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Publication Number
US-12385920-B2
Publication Date
2025-08-12
Expiration Date
Abstract
The disclosure provides, inter alia, methods of detecting IL-6 signaling activity in T cells in breast cancer patients, such as breast cancer patients in remission.
Core Innovation
The disclosure describes methods for detecting IL-6 pathway signaling activity in T cells from breast cancer patients, including patients in remission, using IL-6 pathway detection agents that bind IL-6 pathway proteins or IL-6 pathway probes that hybridize IL-6 pathway mRNA sequences. The IL-6 pathway proteins mentioned include phosphorylated STAT1/STAT3, gp130, IL-6Rα, JAK, ADAM17, and SOCS3, indicating assessment of IL-6 pathway signaling activity via these pathway-associated markers.
The disclosure further links lower IL-6 pathway signaling activity relative to controls with an increased probability of breast cancer relapse. It describes use of this relationship to predict relapse and to guide treating breast cancer patients with IL-6 pathway-defective characteristics using anti-cancer agents.
The disclosure states that experimental results show IL-6-induced phosphorylation of STAT1/STAT3 is impaired in patient naive CD4+ T cells, and that this impairment is associated with reduced IL-6 receptor complex components (gp130 and IL-6Rα) and blunted Th17 differentiation and IL-17 levels. IL-6 signaling responsiveness at diagnosis is described as correlating with worse relapse-free survival and retaining prognostic significance in multivariate analysis.
Claims Coverage
The independent claim covers a treatment method that uses T-cell isolation and Th17 differentiation to identify patients with an increased risk for breast cancer relapse based on reduced Th17 differentiation and/or reduced IL-17 production relative to a control, followed by administering an anti-cancer agent from a specified list. Overall, the claim includes two main inventive features that define the risk-identification criteria and the treatment selection that follows.
Th17 differentiation-based relapse risk identification using reduced Th17 cells or IL-17
isolating T cells from peripheral blood mononuclear cells obtained from the patient; culturing the T cells in a Th17 differentiation medium; identifying the patient as having an increased risk for breast cancer relapse when the patient has a lower level of differentiated Th17 cells relative to a control or a lower level of IL-17 production by the Th17 cells relative to a control.
Treatment with an anti-cancer agent selected from a specified list after increased relapse risk identification
administering to the patient an effective amount of an anti-cancer agent, wherein the anti-cancer agent is anastrozole, capecitabine, cyclophosphamide, docetaxel, doxorubicin, epirubicin, fluorouracil, gemcitabine, goserelin, lapatinib, letrozole, neratinib, paclitaxel, tamoxifen, toremifene, trastuzumab, vinblastine, or a combination of two or more thereof.
The claim set grounds patient identification for increased relapse risk in Th17 differentiation and IL-17 production relative to a control, and then directs administering an effective amount of an anti-cancer agent chosen from the enumerated options.
Stated Advantages
Identifies breast cancer patients with an increased risk for relapse based on lower differentiated Th17 cells and/or lower IL-17 production relative to a control.
Predicts breast cancer relapse and supports treating patients with anti-cancer agents based on the identified increased relapse risk.
Provides prognostic significance for relapse-free survival as described for IL-6 signaling responsiveness at diagnosis.
Documented Applications
Predicting breast cancer relapse and guiding treating breast cancer patients (including patients in remission) using IL-6 pathway activity and/or Th17/IL-17-related measurements.
Guiding treating IL-6 pathway-defective patients with anti-cancer agents.
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