Feasibility of sentinel lymph node biopsy omission after integration of 18F-FDG dedicated lymph node PET in early breast cancer: a prospective phase II trial

Junjie Li; Jingyi Cheng; Guangyu Liu; Yifeng Hou; Genghong Di; Benglong Yang; Yizhou Jiang; Liang Huang; Feilin Qu; Sheng Chen; Yan Wang; Keda Yu; Zhimin Shao

doi:10.20892/j.issn.2095-3941.2022.0085

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Figure 1
CONSORT diagram of patient disposition. *cN+: patients with a positive axillary physical examination.

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Table 1

Patient demographics and clinical characteristics

Characteristics	n (%)
Age (years)	49.9 (28–75)
<50	97 (51.3)
≥50	92 (48.7)
Operation type
Breast-conserving surgery	68 (36)
Mastectomy	121 (64)
Axillary evaluation
SLNB	133 (70.4)
SLNB, then AD	40 (21.2)
AD	16 (8.4)
Pathologic node stage
N0	133 (70.3)
N1mic	16 (8.5)
N1	32 (17)
N2	7 (3.7)
N3	1 (0.5)
T stage
T1a	19 (10.1)
T1b	11 (5.8)
T1c	64 (33.9)
T2	89 (47.1)
Unknown	6 (3.1)
Histology
IDC	180 (95.2)
ILC	9 (4.8)
Grade
I	25 (13.2)
II	96 (50.8)
III	68 (36)
Subtype
HR positive and HER2 negative	120 (63.5)
HR positive and HER2 positive	23 (12.2)
HR negative and HER2 positive	27 (14.3)
HR negative and HER2 negative	19 (10)
Ki67 ≥30%+	78 (41.3)
LVI positive	61 (32.3)

AD, axillary dissection; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; IDC, invasive ductal carcinoma; ILC, invasive lobular carcinoma; LVI, lymphovascular invasion; SLNB, sentinel lymph node biopsy.

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Table 2

Diagnostic performance of LymphPET and ultrasound in axillary staging

Axillary imaging assessment	n	Macrometastases	Micrometastases	Non-metastases	Sensitivity	Specificity	NPV
Ultrasound‡		40	16
US-neg	124	17	12	95	57.5	71.8	86.3
US-det	46	14	4	28
US-met	19	9	0	10
LymphPET†
Negative	131	16	11	104	60	77.2	87.8
Positive	58	24	5	29
Combination*
Negative	100	9	9	82	77.5	61.1	91
Positive	89	31	7	51

‡US-neg, no lymph nodes detected by ultrasound; US-det, lymph nodes detected by ultrasound; US-met, suspected metastatic lymph nodes detected by ultrasound.

†maxLUV of LymphPET was set at 0.27 (negative < 0.27, positive ≥0.27).

*Negative, no lymph nodes detected by ultrasound and maxLUV in LymphPET < 0.27; positive, lymph nodes detected by ultrasound and/or maxLUV in LymphPET ≥0.27.

Sensitivity, specificity, and NVP were calculated according to lymph node macrometastases.

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Table 3

Clinical characteristics of patients with a false-negative axillary node evaluation by LymphPET and ultrasound

Patient ID	Age (years)	Side	Operation	MG	Location	Size cm	Histology	Grade	LV	ER%	PR%	HER2	Ki67	No SLN removed	No. lymph node macrometastases	AD
57	44	Right	M	Mass	Center	1.5	IDC	III	+	80	60	+	15	4	1	0/19
76	67	Right	BCS	MC	Outer upper	3.7	IDC	II	–	80	10	+	20	3	1	0/12
83	41	Right	M	MC	Outer upper	1.5	IDC	II	+	80	80	–	15	5	2	0/15
116	67	Right	M	MC	Outer upper	2.8	IDC	II	+	80	80	–	10	6	3	0/12
117	41	Right	BCS	Mass	Outer upper	3	IDC	II	+	80	80	–	30	3	2	2/20
128	69	Right	M	Mass	Inner upper	2	ILC	II	–	80	20	–	30	3	2	6/24
129	47	Left	M	Mass	Outer	2.2	IDC	II	+	80	80	–	10	4	2	0/25
144	57	Left	M	Mass	Outer lower	3.5	IDC	II	+	80	80	–	30	3	1	1/22
147	61	Right	M	Mass	Outer upper	1.2	IDC	II	–	0	0	–	80	4	1	0/8

AD, axillary dissection; BCS, breast-conserving surgery; ER, estrogen receptor; PR, progesterone receptor; HER2, human epidermal growth factor receptor 2; IDC, invasive ductal carcinoma; ILC, invasive lobular carcinoma; LV, lymphovascular invasion; M, mastectomy; MC, mass with calcification; MG, mammography.