Palbociclib with adjuvant endocrine therapy in early breast cancer: 5-year follow-up analysis of the global multicenter, open-label, randomized phase III PALLAS trial (ABCSG-42/AFT-05/PrE0109/BIG-14-13).

In this article, we report 5-year efficacy outcomes, including updated iDFS and overall survival(OS).

在这篇文章中，我们报告了5年的疗效结果，包括更新的iDFS和总生存（OS）。

patients_and_methods

PALLAS is an international, open-label, randomized phase III trial evaluating the addition of 2 years of palbociclib to adjuvant ET in patients with stage II-III HR-positive/HER2-negative breast cancer.

PALLAS 是一项国际性的、开放标签的、随机III期试验，评估了在辅助内分泌治疗（ET）中加入2年帕博西利对于II-III期激素受体阳性/HER2阴性乳腺癌患者的影响。

The primary endpoint was iDFS.

主要终点是无侵袭性疾病生存期（iDFS）。

Results

The trial enrolled 5753 patients, with 2883 randomized to receive palbociclib plus ET and 2870 to receive ET alone.

该试验共招募了5753名患者，其中2883名随机接受帕博西利联合内分泌治疗（ET），2870名仅接受内分泌治疗（ET）。

With a median follow-up of 59.8 months, the 5-year iDFS was 84.2% [95% confidence interval(CI) 82.7% to 85.6%] in the palbociclib plus ET arm and 82.4% (95% CI 80.8% to 83.9%) in the ET-alone arm [hazard ratio(HR) 0.88, 95% CI 0.77-1.01, log-rank P = 0.0614].

随访中位时间为59.8个月，帕博西利联合内分泌治疗组的5年无侵袭性疾病生存（iDFS）率为84.2%（95%置信区间[CI] 82.7%至85.6%），而仅接受内分泌治疗组的5年iDFS率为82.4%（95% CI 80.8%至83.9%）[风险比（HR）0.88，95% CI 0.77-1.01，对数秩检验P = 0.0614]。

No significant iDFS benefit of palbociclib was observed in any subgroup, including analyses by anatomic stage, T-stage, N-stage, tumor grade, prior (neo)adjuvant chemotherapy, age, or clinical risk.

在包括解剖分期、T分期、N分期、肿瘤分级、先前的新辅助或辅助化疗、年龄或临床风险在内的任何亚组中，未观察到帕博西利显著的无病生存期（iDFS）获益。

The 5-year OS was 92.6% (95% CI 91.5% to 93.6%) in the palbociclib plus ET arm and 93.2% (95% CI 92.1% to 94.1%) in the ET-alone arm (HR 1.09, 95% CI 0.89-1.33, log-rank P = 0.4051).

帕博西利联合内分泌治疗（ET）组的5年总生存（OS）率为92.6%（95%置信区间91.5%至93.6%），而仅接受内分泌治疗（ET）组的5年总生存（OS）率为93.2%（95%置信区间92.1%至94.1%）（风险比HR 1.09，95%置信区间0.89-1.33，对数秩检验P = 0.4051）。

More patients in the ET-alone arm (65.7%) than in the palbociclib plus ET arm (33.0%) received cyclin-dependent kinase 4/6 inhibitors after recurrence.

在ET单独治疗组中，有65.7%的患者在复发后接受了细胞周期依赖性激酶4/6抑制剂治疗，而在帕博西利联合ET治疗组中这一比例为33.0%。

Conversely, more patients in the palbociclib plus ET arm (52.5%) than in the ET-alone arm (41.0%) received chemotherapy after recurrence.

相反，在帕博西利联合ET治疗组中，有52.5%的患者在复发后接受了化疗，而在ET单独治疗组中这一比例为41.0%。

Conclusions

In conclusion, 5-year follow-up from the PALLAS trial confirms initially reported results.

总之，来自PALLAS试验的5年随访结果确认了最初报告的结果。

These long-term findings will provide investigators with important benchmarks for clinical outcomes in the contemporary management of HR-positive/HER2-negative breast cancer, and may be further used to guide adjuvant therapy for patients with high-risk early-stage HR-positive/HER2-negative breast cancer.

这些长期发现将为研究者提供重要基准，用于评估当前HR阳性/HER2阴性乳腺癌的临床结果，并且可以进一步用于指导高风险早期HR阳性/HER2阴性乳腺癌患者的辅助治疗。