CN111863259A - Prognosis model for evaluating tumor immunotherapy-associated myocarditis based on sST2 and application thereof - Google Patents
Prognosis model for evaluating tumor immunotherapy-associated myocarditis based on sST2 and application thereof Download PDFInfo
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- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
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- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
Abstract
The invention relates to a prognosis model for evaluating myocarditis related to tumor immunotherapy based on sST2 and application thereof, belonging to the technical field of biomedical detection. The invention provides a model for evaluating the prognosis of myocarditis related to tumor immunotherapy based on sST 2. The immune myocarditis is a rare but serious adverse reaction in tumor immunotherapy, and the sST2 is a novel cardiac marker and is involved in the process of abnormal cardiac function caused by myocardial hypertrophy, myocardial fibrosis, ventricular remodeling and the like. The invention provides a model for evaluating the prognosis of tumor immunotherapy-associated myocarditis based on sST2, which is beneficial to providing reference information for disease outcome and prognosis of immunotherapy-associated myocarditis patients, thereby assisting clinical establishment of a reasonable diagnosis and treatment scheme.
Description
Technical Field
The invention relates to a prognosis model for evaluating myocarditis related to tumor immunotherapy based on sST2 and application thereof, belonging to the technical field of biomedical detection.
Background
In recent years, the emergence of immune checkpoint inhibitors has revolutionized the concept of tumor therapy, overwriting the conventional mode of tumor therapy. The tumor immunotherapy is approved to enter clinical application in China, and the subsequent immune-related adverse reactions also cause the attention of clinicians. The immune myocarditis is a rare but serious adverse reaction in tumor immunotherapy, and the fatality rate of the immune myocarditis can reach 39.7% -46%. The patients with the immune myocarditis have different clinical manifestations and greatly different severity degrees, and the prognosis and prognosis of the disease are also quite different. Some patients can improve themselves after stopping taking the medicine; some patients need glucocorticoid or immunosuppressant treatment to relieve the symptoms; another 40% of patients eventually die from immune myocarditis. Therefore, accurate prognosis prediction of immune myocarditis patients is required to provide an optimal treatment strategy, which is a problem to be solved at present. At present, the disease evaluation of the immune myocarditis is mainly based on the examination of clinical symptoms, myocardial damage markers, electrocardiogram, heart super, cardiac magnetic resonance and the like. Endocardial biopsy is the gold standard for diagnosing and evaluating immunotherapy-related myocarditis, but is not yet generally popularized due to the defects of invasiveness, risk, biopsy range limitation and the like. Based on the current assessment means, the disease outcome and prognosis of the patients with the immune myocarditis still cannot be accurately judged, so that the clinician can develop the following treatment course of the myocarditis and the problem of whether the patients can receive anti-tumor treatment.
Soluble growth-stimulating expression gene 2 protein (soluble tolerance of tomogenesis-2, sST2) is a member of interleukin-1 receptor family, and is involved in the process of cardiac dysfunction, such as cardiac hypertrophy, cardiac fibrosis and ventricular remodeling. It has been recommended in the diagnostic and therapeutic guidelines for heart failure at home and abroad as a predictor of risk stratification and prognosis information for patients with heart failure.
Disclosure of Invention
The invention aims to solve the technical problem of assisting a clinician in more accurately judging the disease outcome and prognosis of an immune myocarditis patient. St2 elevation was closely correlated with the development of immune myocarditis, and sST2 elevation was positively correlated with disease severity in immunotherapy tumor patients. Furthermore, the higher the sST2 level (plasma sST2 concentration), the worse the prognosis for patients with immune myocarditis. The sST2 can be used as a novel cardiac marker and can effectively indicate the severity of cardiac function change, and the rising level of the sST2 is closely related to the increase of the risk of heart failure. Therefore, it is believed that the sST2 level can assist in determining the prognosis and prognosis of the disease in immunotherapy-related myocarditis.
