Clinical Significance of Tumor Infiltrating Lymphocytes and CD8⁺ T Cells in Patients With Early-stage Breast Cancer: Pooled-analysis of Individual Data From Patients Treated With Dose-dense Adjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,646
- 试验地点
- 1
- 主要终点
- To investigate the long-term prognostic significance of TILs & CD8+ in term of OS
研究概览
简要总结
T cells are a broad class of adaptive immune cells, while CD8⁺ T cells are a specific, specialized subset of T cells, defined by the presence of the CD8 surface receptor. T cells, matured in the thymus, consist of helper, cytotoxic and regulatory functions.
This study aimed to evaluate the clinical importance of Tumor Infiltrating Lymphocytes (TILs) as well as CD8⁺ T cells in patients with early-stage breast cancer (eBC) treated with dose-dense sequential chemotherapy.
The researchers aim to assess tumor samples for TILs and CD8⁺ T cells from eBC patients using immunohistochemistry (IHC). In particular, we will measure the following parameters:
CD8+ T cells found in the tissue around the tumor [stromal], CD8+ cells found inside the tumor [intratumoral], the total number of CD8⁺ cells as well as stromal TILs [cells in the surrounding tissue].
The main point of this study was to better understand the way these immune cells are associated with patients' outcome in a large group of patients with eBC who were treated initially with surgery and then received a dose-intense adjuvant chemotherapy.
详细描述
This study examines the prognostic significance of TILs and CD8+ in patients with eBC treated with dds-CT. From a total of 5,320 patients enrolled in seven prospective clinical studies conducted by the HECOG between 1996 and 2022, 3,646 patients were deemed eligible having donated tissue for central assessment and translational analysis. All patients had received adjuvant dds-CT, including taxanes and anthracyclines, as part of relevant protocols. Adjuvant endocrine therapy and radiotherapy were administered as clinically indicated. Tumor samples were assessed for stromal TILs, stromal CD8+ (sCD8+), intratumoral CD8+ (iCD8+), and total CD8+ density using immunohistochemistry on tissue microarray cores. Intrinsic breast cancer subtypes defined by immunohistochemistry (IHC4), a cost-saving surrogate of gene expression analysis, is frequently used to guiding treatment decisions based on the expression of ER (estrogen receptor), PgR (progesterone receptors, HER2, and Ki67. The analysis explores the prognostic value of these immune markers in the overall cohort and across different molecular subtypes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women older than 18 years with high-risk, operable eBC.
- •Histologically confirmed BC
- •All treated with adjuvant dose-dense sequential chemotherapy (dds-CT).
- •Tumor tissue specimen (FFPE) availability.
排除标准
- •Lack of FFPE samples.
- •Bilateral disease.
- •Distal metastases.
- •Administration of different chemotherapeutic regimens.
- •Previous primary cancers.
结局指标
主要结局
To investigate the long-term prognostic significance of TILs & CD8+ in term of OS
时间窗: Time from study entry to death from any cause, assessed up to 120 months
Overall Survival (OS)
To investigate the long-term prognostic significance of TILs & CD8+ in term of DFS
时间窗: Time from study entry to first recurrence (local, regional, distant) or death from any cause, whichever comes first, assessed up to 120 months
Disease-Free Survival (DFS)
To investigate the long-term prognostic significance of TILs & CD8+ in term of iBCFS
时间窗: Time from study entry to invasive breast cancer recurrence or death, whichever comes first, assessed up to 120 months
Invasive Breast Cancer-Free Survival (iBCFS)
次要结局
未报告次要终点