),既往中位内分泌治疗线数为1(范围,1-4)。最终II研究推荐剂量为瑞博西尼(ribociclib)300 mg, 依维莫司2.5 mg,and 依西美坦25 mg (group 1) 和 瑞博西尼(ribociclib)200 mg, 依维莫司 5 mg, and依西美坦25 mg (group 2)。均为每天口服,d1-d28,28天一周期。

                   研究概况

95例既往内分泌治疗耐药的患者可进行疗效评估,第24周的CBR为41.1% (95% CI, 31.1–51.6)。group 1剂量治疗和group 2剂量治疗的第24周CBRs 比较接近,分别为44.2% (95% CI, 27.0–56.8) 和37.9% (95% CI, 18.6–53.2)。

              疗效评估

疗效评估人群中,中位随访时间为3.1个月,中位PFS为5.7个月(95% CI, 3.6–9.1个月);1年PFS率为33.4% (95% CI, 22.8%–44.4%)。数据分析时中位OS尚未达到。

                     PFS

104例患者进行安全性评估,最常见的血液学不良事件(AEs)(也是总体人群最常见的AEs)是中性粒细胞减少(所有级别为69.2%; 3/4级为51.0%)。另外常见的血液学或实验室异常包括贫血(所有级别为28.8%; 3/4级为9.6%)和血小板减少(所有级别为27.9%; 3/4级为1.0%)。3/4级低磷血症和高血糖发生率分别为5.8%和6.7%。3/4级谷氨酰转移酶、天冬氨酸转氨酶(AST)和丙氨酸转氨酶(ALT)升高的发生率分别为1.9%、1.0%和0%。最常见的非血液学AEs是口腔炎(所有级别为40.4%; 3/4级为2.9%)。任何级别恶心、腹泻的发生率分别为33.7%(3/4级为1.9%)和27.9%(3/4级为1.9%)。没有3/4级 QTc延长的报道。

                  不良事件

综上,TRINITI-1研究表明,对于CDK4/6抑制剂(CDK4/6i)治疗后进展的内分泌耐药HR+/HER2-晚期乳腺癌患者,对CDK4/6和PI3K/AKT/mTOR通路的阻滞显示出抗肿瘤疗效和安全性,值得进一步探索。

原始出处:

Aditya Bardia, Sara A Hurvitz, Angela DeMichele, et al. Phase I/II Trial of Exemestane, Ribociclib, and Everolimus in Women with HR +/HER2 - Advanced Breast Cancer after Progression on CDK4/6 Inhibitors (TRINITI-1). Clin Cancer Res. 2021 Mar 15.  doi: 10.1158/1078-0432.CCR-20-2114.  Online ahead of print.

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    2021-10-17 jklm09
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    2021-09-17 luwei00
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    2021-11-17 soongzhihua
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    2021-06-29 zhouqu_8
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    2021-06-29 zhangj7111
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    2021-06-27 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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