CN113138259B

CN113138259B - Kit for predicting prognosis of liver cancer treated by drug-loaded microsphere chemoembolization

Info

Publication number: CN113138259B
Application number: CN202110412336.9A
Authority: CN
Inventors: 李臻; 纪坤; 张玉元; 李鑫; 吴阳; 葛鹏磊; 谢滢滢; 詹鹏超; 石洋; 余鹏; 王玲
Original assignee: First Affiliated Hospital of Zhengzhou University
Current assignee: First Affiliated Hospital of Zhengzhou University
Priority date: 2021-04-16
Filing date: 2021-04-16
Publication date: 2021-12-31
Anticipated expiration: 2041-04-16
Also published as: CN113138259A

Abstract

The invention belongs to the technical field of medical biology, and particularly discloses a kit for predicting prognosis of liver cancer treatment by drug-loaded microsphere chemoembolization. The kit can predict the survival period of the liver cancer patient after DEB-TACE treatment according to clinical indexes of the liver cancer patient before DEB-TACE treatment, evaluate the prognosis of DEB-TACE treatment of the liver cancer patient, and is beneficial to an interventional doctor to screen patient groups suitable for DEB-TACE treatment before operation; it also facilitates accurate assessment of patient prognosis by clinicians, and the formulation of individualized follow-up regimens based on expected survival.

Description

Kit for predicting prognosis of liver cancer treated by drug-loaded microsphere chemoembolization

Technical Field

The invention belongs to the technical field of medical biology, and particularly relates to a kit for predicting prognosis of liver cancer treatment by drug-loaded microsphere chemoembolization.

Background

According to the global tumor statistics report of 2020, primary liver cancer is one of the most common malignant tumors and has become the cause of death related to the 3 rd tumor in the world, wherein hepatocellular carcinoma (HCC) is the most common pathological type. HCC is insidious, most patients are in the middle and advanced stage at the time of diagnosis, and the chance of radical surgery is lost. For this part of patients, transcatheter chemoembolization (TACE) is recognized as the most effective treatment. In recent years, drug-loaded microspheres (DEBs) have become more and more widely used in clinical medicine-loaded microsphere chemoembolization (DEB-TACE) because of the advantages of loading chemotherapeutic drugs and sustained and slow release in tumor parts.

Since the self-condition, liver function and tumor biological behavior, embolic agent, etc. of HCC patients all affect the DEB-TACE efficacy, the survival benefit of different HCC patients receiving DEB-TACE treatment varies in degree. Therefore, it is particularly necessary to effectively evaluate the curative effect and prognosis of DEB-TACE treatment according to the pre-operation clinical characteristics of HCC patients, and screen HCC patients who can benefit from DEB-TACE treatment.

Currently, several staging systems for HCC have been widely used clinically, such as the barcelona stage, the okada stage, the chinese liver cancer stage, and so on. However, these staging systems are not specifically tailored for the treatment of HCC with DEB-TACE and may lead to a bias in the outcome of the prognostic assessment; moreover, they only classify patients into different stages and cannot give the exact survival of a particular patient, affecting the accuracy of the prognostic assessment. In conclusion, a prognosis prediction tool for accurately evaluating the prognosis of DEB-TACE treatment based on the pre-operation clinical characteristics of HCC patients is needed clinically, and data reference is provided for selection of treatment schemes and formulation of follow-up plans of the patients, so that the burden of the patients can be reduced, and the current accurate treatment concept is met.

As a graphical calculation model, the nomogram can conveniently integrate risk factors of disease occurrence and development to generate survival rate or disease occurrence rate of specific individuals. Currently, the value of the histogram model in the diagnosis and prognosis of various tumors (such as melanoma, prostate cancer, liver cancer, etc.) is gaining increasing acceptance. However, until now, no prognostic nomogram model for DEB-TACE treatment of HCC has been established at home and abroad.

Disclosure of Invention

Aiming at the problems and the defects in the prior art, the invention aims to provide a kit for predicting the prognosis of the drug-loaded microsphere chemoembolization treatment of liver cancer.

In order to realize the purpose of the invention, the technical scheme adopted by the invention is as follows:

the invention provides application of a reagent and/or an instrument for detecting the expression quantity of alpha-fetoprotein, ALRI, tumor diameter, Child-Pugh classification, the proportion of tumor to liver, portal vein invasion state and tumor distant metastasis state in preparation of a product for predicting prognosis of liver cancer treatment by drug-loaded microsphere chemoembolization.

The invention provides a kit for predicting prognosis of liver cancer treatment by drug-loaded microsphere chemoembolization, which comprises a reagent and/or an instrument for detecting the expression quantity of alpha-fetoprotein, ALRI, tumor diameter, Child-Pugh classification, the proportion of tumor to liver, portal vein invasion state and tumor distant metastasis state.

According to the kit for predicting the prognosis of liver cancer treatment by drug-loaded microsphere chemoembolization, preferably, the kit further comprises a readable carrier, wherein the readable carrier is recorded with the contents of the following formulas I to VI,

PI ═ 1.397 × tumor distant metastasis +0.559 × alpha fetoprotein expression +0.612 × ALRI +1.027 × tumor diameter +0.790 × Child-Pugh grade +0.560 × tumor proportion of liver +0.833 × portal vein infringement; formula I

In formula I, values for distant metastasis of tumors: tumor distant metastasis does not occur, and the value is 0; distant metastasis of the tumor occurs, and the value is 1;

the value of the expression quantity of the alpha-fetoprotein is as follows: the expression quantity of the alpha-fetoprotein is less than or equal to 400ng/mL, and the value is 0; the expression quantity of the alpha fetoprotein is more than 400ng/mL, and the value is 1;

the value of ALRI: ALRI is less than or equal to 40 and takes the value of 0; ALRI > 40 is 1;

tumor diameter values: the diameter of the tumor is less than or equal to 5cm, and the value is 0; the diameter of the tumor is more than 5cm, and the value is 1;

the value of Child-Pugh classification: grading Child-Pugh as A, and taking the value as 0; grading Child-Pugh into B, and taking the value as 1;

tumor-to-liver ratio: the proportion of the tumor to the liver is less than or equal to 1/2, and the value is 0; the proportion of the tumor to the liver is more than 1/2, and the value is 1;

portal vein infringement takes values as follows: portal vein invasion does not occur, and the value is 0; portal vein invasion occurs, and the value is 1;

p ═ PI-2.134; formula II

In formula II, PI represents the score obtained in formula I, and P represents the linear predictive value;