Currently, the basis for the severity grading of immune myocarditis is the Common Adverse event evaluation Criteria (Common neurology Criteria for additive Events, CTCAE) version 5.0. The grading system mainly grades according to the symptoms of the patient, whether the patient needs treatment or not, whether the patient is life-threatening or not and whether the patient dies or not, and has certain subjectivity and cannot accurately evaluate the patient. Based on the value of the sST2 level observed in the previous period in the aspect of prognosis prediction of immune myocarditis, the invention provides an evaluation model combining the sST2 level, the cardiac troponin T (cTnT) level (plasma cTnT concentration), the amino-terminal B-type natriuretic peptide (NT-proBNP) level (plasma NT-proBNP concentration) and the heart ultrasonography result, and provides reference information for disease outcome and prognosis of the immune myocarditis patients.
In order to solve the above problems, the technical solution of the present invention is to provide a prognosis model for evaluating tumor immunotherapy-associated myocarditis based on sST2, wherein the prognosis model includes associated risk factors, corresponding assessment scores of the associated risk factors in different states, and a prognosis state corresponding to a total score obtained by adding the assessment scores; the relevant risk factors include plasma sST2 concentration.
Preferably, the associated risk factors also include plasma cTnT concentration, plasma NT-proBNP concentration and cardiac ultrasonography results.
Preferably, the different states of the associated risk factors comprise different concentrations of plasma sST2, different concentrations of plasma cTnT, different concentrations of plasma NT-proBNP and the severity of the abnormal condition of the cardiac ultrasonography outcome.
The invention provides a method for constructing a prognosis model for evaluating myocarditis related to tumor immunotherapy based on sST2, which comprises the following steps:
step 1: obtaining related risk factor detection data, and obtaining the concentration of plasma sST2 when a tumor patient confirms to diagnose myocarditis; obtaining the plasma cTnT concentration of a tumor patient when the myocarditis is diagnosed; obtaining the plasma NT-proBNP concentration of a tumor patient when the myocarditis is diagnosed; obtaining the heart super-examination result of a tumor patient when the myocarditis is diagnosed, wherein the heart super-examination result comprises the heart size, the heart left ventricular wall motion and the valve condition;
step 2: establishing a prognosis evaluation model for evaluation according to the obtained risk factor detection data indexes, specifically as follows: if the concentration of the plasma sST2 is more than or equal to 100ng/mL, the evaluation score of the risk factor is 2; if the risk factor is less than 100ng/mL and greater than or equal to 35ng/mL, the evaluation score of the risk factor is 1; if the risk factor is less than 35ng/mL, the evaluation score of the risk factor is 0;
if the plasma cTnT concentration is more than or equal to 1.00ng/mL, the evaluation score of the risk factor is 2; if the risk factor is less than 1.00ng/mL and greater than or equal to 0.03ng/mL, the evaluation score of the risk factor is 1; if the risk factor is less than 0.03ng/mL, the evaluation score of the risk factor is 0;
if the plasma NT-proBNP concentration is greater than or equal to the upper limit of the reference range, the upper limit of the reference range is 100pg/mL when the age is less than 65 years; when the age is more than or equal to 65 years and the upper limit of the reference range is 300pg/mL, the evaluation score of the risk factor is 1; if the value is less than the upper limit of the reference range, the evaluation score of the risk factor is 0;
the heart super-examination result indicates that the LVEF is less than 40% or is reduced by 10% or more than the baseline, and the evaluation score of the risk factor is 2; if the new abnormal performance is prompted, the evaluation score of the risk factor is 1; the heart super-examination is normal and has no obvious change from before treatment, and the evaluation score of the risk factor is 0;
and step 3: adding the evaluation scores obtained in the step (2) to obtain a total score, wherein the total score is 0-7, and different total scores correspond to different prognosis states; wherein, 0-1 points correspond to low-risk prognosis states, 2-4 points correspond to medium-risk prognosis states, and 5-7 points correspond to high-risk prognosis states; and acquiring a corresponding clinical prognosis state according to the risk assessment value obtained by the risk assessment model.
