1.Application of serum tumor specific protein 70 for prognostic stratification in acute myeloid leukemia
Yiling HUANG ; Fei JIN ; Lixia ZHANG ; Yuan MU ; Fengyun LU ; Wenying XIA ; Qiong ZHU ; Shuxian YANG ; Jian XU ; Shiyang PAN
Chinese Journal of Preventive Medicine 2024;58(10):1541-1547
Objective:To assess the value of serum tumor specific protein 70 (SP70) for prognostic stratification in acute myeloid leukemia (AML).Methods:A cohort study design was adopted. 129 newly diagnosed AML patients from September 2022 to January 2024 at the Hematology Department of the First Affiliated Hospital of Nanjing Medical University were included, as well as a control group consisted of 120 healthy individuals and 7 cases with benign hematologic diseases during the same period (total 127 cases). Clinical data were collected from Electronic Medical Records. According to the 2023 edition of the Chinese Leukemia Diagnosis and Treatment Guidelines, AML patients with good or moderate prognosis were categorized as low-to-intermediate risk, while those with poor prognosis were high-risk group. Univariate and multivariate logistic regression analyses were used to identify variables significantly associated with AML prognostic risk. ROC analysis was used to evaluate diagnostic performance. A nomogram for predicting patient prognostic risk was constructed by R 4.0.2 software, and the internal validation was performed using bootstrapping.Results:Among 129 AML patients, there were 71 males (55.0%) and 58 females (45.0%), with 42 (32.6%) classified as high-risk and 87 (67.4%) as low-intermediate risk. The high-risk group had a significantly higher median age [62 (48, 67) years] compared to the low-intermediate risk group [50 (35, 63) years, Z=-2.381, P=0.017], and a significantly higher proportion of males (30 patients, 71.4%) compared to the low-intermediate risk group (41 patients, 47.1%, χ 2=6.760, P=0.009). Multivariate logistic regression analysis indicated that serum SP70 ( OR=2.54, 95% CI: 1.68-3.84, P<0.001), hemoglobin (HB) ( OR=0.96, 95% CI: 0.93-0.99, P<0.05), and bone marrow blast (BM blast) ( OR=1.07, 95% CI: 1.02-1.13, P<0.05) were independent risk factors for high-risk prognosis in AML patients. ROC analysis showed that the area under the curve (AUC) for SP70 predicting high-risk patients was 0.908 (cut-off value of 5.74 ng/ml, 95% CI: 0.845-0.952, sensitivity 90.5%, specificity 82.8%). The combined model of serum SP70, HB, and BM blasts had an AUC of 0.931 (95% CI: 0.890-0.973); C-index=0.925 (95% CI: 0.876-0.963),with no statistically significant difference compared to serum SP70 alone ( Z=1.693, P>0.05). Conclusion:Serum SP70 may be a promising non-invasive molecular biomarker for prognostic stratification in AML.
2.Application of serum tumor specific protein 70 for prognostic stratification in acute myeloid leukemia
Yiling HUANG ; Fei JIN ; Lixia ZHANG ; Yuan MU ; Fengyun LU ; Wenying XIA ; Qiong ZHU ; Shuxian YANG ; Jian XU ; Shiyang PAN
Chinese Journal of Preventive Medicine 2024;58(10):1541-1547
Objective:To assess the value of serum tumor specific protein 70 (SP70) for prognostic stratification in acute myeloid leukemia (AML).Methods:A cohort study design was adopted. 129 newly diagnosed AML patients from September 2022 to January 2024 at the Hematology Department of the First Affiliated Hospital of Nanjing Medical University were included, as well as a control group consisted of 120 healthy individuals and 7 cases with benign hematologic diseases during the same period (total 127 cases). Clinical data were collected from Electronic Medical Records. According to the 2023 edition of the Chinese Leukemia Diagnosis and Treatment Guidelines, AML patients with good or moderate prognosis were categorized as low-to-intermediate risk, while those with poor prognosis were high-risk group. Univariate and multivariate logistic regression analyses were used to identify variables significantly associated with AML prognostic risk. ROC analysis was used to evaluate diagnostic performance. A nomogram for predicting patient prognostic risk was constructed by R 4.0.2 software, and the internal validation was performed using bootstrapping.Results:Among 129 AML patients, there were 71 males (55.0%) and 58 females (45.0%), with 42 (32.6%) classified as high-risk and 87 (67.4%) as low-intermediate risk. The high-risk group had a significantly higher median age [62 (48, 67) years] compared to the low-intermediate risk group [50 (35, 63) years, Z=-2.381, P=0.017], and a significantly higher proportion of males (30 patients, 71.4%) compared to the low-intermediate risk group (41 patients, 47.1%, χ 2=6.760, P=0.009). Multivariate logistic regression analysis indicated that serum SP70 ( OR=2.54, 95% CI: 1.68-3.84, P<0.001), hemoglobin (HB) ( OR=0.96, 95% CI: 0.93-0.99, P<0.05), and bone marrow blast (BM blast) ( OR=1.07, 95% CI: 1.02-1.13, P<0.05) were independent risk factors for high-risk prognosis in AML patients. ROC analysis showed that the area under the curve (AUC) for SP70 predicting high-risk patients was 0.908 (cut-off value of 5.74 ng/ml, 95% CI: 0.845-0.952, sensitivity 90.5%, specificity 82.8%). The combined model of serum SP70, HB, and BM blasts had an AUC of 0.931 (95% CI: 0.890-0.973); C-index=0.925 (95% CI: 0.876-0.963),with no statistically significant difference compared to serum SP70 alone ( Z=1.693, P>0.05). Conclusion:Serum SP70 may be a promising non-invasive molecular biomarker for prognostic stratification in AML.
