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Ann Oncol:Tucatinib(图卡替尼)或安慰剂联合曲妥珠单抗+卡培他滨治疗经治晚期HER2+乳腺癌患者的疗效

2022-02-03 yd2015 MedSci原创

研究表明,延长随访时间,tucatinib(图卡替尼)联合用药仍持续改善HER2+转移性乳腺癌患者的预后。

HER2CLIMB研究是一项随机、双盲、安慰剂对照试验。纳入既往经治局部晚期或转移性HER2+乳腺癌患者,包括脑转移患者。随机2:1分配至 tucatinib(图卡替尼)或安慰剂联合曲妥珠单抗+卡培他滨治疗。初步分析结果表明,tucatinib(图卡替尼)联合曲妥珠单抗+卡培他滨治疗改善患者的预后。近期,Annals of Oncology杂志上更新了HER2CLIMB研究的最终OS结果。

HER2CLIMB研究纳入612名患者,其中 48%患者基线伴有脑转移。中位随访OS为29.6个月(比初步分析多了15.6个月)。Tucatinib(图卡替尼)联合治疗组的中位OS持续时间为24.7个月(95% CI: 21.6-28.9个月),而安慰剂联合治疗组的中位OS持续时间为19.2个月(95% CI: 16.4-21.4个月)(HR: 0.73, 95% CI: 0.59-0.90, P= 0.004)。Tucatinib联合组2年OS率为51% (95% CI: 46% - 56%),安慰剂联合组为40% (95% CI: 33% - 47%)。

              OS差异

所有亚组的OS获益均偏向于Tucatinib联合组,并与整个研究人群的一致。

              OS亚组分析

Tucatinib(图卡替尼)联合治疗组的中位无进展生存期(PFS)为7.6个月(95% CI: 6.9-8.3个月),而安慰剂联合治疗组为4.9个月(95% CI: 4.1-5.6个月)(HR: 0.57, 95% CI: 0.47-0.70, P<0.00001)。Tucatinib联合组1年PFS率为29% (95% CI: 24%-34%),安慰剂联合组为14% (95% CI: 9%-20%)。

               PFS差异

Tucatinib(图卡替尼)联合用药耐受性良好,因不良事件停药率低。

                不良反应

综上,研究表明,延长随访时间,tucatinib(图卡替尼)联合用药仍持续改善HER2+转移性乳腺癌患者的预后。

原始出处:

Curigliano G, Mueller V, Borges V, Hamilton E, Hurvitz S, Loi S, Murthy R, Okines A, Paplomata E, Cameron D, Carey LA, Gelmon K, Hortobagyi GN, Krop I, Loibl S, Pegram M, Slamon D, Ramos J, Feng W, Winer E. Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis. Ann Oncol. 2021 Dec 23:S0923-7534(21)04879-1. doi: 10.1016/j.annonc.2021.12.005. Epub ahead of print. PMID: 34954044.

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    2022-03-26 minlingfeng
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