The invention provides a prognosis model for evaluating myocarditis related to tumor immunotherapy based on sST2, which is shown in the following table:
the invention provides application of a prognosis model for evaluating myocarditis related to tumor immunotherapy based on sST2 in evaluating prognosis of myocarditis related to tumor immunotherapy.
Compared with the prior art, the invention has the following beneficial effects:
the invention firstly uses the sST2 level as the prognostic evaluation index of the immune myocarditis patient, and establishes a novel disease evaluation model aiming at the immune myocarditis patient by combining the traditional cTnT, NT-proBNP level and the cardiac ultrasonography result. Through clinical verification, the model can effectively provide important reference information for disease outcome of patients with immune myocarditis, and can identify people with high death risk, thereby being beneficial to doctors to formulate a reasonable treatment scheme and timely and effective doctor-patient communication.
Detailed Description
In order to make the invention more comprehensible, preferred embodiments are described in detail as follows:
the invention provides a prognosis model for evaluating myocarditis related to tumor immunotherapy based on sST2, which comprises related risk factors, corresponding assessment scores of the related risk factors in different states and a prognosis state corresponding to a total score obtained by adding the assessment scores. Relevant risk factors include plasma sST2 concentration, plasma cTnT concentration, plasma NT-proBNP concentration and cardiac ultrasonography results. The different states of the relevant risk factors include different concentrations of plasma sST2, different concentrations of plasma cTnT, different concentrations of plasma NT-proBNP and the severity of the abnormal condition of the cardiac ultrasonography results.
The invention provides a method for constructing a prognosis model for evaluating myocarditis related to tumor immunotherapy based on sST2, which comprises the following steps:
step 1: obtaining related risk factor detection data, and obtaining the concentration of plasma sST2 when a tumor patient confirms to diagnose myocarditis; obtaining the plasma cTnT concentration of a tumor patient when the myocarditis is diagnosed; obtaining the plasma NT-proBNP concentration of a tumor patient when the myocarditis is diagnosed; obtaining the heart super-examination result of a tumor patient when the myocarditis is diagnosed, wherein the heart super-examination result comprises heart size, heart left ventricular wall activity, valve condition and the like;
step 2: establishing a prognosis evaluation model for evaluation according to the obtained risk factor detection data indexes, specifically as follows: if the concentration of the plasma sST2 is more than or equal to 100ng/mL, the evaluation score of the risk factor is 2; if the risk factor is less than 100ng/mL and greater than or equal to 35ng/mL, the evaluation score of the risk factor is 1; if the risk factor is less than 35ng/mL, the evaluation score of the risk factor is 0;
if the plasma cTnT concentration is more than or equal to 1.00ng/mL, the evaluation score of the risk factor is 2; if the risk factor is less than 1.00ng/mL and greater than or equal to 0.03ng/mL, the evaluation score of the risk factor is 1; if the risk factor is less than 0.03ng/mL, the evaluation score of the risk factor is 0;
if the plasma NT-proBNP concentration is greater than or equal to the upper limit of the reference range, the upper limit of the reference range is 100pg/mL when the age is less than 65 years; when the age is more than or equal to 65 years and the upper limit of the reference range is 300pg/mL, the evaluation score of the risk factor is 1; if the value is less than the upper limit of the reference range, the evaluation score of the risk factor is 0;
the heart super-examination result indicates that the LVEF is less than 40% or is reduced by 10% or more than the baseline, and the evaluation score of the risk factor is 2; if the new abnormal performance is prompted, the evaluation score of the risk factor is 1; the heart super-examination is normal and has no obvious change from before treatment, and the evaluation score of the risk factor is 0;
and step 3: adding the evaluation scores obtained in the step (2) to obtain a total score, wherein the total score is 0-7, and different total scores correspond to different prognosis states; wherein, 0-1 points correspond to low-risk prognosis states, 2-4 points correspond to medium-risk prognosis states, and 5-7 points correspond to high-risk prognosis states; and acquiring a corresponding clinical prognosis state according to the risk assessment value obtained by the risk assessment model.