3.Development of gene sequencing technology and its application and challenges in tumor liquid biopsy
Chinese Journal of Laboratory Medicine 2024;47(11):1231-1236
Sequencing is becoming increasingly important in the early detection, companion diagnostics, molecular subtyping, and prognosis assessment of malignant tumors. In this special column of'tumors and sequencing′, renowned experts in the field of laboratory medicine elaborate on cutting-edge concepts, technologies, and applications related to drug target gene and polymorphism analysis, novel techniques of liquid biopsy, and the clinical cases of mutated genes in solid tumors and hematoma. Notably, liquid biopsy techniques based on circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) are advancing rapidly, offering the potential to serve as non-invasive diagnostic tools that facilitate precision medicine in oncology. To address the limitations of current ctDNA next-generation sequencing (NGS), future developments may focus on NGS targeting CTC-DNA for more precise tumor-targeted therapy. Despite the progress, challenges remain in integrating oncogene sequencing into clinical laboratories and advancing laboratory medicine. Addressing these challenges is crucial to improving public health.
4.National survey report on the current situations and development requirements of emergency testing
Cunling YAN ; Shiyang PAN ; Chengbin WANG ; Chuanxin WANG
Chinese Journal of Laboratory Medicine 2022;45(6):623-636
Objective:To investigate the current situations and development requirements of emergency testing among secondary and tertiary hospitals in China.Methods:The data were collected from secondary and tertiary hospitals via online questionnaire across 31 provinces in China from February 1 to March 1, 2021. The questionnaire involves various aspects of emergency testing, including area of emergency laboratory, staffs and equipment configuration, inspection items, Turn-around time (TAT), reagents and consumables management, pre-analysis quality control, laboratory information system, critical values management and biosafety, etc.Results:A total of 2 187 questionnaires were obtained, and 1 503 valid questionnaires from 755 secondary hospitals and 748 tertiary hospitals were finally analyzed. The research data showed that daily average number of patients visiting emergency department exceeding 300 person-time in 29.41% (220/748) tertiary hospitals, but that number was less than 100 person-time in 76.69% (579/755) secondary hospitals; daily average emergency tests exceeding 5 000 was reported in 24.47% (183/748) tertiary hospitals, and less than 2 000 was reported in 93.51% (706/755) secondary hospitals; the area of emergency laboratory was less than 100 m 2 in 68.79% (238/346) tertiary hospitals with independent emergency testing laboratory; there were no fixed staffs of emergency testing in 56.02% (842/1 503) hospitals; the biochemical/immunoassay analyzer in 8.65% (130/1 503) hospitals did not have STAT position; one hundred and twenty-six hospitals (8.38%) did not have stock in and stock out record for reagents and consumes materials; the conventional statistical analysis of unqualified specimen was not carried out in 24.62% (370/1 503) hospitals; priority on emergent specimen was not set in 58.62% (881/1 503) hospitals; whole process monitoring function was not equipped in 48.64% (731/1 503) hospitals; there was no conventional communication working mechanism with clinicians on critical value in 7.32% (110/1 503) hospitals; overall, 50.23% (755/1 503) participants did not consider that biosafety risks exist in their emergency testing laboratory. Conclusions:This survey objectively presents the current situations and future development requirements of emergency testing among secondary and tertiary hospitals in China. The survey also reflects that some important process and concepts need to be improved, and extensive attention should be paid by laboratory and hospital administrator, in the area such as communication with clinician, site construction and staff configuration, administration on the priority of emergency testing, administration on the reagent and consumable materials, laboratory informatization construction, laboratory biosafety, and so on.
