Aoyama Yosuke, Ozaki Yukinori, Kizawa Rika, Masuda Jun, Kawai Saori, Kurata Mami, Maeda Tetsuyo, Yoshida Kazuyo, Yamashita Nami, Nishimura Meiko, Hosonaga Mari, Fukada Ippei, Hara Fumikata, Kobayashi Takayuki, Takano Toshimi, Ueno Takayuki
Breast Oncology Center, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto, Tokyo, 135-8550, Japan.
Breast Cancer. 2025 Mar;32(2):329-336. doi: 10.1007/s12282-024-01657-4. Epub 2024 Dec 7.
Neoadjuvant pembrolizumab plus chemotherapy and adjuvant pembrolizumab have been established as the optimal systemic therapies for patients with early stage triple-negative breast cancer (TNBC); however, their efficacy and feasibility in the Japanese population remain unexplored.
This study included patients with early stage TNBC or low estrogen receptor (ER) positivity (1-9%) with human epidermal growth factor receptor type 2- (HER2-) negative breast cancer who received neoadjuvant pembrolizumab plus chemotherapy from October 2022 at Cancer Institute Hospital of Japanese Foundation for Cancer Research. Information regarding clinicopathological features, systemic therapy, treatment outcomes, and adverse events of patients who underwent surgery by February 2024 was retrospectively collected.
Overall, 69 patients received neoadjuvant pembrolizumab plus carboplatin and paclitaxel therapy, and 46 underwent surgery by February 2024. The median age of the patients was 53.5 years, and 80.4% and 19.6% had stage II and III disease, respectively. TNBC and ER-low HER2-negative breast cancer accounted for 82.6% and 17.4% cases, respectively. Overall pathological complete response rate was 56.5%, with 87.5% in patients with ER-low HER2-negative tumors. The completion rates for neoadjuvant pembrolizumab, chemotherapy, and pembrolizumab plus chemotherapy were 65.2%, 56.5%, and 52.2%, respectively. Furthermore, 80.4% and 15.2% of patients experienced grade 3 or higher treatment-related adverse events and immune-related adverse events, respectively, and 34% experienced unexpected hospitalization during neoadjuvant treatment.
The efficacy and safety profiles of neoadjuvant pembrolizumab plus chemotherapy in the Japanese population are consistent with previous reports. This regimen may have therapeutic potential against ER-low HER2-negative tumors and TNBC.
新辅助派姆单抗联合化疗以及辅助派姆单抗已被确立为早期三阴性乳腺癌（TNBC）患者的最佳全身治疗方案；然而，其在日本人群中的疗效和可行性仍有待探索。
本研究纳入了2022年10月起在日本癌症研究基金会癌症研究所医院接受新辅助派姆单抗联合化疗的早期TNBC或雌激素受体（ER）低表达（1-9%）且人表皮生长因子受体2（HER2）阴性乳腺癌患者。回顾性收集了截至2024年2月接受手术患者的临床病理特征、全身治疗、治疗结果及不良事件等信息。
总体而言，69例患者接受了新辅助派姆单抗联合卡铂和紫杉醇治疗，截至2024年2月，46例患者接受了手术。患者的中位年龄为53.5岁，分别有80.4%和19.6%的患者患有Ⅱ期和Ⅲ期疾病。TNBC和ER低表达HER2阴性乳腺癌分别占病例的82.6%和17.4%。总体病理完全缓解率为56.5%，ER低表达HER2阴性肿瘤患者的这一比例为87.5%。新辅助派姆单抗、化疗以及派姆单抗联合化疗的完成率分别为65.2%、56.5%和52.2%。此外，分别有80.4%和15.2%的患者发生3级或更高等级的治疗相关不良事件和免疫相关不良事件，34%的患者在新辅助治疗期间意外住院。
新辅助派姆单抗联合化疗在日本人群中的疗效和安全性与既往报道一致。该方案可能对ER低表达HER2阴性肿瘤和TNBC具有治疗潜力。
