| Objectives:To evaluate the diagnostic performance of one-step nucleic acid amplification(OSNA)for sentinel lymph node(SLN)metastasis and macrometastasis in breast cancer and provide clinical references for OSNA,a diagnostic meta-analysis was conducted on per-patient basis and per-node basis,respectively.Methods:Fourteen databases including PubMed,Web of Science,Cochrane library,Scopus,BMJ Journals Online,Wiley Online Library,Elsevier Science,Springer-Link,Taylor & Francis Online,Karger Publishers,China National Knowledge Infrastructure,Wanfang Data,Vip Chinese Journal Service Platform and Chinese Biomedical Database were retrieved.Chinese and English literatures published up to December 31,2018 were searched.The literatures were screened according to pre-established inclusion and exclusion criteria.The diagnostic meta-analysis was conducted using Stata software.Based on per-patient and per-nodes analysis,the sensitivity,specificity,positive predictive value(PLR),negative predictive value(NLR),diagnostic odds ratio(DOR)and area under the curve(AUC)of OSNA for the diagnosis of SLN metastasis and macrometastasis in breast cancer were evaluated,respectively.Subgroup analysis and meta-regression were performed,and race of patients,number of patients / nodes,gold standard method,whether cytokeratin 19 immunohistochemistry(CK19 IHC)was used,and whether tissue distribution bias(TAB)was excluded were set as covariates.Results:1.The per-patient analysis of OSNA for the diagnosis of SLN metastasis in breast cancer included 12 literatures.The sensitivity of OSNA was 0.87(95% CI 0.81-0.91),specificity was 0.92(95% CI 0.86-0.95),PLR was 10.65(95% CI 6.18-18.34),NLR was 0.14(95% CI 0.10-0.20),DOR was 75.08(95% CI 37.77-149.22)and AUC was 0.94(95% CI 0.91-0.95),respectively.2.Subgroup analysis and meta-regression of OSNA for the diagnosis of SLN metastasis in breast cancer was conducted based on per-patient analysis.The sensitivity and specificity of Asian patients were 0.82 and 0.92,while the sensitivity and specificity of patients in other races were 0.91 and 0.90,respectively,the difference in sensitivity was statistically significant(P<0.05)and the difference in specificity was not statistically significant(P>0.05).The sensitivity and specificity in the literatures with <100 patients were 0.95 and 0.94,while the sensitivity and specificity in the literatures with ?100 patients were 0.85 and 0.91,respectively,the differences in sensitivity and specificity were not statistically significant(P>0.05).The sensitivity and specificity in the literatures using hematoxylin and eosin(HE)staining was 0.87 and 0.89,while the sensitivity and specificity in the literatures using HE staining and IHC were 0.88 and 0.95,respectively,the differences in sensitivity and specificity were statistically significant(P<0.05).3.The per-node analysis of OSNA for the diagnosis of SLN metastasis in breast cancer included 18 literatures.The sensitivity of OSNA was 0.90(95% CI 0.86-0.93),specificity was 0.96(95% CI 0.95-0.97),PLR was 22.62(95% CI 16.57-30.87),NLR was 0.11(95% CI 0.08-0.15),DOR was 211.81(95% CI 120.75-371.53)and AUC was 0.98(95% CI 0.96-0.99),respectively.4.Subgroup analysis and meta-regression of OSNA for the diagnosis of SLN metastasis in breast cancer was conducted based on per-node analysis.The sensitivity and specificity of Asian patients were 0.83 and 0.95,while the sensitivity and specificity of patients in other races were 0.93 and 0.97,respectively,the differences in specificity and specificity were statistically significant(P<0.05).The sensitivity and specificity in the literatures with <100 nodes were 0.91 and 0.97,while the sensitivity and specificity in the literatures with ?100 nodes were 0.89 and 0.96 respectively,the differences in sensitivity and specificity were statistically significant(P<0.05).The sensitivity and specificity in the literatures using HE staining were 0.89 and 0.95,while the sensitivity and specificity in the literatures using HE staining and IHC were 0.91 and 0.97,respectively,the differences in sensitivity and specificity were statistically significant(P<0.05).The sensitivity and specificity in the literatures using CK19 IHC were 0.90 and 0.97,while