5.The value of NLR, FIB, CEA and CA19-9 in colorectal cancer
Xiang QIAN ; Hong WANG ; Zhen REN ; Fei JIN ; Shiyang PAN
Chinese Journal of Preventive Medicine 2021;55(4):499-505
Objective:To investigate the clinical value of neutrophil-lymphocyte ratio (NLR), fibrinogen (FIB), carcinoembryonic antigen (CEA) and carbohydrate antigen 19-9 (CA19-9) in the diagnosis and prognosis of colorectal cancer.Methods:A case-control study design was used to select 155 patients with colorectal cancer[98 males and 57 females, aged (63.12±13.99)years old], 90 patients with colorectal polyps[62 males and 28 females, aged (56.86±12.74)years old] and 150 healthy subjects[93 males and 57 females, aged (57.02±10.91)years old] from the First Affiliated Hospital of Nanjing Medical University from October 2017 to March 2018. Blood routine tests were detected by instrument method, FIB was detected by Clauss method, and CEA and CA19-9 were detected by electrochemiluminescence method. The levels of the NLR, FIB, CEA and CA19-9 in the 3 groups were compared. The diagnostic efficacy of NLR, FIB, CEA and CA19-9 of colorectal cancer was compared according to the ROC curve. The relationship between the level of NLR, FIB, CEA and CA19-9 and their clinicopathological features in colorectal cancer patients was assessed. According to the median levels of NLR, FIB, CEA and CA19-9, 112 follow-up of colorectal cancer patients could be divided into the high-value group and the low-value group. Kaplan-Meier, log-rank test and Cox regression analysis were used to analyze the relationship between the levels of the four indicators and the prognosis of colorectal cancer.Results:The levels of NLR, FIB, CEA and CA19-9 in colorectal cancer group were 2.11(1.52, 2.86), 3.21(2.58, 3.86)g/L, 3.93(2.27, 8.78)μg/L, 15.11(9.10, 25.73)U/ml. The levels of NLR, FIB, CEA and CA19-9 in colorectal polyp group were 1.74(1.39, 2.17), 2.54(2.26, 3.03)g/L, 1.99(1.18, 2.70)μg/L, 9.83(6.13, 15.68)U/ml. The levels of NLR, FIB, CEA and CA19-9 in healthy control group were 1.68(1.33, 2.28), 2.56(2.30, 2.82)g/L, 1.85(1.28, 2.59)μg/L, 10.03(6.86, 13.26)U/ml. The levels of NLR, FIB, CEA and CA19-9 in colorectal cancer group were significantly higher than those in colorectal polyp group ( Z values were 3.568, 5.913, 6.880 and 4.022, P values were all<0.05) and healthy control group( Z values were 3.916, 7.381, 9.131 and 5.251, P values were all<0.05). The levels of NLR, FIB, CEA and CA19-9 in colorectal polyp group were not remarkably different from those in healthy control group ( Z values were 0.217, 0.179, 0.320 and 0.061, P values were all>0.05). The diagnostic performance of CEA was the best in single test, followed by FIB, CA19-9 and NLR. The sensitivity of combined NLR+FIB+CEA or NLR+FIB+CEA+CA19-9 was the highest with 72.3%. NLR and FIB levels were associated with tumor sites ( Z values were 3.587 and 7.089, P values were both<0.05). FIB and CEA levels were correlated with the depth of tumor invasion ( Z values were 3.250 and 3.245, P values were both <0.05). NLR, FIB, CEA and CA19-9 levels were both associated with lymph node metastasis ( Z values were 2.010, 3.276, 3.312 and 2.921, P values were all<0.05). The prognosis of patients in the high-value NLR, FIB, CEA and CA19-9 groups was significantly worse than that in the low-value group (χ 2 values were 5.744, 6.048, 4.389 and 6.942, P values were all<0.05).Cox multivariate regression analysis showed lymph node metastasis, NLR >2.15 and CA19-9 >15.47 U/ml are independent factors affecting the prognosis of colorectal cancer. Conclusion:NLR, FIB, CEA and CA19-9 can be applied in the auxiliary diagnosis and prognosis of colorectal cancer.
