Atezolizumab与化疗联合治疗已经显示出对PD-L1阳性三阴性乳腺癌（TNBC）转移患者的无进展生存和总生存有所改善。Atezolizumab与蒽环-和紫杉醇-based 新辅助化疗也显示出提高早期TNBC的病理完全缓解率（pCR）的趋势。该试验评估了临床II-III期TNBC患者中新辅助卡铂和紫杉醇与或无Atezolizumab联合治疗的疗效。共同的主要目标是评估与单独应用化疗相比，化疗和Atezolizumab是否能提高mITT总体患者群中的pCR率和肿瘤浸润淋巴细胞（TIL）百分比。随机分配了67名患者（25-78岁；年龄中位数52岁），其中22名患者分配给A组，45名患者分配给B组。中位随访时间为6.6个月。在经修改的执行意愿总体人群中（所有接受至少一剂联合疗法的主要终点指标可评估患者），A组的pCR率为18.8%（95% CI 4.0-45.6%），B组的pCR率为55.6%（95% CI 40.0-70.4%）（估计的治疗差异：36.8%，95% CI 8.5-56.6%；p = 0.018）。A组和B组分别有62.5%和57.8%的患者发生了3级或更高级别的治疗相关不良事件。在随访期间，B组中的一名患者因疾病复发去世。 TIL百分比在A组（均值±SD：0.6%±21.0%）和B组（5.7%±15.8%）的周期1基线略有增加（p = 0.36）。pCR患者的中位数TIL百分比（24.8%）高于非pCR患者（14.2%）（p = 0.02）。尽管亚组分析受到样本量的限制，但化疗和Atezolizumab治疗的PD-L1阳性患者的pCR率为75%（12/16）。在临床II和III期TNBC患者中，Atezolizumab与新辅助卡铂和紫杉醇联合使用，可显着提高pCR率，具有统计学意义和临床意义（由National Cancer Institute资助）。©2022.作者（S）。

Atezolizumab with chemotherapy has shown improved progression-free and overall survival in patients with metastatic PD-L1 positive triple negative breast cancer (TNBC). Atezolizumab with anthracycline- and taxane-based neoadjuvant chemotherapy has also shown increased pathological complete response (pCR) rates in early TNBC. This trial evaluated neoadjuvant carboplatin and paclitaxel with or without atezolizumab in patients with clinical stages II-III TNBC. The co-primary objectives were to evaluate if chemotherapy and atezolizumab increase pCR rate and tumor infiltrating lymphocyte (TIL) percentage compared to chemotherapy alone in the mITT population. Sixty-seven patients (ages 25-78 years; median, 52 years) were randomly assigned - 22 patients to Arm A, and 45 to Arm B. Median follow up was 6.6 months. In the modified intent to treat population (all patients evaluable for the primary endpoints who received at least one dose of combination therapy), the pCR rate was 18.8% (95% CI 4.0-45.6%) in Arm A, and 55.6% (95% CI 40.0-70.4%) in Arm B (estimated treatment difference: 36.8%, 95% CI 8.5-56.6%; p = 0.018). Grade 3 or higher treatment-related adverse events occurred in 62.5% of patients in Arm A, and 57.8% of patients in Arm B. One patient in Arm B died from recurrent disease during the follow-up period. TIL percentage increased slightly from baseline to cycle 1 in both Arm A (mean ± SD: 0.6% ± 21.0%) and Arm B (5.7% ± 15.8%) (p = 0.36). Patients with pCR had higher median TIL percentages (24.8%) than those with non-pCR (14.2%) (p = 0.02). Although subgroup analyses were limited by the small sample size, PD-L1-positive patients treated with chemotherapy and atezolizumab had a pCR rate of 75% (12/16). The addition of atezolizumab to neoadjuvant carboplatin and paclitaxel resulted in a statistically significant and clinically relevant increased pCR rate in patients with clinical stages II and III TNBC. (Funded by National Cancer Institute).© 2022. The Author(s).