P₆＝S₀(6)^expP(ii) a Formula III

In the formula III, S₀(6) The average survival probability of the liver cancer patient after 6 months of chemoembolization treatment by the drug-loaded microspheres is shown, and P is a linear predicted value calculated according to formula II; p₆The probability of survival of a liver cancer patient after 6 months of test treatment by drug-loaded microsphere chemoembolization is shown;

P₁₂＝S₀(12)^expP(ii) a Formula IV

In the formula IV, S₀(12) Represents the average survival probability of the liver cancer patient after 12 months of chemotherapy and embolism treatment by the drug-loaded microsphere, P represents the linear predictive value calculated according to the formula II, P₁₂Representing the survival probability of a test liver cancer patient for 12 months after carrying out chemotherapy and embolism treatment by the drug-loaded microspheres;

P₂₄＝S₀(24)^expP(ii) a Formula V

In the formula V, S₀(24) Represents the average survival probability of the liver cancer patient after 24 months of chemotherapy and embolism treatment by the drug-loaded microsphere, P represents the linear predictive value calculated according to the formula II, P₂₄The probability of survival of a liver cancer patient after 24 months of test treatment by the drug-loaded microsphere chemoembolization is shown;

point ═ (PI) × 100/1.397; formula VI

In formula VI, Point represents the total risk score, and PI represents the score calculated by formula I; 100/1.397 means that the maximum risk factor of 1.397 is defined as 100 points, with a corresponding score per unit of risk factor.

According to the kit for predicting the prognosis of liver cancer by drug-loaded microsphere chemoembolization treatment, preferably, the readable carrier is a kit instruction; the contents of formula I, formula II, formula III, formula IV, formula V and formula VI are printed on the card.

According to the kit for predicting the prognosis of liver cancer treatment by drug-loaded microsphere chemoembolization, preferably, the readable carrier is a computer readable carrier.

The third aspect of the invention provides a product for predicting the prognosis of treating liver cancer by carrying medicine microsphere chemoembolization, which comprises a carrier and a survival probability nomogram arranged on the carrier; the carrier is a card and/or a computer; the survival probability nomogram comprises twelve straight lines which are sequentially arranged from top to bottom and are parallel to each other, each straight line represents a scale, and scales are marked on the scale;

the scale value of the 1 st scale is 0-100, the scale value 0 is at the extreme point of the leftmost end, the scale value 100 is at the extreme point of the rightmost end, and the scale of the scale is divided equally;

the scale value of the 2 nd scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 40;

the scale value of the 3 rd scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 44;

the scale value of the 4 th scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 74;

the scale value of the 5 th scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 57;

the scale value of the 6 th scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 40;

the scale value of the 7 th scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 60;

the scale value of the 8 th scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 100;

the scale value of the 9 th scale is 0-400, the scale value 0 is at the extreme point of the leftmost end, the scale value 400 is at the extreme point of the rightmost end, and the scales of the scale are divided equally;

the scale value of the 10 th scale is 0.9-0.2, the scale value is 0.9 at the extreme point of the leftmost end, the scale value is 0.2 at the extreme point of the rightmost end, the scale unit of the scale is 0.1, and the scale distribution on the scale is obtained by performing index conversion on the linear predicted value according to the formula III;

the scale value of the 11 th scale is 0.9-0.1, the scale value is 0.9 at the extreme point of the leftmost end, the scale value is 0.1 at the extreme point of the rightmost end, the scale unit of the scale is 0.1, and the scale distribution on the scale is obtained by performing index conversion on the linear predicted value according to the formula IV;

the scale value of the 12 th scale is 0.9-0.1, the scale value is 0.9 at the extreme point of the leftmost end, the scale value is 0.1 at the extreme point of the rightmost end, the scale unit of the scale is 0.1, and the scale distribution on the scale is obtained by performing index conversion on the linear predicted value according to the formula V;

wherein the 1 st scale represents a scale with a score corresponding to the scale on the 2 nd to 8 th scales; the 2 nd scale represents the alpha-fetoprotein expression amount in the kit of the second aspect, the scale value of the alpha-fetoprotein expression amount of less than or equal to 400ng/mL on the 2 nd scale is 0, and the scale value of the alpha-fetoprotein expression amount of more than 400ng/mL on the 2 nd scale is 1; the 3 rd scale represents the ALRI described in the kit of the second aspect, the scale value corresponding to the 3 rd scale with the ALRI less than or equal to 40 is 0, and the scale value corresponding to the 3 rd scale with the ALRI greater than or equal to 40 is 1; the 4 th scale represents the tumor diameter in the kit of the second aspect, the scale value of the 4 th scale corresponding to the tumor diameter of less than or equal to 5cm is 0, and the scale value of the 4 th scale corresponding to the tumor diameter of more than 5cm is 1; the 5 th scale represents the Child-Pugh classification in the kit of the second aspect, the Child-Pugh classification is that the scale value corresponding to the A on the 5 th scale is 0, and the Child-Pugh classification is that the scale value corresponding to the B on the 5 th scale is 1; the 6 th scale represents the proportion of the tumor to the liver in the kit of the second aspect, the scale value corresponding to the proportion of the tumor to the liver being not more than 1/2 on the 6 th scale is 0, and the scale value corresponding to the proportion of the tumor to the liver being more than 1/2 on the 6 th scale is 1; the 7 th scale represents the portal vein invasion state in the kit of the second aspect, the portal vein invasion state is that portal vein invasion does not occur, and the corresponding scale value on the 7 th scale is 0; the portal vein invasion state is portal vein invasion, and the corresponding scale value on the 7 th scale is 1; the 8 th scale represents the tumor distant metastasis state in the kit of the second aspect, the tumor distant metastasis state is that tumor distant metastasis does not occur, and the corresponding scale value on the 8 th scale is 0; the distant metastasis state of the tumor is the distant metastasis of the tumor, and the corresponding scale value on the 8 th scale is 1; scale 9 represents the total risk score; the 10 th scale represents the survival probability of the liver cancer patient after 6 months of chemoembolization treatment by the drug-loaded microspheres; the 11 th scale represents the survival probability of the liver cancer patient after 12 months of chemotherapy and embolism treatment by the drug-loaded microspheres; the 12 th scale represents the probability of survival of a liver cancer patient 24 months after treatment with the drug-loaded microsphere chemoembolization.