6.Risk factors and risk model of lymph node metastasis in early gastric cancer
Fei JIN ; Xiang QIAN ; Fang NI ; Shiyang PAN
Chinese Journal of Preventive Medicine 2021;55(8):990-994
To investigate the risk factors of lymph node metastasis in early gastric cancer (EGC) and to develop a risk model for the presence of lymph node metastasis. A total of 172 EGC patients, with a median age of 62(52, 68) years, who underwent gastric cancer resection in the First Affiliated Hospital of Nanjing Medical University from January 2017 to June 2019 were selected. Clinical data of the patients were collected through the case system. Logistic regression analysis was used to determine the variables significantly related to lymph node metastasis. ROC curve and calibration curve were used to evaluate the risk model. The results showed that the lymph node metastasis rate of 172 EGC patients was 19.19% (33/172). Tumor size, depth of invasion, degree of differentiation and vascular tumor thrombus were associated with lymph node metastasis ( P<0.05), but age ≥ 60 years ( OR=5.556, 95% CI: 1.757-17.569, P=0.004), invasion depth ( OR=4.218,95% CI:1.418-12.548, P=0.010) and vascular cancer embolus ( OR=13.878,95% CI:4.081-47.196, P<0.001) were independent risk factors for lymph node metastasis of EGC. The consistency index of the risk model based on the above risk factors was 0.8835 (95% CI: 0.818 8-0.948 2). The calibration curve shows that the risk assessment model is in good agreement with the actual results, indicating that the model has high accuracy and discrimination.The most common site of metastasis was group 3, followed by group 4. Therefore, patients over 60 years old with submucosal invasion and vascular tumor thrombus may have a higher risk of lymph node metastasis.
7.Clinical value of tumor-associated autoantibodies in diagnosis of early non-small cell lung cancer
Zhen REN ; Hongmei DING ; Xiang QIAN ; Shiyang PAN
Chinese Journal of Preventive Medicine 2021;55(12):1426-1434
Objective:To investigate the auxiliary diagnostic value of seven tumor-associated autoantibodies (AABs) P53, PGP9.5, SOX2, GAGE7, GBU4-5, MAGEA1 and CAGE in early non-small cell lung cancer (NSCLC).Methods:The case-control study enrolled 195 patients with early NSCLC [71 males and 124 females, aged (55.70±11.78) years old], 114 patients with benign lung disease [44 males and 70 females, aged (52.85±12.31) years old] and 100 healthy subjects [39 males and 61 females, aged (53.62±9.97) years old] from the First Affiliate Hospital of Nanjing Medical University from June 2020 to December 2020. AABs were detected by enzyme-linked-immunosorbent serologic assay (ELISA), and carcinoembryonic antigen (CEA),cytokeratin 19-fragments (CYFRA21-1) and neuron specific enolase (NSE) were detected by electrochemiluminescence. The levels of AABs,CEA,CYFRA21-1 and NSE in the 3 groups were compared. Patients with benign lung diseases and healthy subjects were combined into the control group, and the positive rate of each indicator in the NSCLC group and the control group was compared. The diagnostic efficacy of single and combined tests for NSCLC were obtained using receiver operating characteristic (ROC) curves. Besides, the relationship between the levels of AABs, CEA, CYFRA21-1 and NSE and their clinicopathological features and preoperative imaging parameters in NSCLC patients was assessed.Results:The levels of SOX2 [0.70 (0.10, 2.40) U/mL] and GBU4-5 [1.30 (0.30, 8.90) U/mL] in NSCLC group were higher than those in benign disease group [SOX2: 0.50 (0.10, 1.60) U/mL, GBU4-5: 0.80 (0.10, 2.30) U/mL, Z values were 27.258 and 45.797; P values were all<0.05] and health control group [SOX2: 0.45 (0.10, 1.08) U/mL, GBU4-5: 0.75 (0.20, 1.78) U/mL, Z