the sensitivity and specificity in the literatures without CK19 IHC were 0.90 and 0.95,respectively,the differences in sensitivity and specificity were statistically significant(P<0.05).The sensitivity and specificity in the literatures excluding TAB were 0.96 and 0.98,while the sensitivity and specificity in the literatures having TAB were 0.87 and 0.95,respectively,the difference in sensitivity was not statistically significant(P>0.05)and the difference in specificity was statistically significant(P<0.05).5.The per-patient analysis of OSNA for the diagnosis of SLN macrometastasis in breast cancer included 8 literatures.The sensitivity of OSNA was 0.80(95% CI 0.72-0.86),specificity was 0.96(95% CI 0.92-0.98),PLR was 21.67(95% CI 10.78-43.57),NLR was 0.21(95% CI 0.15-0.29),DOR was 103.00(95% CI 53.91-196.78)and AUC was 0.92(95% CI 0.90-0.94),respectively.6.Subgroup analysis and meta-regression of OSNA for the diagnosis of SLN macrometastasis in breast cancer was conducted based on per-patient analysis.The sensitivity and specificity of Asian patients were 0.77 and 0.96,while the sensitivity and specificity of patients in other races were 0.90 and 0.97,respectively,the difference in sensitivity was statistically significant(P<0.05)and the difference in specificity was not statistically significant(P>0.05).The sensitivity and specificity in the literatures using HE staining were 0.80 and 0.95,while the sensitivity and specificity in the literatures using HE staining and IHC were 0.80 and 0.97,respectively,the difference in sensitivity was statistically significant(P<0.05)and the difference in specificity was not statistically significant(P>0.05).7.The per-node analysis of OSNA for the diagnosis of SLN macrometastasis in breast cancer included 12 literatures.The sensitivity of OSNA was 0.85(95% CI 0.80-0.88),specificity was 0.98(95% CI 0.97-0.99),PLR was 55.11(95% CI 30.07-101.00),NLR was 0.15(95% CI 0.12-0.20),DOR was 355.80(95% CI 202.40-625.46)and AUC was 0.94(95% CI 0.92-0.96),respectively.8.Subgroup analysis and meta-regression of OSNA for the diagnosis of SLN macrometastasis in breast cancer was conducted based on per-node analysis.The sensitivity and specificity in the literatures using HE staining were 0.85 and 0.99,while the sensitivity and specificity in the literatures using HE staining and IHC were 0.85 and 0.98,respectively,the difference in sensitivity was statistically significant(P<0.05)and the difference in specificity was not statistically significant(P>0.05).The sensitivity and specificity in the literatures using CK19 IHC were 0.82 and 0.99,while the sensitivity and specificity in the literatures without CK19 IHC were 0.88 and 0.98,respectively,the difference in sensitivity was statistically significant(P<0.05)and the difference in specificity was not Statistical significance(P>0.05).The sensitivity and specificity in the literatures excluding TAB were 0.83 and 0.98.while the sensitivity and specificity in the literatures having TAB were 0.85 and 0.98,respectively,the difference in sensitivity was statistically significant(P<0.05)and the difference in specificity was not Statistical significance(P>0.05).Conclusion:1.OSNA has an accurate diagnostic effect on SLN metastasis and macrometastasis in breast cancer.OSNA can be used as a routine diagnostic method for SLN biopsy in breast cancer patients.2.The diagnostic efficacy of OSNA on per-patient basis was inferior to the diagnostic efficacy of OSNA on per-node basis.3.The sensitivity of OSNA for SLN metastasis in breast cancer is higher than the sensitivity of SLN macrometastasis,but the specificity of OSNA for SLN metastasis in breast cancer is lower than the specificity of SLN macrometastasis.4.The diagnostic efficacy of OSNA for Asia breast cancer patients is inferior to the diagnostic efficacy of OSNA for breast cancer patients in other races.5.After the combination with CK19 IHC,OSNA has improved diagnostic efficiency for SLN metastasis and reduced diagnostic efficiency for SLN macrometastasis.6.After excluding TAB,OSNA has improved diagnostic efficiency for SLN metastasis and reduced diagnostic efficiency for SLN macrometastasis. |
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