肿瘤药学2022年12月第12卷第6期Anti-tumor Pharmacy,December 2022,Vol.12,No.6乳腺癌专栏D0I:10.3969/i.issm.2095-1264.2022.06.01文章编号：2095-1264(2022)06-0685-05内分泌优先原则在靶向治疗时代仍然适用？SYSUCC-002研究解读袁中玉(中山大学肿澹防治中心内科，广东广州，510060)摘要：微素受体(HR)阳性伴人表皮生长固子受体2(HER2)阳性乳藤癌(HR+/HER2+乳藤癌)是相对特殊的分子亚型，目前暂无HR+HER2+晚期乳腺癌一线治疗方案选择的临床证据。为此，研究者开晨了SYSUCC-002研究。SYSUCC-002研究是一项多中心、开放、随机、非劣效、Ⅲ期临床研究(NCT01950182),旨在比较内分汝治疗联合靶向治疗对比化疗联合粑向治疗两种治疗方式的有效性和安全性。该研究共入组392例HR+/HER24晚期乳腺癌患者，按照1：1随机分为内分泌治疗组(ET组)（内分泌治疗+曲妥珠单抗）和化疗组(CT组)（紫杉醇、卡培他滨或长森瑞滨+曲妥珠单抗)。研究的主要终点为无进展生存时间(PFS),危险比(HR)的非劣效性上限为1.35。研究的主要终点结果显示，CT组和ET组患者的中位PFS分别为19.2个月和14.8个月，HR为0.88(95%C:0.71~1.09)(1ognkP=0.250)。研究的次要终点结采显示，两组患者OS无显著差异。进一步亚组分析显示，影响PFS的主要因素是无病间期(DFI),对于DFI24个月的患者采用CT方案PFS更优，而DFH>24个月的患者采用ET方案PFS更优(P=0.016)。对于HR+/HER2+晚期乳撩癌患者，曲妥珠单抗联合内分泌治疗的疗效不亚于曲妥珠单抗联合化疗，且毒性更低，有更好的时受性。随着双靶时代的到来，内分泌优先原则这一治疗理念将继续指导临床医生作出决策。关键词：乳藤癌；人表皮生长固子受体2阳性；激素受体阳性；一线治疗；曲妥珠单抗联合内分泌治疗中图分类号：R737.9文献标识码：AIs endocrine priority still relevant in the era of targeted therapy?-SYSUCC-002 research interpretationYUAN Zhongyu(Medical Department,Sun Yat-sen University Cancer Center,Guangzhou,510060,Guangdong,China)Abstract:Hormone receptor (HR)-positive breast cancer with human epidermal growth factor receptor 2(HER2)-posi-tive breast cancer(HR+/HER2+breast cancer)is a relatively specific molecular subtype.There is currently no clinical evi-dence for first-line treatment of HR+/HER2+advanced breast cancer.For this purpose,the SYSUCC-002 study was con-ducted.SYSUCC002 is a multicenter,open,mandomized,non-inferiority,phase l clinical study (NCT01950182)designed tocompare the efficacy and safety of endocrine therapy combined with targeted therapy versus chemotherapy combined withtargeted therapy.392 patients with HR+/HER2+advanced breast cancer were randomized 1:I into endocrine therapy(ET)group [endocrine therapy trastuzmab]and chemotherapy (CT)group (paclitaxel,capecitabine or vinrelbine +trastuzum-ab).The primary endpoint was progression-free survival(PFS)with a hazard ratio (HR)non-inferiority upper limit of 1.35.The primary endpoint results showed that the median PFS in the CT and ET groups were 19.2 months and 14.8 months,re-spectively,HR 0.88(95%Cl:0.71~1.09)(log-rank P=0.250).Secondary endpoint results of the study showed no differencein OS between the two gmups.Further subgroup analysis showed that the main factor affecting PFS was disease-free interval(DFD).For patients with DFIs24 months,those in CT group had better PFS,whereas for patients with DF1>24 months,those作者简介：袁中玉，男，医学博士，教授，主任医师，研究方向：乳腺癌。(C)1994-2023 China Academic Journal Electronic Publishing House.All rights reserved.http://www.cnki.net-685