values were 32.551 and 40.456; P values were all<0.05], and there was no significant difference between benign disease group and health control group ( Z values were 5.293 and 5.340, P values were all>0.05). The levels of CEA [1.75 (1.08, 2.72) U/mL] and CYFRA21-1 [1.81 (1.41, 2.36) U/mL] in NSCLC group were higher than those in healthy control group [CEA: 1.22 (0.68, 1.81) U/mL, CYFRA21-1: 1.43 (1.14, 1.74) U/mL, Z values were 64.100 and 37.597; P values were all<0.05], but there was no significant difference between NSCLC group and benign group [CEA: 1.74 (1.01, 2.51) U/mL, CYFRA21-1: 1.82 (1.45, 2.46) U/mL, Z values were 7.275 and 10.621; P values were all>0.05]. The positive rates of P53, SOX2, GAGE7, GBU4-5 and CEA in NSCLC group were higher than those in the control group [P53: 10.3% vs 0.9%, SOX2: 11.3% vs 2.3%, GAGE7: 11.3% vs 0.5%, GBU4-5: 30.1% vs 5.6%, CEA: 9.7% vs 0.9%, χ2 values were 17.420, 13.242, 22.485, 43.211, 16.255, respectively; P values were all<0.05]. The diagnostic efficiency of the combined detection of seven AABs was better than that of single detection. Seven AABs combined with CEA [area under curve (AUC): 0.732, sensitivity: 64.10%] and with CYFRA21-1 (AUC: 0.737, sensitivity: 58.97%) greatly improved the diagnostic efficiency and sensitivity of CEA (AUC: 0.583, sensitivity: 50.77%) and CYFRA21-1 (AUC: 0.552, sensitivity: 44.10%). The levels of SOX2 and CEA in NSCLC patients were correlated with the degree of tumor invasion ( H values were 6.436 and 14.071; P values were all<0.05); the levels of GAGE7 and CEA were correlated with the nodule density ( H values were 7.643 and 12.268; P values were all<0.05); and the levels of SOX2, GAGE7, CEA and CYFRA21-1 were all correlated with the nodule size ( H values were 10.837, 11.528, 31.835, 20.338; P values were all<0.05). Conclusion:The detection of AABs combined with CEA and CYFRA21-1 is helpful for the early auxiliary diagnosis of NSCLC, and plays an important role in prevention and screening for early lung cancer.
8.The value of NLR, FIB, CEA and CA19-9 in colorectal cancer
Xiang QIAN ; Hong WANG ; Zhen REN ; Fei JIN ; Shiyang PAN
Chinese Journal of Preventive Medicine 2021;55(4):499-505
Objective:To investigate the clinical value of neutrophil-lymphocyte ratio (NLR), fibrinogen (FIB), carcinoembryonic antigen (CEA) and carbohydrate antigen 19-9 (CA19-9) in the diagnosis and prognosis of colorectal cancer.Methods:A case-control study design was used to select 155 patients with colorectal cancer[98 males and 57 females, aged (63.12±13.99)years old], 90 patients with colorectal polyps[62 males and 28 females, aged (56.86±12.74)years old] and 150 healthy subjects[93 males and 57 females, aged (57.02±10.91)years old] from the First Affiliated Hospital of Nanjing Medical University from October 2017 to March 2018. Blood routine tests were detected by instrument method, FIB was detected by Clauss method, and CEA and CA19-9 were detected by electrochemiluminescence method. The levels of the NLR, FIB, CEA and CA19-9 in the 3 groups were compared. The diagnostic efficacy of NLR, FIB, CEA and CA19-9 of colorectal cancer was compared according to the ROC curve. The relationship between the level of NLR, FIB, CEA and CA19-9 and their clinicopathological features in colorectal cancer patients was assessed. According to the median levels of NLR, FIB, CEA and CA19-9, 112 follow-up of colorectal cancer patients could be divided into the high-value group and the low-value group. Kaplan-Meier, log-rank test and Cox regression analysis were used to analyze the relationship between the levels of the four indicators and the prognosis of colorectal cancer.Results:The levels of NLR, FIB, CEA and CA19-9 in colorectal cancer group