Expanded evidence that the 31-gene expression profile test provides clinical utility for melanoma management in a multicenter study

Figures & data

Table 1. Provider demographics.

Site	Location	Specialty^a	No. Providers	No. Patients Enrolled
Atlantic Health	Morristown, NJ	S	1	16
Bend Memorial Clinic	Bend, OR	D, M, S	4	41
Cancer Solutions	Dallas, TX	S	1	36
Hackensack Meridian Health	Hackensack, NJ	S	2	9
Hoag	Newport Beach, CA	D, S	2	20
Kansas Medical Clinic	Topeka, KS	D	2	48
Larry D. Dillon Surgical Oncology and General Surgery	Colorado Springs, CO	S	1	91
Lovelace Women’s Hospital	Albuquerque, NM	S	1	29
Midlands Clinic PC	Dakota Dunes, SD	D	1	19
Mortan Plant Mease Healthcare	Clearwater, FL	S	1	22
Northeast Dermatology Associates	Newburyport, MA	D	12	20
Oregon Health & Science University	Portland, OR	D, S	3	75
ProMedica Cancer Institute	Maumee, OH	S	1	20
Thomas Jefferson University	Philadelphia, PA	M, S	2	19
University of California, Irvine	Irvine, CA	S	2	23
University of Tennessee Health Science Center	Memphis, TN	M, S	1	52
West County Dermatology	Chesterfield, MO	D, S	2	5

^aAbbreviations. D, Dermatology, M, Medical Oncology, S, Surgical Oncology.

Table 2. Patient demographics.

Descriptor	Class 1 (n = 328)	Class 2 (n = 105)	Combined (n = 433)	p value*
Age, median years (range)	61.0 (18.9–90.7)	68.8 (31.3–95.4)	63.5 (18.9–95.4)	<.001
Breslow thickness, median mm (range)	0.9 (0.1–18.0)	2.2 (0.3–10.3)	1.0 (0.1–18.0)	<.001
Ulceration, n (%)				<.001
Present	16 (4.9)	54 (51.4)	70 (16.2)
Absent	299 (91.2)	47 (44.8)	346 (79.9)
Unknown	13 (4.0)	4 (3.8)	17 (3.9)
Mitotic rate, median 1/mm^2 (range)	1.0 (0–47.0)	3.0 (0–23.0)	1.0 (0–47.0)	<.001
AJCC8th stage, n (%)				<.001
Stage IA	169 (51.5)	12 (11.4)	181 (41.8)
Stage IB	124 (37.8)	19 (18.1)	143 (33.0)
Stage IIA	26 (7.9)	34 (32.4)	60 (13.9)
Stage IIB	6 (1.8)	27 (25.7)	33 (7.6)
Stage IIC	3 (0.9)	13 (12.4)	16 (3.7)
Physician specialty, n (%)				<.001
Dermatology	86 (26.2)	11 (10.5)	97 (22.4)
Surgical oncology	228 (69.5)	94 (89.5)	322 (74.4)
Medical oncology	14 (4.3)	0 (0)	14 (3.2)

*Comparisons between Class 1 and Class 2 were made using the Mann-Whitney U test for continuous variables and Pearson chi-square test for categorical variables, two-tailed p value.

Figure 1. Study Design.

Figure 2. Percent of 5-year overall management that changed for patients with stage I-II melanoma after receiving the 31-GEP test result.

Figure 3. Percent proposed 5-year lab work, clinic visit, and imaging frequency that changed after receiving 31-GEP result for low- and high-risk populations.

Table 3. Change in planned melanoma management in alignment with 31-GEP test results.

	Overall Change, % (n/N)			Changed in direction of 31-GEP risk, % (n/N)*
Type of Management	Total n = 433	Class 1 n = 328	Class 2 n = 105	% Class 1 reduced	% Class 2 increased
Lab work	19.9% (86/433)	13.1% (43/328)	41.0% (43/105)	65.1% (28/43)	74.4% (32/43)
Clinic visits	35.8% (155/433)	28.0% (92/328)	60.0% (63/105)	66.3% (61/92)	81.0% (51/63)
Imaging	37.0% (160/433)	20.1% (66/328)	89.5% (94/105)	74.2% (49/66)	72.3% (68/94)

*Based on 5-year planned management changes proposed at visit 2 relative to visit 1 for patients that received a Class 1 (low-risk 31-GEP result) or Class 2 (high-risk 31-GEP result).

Figure 4. Percent 5-year surveillance imaging plans that changed for patients with stage I-II melanoma after receiving 31-GEP result. The percent of patients with stage I-II melanoma for whom clinicians increased, decreased or did not change management plans after receiving either a Class 1 or Class 2 31-gene expression profile (31-GEP) result. MRI, magnetic resonance imaging; PET/CT, positron emission tomography/computed tomography; CT, computed tomography; US, ultrasound; CXR, chest x-ray.

Table 4. Number of patients with planned management at each NCCN-based risk level at visit 1 and visit 2.

	Visit 1: Treat as	Visit 2: Treat as
		High risk	Intermediate risk	Low risk
All Classes (n = 433)	High risk	107	23	1
	Intermediate risk	25	112	38
	Low risk	4	17	106
		High risk	Intermediate risk	Low risk
Class 1 (n = 328)	High risk	73	16	1
	Intermediate risk	8	88	38
	Low risk	0	6	98
		High risk	Intermediate risk	Low risk
Class 2 (n = 105)	High risk	34	7	0
	Intermediate risk	17	24	0
	Low risk	4	11	8

Plan risk was defined based on NCCN guideline recommendations for imaging and clinic visits for patients with stage 0-IIA (low-risk) and stage IIB-IV (high-risk) melanoma. High risk: >4 clinical visits within the first 2 years and any imaging indicated. Intermediate risk: either ≤4 clinic visits within the first 2 years AND imaging OR >4 clinic visits in the first 2 years and no imaging. Low risk: ≤4 clinic visits in the first 2 years with no imaging. Risk groups were determined based on NCCN guidelines. A blue box indicates a reduction in planned management intensity after receiving a Class 1 result, and a red box indicates an escalation in planned management intensity after receiving a Class 2 result.

Data availability statement

Patient data will not be made publicly available.