The invention provides a prognosis model for evaluating myocarditis related to tumor immunotherapy based on sST2, which is shown in the following table:
the invention discloses application of a prognosis model for evaluating myocarditis related to tumor immunotherapy based on sST2 in evaluating prognosis of myocarditis related to tumor immunotherapy.
The invention is used as a method for prognosis evaluation of patients with immune myocarditis, which allows the prognosis score of the patients to be obtained by inputting the prognosis score into an intelligent medical system or a computer of a doctor in the form of computer software (computer program) and directly extracting and calculating automatic information, so as to assist the doctor to use more conveniently and conveniently, thereby assisting the doctor to judge and implement a corresponding clinical treatment scheme.
The invention will be further illustrated with reference to the following specific examples. It is to be understood that these examples are for illustrative purposes only and are not limiting upon the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Examples
The sST2 level was obtained when the tumor patients had diagnosed myocarditis: detection was performed by double-antibody sandwich enzyme-linked immunosorbent assay (ELISA). Obtaining the cTnT level of the tumor patient when the myocarditis is diagnosed: the sandwich method principle and the electrochemical luminescence method are adopted for quantitative detection. Obtaining the NT-proBNP level of a tumor patient when the myocarditis is diagnosed: the sandwich method principle and the electrochemical luminescence method are adopted for quantitative detection. The reference interval age is less than 65 years old and 0-100 pg/mL; the age is more than or equal to 65 years, and 0-300 pg/mL. Obtaining the heart super-examination result of a tumor patient when the myocarditis is diagnosed: including heart size, heart left ventricular wall motion, valve condition, etc.
Patient 2020-6-1 is at a visit, age 70, female. 2020-1-8 can be used for diagnosing lung squamous carcinoma at late stage. 2020-1-20 starting PD-1 monoclonal antibody immunotherapy. 2020-2-25 confirmed diagnosis of immune myocarditis, the examination results at that time were as follows: sST2156.5ng/mL, cTnT 1.012ng/mL, NT-proBNP 970pg/mL, cardiotachometer: no obvious abnormality was observed.
In this example, the patient diagnosed immune myocarditis with sST2156.5 ng/mL, i.e., not less than 100ng/mL, and the data index for the risk factor was 2 points.
In this example, cTnT 1.012ng/mL, i.e. more than or equal to 1.00ng/mL, when the patient confirmed to diagnose the immune myocarditis, the data index of the risk factor is 2 points.
In this example, the patient diagnosed immune myocarditis with NT-proBNP 970pg/mL, i.e., 300pg/mL (age 65) or more, with a data index of risk factors of 1 point.
In this example, the patient was diagnosed with hypercardia at the time of immune myocarditis: no obvious abnormality is found, and the data index of the risk factor is 0 point.
Therefore, the prognosis of the patient is divided into 5 points, belonging to the high-risk patient with high prognosis.
While the invention has been described with respect to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention. Those skilled in the art can make various changes, modifications and equivalent arrangements, which are equivalent to the embodiments of the present invention, without departing from the spirit and scope of the present invention, and which may be made by utilizing the techniques disclosed above; meanwhile, any changes, modifications and variations of the above-described embodiments, which are equivalent to those of the technical spirit of the present invention, are within the scope of the technical solution of the present invention.
Claims (6)
1. A prognostic model for evaluating tumor immunotherapy-associated myocarditis based on sST2, comprising: the model comprises related risk factors, corresponding assessment scores of the related risk factors in different states and a prognosis state corresponding to a total score obtained by adding the assessment scores; the relevant risk factors include plasma sST2 concentration.
