https://scholars.lib.ntu.edu.tw/handle/123456789/494539
標題: | Overall survival with ribociclib plus endocrine therapy in breast cancer | 作者: | Im S.-A YEN-SHEN LU Bardia A Harbeck N Colleoni M Franke F Chow L Sohn J Lee K.-S Campos-Gomez S Villanueva-Vazquez R Jung K.-H Chakravartty A Hughes G Gounaris I Rodriguez-Lorenc K Taran T Hurvitz S Tripathy D. |
公開日期: | 2019 | 出版社: | Massachussetts Medical Society | 卷: | 381 | 期: | 4 | 起(迄)頁: | 307-316 | 來源出版物: | New England Journal of Medicine | 摘要: | BACKGROUND: An earlier analysis of this phase 3 trial showed that the addition of a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor to endocrine therapy provided a greater benefit with regard to progression-free survival than endocrine therapy alone in premenopausal or perimenopausal patients with advanced hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Here we report the results of a protocol-specified interim analysis of the key secondary end point of overall survival. METHODS: We randomly assigned patients to receive either ribociclib or placebo in addition to endocrine therapy (goserelin and either a nonsteroidal aromatase inhibitor or tamoxifen). Overall survival was evaluated with the use of a stratified log-rank test and summarized with the use of Kaplan-Meier methods. RESULTS: A total of 672 patients were included in the intention-to-treat population. There were 83 deaths among 335 patients (24.8%) in the ribociclib group and 109 deaths among 337 patients (32.3%) in the placebo group. The addition of ribociclib to endocrine therapy resulted in significantly longer overall survival than endocrine therapy alone. The estimated overall survival at 42 months was 70.2% (95% confidence interval [CI], 63.5 to 76.0) in the ribociclib group and 46.0% (95% CI, 32.0 to 58.9) in the placebo group (hazard ratio for death, 0.71; 95% CI, 0.54 to 0.95; P = 0.00973 by log-rank test). The survival benefit seen in the subgroup of 495 patients who received an aromatase inhibitor was consistent with that in the overall intention-to-treat population (hazard ratio for death, 0.70; 95% CI, 0.50 to 0.98). The percentage of patients who received subsequent antineoplastic therapy was balanced between the groups (68.9% in the ribociclib group and 73.2% in the placebo group). The time from randomization to disease progression during receipt of second-line therapy or to death was also longer in the ribociclib group than in the placebo group (hazard ratio for disease progression or death, 0.69; 95% CI, 0.55 to 0.87). CONCLUSIONS: This trial showed significantly longer overall survival with a CDK4/6 inhibitor plus endocrine therapy than with endocrine therapy alone among patients with advanced hormone-receptor-positive, HER2-negative breast cancer. No new concerns regarding toxic effects emerged with longer follow-up. Copyright ? 2019 Massachusetts Medical Society. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85068361995&doi=10.1056%2fNEJMoa1903765&partnerID=40&md5=9662deb6f393d06444b269f6b0269223 https://scholars.lib.ntu.edu.tw/handle/123456789/494539 |
ISSN: | 0028-4793 | DOI: | 10.1056/NEJMoa1903765 | SDG/關鍵字: | anastrozole; aromatase inhibitor; goserelin; hormone receptor; letrozole; placebo; ribociclib; tamoxifen; aminopyridine derivative; antineoplastic agent; aromatase inhibitor; cyclin dependent kinase; epidermal growth factor receptor 2; ERBB2 protein, human; estrogen receptor; progesterone receptor; protein kinase inhibitor; purine derivative; ribociclib; tamoxifen; adult; antineoplastic activity; Article; breast cancer; cancer hormone therapy; cancer recurrence; cancer survival; comparative effectiveness; controlled study; disease exacerbation; double blind procedure; female; follow up; hepatobiliary disease; human; human epidermal growth factor receptor 2 negative breast cancer; major clinical study; metastasis; multiple cycle treatment; neutropenia; overall survival; phase 3 clinical trial; premenopause; priority journal; progression free survival; QT prolongation; randomized controlled trial; antagonists and inhibitors; breast tumor; climacterium; clinical trial; comparative study; intention to treat analysis; middle aged; mortality; survival analysis; Adult; Aminopyridines; Antineoplastic Combined Chemotherapy Protocols; Aromatase Inhibitors; Breast Neoplasms; Cyclin-Dependent Kinases; Double-Blind Method; Female; Follow-Up Studies; Humans; Intention to Treat Analysis; Middle Aged; Perimenopause; Premenopause; Protein Kinase Inhibitors; Purines; Receptor, ErbB-2; Receptors, Estrogen; Receptors, Progesterone; Survival Analysis; Tamoxifen |
顯示於: | 醫學院附設醫院 (臺大醫院) |
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