Staining for p53 and Ki-67 increases the sensitivity of EUS-FNA to detect pancreatic malignancy

Table 1 Patient data for those with pancreatic lesions definitively diagnosed as benign or malignant (not all laboratory data were available for each patient)

	Malignant (n = 49)	Benign (n = 12)
Age [median (range)]	61 (34-88)	60 (15-73)
Sex (M:F)	27:22:00	8:04
Location of pancreatic lesion
Head/uncinate process	39	10
Body	9	2
Tail	1	0
Serum enzymes [median (range)]
Total bilirubina (mg/dL)	3 (1-28)	1 (0-5)
AST (U/L)	63 (11-603)	35 (13-182)
ALT (U/L)	74 (5-694)	33 (13-167)
ALP (U/L)	211 (54-1307)	136 (59-1409)
Amylase (U/L)	94 (15-182)	80 (11-285)
Lipase (U/L)	26 (13-199)	29 (16-95)
Serum tumor markers [median (range)]
CEA (ng/mL)	5 (1-403)	3 (0-32)
CA19-9a (U/mL)	339 (0-9929)	28 (0-1507)

^aP < 0.05, benign group compared with malignant. ALP: alkaline phosphatase; ALT: alanine aminotransferase; AST: aspartate aminotransferase; CEA: carcinoembryonic antigen.

Table 2 Distribution of positive tumor marker stains, alone or in select parallel combinations, according to cytology and final diagnosis

Malignant (n=49)				Final diagnosis cytology	Benign (n=12)
Benign (n=8)	Atypical (n=17)	Suspicious (n=4)	Malignant (n=20)		Benign (n=5)	Atypical (n=7)	Suspicious (n=0)	Malignant (n=0)
1	4	0	9	p53	0	0	0	0
2	4	0	14	Ki-67	0	0	0	0
6	8	1	15	CEA	4	3	0	0
4	10	0	13	CA19-9	1	2	0	0
2	6	0	16	p53:Ki-67	0	0	0	0
6	12	1	17	p53:Ki-67:CEA	4	3	0	0
5	14	0	19	p53:Ki-67:CA19-9	1	2	0	0
6	15	1	19	All 4 stains	4	3	0	0

CEA: carcinoembryonic antigen.

Table 3 Diagnostic accuracy of routine cytology and immunohistochemistry, alone or in selected combinations, in detection of pancreatic cancer via endoscopic ultrasound-guided fine needle aspiration

	Sensitivity (%)	Specificity (%)	PPV (%)	NPV (%)	PLR	NLR
Cytology	41	100	100	29	¥	0.59
p53 + cytology	51	100	100	33	¥	0.49
Ki-67 + cytology	53	100	100	34	¥	0.47
CEA + cytology	71	42	83	26	1	0.7
CA19-9 + cytology	69	75	92	38	3	0.41
p53+Ki-67 + cytology	57	100	100	36	¥	0.43
p53+Ki-67 + CEA+cytology	80	42	85	33	1	0.49
p53+Ki-67 + CA19-9 + cytology	80	75	93	47	3	0.27
All 4 stains + cytology	86	42	86	42	1	0.34

CEA: carcinoembryonic antigen; IH: immunohistochemistry; NLR: negative likelihood ratio; NPV: negative predictive value; PLR: positive likelihood ratio; PPV: positive predictive value.

Table 4 Diagnostic accuracy of immunohistochemistry, alone or in selected combinations, as applied only to cytologically benign, atypical and suspicious specimens

	Sensitivity (%)	Specificity (%)	PPV (%)	NPV (%)	PLR	NLR
p53	17	100	100	33	¥	0.83
Ki-67	21	100	100	34	¥	0.79
CEA	52	42	68	26	1	1.16
CA19-9	48	75	82	38	2	0.69
p53 + Ki-67	28	100	100	36	¥	0.72
p53 + Ki-67 + CEA	66	42	73	33	1	0.83
p53 + Ki-67 + CA19-9	66	75	86	47	3	0.46
All 4 stains	76	42	76	42	1	0.58

CEA: carcinoembryonic antigen; IH: immunohistochemistry; NLR: negative likelihood ratio; NPV: negative predictive value; PLR: positive likelihood ratio; PPV: positive predictive value.