The fourth invention aspect of the invention provides a prediction system for predicting the prognosis of the drug-loaded microsphere chemoembolization treatment of liver cancer, which comprises: the device comprises a variable input module, an analysis module and an output module;

the variable input module comprises seven variable input sub-modules, wherein the seven variable input sub-modules are an alpha fetoprotein input sub-module, an ALRI input sub-module, a tumor diameter input sub-module, a Child-Pugh grading input sub-module, a tumor liver proportion input sub-module, a portal vein invasion state input sub-module and a tumor distant metastasis state input sub-module respectively;

the analysis module can establish a survival probability nomogram and calculate a total risk score based on the variables input by the variable input module, wherein the total risk score is the sum of the risk scores of the expression quantity of the alpha-fetoprotein, the ALRI, the tumor diameter, the Child-Pugh classification, the proportion of the tumor to the liver, the portal vein invasion state and the far tumor metastasis state; calculating the survival time predicted value of the liver cancer patient after the chemotherapy and embolism treatment by the drug-loaded microspheres according to the total risk score;

the output module is used for outputting the life prediction value of the chemotherapy embolization treatment of the liver cancer patient;

wherein the expression level of the alpha-fetoprotein is less than or equal to 400ng/mL, and the corresponding risk score is 0; the expression level of the alpha fetoprotein is more than 400ng/mL, and the corresponding risk score is 40;

the ALRI is less than or equal to 40, and the corresponding risk score is 0; when the ALRI is more than 40, the corresponding risk score is 44;

the diameter of the tumor is less than or equal to 5cm, and the corresponding risk score is 0; when the tumor diameter is larger than 5cm, the corresponding risk score is 74;

the Child-Pugh is classified as A, and the corresponding risk score is 0; the Child-Pugh is graded as B, and the corresponding risk score is 57;

the proportion of the tumor to the liver is less than or equal to 1/2, and the corresponding risk score is 0; the proportion of the tumor to the liver is more than 1/2, and the corresponding risk score is 40;

the portal vein violation state is that portal vein violation does not occur, and the corresponding risk score is 0; the portal vein violation state is portal vein violation occurrence, and the corresponding risk score is 60;

the state of the tumor distant metastasis is that the tumor distant metastasis does not occur, and the corresponding risk score is 0; the tumor distant metastasis state is the occurrence of tumor distant metastasis, and the corresponding risk score is 100.

According to the above prediction system, preferably, the analysis module is capable of performing the following calculations of formulas I to VI:

p ═ PI-2.134; formula II

P₆＝S₀(6)^expP(ii) a Formula III

P₁₂＝S₀(12)^expP(ii) a Formula IV

P₂₄＝S₀(24)^expP(ii) a Formula V

point ═ (PI) × 100/1.397; formula VI

According to the prediction system, preferably, the method for establishing the survival probability nomogram based on the variables input by the variable input module is to use an R language RMS operation package to complete nomogram visualization of a Cox regression model.

According to the prediction system, the variable input module and the analysis module are preferably connected in a wired mode and/or a wireless mode; the analysis module and the output module are connected in a wired mode and/or a wireless mode.

According to the prediction system, the output module is preferably a display, a printer or an audio output device.

According to the prediction system, preferably, the analysis module is a computer host, a central processing unit or a network server.

The expression level of the alpha-fetoprotein in the invention refers to the expression level of the alpha-fetoprotein in the serum of the liver cancer before DEB-TACE treatment; ALRI refers to glutamic-oxaloacetic transaminase (U/L) and lymphocyte (10) in serum of liver cancer patient before DEB-TACE treatment⁹a/L) ratio; the tumor diameter is measured by enhanced CT/MRI before DEB-TACE treatment; the proportion of the tumor to the liver is measured by enhanced CT/MRI before DEB-TACE treatment; before the treatment of DEB-TACE, the Child-Pugh classification is judged according to the total bilirubin level, the albumin level, the existence of hepatic encephalopathy, the existence of ascites and prothrombin time in the serum of a liver cancer patient, and is specifically referred to the Child-Pugh classification standard; the portal vein invasion is judged before DEB-TACE treatment according to the fact that filling defects exist in portal veins of enhanced CT/MRI venous period and parts of the defects are strengthened; the tumor distant metastasis refers to the tumor metastasis to other organs except the liver before DEB-TACE treatment, and can be detected and diagnosed by imaging examination such as CT, MRI, PET/CT, nuclide bone scan and the like.

Compared with the prior art, the invention has the following positive beneficial effects:

(1) according to the application, through researching clinical data before DEB-TACE treatment of an HCC patient receiving DEB-TACE as initial treatment and a survival period after DEB-TACE treatment, the expression quantity of alpha-fetoprotein in serum before DEB-TACE treatment of the HCC patient, an ALRI value, Child-Pugh classification, tumor diameter, the proportion of tumor to liver, portal vein invasion state and tumor distant metastasis state are found for the first time to be independent prognostic factors influencing OS after DEB-TACE operation of the HCC patient, and the prognosis of the HCC patient after DEB-TACE operation can be predicted. Meanwhile, according to the screened DEB-TACE postoperative independent prognostic factors of the HCC patient, a nomogram prediction model capable of predicting the survival rates of the DEB-TACE of the HCC patient after 6 months, 1 year and 2 years is established, and the nomogram prediction model shows good prediction capability in modeling population and verification population; in the aspect of calibration degree, the predicted result and the actual result of the histogram model built by the method keep higher consistency; in the aspect of discrimination, the C-index of the histogram model established by the invention for predicting the DEB-TACE postoperative survival of the liver cancer patient is 0.767 (modeling group), and the C index range of the BCLC, Okuda and CNLC staged models is only 0.557-0.676; therefore, the difference between the predicted value and the actual value of the nomogram prediction model constructed by the invention is small.

(2) The nomogram prediction model constructed by the invention can predict the survival period of the liver cancer patient after DEB-TACE treatment according to clinical indexes of the liver cancer patient before DEB-TACE treatment, evaluate the DEB-TACE treatment prognosis of the liver cancer patient, help an interventionalist to screen patient groups suitable for DEB-TACE treatment before operation, and divide the patient into low, medium and high risk groups by the prognostic risk layering system established on the basis, so that the individual treatment scheme can be accurately formulated for different risk layering groups.

(3) The nomogram prediction model constructed by the invention can predict the survival period of the liver cancer patient after DEB-TACE treatment, can be convenient for a clinician to accurately evaluate the prognosis of the patient, and can make an individualized follow-up scheme according to the expected survival period, if the expected prognosis is worse, the interval of each follow-up is shortened, and the treatment scheme is adjusted according to the change of the disease condition; if the prognosis is expected to be good, the follow-up interval can be properly prolonged, so as to reduce the economic and psychological burden of the patient.