were 2.11(1.52, 2.86), 3.21(2.58, 3.86)g/L, 3.93(2.27, 8.78)μg/L, 15.11(9.10, 25.73)U/ml. The levels of NLR, FIB, CEA and CA19-9 in colorectal polyp group were 1.74(1.39, 2.17), 2.54(2.26, 3.03)g/L, 1.99(1.18, 2.70)μg/L, 9.83(6.13, 15.68)U/ml. The levels of NLR, FIB, CEA and CA19-9 in healthy control group were 1.68(1.33, 2.28), 2.56(2.30, 2.82)g/L, 1.85(1.28, 2.59)μg/L, 10.03(6.86, 13.26)U/ml. The levels of NLR, FIB, CEA and CA19-9 in colorectal cancer group were significantly higher than those in colorectal polyp group ( Z values were 3.568, 5.913, 6.880 and 4.022, P values were all<0.05) and healthy control group( Z values were 3.916, 7.381, 9.131 and 5.251, P values were all<0.05). The levels of NLR, FIB, CEA and CA19-9 in colorectal polyp group were not remarkably different from those in healthy control group ( Z values were 0.217, 0.179, 0.320 and 0.061, P values were all>0.05). The diagnostic performance of CEA was the best in single test, followed by FIB, CA19-9 and NLR. The sensitivity of combined NLR+FIB+CEA or NLR+FIB+CEA+CA19-9 was the highest with 72.3%. NLR and FIB levels were associated with tumor sites ( Z values were 3.587 and 7.089, P values were both<0.05). FIB and CEA levels were correlated with the depth of tumor invasion ( Z values were 3.250 and 3.245, P values were both <0.05). NLR, FIB, CEA and CA19-9 levels were both associated with lymph node metastasis ( Z values were 2.010, 3.276, 3.312 and 2.921, P values were all<0.05). The prognosis of patients in the high-value NLR, FIB, CEA and CA19-9 groups was significantly worse than that in the low-value group (χ 2 values were 5.744, 6.048, 4.389 and 6.942, P values were all<0.05).Cox multivariate regression analysis showed lymph node metastasis, NLR >2.15 and CA19-9 >15.47 U/ml are independent factors affecting the prognosis of colorectal cancer. Conclusion:NLR, FIB, CEA and CA19-9 can be applied in the auxiliary diagnosis and prognosis of colorectal cancer.
9.Risk factors and risk model of lymph node metastasis in early gastric cancer
Fei JIN ; Xiang QIAN ; Fang NI ; Shiyang PAN
Chinese Journal of Preventive Medicine 2021;55(8):990-994
To investigate the risk factors of lymph node metastasis in early gastric cancer (EGC) and to develop a risk model for the presence of lymph node metastasis. A total of 172 EGC patients, with a median age of 62(52, 68) years, who underwent gastric cancer resection in the First Affiliated Hospital of Nanjing Medical University from January 2017 to June 2019 were selected. Clinical data of the patients were collected through the case system. Logistic regression analysis was used to determine the variables significantly related to lymph node metastasis. ROC curve and calibration curve were used to evaluate the risk model. The results showed that the lymph node metastasis rate of 172 EGC patients was 19.19% (33/172). Tumor size, depth of invasion, degree of differentiation and vascular tumor thrombus were associated with lymph node metastasis ( P<0.05), but age ≥ 60 years ( OR=5.556, 95% CI: 1.757-17.569, P=0.004), invasion depth ( OR=4.218,95% CI:1.418-12.548, P=0.010) and vascular cancer embolus ( OR=13.878,95% CI:4.081-47.196, P<0.001) were independent risk factors for lymph node metastasis of EGC. The consistency index of the risk model based on the above risk factors was 0.8835 (95% CI: 0.818 8-0.948 2). The calibration curve shows that the risk assessment model is in good agreement with the actual results, indicating that the model has high accuracy and discrimination.The most common site of metastasis was group 3, followed by group 4. Therefore, patients over 60 years old with submucosal invasion and vascular tumor thrombus may have a higher risk of lymph node metastasis.
