A phase III trial of adjuvant ribociclib plus endocrine therapy versus endocrine therapy alone in patients with HR-positive/HER2-negative early breast cancer: final invasive disease-free survival results from the NATALEE trial.

This is the final preplanned analysis of invasive disease-free survival (iDFS).

这是对侵袭性疾病无复发生存期（iDFS）的最终预先计划分析。

patients_and_methods

Premenopausal/postmenopausal women and men were randomized 1 : 1 to ribociclib (n = 2549; 400 mg/day, 3 weeks on/1 week off for 36 months) plus NSAI (letrozole 2.5 mg/day or anastrozole 1 mg/day for 60 months) or NSAI alone (n = 2552).

绝经前/绝经后女性和男性按1:1的比例随机分配至利博西利（n = 2549；每日400毫克，连续3周后停药1周，持续36个月）联合NSAI（来曲唑2.5毫克/天或阿那曲唑1毫克/天，持续60个月）或仅接受NSAI治疗（n = 2552）。

Men and premenopausal women also received goserelin (3.6 mg once every 28 days).

男性和绝经前女性还接受了戈舍瑞林（每28天一次，3.6毫克）。

Patients had anatomical stage IIA (N0 with additional risk factors or N1), IIB, or III disease.

患者具有解剖学分期IIA（N0伴有额外风险因素或N1）、IIB或III期疾病。

The primary endpoint was iDFS.

主要终点是无病生存期（iDFS）。

Secondary efficacy endpoints were recurrence-free survival (RFS), distant DFS, and overall survival. This final iDFS analysis was planned after ∼500 events.

次要疗效终点包括无复发生存期（RFS）、远处无病生存期（DFS）和总生存期。此次最终无进展生存期（iDFS）分析计划在约500个事件发生后进行。

Results

At data cut-off (21 July 2023), ribociclib was stopped for 1996 patients (78.3%); 1091 (42.8%) completed 3 years of ribociclib, and ribociclib treatment was ongoing for 528 (20.7%).

截至数据截止日期（2023年7月21日），1996名患者（78.3%）已停止使用利布西利布；1091名患者（42.8%）完成了3年的利布西利布治疗，而528名患者（20.7%）仍在接受利布西利布治疗。

Median follow-up for iDFS was 33.3 months.

iDFS的中位随访时间为33.3个月。

Overall, 226 and 283 iDFS events occurred with ribociclib plus NSAI versus NSAI alone, respectively.

总体而言，与单独使用NSAI相比，联合使用ribociclib加NSAI的iDFS事件分别为226和283。

Ribociclib plus NSAI demonstrated significant iDFS benefit over NSAI alone [hazard ratio0.749, 95% confidence interval(CI) 0.628-0.892; P = 0.0012].

与单独使用NSAI相比，Ribociclib联合NSAI显示出显著的无侵袭性疾病生存(iDFS)获益[风险比为0.749，95%置信区间(CI)为0.628-0.892；P = 0.0012]。

The 3-year iDFS rates were 90.7% (95% CI 89.3% to 91.8%) versus 87.6% (95% CI 86.1% to 88.9%).

3年iDFS率分别为90.7%（95% CI 89.3%至91.8%）与87.6%（95% CI 86.1%至88.9%）。

A consistent benefit was observed across prespecified subgroups, including stage (II/III) and nodal status (positive/negative).

在预先设定的亚组中观察到一致的益处，包括分期（II/III）和淋巴结状态（阳性/阴性）。

Distant DFS and RFS favored ribociclib plus NSAI.

远处无病生存期（Distant DFS）和无复发生存期（RFS）倾向于利博西利联合NSAI。

Overall survivaldata were immature.

总生存数据尚不成熟。

No new safety signals were observed.

未观察到新的安全信号。

Conclusions

With longer follow-up and most patients off ribociclib, NATALEE continues to demonstrate iDFS benefit with ribociclib plus NSAI over NSAI alone in the overall population and across key subgroups.

随着更长时间的随访和大多数患者停用利博西利，NATALEE 研究继续显示，在整体人群以及关键亚组中，利博西利联合NSAI（非甾体芳香酶抑制剂）相比仅使用NSAI，对无侵袭性疾病生存（iDFS）有持续的益处。

Observed adverse events remained stable.

观察到的不良事件保持稳定。