Drawings

FIG. 1 is a histogram model of survival probability of the present invention for predicting prognosis of liver cancer by chemoembolization with drug-loaded microspheres;

FIG. 2 is a schematic diagram of a prediction model webpage calculator for predicting the prognosis of liver cancer after chemoembolization treatment with drug-loaded microspheres according to the present invention;

FIG. 3 is a calibration curve between the survival rate predicted by the histogram model of the survival probability after predicting the prognosis of the drug-loaded microsphere chemoembolization for treating liver cancer and the actual survival rate of a patient according to the present invention, wherein A is a modeling group and B is a verification group;

FIG. 4 is a ROC curve chart and an AUC chart of the probability of survival nomogram model for predicting the prognosis of liver cancer after the chemotherapy and embolism treatment of the drug-loaded microspheres; wherein, A is a module building ROC curve diagram; b is a validation set ROC graph; c is a modeling group AUC graph; d is a validation group AUC graph;

FIG. 5 is a plot of survival probability for the prediction of the prognosis of embolization of liver cancer with drug-loaded microspheres for chemotherapy and the survival curves of the models in each stage; wherein, A is a column line diagram model, and B is the Chinese liver cancer stage; c is the Barcelona stage and D is the Okuda stage.

Example 1: sample collection and sample processing

(1) A total of 302 patients with reluctant or inability to surgically resect HCC who received DEB-TACE as an initial treatment at the first subsidiary hospital of zheng zhou university from 2016 at 6 months to 2020 at 5 months. The inclusion criteria were: 1) the age > 18 years; 2) liver function Child-Pugh A or B grade; 3) eastern American cooperative group of tumors (ECOG) score 0-2; 4) histologically or imagewise confirmed HCC, unwilling or inoperable for resection, has at least one measurable lesion; 5) has not been subjected to other treatments such as surgery, cTACE, ablation or targeted drugs, etc.; 6) DEB-TACE is the initial treatment modality. Exclusion criteria were: 1) liver function Child-Pugh grade C; 2) ECOG score 3-4 points; 3) hepatic or inferior vena cava infringement; 4) complete occlusion of the portal trunk; 5) (ii) suffers from other malignancies; 6) incomplete clinical or follow-up data; 7) severe cardio-hepatic renal dysfunction, blood coagulation dysfunction (prothrombin activity < 40% or platelet count <40,000/mm 3).

The diagnosis of HCC refers to the diagnosis standard used in the primary liver cancer diagnosis and treatment code (2019 edition) of China: 1) nodules with the inner diameter of the liver less than or equal to 2cm, and at least 2 items of dynamically enhanced MRI, dynamically enhanced CT, ultrasonic contrast or hepatocyte specific contrast agent Gd-EOB-DTPA enhanced MRI show the typical characteristics of the liver cancer of 'fast-in and fast-out'; 2) nodules with the internal diameter of the liver being larger than 2cm, and at least 1 imaging examination shows typical liver cancer characteristics; 3) histopathological and/or cytological examinations diagnose hepatocellular carcinoma.

(2) Demographic data (gender, age, ECOG scores, etc.), laboratory indices (blood routine, liver function, kidney function, coagulation function, AFP, etc.), tumor characteristics (tumor location, maximum diameter, number, extent, presence or absence of envelope, presence or absence of portal vein invasion, etc.), and follow-up data (tumor response, survival status, etc.) were collected for each patient.

The neutrophil-to-lymphocyte ratio (NLR), AST-to-lymphocyte ratio (ALRI), AST-to-platelet ratio (APRI), and Child-Pugh score were calculated from the above clinical pathology characteristics, and each patient was staged according to the Okuda stage, BCLC stage, and CNLN stage criteria, respectively. The information of HCC diagnosis, preoperative oncology characteristics, postoperative tumor reaction and the like is obtained by two radiologists with more than 10 years of working experience according to corresponding imaging images; the DEB-TACE procedure was performed by two interventionalists with more than 10 years of work experience.

(3) DEB-TACE surgical procedure: lying on the DSA table, performing electrocardiographic monitoring, inhaling oxygen through a nasal catheter, and disinfecting and paving the towel in the inguinal regions at two sides. The right femoral artery is punctured by an improved Seldingers method, a 5F sheath is placed, blood vessels (hepatic artery, diaphragmatic artery, superior mesenteric artery, left gastric artery and the like) of a 5F RH catheter are imaged under the cooperation of a guide wire to determine blood supply arteries of tumors, evaluate the positions, sizes and numbers of the tumors, and determine whether hepatic artery-portal vein (or hepatic vein) fistula exists or not. 100mg oxaliplatin and 500mg fluorouracil hydrate solution 100ml are slowly infused through a catheter. The catheter or microcatheter was further super-selected into the target vessel and 1 vial of pre-prepared DEB was slowly injected until the contrast showed disappearance of tumor staining. The DEB particle size is selected from 100-300 μm or 300-500 μm according to the tumor size and blood supply condition, and the loading drug is 60mg of pirarubicin. If the contrast is checked after the DEB is injected completely, if the tumor staining still exists, the blank microspheres of 300-.

(4) Follow-up: follow-up was performed 1 month after DEB-TACE surgery and every 3 months thereafter, and the Overall Survival (OS) and survival status of each patient were recorded by outpatient clinic, telephone or a combination thereof. OS is defined as the time from the first DEB-TACE to the death of the patient or the end of the follow-up. The follow-up endpoint was patient death or 2020-12-31.

(5) 70% (212 cases) of patients were randomly divided into building groups, and the remaining 30% (90 cases) were classified as verification groups.

Example 2: independent factor screening related to DEB-TACE postoperative survival period of liver cancer patient

(1) Clinical factors that may be associated with the survival of liver cancer patients after DEB-TACE surgery were analyzed using one-way Cox regression:

in the modeling module, SPSS 21.0 statistical software is used for carrying out single-factor Cox regression analysis on clinical factors possibly related to the DEB-TACE postoperative survival of the liver cancer patient, and the prognostic value of the clinical factors on the DEB-TACE postoperative survival of the liver cancer patient is evaluated. Through single-factor Cox regression analysis, it was found that glutamic-oxaloacetic transaminase, glutamyl transpeptidase, alkaline phosphatase, alpha fetoprotein expression level, bilirubin, ascites presence, tumor diameter, tumor number, tumor-to-liver ratio, tumor envelope presence, portal vein invasion, distant metastasis of tumor, APRI, Child-Pugh classification, NLR, and ALR were associated with DEB-TACE postoperative OS of liver cancer patients (P < 0.05) (the single-factor Cox regression analysis results are shown in table 1).