10.Clinical value of tumor-associated autoantibodies in diagnosis of early non-small cell lung cancer
Zhen REN ; Hongmei DING ; Xiang QIAN ; Shiyang PAN
Chinese Journal of Preventive Medicine 2021;55(12):1426-1434
Objective:To investigate the auxiliary diagnostic value of seven tumor-associated autoantibodies (AABs) P53, PGP9.5, SOX2, GAGE7, GBU4-5, MAGEA1 and CAGE in early non-small cell lung cancer (NSCLC).Methods:The case-control study enrolled 195 patients with early NSCLC [71 males and 124 females, aged (55.70±11.78) years old], 114 patients with benign lung disease [44 males and 70 females, aged (52.85±12.31) years old] and 100 healthy subjects [39 males and 61 females, aged (53.62±9.97) years old] from the First Affiliate Hospital of Nanjing Medical University from June 2020 to December 2020. AABs were detected by enzyme-linked-immunosorbent serologic assay (ELISA), and carcinoembryonic antigen (CEA),cytokeratin 19-fragments (CYFRA21-1) and neuron specific enolase (NSE) were detected by electrochemiluminescence. The levels of AABs,CEA,CYFRA21-1 and NSE in the 3 groups were compared. Patients with benign lung diseases and healthy subjects were combined into the control group, and the positive rate of each indicator in the NSCLC group and the control group was compared. The diagnostic efficacy of single and combined tests for NSCLC were obtained using receiver operating characteristic (ROC) curves. Besides, the relationship between the levels of AABs, CEA, CYFRA21-1 and NSE and their clinicopathological features and preoperative imaging parameters in NSCLC patients was assessed.Results:The levels of SOX2 [0.70 (0.10, 2.40) U/mL] and GBU4-5 [1.30 (0.30, 8.90) U/mL] in NSCLC group were higher than those in benign disease group [SOX2: 0.50 (0.10, 1.60) U/mL, GBU4-5: 0.80 (0.10, 2.30) U/mL, Z values were 27.258 and 45.797; P values were all<0.05] and health control group [SOX2: 0.45 (0.10, 1.08) U/mL, GBU4-5: 0.75 (0.20, 1.78) U/mL, Z values were 32.551 and 40.456; P values were all<0.05], and there was no significant difference between benign disease group and health control group ( Z values were 5.293 and 5.340, P values were all>0.05). The levels of CEA [1.75 (1.08, 2.72) U/mL] and CYFRA21-1 [1.81 (1.41, 2.36) U/mL] in NSCLC group were higher than those in healthy control group [CEA: 1.22 (0.68, 1.81) U/mL, CYFRA21-1: 1.43 (1.14, 1.74) U/mL, Z values were 64.100 and 37.597; P values were all<0.05], but there was no significant difference between NSCLC group and benign group [CEA: 1.74 (1.01, 2.51) U/mL, CYFRA21-1: 1.82 (1.45, 2.46) U/mL, Z values were 7.275 and 10.621; P values were all>0.05]. The positive rates of P53, SOX2, GAGE7, GBU4-5 and CEA in NSCLC group were higher than those in the control group [P53: 10.3% vs 0.9%, SOX2: 11.3% vs 2.3%, GAGE7: 11.3% vs 0.5%, GBU4-5: 30.1% vs 5.6%, CEA: 9.7% vs 0.9%, χ2 values were 17.420, 13.242, 22.485, 43.211, 16.255, respectively; P values were all<0.05]. The diagnostic efficiency of the combined detection of seven AABs was better than that of single detection. Seven AABs combined with CEA [area under curve (AUC): 0.732, sensitivity: 64.10%] and with CYFRA21-1 (AUC: 0.737, sensitivity: 58.97%) greatly improved the diagnostic efficiency and sensitivity of CEA (AUC: 0.583, sensitivity: 50.77%) and CYFRA21-1 (AUC: 0.552, sensitivity: 44.10%). The levels of SOX2 and CEA in NSCLC patients were correlated with the degree of tumor invasion ( H values were 6.436 and 14.071; P values were all<0.05); the levels of GAGE7 and CEA were correlated with the nodule density ( H values were 7.643 and 12.268; P values were all<0.05); and the levels of SOX2, GAGE7, CEA and CYFRA21-1 were all correlated with the nodule size ( H values were 10.837, 11.528, 31.835, 20.338; P values were all<0.05). Conclusion:The detection of AABs combined with CEA and CYFRA21-1 is helpful for the early auxiliary diagnosis of NSCLC, and plays an important role in prevention and screening for early lung cancer.

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