{"title":"Real-world efficacy and safety of neoadjuvant immunochemotherapy in patients with triple-negative breast cancer.","authors":"Ruoxi Xu, Pinchao Fan, Yiqiu Liu, Chengjun Zhu, Dandan Wang, Fang Yang, Xiaoxiang Guan","doi":"10.1080/1750743X.2026.2746875","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim: </strong>To evaluate the real‑world efficacy and safety of adding programmed cell death protein 1 (PD-1) inhibitors to neoadjuvant chemotherapy in Chinese patients with triple‑negative breast cancer (TNBC).</p><p><strong>Patients and methods: </strong>This single-center retrospective study enrolled 218 TNBC patients receiving neoadjuvant therapy, including 116 in the neoadjuvant chemotherapy (NAC) cohort and 102 in the neoadjuvant immunochemotherapy (NAIC) cohort. Clinical, biological, pathological and therapeutic data were collected. Primary endpoints were pathological complete response (pCR) and event-free survival (EFS).</p><p><strong>Results: </strong>Multivariate analysis showed Ki-67 >30% (<i>p</i> = 0.003) and PD-1 inhibitor addition (<i>p</i> < 0.001) were independently associated with higher pCR. NAIC significantly reduced recurrence (7.8% vs. 25.0%, <i>p</i> < 0.001). Miller-Payne grades 2-4 were independent prognostic factors for improved EFS compared with grade 1 (all <i>p</i> < 0.05); grade 5 was excluded due to collinearity with pCR. Except for immune-related adverse events (irAEs), the incidence of other adverse events (AEs) showed no significant differences between the two groups (all <i>p</i> > 0.05).</p><p><strong>Conclusions: </strong>Compared with NAC alone, NAIC significantly improves the pCR rate and reduces the recurrence risk in TNBC patients, with generally manageable toxicity in this real-world cohort, which supports its favorable clinical application value.</p>","PeriodicalId":13328,"journal":{"name":"Immunotherapy","volume":" ","pages":"1-12"},"PeriodicalIF":2.3000,"publicationDate":"2026-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Immunotherapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/1750743X.2026.2746875","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Aim: To evaluate the real‑world efficacy and safety of adding programmed cell death protein 1 (PD-1) inhibitors to neoadjuvant chemotherapy in Chinese patients with triple‑negative breast cancer (TNBC).
Patients and methods: This single-center retrospective study enrolled 218 TNBC patients receiving neoadjuvant therapy, including 116 in the neoadjuvant chemotherapy (NAC) cohort and 102 in the neoadjuvant immunochemotherapy (NAIC) cohort. Clinical, biological, pathological and therapeutic data were collected. Primary endpoints were pathological complete response (pCR) and event-free survival (EFS).
Results: Multivariate analysis showed Ki-67 >30% (p = 0.003) and PD-1 inhibitor addition (p < 0.001) were independently associated with higher pCR. NAIC significantly reduced recurrence (7.8% vs. 25.0%, p < 0.001). Miller-Payne grades 2-4 were independent prognostic factors for improved EFS compared with grade 1 (all p < 0.05); grade 5 was excluded due to collinearity with pCR. Except for immune-related adverse events (irAEs), the incidence of other adverse events (AEs) showed no significant differences between the two groups (all p > 0.05).
Conclusions: Compared with NAC alone, NAIC significantly improves the pCR rate and reduces the recurrence risk in TNBC patients, with generally manageable toxicity in this real-world cohort, which supports its favorable clinical application value.
期刊介绍:
Many aspects of the immune system and mechanisms of immunomodulatory therapies remain to be elucidated in order to exploit fully the emerging opportunities. Those involved in the research and clinical applications of immunotherapy are challenged by the huge and intricate volumes of knowledge arising from this fast-evolving field. The journal Immunotherapy offers the scientific community an interdisciplinary forum, providing them with information on the most recent advances of various aspects of immunotherapies, in a concise format to aid navigation of this complex field.
Immunotherapy delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for this vitally important area of research. Unsolicited article proposals are welcomed and authors are required to comply fully with the journal''s Disclosure & Conflict of Interest Policy as well as major publishing guidelines, including ICMJE and GPP3.