TABLE 1 Single-factor Cox regression analysis of Total survival of liver cancer patients

Note: ECOG score: eastern american tumor cooperative group physical status score; ALRI: glutamic-oxaloacetic transaminase (U/L) and lymphocytes (10)⁹a/L) ratio; NLR: neutrophils (10)⁹/L) and lymphocytes (10)⁹a/L) ratio; APRI: glutamic-oxaloacetic transaminase (U/L) and platelets (10)⁹a/L) ratio; HR to risk ratio; and CI is confidence interval.

(2) Independent prognostic factors related to DEB-TACE postoperative survival of liver cancer patients are analyzed by applying multifactorial Cox regression:

the clinical factors with P < 0.05 in the single-factor Cox regression analysis are brought into the multi-factor analysis, and the results reveal that the expression level of the alpha-fetoprotein, ALRI, Child-Pugh classification, tumor diameter, the proportion of the tumor to the liver, portal vein invasion and distant metastasis of the tumor are independent prognostic factors influencing OS after DEB-TACE of HCC patients (the results are shown in a table 2).

TABLE 2 Multi-factor Cox regression analysis of Total survival of liver cancer patients

Note: ALRI: glutamic-oxaloacetic transaminase (U/L) and lymphocytes (10)⁹a/L) ratio; HR to risk ratio; CI is a confidence interval; re is a reference item; beta: and (4) regression coefficients.

Example 3: establishment of model for predicting DEB-TACE postoperative life of liver cancer patient

And (3) assigning independent prognostic factors related to the DEB-TACE postoperative survival of the liver cancer patient, which are obtained by multi-factor Cox regression analysis, wherein the assignment conditions are shown in Table 3.

TABLE 3 assignment of independent prognostic factors associated with DEB-TACE postoperative survival in liver cancer patients

Variables of	Assignment of value
		Distant metastasis of tumor	With distant metastasis being 1 and without distant metastasis being 0
ALRI	≤40＝0，＞40＝1
		Child-Pugh fractionation	A＝0，B＝1
Tumor diameter	≤5cm＝0，＞5cm＝1
		The ratio of tumor to liver	≤1/2＝0，＞1/2＝1
Portal vein infringement	None is equal to 0 and there is equal to 1
		Expression level of alpha-fetoprotein	≤400ng/mL＝0，＞400ng/mL＝1

Establishing a risk function expression of each factor according to the beta values of the 7 screened independent prognostic factors according to the multi-factor Cox regression analysis result, wherein the risk function expression of each factor is as follows:

portal vein infringement takes values as follows: portal vein invasion does not occur, and the value is 0; portal vein infringement occurs with a value of 1.

P ═ PI-2.134; formula II

In formula II, PI represents the score obtained in formula I, and P represents the linear predictive value; 2.134 is baseBasal constants, basal constant 2.134 ═ 1.397 × (mean value of distant metastasis co-variation in tumors ═ 0.107) +0.559 × (expression of alpha fetoprotein > 400ng × mL ×)^-1Mean covariate value of 0.510) +0.612 x (ALRI > 40 covariate value of 0.529) +0.790 x (Child-Pugh B grade covariate value of 0.199) +1.027 x (tumor diameter > 5cm covariate value of 0.786) +0.560 x (tumor to liver ratio > 1/2 covariate value of 0.170) +0.833 x (mean covariate with portal vein invasion value of 0.379).

P₆＝S₀(6)^expP(ii) a Formula III

In the formula III, S₀(6) The average survival probability of the liver cancer patient after 6 months of chemoembolization treatment by the drug-loaded microspheres is shown, and P is a linear predicted value calculated according to formula II; p₆Shows the survival probability of the liver cancer patient after 6 months of the treatment of the drug-loaded microsphere chemoembolization.

P₁₂＝S₀(12)^expP(ii) a Formula IV

In the formula IV, S₀(12) Represents the average survival probability of the liver cancer patient after 12 months of chemotherapy and embolism treatment by the drug-loaded microsphere, P represents the linear predictive value calculated according to the formula II, P₁₂Shows the survival probability of the tested liver cancer patients after 12 months of chemoembolization treatment by the drug-loaded microspheres.

P₂₄＝S₀(24)^expP(ii) a Formula V

In the formula V, S₀(24) Represents the average survival probability of the liver cancer patient after 24 months of chemotherapy and embolism treatment by the drug-loaded microsphere, P represents the linear predictive value calculated according to the formula II, P₂₄Shows the survival probability of the tested liver cancer patients after 24 months of chemoembolization treatment by the drug-loaded microspheres.

Point ═ (PI) × 100/1.397; formula VI

The numerical value of Point is calculated by substituting formula VI with PI, and can be substituted into formula II-formula V with PI to obtain P₆、P₁₂、P₂₄The numerical values of (A) correspond to (B), and when the total risk score is known in practical application, P can be obtained correspondingly₆、P₁₂、P₂₄The numerical value of (2) is more convenient.

Specifically, S₀(6)＝0.898；S₀(12)＝0.696；S₀(24)＝0.406。

Obtaining a total risk score by formula I through formula VI conversion; converting the formula I through a formula II to obtain a linear predicted value; 6-month survival probability can be calculated by the formula I through the formula III conversion; the 12-month survival probability can be calculated by the formula I through the formula IV conversion; the 24-month survival probability can be calculated by formula I through formula V conversion.

The formulas I, ii, iii, IV, V and VI created by Cox regression analysis are converted to visualized nomograms (as shown in fig. 1) printed on cards or edited on a computer using the R language RMS calculation package.

