本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2305488

摘要内容如下：

背景

在激素受体（HR）阳性、人类表皮生长因子受体2（HER2）阴性的晚期乳腺癌患者中，Ribociclib已被证明具有显著的总体生存获益。这种对晚期乳腺癌的益处是否会延伸到早期乳腺癌尚不清楚。

方法

在这项国际、开放标签、随机、3期试验中，我们将HR阳性、HER2阴性的早期乳腺癌患者按1:1的比例随机分配接受ribociclib（剂量为每天400 mg，持续3周，然后停药1周，持续3年）加非甾体类芳香化酶抑制剂（NSAI；每天2.5 mg剂量的来曲唑或每天1 mg剂量的阿那曲唑，持续≥5年）或单独使用NSAI。绝经前女性和男性也接受戈舍瑞林治疗，每28天一次。符合条件的患者为解剖学II期或III期乳腺癌。在此，我们报告了一项预先指定的无侵袭性疾病生存率（主要终点）的中期分析结果。还报告了其他疗效和安全性结果。使用Kaplan-Meier方法评估侵袭性无病生存率。使用分层对数秩检验进行统计学比较，方案规定的终止边界为单侧p值阈值0.0128，以获得更好的疗效。

结果

截至该预先指定的中期分析的数据截止日期（2023年1月11日），共有426名患者患有侵袭性疾病、复发或死亡。与单独使用NSAI相比，ribociclib联合NSAI具有显著的侵袭性无病生存益处。3年时，ribociclib联合NSAI组的无侵袭性疾病生存率为90.4%，而单独使用NSAI组为87.1%（侵袭性疾病、复发或死亡的风险比为0.75；95%置信区间，0.62至0.91；P=0.00 3）。次要终点——远期无病生存期和无复发生存期——也有利于ribociclib+NSAI。Ribociclib的3年方案（起始剂量为400 mg）加上NSAI与任何新的安全性信号无关。

结论

在HR阳性、HER2阴性的II期或III期早期乳腺癌患者中，ribociclib联合NSAI显著提高了侵袭性无病生存率。（由诺华公司资助；Natalee ClinicalTrials.gov编号，NCT03701334。）

英文原文如下：

Abstracts

BACKGROUND  Ribociclib has been shown to have a significant overall survival benefit in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether this benefit in advanced breast cancer extends to early breast cancer is unclear.

METHODS  In this international, open-label, randomized, phase 3 trial, we randomly assigned patients with HR-positive, HER2-negative early breast cancer in a 1:1 ratio to receive ribociclib (at a dose of 400 mg per day for 3 weeks, followed by 1 week off, for 3 years) plus a nonsteroidal aromatase inhibitor (NSAI; letrozole at a dose of 2.5 mg per day or anastrozole at a dose of 1 mg per day for ≥5 years) or an NSAI alone. Premenopausal women and men also received goserelin every 28 days. Eligible patients had anatomical stage II or III breast cancer. Here we report the results of a prespecified interim analysis of invasive disease-free survival, the primary end point; other efficacy and safety results are also reported. Invasive disease-free survival was evaluated with the use of the Kaplan-Meier method. The statistical comparison was made with the use of a stratified log-rank test, with a protocol-specified stopping boundary of a one-sided P-value threshold of 0.0128 for superior efficacy.

RESULTS  As of the data-cutoff date for this prespecified interim analysis (January 11, 2023), a total of 426 patients had had invasive disease, recurrence, or death. A significant invasive disease-free survival benefit was seen with ribociclib plus an NSAI as compared with an NSAI alone. At 3 years, invasive disease-free survival was 90.4% with ribociclib plus an NSAI and 87.1% with an NSAI alone (hazard ratio for invasive disease, recurrence, or death, 0.75; 95% confidence interval, 0.62 to 0.91; P = 0.003). Secondary end points - distant disease-free survival and recurrence-free survival - also favored ribociclib plus an NSAI. The 3-year regimen of ribociclib at a 400-mg starting dose plus an NSAI was not associated with any new safety signals.

CONCLUSIONS  Ribociclib plus an NSAI significantly improved invasive disease-free survival among patients with HR-positive, HER2-negative stage II or III early breast cancer. (Funded by Novartis; NATALEE ClinicalTrials.gov number, NCT03701334.).

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