Version May 2024
| Reference | n | Original assay (cut off for positivity) | IHC assay concordance with original assay | Outcome according to biomarker |
| McCarty et al, 1985 | 134 patients | LBA (≥20 fmol/mg) | 89% | Objective clinical response to hormonal therapy: specificity 89%, sensitivity 93%. |
| Barnes et al, 1996 | 170 patients | LBA (≥20 fmol/mg) | 81% | Response to tamoxifen in 72% ER/PR positive and in 61% ER positive/PR negative; superior result with IHC. |
| Harvey et al, 1999 | 1982 patients | LBA (≥3 fmol/mg) | 71% | In multivariate analysis, ER status determined by IHC was significantly better than ER status by LBA at predicting better DFS; results were similar for prediction of overall survival. |
| Elledge et al, 2000 | 205 patients | LBA (≥3 fmol/mg) | 90% | Overall response rate 56% if LBA positive versus 60% if IHC positive. In multivariate analysis, there was significant correlation between IHC for ER and response to tamoxifen. |
| Thomson et al, 2002 | 332 patients | LBA (positive if ≥20 fmol/mg) | Spearman's rank correlation coefficient 0.55 | Significant interaction between IHC score of zero and lack of benefit from ovarian ablation. |
| Regan et al, 2006 | 571 patients | LBA (positive if ≥20 fmol/mg) | Concordance 88% (k = 0.66) in postmenopausal patients | Hazard ratios were similar for association between DFS and ER status or PR status by either LBA or IHC. In premenopausal women, IHC was better than LBA for predicting DFS. |
| Khoshnoud et al, 2011 | 683 patients | LBA (positive if ≥50 fmol/mg) | Overall concordance rate 88% | Hazard ratios were similar for association of tamoxifen use with improved recurrence free survival regardless of assay used. |
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