The specific command for converting the R language RMS operation packet into the visual nomogram is as follows:

# Call required calculation Package

library(rms)

library(foreign)

library(survival)

# read data

Table (modeling group txt, head T, sep T)

# construction of Cox regression model

cox < -cph (Surv (time) stage) -alpha fetoprotein + ALRI + tumor diameter + Child _ Pugh grade + proportion of the liver + portal vein invasion + distant metastasis of the tumor, Surv ═ T, x ═ T, y ═ T, data ═ ser)

surv<-Survival(cox)

# plot survival probability nomogram

sur_0.5_year<-function(x)surv(1*12*0.5,lp＝x)

sur_1_year<-function(x)surv(1*12*1,lp＝x)

sur_2_year<-function(x)surv(1*12*2,lp＝x)

nom_sur<-nomogram(cox,fun＝list(sur_0.5_year,sur_1_year,sur_2_year),lp＝

F, funlabel ═ c ('6 month survival ', '12 month survival ', '24 month survival ═ c-

'),maxscale＝100,fun.at＝c('0.9','0.8','0.7','0.6','0.5','0.4','0.3','0.2','0.1'))

plot(nom_sur,xfrac＝0.25)。

The survival probability nomogram prediction model shown in fig. 1 can be obtained through the steps.

The survival probability nomogram comprises twelve straight lines which are sequentially arranged from top to bottom and are parallel to each other, each straight line represents a scale, and scales are marked on the scale;

wherein the 1 st scale represents a scale with a score corresponding to the scale on the 2 nd to 8 th scales; the 2 nd scale represents the expression quantity of alpha-fetoprotein, the corresponding scale value of the expression quantity of the alpha-fetoprotein being less than or equal to 400ng/mL on the 2 nd scale is 0, and the corresponding scale value of the expression quantity of the alpha-fetoprotein being more than 400ng/mL on the 2 nd scale is 1; the 3 rd scale represents ALRI, the scale value corresponding to the 3 rd scale with the ALRI less than or equal to 40 is 0, and the scale value corresponding to the 3 rd scale with the ALRI more than 40 is 1; the 4 th scale represents the tumor diameter, the scale value corresponding to the 4 th scale when the tumor diameter is less than or equal to 5cm is 0, and the scale value corresponding to the 4 th scale when the tumor diameter is more than 5cm is 1; the 5 th scale represents the Child-Pugh classification, the Child-Pugh classification is that the scale value corresponding to the A on the 5 th scale is 0, and the Child-Pugh classification is that the scale value corresponding to the B on the 5 th scale is 1; the 6 th scale represents the proportion of the tumor to the liver, the scale value corresponding to the 6 th scale when the proportion of the tumor to the liver is less than or equal to 1/2 is 0, and the scale value corresponding to the 6 th scale when the proportion of the tumor to the liver is more than 1/2 is 1; the 7 th scale represents the portal vein invasion state, the portal vein invasion state is that portal vein invasion does not occur, and the corresponding scale value on the 7 th scale is 0; the portal vein invasion state is portal vein invasion, and the corresponding scale value on the 7 th scale is 1; the 8 th scale represents the distant tumor metastasis state, the distant tumor metastasis state is that the distant tumor metastasis does not occur, and the corresponding scale value on the 8 th scale is 0; the distant metastasis state of the tumor is the distant metastasis of the tumor, and the corresponding scale value on the 8 th scale is 1; scale 9 represents the total risk score; the 10 th scale represents the survival probability of the liver cancer patient after 6 months of chemoembolization treatment by the drug-loaded microsphere; the 11 th scale represents the survival probability of the liver cancer patient 12 months after the chemotherapy and embolism treatment by the drug-loaded microspheres; the 12 th scale represents the total risk score for survival 24 months after chemoembolization treatment with drug-loaded microspheres in liver cancer patients.

The existence of distant metastasis of tumor, the diameter of tumor, portal vein invasion, Child-Pugh classification, ALRI, AFP and the proportion of tumor to liver in the survival probability nomogram correspond to different risk score ranges respectively (see table 4 specifically), and the total risk score is the sum of the existence of distant metastasis of tumor, the diameter of tumor, portal vein invasion, Child-Pugh classification, ALRI, AFP and the sum of the risk scores of the proportion of tumor to liver.

TABLE 4 Risk score of independent prognostic factors affecting DEB-TACE postoperative survival in liver cancer patients

And drawing a vertical line at the position of the total risk score, wherein the intersection point of the vertical line and the 6-month survival rate line is the probability of the 6-month survival rate of the patient, and the 1-year and 2-year survival rates of the patient can be obtained by the same method. Different overall risk scores correspond to different 6-month, 1-year, and 2-year survival rates.

For example, if a patient has AFP ≦ 400ng/ml (score 0), ALRI > 40 (score 44), tumor diameter > 5cm (score 74), Child-Pugh grade A (score 0), tumor range less than half liver (score 0), portal vein invasion (score 60), no distant metastasis (score 0), his/her total score is 178 scores, corresponding to 6 months, 1 year, 2 years survival rates of 86.1%, 60.4%, 28.5%, respectively.

For the convenience of clinical use, an R language (4.0.3 edition) is applied, a webpage calculator (https:// jikun. shinyapps. io/deb _ tag /) of a prediction model for predicting the prognosis of the drug-loaded microsphere chemoembolization treatment of liver cancer is provided, and corresponding survival rate can be obtained only by selecting a right strain on a webpage, so that the calculation speed is greatly improved, and errors caused by manual calculation can be avoided (see figure 2).

Example 4: nomogram model verification for predicting prognosis of drug-loaded microsphere chemoembolization treatment liver cancer

The invention predicts the discrimination and calibration degree of the histogram model after the drug-loaded microsphere chemoembolization treatment of liver cancer and evaluates the model building and verification groups by applying R language (4.0.3 edition).

The C-index (C-index) is an index of discrimination test, and the larger the numerical value is, the smaller the difference between the predicted value and the actual value of the model is. The calibration graph is used to evaluate the calibration degree of the model, and the closer the curve is to 45 degrees represents the higher the consistency of the predicted result and the actual result. In addition, the Receiver Operating Curve (ROC) is used for comparing the prediction accuracy of the histogram model of the present invention with that of the Okuda stage, BCLC stage and CNLN stage models, and the larger the area under the curve (AUC) is, the more accurate the prediction result is.

And (3) verifying the calibration degree: the biotrap method is adopted, repeated sampling is carried out for 1000 times, and the calibration curve between the survival probability predicted by the histogram model for predicting the prognosis of the drug-loaded microsphere chemoembolization liver cancer treatment established by the invention and the actual survival probability is verified, and the result is shown in figure 3. As can be seen from FIG. 3, the prediction survival rate and the actual survival rate of the nomogram model constructed by the method have higher consistency.

