Neoadjuvant Abemaciclib plus Letrozole Versus Chemotherapy in Patients with HR+/HER2- Highly Proliferative Breast Cancer.

This study evaluates whether 12 months of letrozole plus abemaciclib could be an alternative.

本研究评估了12个月的来曲唑加阿贝西利是否可以作为一种替代方案。

patients_and_methods

The phase II, open-label CARABELA trial randomized patients with HR+/HER2- stage II to III breast cancer with Ki-67 ≥20% to receive letrozole/abemaciclib for 12 months or chemotherapy for 6 months.

II期、开放标签的CARABELA试验对HR+/HER2- II至III期乳腺癌患者进行了随机分组，这些患者的Ki-67≥20%，他们被随机分配接受12个月的来曲唑/阿贝西利治疗或6个月的化疗。

Patients were stratified by menopausal status, tumor-node-metastasis, and Ki-67 index (<30% vs. ≥30%).

患者根据绝经状态、肿瘤-淋巴结-转移情况以及Ki-67指数（<30% vs. ≥30%）进行分层。

The primary endpoint was the rate of residual cancer burden (RCB) 0 to I.

主要终点是残余癌负荷（RCB）0至I级的比率。

Secondary endpoints included clinical response rate (CRR) and correlations of Ki-67 and recurrence score (RS) with tumor response.

次要终点包括临床反应率（CRR）以及Ki-67和复发评分（RS）与肿瘤反应的相关性。

A Bayesian design aimed to assess treatment similarity.

贝叶斯设计旨在评估治疗相似性。

Results

A total of 200 patients (median age 53 years, 57% postmenopausal, 79% stage II, 77% Ki-67 ≥30%, 58% RS ≥26) were randomized.

共有200名患者（中位年龄53岁，57%为绝经后，79%为II期，77%的Ki-67 ≥30%，58%的RS ≥26）被随机分配。

RCB 0 to I was achieved in 13% [letrozole/abemaciclib; 95% credible intervals (CrI), 7.4%-20.5%] versus 18% (chemotherapy; 95% CrI, 11.5%-26.4%), failing to show similarity between treatment arms.

RCB 0至I级在13%的患者中实现（letrozole/abemaciclib；95%可信区间（CrI），7.4%-20.5%）与18%的患者（化疗；95% CrI，11.5%-26.4%），未能显示出治疗组之间的相似性。

The CRR were 78% (letrozole/abemaciclib) versus 71% (chemotherapy; P = 0.26).

完全缓解率（CRR）为78%（letrozole/abemaciclib）与71%（化疗；P = 0.26）。

Tumors with Ki-67 ≥30% and/or RS results ≥26 showed a trend toward higher RCB 0 to I rates with chemotherapy (23% vs. 17%; P = 0.52).

Ki-67 ≥30% 和/或 RS 结果 ≥26 的肿瘤在接受化疗后，RCB 0至I级的比率呈现上升趋势（23% 对比 17%；P = 0.52）。

RCB 0 to I rates were similar between treatments for tumors with Ki-67 <30% or RS <26.

对于Ki-67 <30% 或 RS <26 的肿瘤，不同治疗方案之间的RCB 0至I级比率相似。

Conclusions

CARABELA trial results suggest that 12 months of letrozole/abemaciclib may not offer similar efficacy to that of chemotherapy in achieving RCB 0 to I.

CARABELA试验结果表明，12个月的来曲唑/阿贝西利治疗可能无法达到与化疗相似的疗效，以实现RCB 0至I级。

However, in less proliferative tumors (RS <26 or Ki-67 <30%), outcomes were comparable, suggesting that letrozole/abemaciclib could replace (neo)adjuvant chemotherapy in selected patients.

然而，在增殖活性较低的肿瘤（RS <26或Ki-67 <30%）中，结果是可比的，这表明来曲唑/阿贝西利可以在选定的患者中替代（新）辅助化疗。