基于 DNA 超分子水凝胶的保护性 NK 细胞储库用于增强三阴性乳腺癌治疗
Protective NK Cell Reservoir Based on DNA Supramolecular Hydrogel for Enhanced Triple-Negative Breast Cancer Therapy.
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
新辅助卡铂与紫杉醇联合或不联合 atezolizumab 治疗三阴性乳腺癌（TNBC）的随机 II 期研究 - NCI 10013
英文原题：A randomized phase 2 study of neoadjuvant carboplatin and paclitaxel with or without atezolizumab in triple negative breast cancer (TNBC) - NCI 10013.
查看英文原题
A randomized phase 2 study of neoadjuvant carboplatin and paclitaxel with or without atezolizumab in triple negative breast cancer (TNBC) - NCI 10013.
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中文摘要
阿替利珠单抗联合化疗已改善转移性PD-L1阳性三阴性乳腺癌（TNBC）患者的无进展生存期和总生存期；阿替利珠单抗联合蒽环类和紫杉类新辅助化疗，也提高了早期TNBC的病理完全缓解（pCR）率。本试验在临床Ⅱ–Ⅲ期TNBC患者中评估卡铂和紫杉醇新辅助治疗联合或不联合阿替利珠单抗。共同主要目标是在改良意向治疗（mITT）人群中，评估联合治疗是否较单纯化疗提高pCR率和TIL（肿瘤浸润淋巴细胞）比例。共67例患者随机分组：A组22例，B组45例；患者年龄25–78岁，中位年龄52岁，中位随访6.6个月。在mITT人群中（所有可评估主要终点且至少接受一剂联合治疗的患者），A组pCR率为18.8%（95%置信区间：4.0%–45.6%），B组为55.6%（95%置信区间：40.0%–70.4%）；估计治疗差异为36.8%（95%置信区间：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3级及以上治疗相关不良事件。随访期间，B组1例患者因疾病复发死亡。A组和B组从基线至第1周期TIL比例均轻度升高（平均变化分别为0.6%±21.0%和5.7%±15.8%；p=0.36）。达到pCR的患者TIL比例中位数高于未达到pCR者（24.8%比14.2%；p=0.02）。尽管受样本量较小所限，亚组分析显示，接受化疗联合阿替利珠单抗的PD-L1阳性患者pCR率为75%（12/16）。在临床Ⅱ期和Ⅲ期TNBC患者中，新辅助卡铂、紫杉醇联合阿替利珠单抗显著且具有临床意义地提高了pCR率。（本研究由美国国家癌症研究所资助。）
展开英文摘要原文
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).
论文信息
- 作者
- Ademuyiwa FO、Gao F、Street CR、Chen I、Northfelt DW、Wesolowski R、Arora M、Brufsky A
- 第一作者单位
- Washington University School of Medicine, St Louis, MO, 63110, USA. bisiademuyiwa@wustl.edu.United States
- 通讯作者单位
- Washington University School of Medicine, St Louis, MO, 63110, USA. gillandersw@wustl.edu.United States
- 期刊
- NPJ breast cancer2022 Dec 30
- 原文标识
- PubMed 36585404 · DOI 10.1038/s41523-022-00500-3
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