And (3) discrimination verification: a lotstem method is adopted, repeated sampling is carried out for 1000 times, and the nomogram model for predicting the prognosis of liver cancer by the drug-loaded microsphere chemoembolization treatment is verified to be used for predicting the C index of the liver cancer prognosis, and the result is as follows: in the modeling group, the C index of the histogram model is 0.767, which is higher than that of CNLC (0.673), BCLC (0.601) and Okuda (0.607); in the validation set, the C index of the histogram model is 0.755, which is also higher than the CNLC stage (0.667), BCLC stage (0.676) and Okuda stage (0.557).

The ROC graph and AUC graph of the modeling and validation sets were plotted, and the results are shown in fig. 4. As can be seen from fig. 4, the AUC of the modeled group histogram model at 6 months, 1 year, and 2 years is 0.747, 0.848, and 0.886, respectively, and the AUC of the validation group is 0.744, 0.796, and 0.886, respectively, and the AUC at any time in both groups is significantly higher than that in the CNLC, BCLC, and Okuda stages (P < 0.05). Therefore, compared with CNLC, BCLC and Okuda staging, the difference between the predicted value and the actual value of the nomogram model is smaller, and the prediction capability is better.

Example 5: prognostic stratification risk system

Using X-tile software (version 3.6.1), liver cancer patients were divided into 3 risk groups based on total risk score of nomograms predictive of prognosis of drug-loaded microsphere chemoembolization treatment of liver cancer: low risk component (0-117 points), medium risk component (118-254 points), high risk component (255-415 points). Survival analysis is carried out on the divided population with low risk group, middle risk group and high risk group by adopting a Kaplan-Meier method, the survival difference is analyzed by adopting Log-rank test, and the result is shown as A in figure 5. As can be seen from A in FIG. 5, the survival difference among the low-risk group, the middle-risk group and the high-risk group is statistically significant (P < 0.001), and the higher the risk, the worse the prognosis of the patient; the invention is proved that the prognosis stratification risk system established based on the nomogram prediction model can clearly distinguish the prognosis of the chemotherapy embolism treatment of the drug-loaded microsphere of the liver cancer patient, and the distinguishing capability is strong.

Meanwhile, in order to further verify the feasibility of a prognosis hierarchical risk system established on the basis of a nomogram model for predicting the prognosis of the drug-loaded microsphere chemoembolization treatment of liver cancer, the invention also adopts methods of Chinese liver cancer staging (CNLC), Barcelona staging (BCLC) and Okuda staging to carry out prognosis differentiation on liver cancer patients respectively, a Kaplan-Meier method is adopted to carry out survival analysis, the survival difference is analyzed by Log-rank test, and the result is shown as B-C in figure 5.

As can be seen in FIG. 5, both the CNLC fraction and the Okuda fraction showed clear prognostic stratification, while the B, C-stage survival curves of the BCLC fraction coincided (P > 0.05). Therefore, the prognosis stratification risk system established on the basis of the nomogram model for predicting the prognosis of the drug-loaded microsphere chemoembolization treatment liver cancer has good prognosis differentiation capability on HCC patients.

Example 4: prediction system for predicting prognosis of liver cancer treated by drug-loaded microsphere chemoembolization

In order to facilitate clinical use, a prediction system for predicting the prognosis of the drug-loaded microsphere chemoembolization treatment of liver cancer is also provided, and the prediction system comprises: the device comprises a variable input module, an analysis module and an output module; the variable input module is connected with the analysis module in a wired mode and/or a wireless mode; the analysis module is connected with the output module in a wired mode and/or a wireless mode; the output module is a display, a printer or an audio output device; the analysis module is a computer host, a central processing unit or a network server.

The variable input module comprises seven variable input sub-modules, wherein the seven variable input sub-modules are an alpha fetoprotein input sub-module, an ALRI input sub-module, a tumor diameter input sub-module, a Child-Pugh grading input sub-module, a tumor liver proportion input sub-module, a portal vein invasion state input sub-module and a tumor distant metastasis state input sub-module respectively.

The analysis module can establish a survival probability nomogram and calculate a total risk score based on the variables input by the variable input module, wherein the total risk score is the sum of the risk scores of the expression quantity of the alpha-fetoprotein, the ALRI, the tumor diameter, the Child-Pugh classification, the proportion of the tumor to the liver, the portal vein invasion state and the far tumor metastasis state; calculating the life prediction value of the chemotherapy embolism treatment of the drug-loaded microspheres of the liver cancer patient according to the total risk score; the output module is used for outputting the life prediction value of the chemotherapy embolization treatment of the liver cancer patient.

Wherein the analysis module is capable of performing the following operations of formulas I-VI:

P ═ PI-2.134; formula II

In formula II, PI represents the score obtained in formula I, and P represents the linear predictive value; 2.134 is the basic constant, 2.134 is 1.397 x (mean value of distant metastasis common variation of tumor is 0.107) +0.559 x (expression of alpha-fetoprotein > 400ng mL)^-1Mean covariate value of 0.510) +0.612 x (ALRI > 40 covariate value of 0.529) +0.790 x (Child-Pugh B grade covariate value of 0.199) +1.027 x (tumor diameter > 5cm covariate value of 0.786) +0.560 x (tumor to liver ratio > 1/2 covariate value of 0.170) +0.833 x (mean covariate with portal vein invasion value of 0.379).

P₆＝S₀(6)^expP(ii) a Formula III

In the formula III, S₀(6) To representThe average survival probability of the liver cancer patient after 6 months of chemoembolization treatment by the drug-loaded microspheres, wherein P represents a linear predicted value calculated according to formula II; p₆Shows the survival probability of the liver cancer patient after 6 months of the treatment of the drug-loaded microsphere chemoembolization.

