Table 1.

Diagnostic performance of ¹⁸F‐FES PET for the identification of estrogen receptor status in tumors of patients with breast cancer

Study	TP	FP	FN	TN	Total n	Sensitivity (95% CI)a	Specificity (95% CI)a	Tissue assayb definition of ER‐positive	18F‐FES PET definition of ER‐positive	Meta‐analysis inclusionc
										1	2	3	4
Chae 2019 21	36	0	11	38	85	0.77 (0.63–0.86)	1.00 (0.90–1)	Allred ≥3	Qualitative	X		X	X
Gupta 2017 32 d Nonbreast	4	0	0	0	4	0.98 (0.50–1)	Indeterminate	Not stated, but all ER‐positive were ≥ 15% of cells	Qualitative	—e		X	X
Breast	6	0	0	0	6	0.98 (0.60–1)	Indeterminate				—e	(X)	(X)
Unclear location	0	0	0	2	2							(X)	(X)
Peterson 2008 33 f Nonbreast	3	0	0	2	5	0.97 (0.43–1)	0.96 (0.33–1)	≥5% of cells	SUVmean >1	X		X	X
Breast	9	1	0	2	12	0.99 (0.69–1)	0.66 (0.21–0.93)				X	(X)	(X)
Peterson 2014 34 g Nonbreast	8	0	0	2	10	0.99 (0.67–1)	0.96 (0.33–1)	Allred >2	SUVmean >1.5	X		X	X
Breast	4	0	0	0	4	0.98 (0.50–1)	Indeterminate				—e	(X)	(X)
Venema 2017 35	11	0	0	2	13	0.99 (0.73–1)	0.96 (0.33–1)	≥1% of cells	SUVmax >1.5	X		X	X
Chae 2017 38	24	0	2	0	26	0.92 (0.75–0.98)	Indeterminate	Allred ≥6	Qualitative		—e	—e	—e
Gemignani 2013 37	34	2	6	6	48	0.85 (0.71–0.93)	0.74 (0.41–0.93)	≥1% of cells	SUVmean >1.5		X	X	X
Yang 2013 36	11	1	0	6	18	0.99 (0.73–1)	0.85 (0.48–0.97)	≥1% of cells	SUVmax >1.5h		X	X	X
Dehdashti 1995 39	11	0	5	20	36	0.69 (0.44–0.86)	1 (0.83–1)	RBA, >3 fmol/mg or IHC (criteria not stated)	Qualitative				X
Mintun 1988 15	8	2	0	0	10	0.99 (0.67–1)	0.05 (0–0.67)	RBA, >3 fmol/mg	Qualitative				X
Mortimer 1996 18	16	0	5	20	41	0.76 (0.55–0.89)	1 (0.83–1)	RBA, >3 fmol/mg or IHC (criteria not stated)	Qualitative				X
van Kruchten 2012 24	22	0	1	10	33	0.95 (0.79–0.99)	0.99 (0.71–1)	IHC (criteria not stated) and/or clinical outcome	SUVmax >1.5				X

^aWilson confidence interval, continuity correction of 0.1 applied to all cells.

^bAll immunohistochemistry in primary analysis and secondary analysis 1.

^c(1) Primary analysis: Nonbreast lesions in patients with advanced/metastatic breast cancer—includes lymph nodes, chest wall, and pleura (37 Chae 2019, 3 Gupta, 4 Peterson 2014, 4 Peterson 2008, all ER positive; 30 Chae 2019 ER negative); (2) Secondary analysis 1: Breast lesions in patients with any‐stage breast cancer; (3) Secondary analysis 2: Combined breast and nonbreast lesions; (4) Secondary analysis 3: Additional breast and nonbreast lesions, in patients with any‐stage breast cancer, non‐IHC tissue assay.

^dAs determined from patient‐level data provided in Table 4 of the publication; location not provided for 2 TN lesions.

^eExcluded from hierarchical summary receiver‐operating characteristic analysis (meta‐analysis summary sensitivity and specificity)—no ER‐negative lesions in study.

^fUnpublished patient‐level lesion location data provided by the authors.

^gAs determined from patient‐level data provided in Appendix Table 2 of the publication.

^hNo ¹⁸F‐FES positive/negative determination in manuscript, but data values available for use of SUVmax cutoff.

Abbreviations: CI, confidence interval; ER, estrogen receptor; ¹⁸F‐FES, 16α‐18F‐fluoro‐17β‐estradiol; FN, false negative; FP, false positive; IHC, immunohistochemistry; PET, positron emission tomography; RBA, relative binding affinity; SUV, standardized uptake value; TN, true negative; TP, true positive.