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肿瘤细胞密度和浸润性淋巴细胞作为 HER2 阳性乳腺癌的生存替代指标

英文原题:Tumor Cellularity and Infiltrating Lymphocytes as a Survival Surrogate in HER2-Positive Breast Cancer.

查看英文原题

Tumor Cellularity and Infiltrating Lymphocytes as a Survival Surrogate in HER2-Positive Breast Cancer.

PubMed 2022/03/08(内容时间) J Natl Cancer Inst Q1 · IF 7.7(JCR 2025)

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中文摘要

在早期HER2阳性乳腺癌中,需要能够指导全身治疗降阶梯和/或升阶梯的生物标志物。CelTIL评分是一种新型的联合生物标志物,基于间质TIL(肿瘤浸润淋巴细胞)和肿瘤细胞密度,仅在抗HER2治疗第2周的肿瘤活检中测定。

我们在NeoALTTO III期试验中评估了CelTIL在196例接受标准曲妥珠单抗为基础化疗的早期HER2阳性疾病患者中的预后价值。使用预先设定的CelTIL截断值,观察到CelTIL高评分与CelTIL低评分之间具有更好的5年无事件生存率和总生存率,分别为76.4%(95% CI = 68.0%至85.0%)vs 59.7%(95% CI = 50.0%至72.0%)(风险比 = 0.40,95% CI = 0.17至0.94)和86.4%(95% CI = 80.0%至94.0%)vs 73.5%(95% CI = 64.0%至84.0%)(风险比 = 0.43,95% CI = 0.20至0.92)。在调整基线TIL(肿瘤浸润淋巴细胞)、激素受体状态、治疗前肿瘤大小和淋巴结状态、手术类型、治疗组和病理完全缓解后,统计学显著性仍然保持。

进一步开展研究以支持CelTIL作为早期读出生物标志物,帮助在HER2阳性乳腺癌中进行全身治疗降阶梯或升阶梯,似乎是必要的。

展开英文摘要原文

In early-stage HER2-positive breast cancer, biomarkers that guide deescalation and/or escalation of systemic therapy are needed. CelTIL score is a novel, combined biomarker based on stromal tumor-infiltrating lymphocytes and tumor cellularity and is determined in tumor biopsies at week 2 of anti-HER2 therapy only.

We evaluated the prognostic value of CelTIL in 196 patients with early-stage HER2-positive disease treated with standard trastuzumab-based chemotherapy in the NeoALTTO phase III trial. Using a prespecified CelTIL cutoff, a better 5-year event-free survival and overall survival was observed between CelTIL-high and CelTIL-low score with a 76. 4% (95% confidence interval [CI] = 68. 0% to 85. 0%) vs 59. 7% (95% CI = 50. 0% to 72.

0%) (hazard ratio = 0. 40, 95% CI = 0. 17 to 0. 94) and 86. 4% (95% CI = 80. 0% to 94. 0%) vs 73. 5% (95% CI = 64. 0% to 84. 0%) (hazard ratio = 0. 43, 95% CI = 0. 20 to 0. 92), respectively. Statistical significance was maintained after adjusting for baseline tumor-infiltrating lymphocytes, hormone receptor status, pretreatment tumor size and nodal status, type of surgery, treatment arm, and pathological complete response.

Further studies to support CelTIL as an early readout biomarker to help deescalate or escalate systemic therapy in HER2-positive breast cancer seem warranted.

论文信息

作者
Chic N、Luen SJ、Nuciforo P、Salgado R、Fumagalli D、Hilbers F、Wang Y、de Azambuja E
第一作者单位
Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.Spain
通讯作者单位
Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.Australia
文献类型
III 期临床试验 · 非美国政府资助研究
期刊
Journal of the National Cancer Institute2022 Mar 8
原文标识
PubMed 33787900 · DOI 10.1093/jnci/djab057