P₁₂＝S₀(12)^expP(ii) a Formula IV

P₂₄＝S₀(24)^expP(ii) a Formula V

Point ═ (PI) × 100/1.397; formula VI

The expression quantity of the alpha-fetoprotein is less than or equal to 400ng/mL, and the corresponding risk score is 0; the expression level of the alpha fetoprotein is more than 400ng/mL, and the corresponding risk score is 40;

the ALRI is less than or equal to 40, and the corresponding risk score is 0; the ALRI is more than 40, and the corresponding risk score is 44;

the diameter of the tumor is less than or equal to 5cm, the corresponding risk score is 0, the diameter of the tumor is more than 5cm, and the corresponding risk score is 74;

the state of tumor distant metastasis is that tumor distant metastasis does not occur, the corresponding risk score is 0,

the tumor distant metastasis state is the occurrence of tumor distant metastasis, and the corresponding risk score is 100.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. The application of a reagent and/or an instrument for detecting the expression quantity of alpha-fetoprotein, ALRI, tumor diameter, Child-Pugh classification, the proportion of tumor to liver, portal vein invasion state and tumor distant metastasis state in the preparation of a product for predicting the prognosis of liver cancer treatment by drug-loaded microsphere chemoembolization; the product comprises a readable carrier, wherein the readable carrier is recorded with the contents of the following formulas I to VI,

p ═ PI-2.134; formula II

P₆＝S₀(6)^expP(ii) a Formula III

P₁₂＝S₀(12)^expP(ii) a Formula IV

P₂₄＝S₀(24)^expP(ii) a Formula V

point ═ (PI) × 100/1.397; formula VI

2. A kit for predicting prognosis of liver cancer treatment by drug-loaded microsphere chemoembolization is characterized by comprising reagents and/or instruments for detecting an alpha-fetoprotein expression level, ALRI, tumor diameter, Child-Pugh classification, tumor-to-liver ratio, portal vein invasion state and tumor distant metastasis state; the kit also comprises a readable carrier, wherein the readable carrier is recorded with the contents of the following formulas I to VI,

p ═ PI-2.134; formula II

P₆＝S₀(6)^expP(ii) a Formula III

P₁₂＝S₀(12)^expP(ii) a Formula IV

P₂₄＝S₀(24)^expP(ii) a Formula V

point ═ (PI) × 100/1.397; formula VI

3. The kit for predicting the prognosis of liver cancer treatment by drug-loaded microsphere chemoembolization according to claim 2, wherein the readable carrier is a kit instruction; the contents of formula I, formula II, formula III, formula IV, formula V and formula VI are printed on the card.

4. A product for predicting the prognosis of liver cancer treatment by drug-loaded microsphere chemoembolization is characterized by comprising a carrier and a survival probability nomogram arranged on the carrier; the carrier is a card and/or a computer;

the scale value of the 10 th scale is 0.9-0.2, the scale value is 0.9 at the extreme point of the leftmost end, the scale value is 0.2 at the extreme point of the rightmost end, and the scale unit of the scale is 0.1;

the scale value of the 11 th scale is 0.9-0.1, the scale value is 0.9 at the extreme point of the leftmost end, the scale value is 0.1 at the extreme point of the rightmost end, and the scale unit of the scale is 0.1;

the scale value of the 12 th scale is 0.9-0.1, the scale value is 0.9 at the extreme point of the leftmost end, the scale value is 0.1 at the extreme point of the rightmost end, and the scale unit of the scale is 0.1;

wherein the 1 st scale represents a scale with a score corresponding to the scale on the 2 nd to 8 th scales; the 2 nd scale represents the alpha-fetoprotein expression level in the kit according to any one of claims 2-3, wherein the scale value of the alpha-fetoprotein expression level of 400ng/mL or less on the 2 nd scale is 0, and the scale value of the alpha-fetoprotein expression level of 400ng/mL on the 2 nd scale is 1; the 3 rd scale represents ALRI as defined in the kit of any one of claims 2 to 3, ALRI ≦ 40 corresponding to a scale value of 0 on the 3 rd scale, and ALRI > 40 corresponding to a scale value of 1 on the 3 rd scale; the 4 th scale represents the tumor diameter of the kit according to any one of claims 2 to 3, wherein the tumor diameter of 5cm or less corresponds to a scale value of 0 on the 4 th scale, and the tumor diameter of > 5cm corresponds to a scale value of 1 on the 4 th scale; the 5 th scale represents the Child-Pugh scale as defined in any one of the kits of claims 2 to 3, wherein the Child-Pugh scale is such that A corresponds to a scale value of 0 on the 5 th scale and the Child-Pugh scale is such that B corresponds to a scale value of 1 on the 5 th scale; the 6 th scale represents the tumor to liver ratio of the kit of any one of claims 2 to 3, wherein the tumor to liver ratio of 1/2 is 0 on the 6 th scale and the tumor to liver ratio of 1/2 is 1 on the 6 th scale; the 7 th scale represents portal vein infringement status as defined in the kit according to any one of claims 2 to 3, the portal vein infringement status being that portal vein infringement has not occurred, and the corresponding scale value on the 7 th scale is 0; the portal vein invasion state is portal vein invasion, and the corresponding scale value on the 7 th scale is 1; the 8 th scale represents the tumor distant metastasis status of the kit according to any one of claims 2 to 3, wherein the tumor distant metastasis status is that tumor distant metastasis does not occur, and the corresponding scale value on the 8 th scale is 0; the distant metastasis state of the tumor is the distant metastasis of the tumor, and the corresponding scale value on the 8 th scale is 1; scale 9 represents the total risk score; the 10 th scale represents the survival probability of the liver cancer patient after 6 months of chemoembolization treatment by the drug-loaded microspheres; the 11 th scale represents the survival probability of the liver cancer patient after 12 months of chemotherapy and embolism treatment by the drug-loaded microspheres; the 12 th scale represents the probability of survival of a liver cancer patient 24 months after treatment with the drug-loaded microsphere chemoembolization.

5. A prediction system for predicting the prognosis of liver cancer treated by drug-loaded microsphere chemoembolization is characterized by comprising: the device comprises a variable input module, an analysis module and an output module;

when the ALRI is less than or equal to 40, the corresponding risk score is 0; when the ALRI is more than 40, the corresponding risk score is 44;

when the diameter of the tumor is less than or equal to 5cm, the corresponding risk score is 0, and when the diameter of the tumor is more than 5cm, the corresponding risk score is 74;

6. The prediction system of claim 5, wherein the analysis module is capable of performing the following operations from formula I to formula VI:

p ═ PI-2.134; formula II

P₆＝S₀(6)^expP(ii) a Formula III

P₁₂＝S₀(12)^expP(ii) a Formula IV

P₂₄＝S₀(24)^expP(ii) a Formula V

point ═ (PI) × 100/1.397; formula VI

7. The prediction system of claim 5 or 6, wherein the method for establishing a probability-of-survival nomogram based on the variables input by the variable input module is to perform nomogram visualization of a Cox regression model using the R language RMS computation package.

8. The prediction system according to claim 5 or 6, wherein the variable input module and the analysis module are connected by a wire and/or a wireless way; the analysis module and the output module are connected in a wired mode and/or a wireless mode.

9. The prediction system of claim 5 or 6, wherein the output module is a display, a printer, or an audio output device; the analysis module is a computer host, a central processing unit or a network server.