2. The sST 2-based prognostic model for evaluating tumor immunotherapy-associated myocarditis of claim 1, wherein: the relevant risk factors also include plasma cTnT concentration, plasma NT-proBNP concentration and cardiac ultrasonography results.
3. The sST 2-based prognostic model for evaluating tumor immunotherapy-associated myocarditis of claim 2, wherein: the different states of the relevant risk factors include different concentrations of plasma sST2, different concentrations of plasma cTnT, different concentrations of plasma NT-proBNP, and abnormal condition severity of cardiac ultrasonography results.
4. A prognostic model construction method based on sST2 for evaluating myocarditis related to tumor immunotherapy is characterized by comprising the following steps of; the method comprises the following steps:
step 1: obtaining relevant risk factor detection data; obtaining the concentration of plasma sST2 when a tumor patient confirms to diagnose myocarditis; obtaining the plasma cTnT concentration of a tumor patient when the myocarditis is diagnosed; obtaining the plasma NT-proBNP concentration of a tumor patient when the myocarditis is diagnosed; obtaining the heart super-examination result of a tumor patient when the myocarditis is diagnosed, wherein the heart super-examination result comprises the heart size, the heart left ventricular wall motion and the valve condition;
step 2: establishing a prognosis evaluation model for evaluation according to the obtained risk factor detection data indexes, specifically as follows: if the concentration of the plasma sST2 is more than or equal to 100ng/mL, the evaluation score of the risk factor is 2; if the risk factor is less than 100ng/mL and greater than or equal to 35ng/mL, the evaluation score of the risk factor is 1; if the risk factor is less than 35ng/mL, the evaluation score of the risk factor is 0;
if the plasma cTnT concentration is more than or equal to 1.00ng/mL, the evaluation score of the risk factor is 2; if the risk factor is less than 1.00ng/mL and greater than or equal to 0.03ng/mL, the evaluation score of the risk factor is 1; if the risk factor is less than 0.03ng/mL, the evaluation score of the risk factor is 0;
if the plasma NT-proBNP concentration is greater than or equal to the upper limit of the reference range, the upper limit of the reference range is 100pg/mL when the age is less than 65 years; when the age is more than or equal to 65 years and the upper limit of the reference range is 300pg/mL, the evaluation score of the risk factor is 1; if the value is less than the upper limit of the reference range, the evaluation score of the risk factor is 0;
the heart super-examination result indicates that the LVEF is less than 40% or is reduced by 10% or more than the baseline, and the evaluation score of the risk factor is 2; if the new abnormal performance is prompted, the evaluation score of the risk factor is 1; the heart super-examination is normal and has no obvious change from before treatment, and the evaluation score of the risk factor is 0;
and step 3: adding the evaluation scores obtained in the step (2) to obtain a total score, wherein the total score is 0-7, and different total scores correspond to different prognosis states; wherein, 0-1 points correspond to low-risk prognosis states, 2-4 points correspond to medium-risk prognosis states, and 5-7 points correspond to high-risk prognosis states; namely, the corresponding clinical prognosis state is obtained according to the risk assessment value obtained by the risk assessment model.
5. A prognostic model for evaluating tumor immunotherapy-associated myocarditis based on sST2, comprising; the model is shown in the following table:
6. an application of a prognostic model for evaluating myocarditis related to tumor immunotherapy based on sST2 in evaluating the prognosis of myocarditis related to tumor immunotherapy.
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| CN114778417A (en) * | 2022-04-29 | 2022-07-22 | 复旦大学附属中山医院 | Biomarker, kit, model establishing method and application for immune checkpoint inhibitor related adverse reaction risk prediction |
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| CN113186225B (en) * | 2021-05-13 | 2021-11-02 | 中国医学科学院北京协和医院 | PD1/PDL1 monoclonal antibody immunogenic myocarditis model and preparation method thereof |
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