Methods and systems for evaluation of immune cell infiltrate in stage iv colorectal cancer

A technology for colorectal tumors and cells, applied in measurement devices, instruments, disease diagnosis, etc., can solve problems such as the absence of biomarkers

Pending Publication Date: 2021-09-28
VENTANA MEDICAL SYST INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

To date, there are no established biomarkers that predict response to PD-1 blockade within dMMR tumors

Method used

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  • Methods and systems for evaluation of immune cell infiltrate in stage iv colorectal cancer
  • Methods and systems for evaluation of immune cell infiltrate in stage iv colorectal cancer
  • Methods and systems for evaluation of immune cell infiltrate in stage iv colorectal cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0170] Embodiment 1. A method of treating a subject with stage IV colorectal cancer, the method comprising:

[0171] (a) obtaining an immune environment score (ICS) from a tissue sample of a colorectal tumor collected from said subject by:

[0172] (i) identifying a tumor core (CT) region of interest (ROI) of a test sample from the subject's tumor;

[0173] (ii) detecting CD8 in at least a portion of said ROI + cells; and

[0174] (iii) Obtain CD8 within the ROI + Cell density to calculate the ICS; and

[0175] (b) selecting a treatment for said subject based on said ICS.

Embodiment 2

[0176] Embodiment 2. The method of embodiment 1, wherein the stage IV colorectal cancer has been diagnosed with defective DNA mismatch repair and / or microsatellite instability (MSI).

Embodiment 3

[0177] Embodiment 3. The method according to embodiment 1 or 2, wherein:

[0178] (b1) If the ICS is low, choose a treatment that includes a full course of adjuvant chemotherapy and optionally checkpoint inhibitor-directed therapy; and

[0179] (b2) If the ICS is high, select a treatment comprising checkpoint inhibitor directed therapy and optionally course curtailed adjuvant chemotherapy.

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Abstract

Immune context scores are calculated for stage IV colorectal tumor tissue samples using non-continuous scoring functions. Feature metrics for at least one immune cell marker are calculated for a region or regions of interest, the feature metrics including at least a density of human CD8+ cells in a region of interest including a tumor core to generate an immune context score. The immune context score can then be used as a predictive metric (e.g. likelihood of response to a particular treatment course). The immune context score may then be incorporated into diagnostic and / or treatment decisions.

Description

[0001] Cross references to related patent applications [0002] This application is an international application claiming the benefit of U.S. Provisional Patent Application No. 62 / 801,482, filed February 5, 2019, the contents of which are hereby incorporated by reference in their entirety. technical field [0003] The present invention relates to the detection, characterization and enumeration of discrete populations of immune cells in tumor samples for the prediction and treatment of proliferative diseases, such as colorectal cancer. Background technique [0004] The presence or absence of an inflammatory response is known to be a prognostic factor in many different cancer types including colorectal cancer, melanoma, breast cancer, ovarian cancer, non-Hodgkin's lymphoma, head and neck cancer , non-small cell lung cancer (NSCLC), esophageal cancer, and urothelial cancer. See Pagès et al. (2010). For example, in colorectal cancer, the relative amount of immune cell infiltra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/574
CPCG01N33/57419G01N2800/52G01N2333/70517G01N2333/7051
Inventor K·山姆金F·A·西尼罗普
Owner VENTANA MEDICAL SYST INC
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