Atezolizumab Monotherapy Window Preceding Combined Neoadjuvant Chemotherapy and Immune Therapy in Triple-Negative Breast Cancer-The neoMono Trial.

The neoMono trial prospectively investigated whether the addition of an atezolizumab monotherapy window before neoadjuvant atezolizumab and chemotherapy improves pathologic complete remission (pCR) rates in early TNBC.

neoMono试验前瞻性地研究了在新辅助阿替利珠单抗和化疗之前增加阿替利珠单抗单药治疗窗是否能提高早期TNBC的病理完全缓解（pCR）率。

patients_and_methods

neoMono is a phase 2 randomized multicenter trial that recruited patients with primary TNBC larger than 10 mm.

neoMono 是一项 II 期随机多中心试验，招募了原发性肿瘤直径大于 10 毫米的三阴性乳腺癌（TNBC）患者。

Neoadjuvant treatment in both arms consisted of neoadjuvant atezolizumab and chemotherapy, with treatment in arm A preceded by atezolizumab monotherapy 2 weeks before combination therapy.

两组的新辅助治疗均包括新辅助阿替利珠单抗和化疗，其中 A 臂的治疗在联合治疗前 2 周先行阿替利珠单药治疗。

This study used a Bayesian trial design.

本研究采用了贝叶斯试验设计。

Results

A total of 359 patients were included.

共有359名患者被纳入研究。

Overall, pCR rates in study arms A and B were similar (intention-to-treatpopulation: 65.7% and 69.0%, respectively).

总体而言，研究组A和B的病理完全缓解（pCR）率相似（意向治疗人群分别为65.7%和69.0%）。

In an exploratory analysis, pCR rates in PD-L1-positive tumors were 91.5% in arm A and 82.2% in arm B.

在一项探索性分析中，PD-L1阳性肿瘤的pCR率在A组为91.5%，在B组为82.2%。

The corresponding pCR rates in the PD-L1-negative group were 56.1% in arm A and 64.5% in arm B.

PD-L1阴性组中，A臂的相应pCR率为56.1%，B臂为64.5%。

In patients with low-risk TNBC (cT1c and cN0), pCR rates in the PD-L1-positive group were 100.0% in arm A and 90.0% in arm B, and the corresponding pCR rates in the PD-L1 (immune cell)-negative group were 65.9% and 76.3%, respectively.

在低危三阴性乳腺癌（cT1c和cN0）患者中，PD-L1阳性组的pCR率在A臂为100.0%，在B臂为90.0%，而相应的PD-L1（免疫细胞）阴性组的pCR率分别为65.9%和76.3%。

Conclusions

The neoMono trial demonstrated the highest pCR rates reported in a phase II/III trial in TNBC, particularly in the case of PD-L1 positivity.

neoMono试验在三阴性乳腺癌(TNBC)的II/III期试验中报告了最高的病理完全缓解(pCR)率，特别是在PD-L1阳性的情况下。

Although no significant impact of an ICI monotherapy window on the pCR rate in the unselected intention-to-treatpopulation could be demonstrated, our data reinforce the use of combinations of neoadjuvant chemotherapy and ICI in this indication.

尽管在未选择意向治疗人群中，免疫检查点抑制剂(ICIs)单药治疗对病理完全缓解(pCR)率没有显著影响，但我们的数据强化了在这一适应症中使用新辅助化疗与ICIs联合治疗的使用。