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接受瑞博西尼联合内分泌治疗的乳腺癌患者总生存期
Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer


Seock-Ah Im ... 肿瘤 • 2019.07.25
相关阅读
• 瑞博西尼对HR阳性晚期乳腺癌一线治疗的研究

摘要


背景

之前对本3期试验所做的分析表明,对于患激素受体阳性、人表皮生长因子受体2(HER2)阴性晚期乳腺癌的绝经前或围绝经期患者,与单独采用内分泌治疗相比,在内分泌治疗的基础上加用细胞周期蛋白依赖性激酶4和6(CDK4/6)抑制剂使患者在无进展生存期方面有更大获益。我们在本文中报告了对关键次要终点总生存期进行研究方案规定的期中分析之后获得的结果。

 

方法

我们将患者随机分组,分别在内分泌治疗(戈舍瑞林联合非甾体芳香化酶抑制剂或联合他莫昔芬)的基础上加用瑞博西尼(ribociclib)或安慰剂。采用分层时序检验评估了总生存期,采用Kaplan-Meier方法对其进行了总结。

 

结果

共有672例患者被纳入意向治疗人群。瑞博西尼组335例患者中有83例死亡(24.8%),安慰剂组337例患者中有109例死亡(32.3%)。瑞博西尼联合内分泌治疗的患者总生存期显著超过单独内分泌治疗。瑞博西尼组和安慰剂组在42个月时的估计总生存率分别为70.2%(95%置信区间[CI],63.5%~76.0%)和46.0%(95% CI,32.0%~58.9%)(死亡的风险比,0.71;95% CI,0.54~0.95;时序检验P=0.00973)。在接受芳香化酶抑制剂治疗的495例患者组成的亚组中,我们观察到的生存获益与整体意向治疗人群一致(死亡的风险比,0.70;95% CI,0.50~0.98)。两组中接受后续抗肿瘤治疗的患者百分比平衡(瑞博西尼组68.9%,安慰剂组73.2%)。与安慰剂组相比,瑞博西尼组从随机分组至二线治疗期间疾病进展或至死亡的时间较长(疾病进展或死亡的风险比,0.69;95% CI,0.55~0.87)。

 

结论

此项试验表明,激素受体阳性、HER2阴性晚期乳腺癌患者接受CDK4/6抑制剂联合内分泌治疗的总生存期显著超过单独接受内分泌治疗。随着随访时间的延长,在毒性作用方面并未出现新的问题(由诺华公司资助;MONALEESA-7在ClinicalTrials.org注册号为NCT02278120)。





作者信息

Seock-Ah Im, M.D., Ph.D., Yen-Shen Lu, M.D., Ph.D., Aditya Bardia, M.D., Nadia Harbeck, M.D., Ph.D., Marco Colleoni, M.D., Fabio Franke, M.D., Louis Chow, M.D., Joohyuk Sohn, M.D., Keun-Seok Lee, M.D., Ph.D., Saul Campos-Gomez, M.D., Rafael Villanueva-Vazquez, M.D., Kyung-Hae Jung, M.D., Arunava Chakravartty, Ph.D., Gareth Hughes, Ph.D., Ioannis Gounaris, M.D., Ph.D., Karen Rodriguez-Lorenc, M.D., Tetiana Taran, M.D., Sara Hurvitz, M.D., and Debu Tripathy, M.D.
From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) — all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d’Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.). Address reprint requests to Dr. Tripathy at the University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd., Unit 1354, Houston, TX 77030, or at dtripathy@mdanderson.org.

 

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