Table 1.

Patients’ clinical characteristics and univariate survival analyses for RFS, DMFS and OS. P values smaller than 0.001 are denoted as <0.001.

	Patients	RFS		DMFS		OS
	No (%)	HR (95% CI)	p	HR (95% CI)	p	HR (95% CI)	p
Age, years
18 to <50	377 (39)	1		1		1
50 to <65	398 (41)	1.04 (0.80 1.35)	0.78	1.16 (0.81 1.65)	0.42	1.16 (0.81 1.66)	0.42
≥ 65	195 (20)	1.14 (0.84 1.55)	0.41	1.41 (0.94 2.11)	0.10	1.41 (0.94 2.11)	0.10
Gender
Female	472 (49)	1		1		1
Male	498 (51)	1.47 (1.16 1.86)	0.001	1.41 (1.03 1.92)	0.03	1.41 (1.03 1.92)	0.03
Confirmation of lymph node-negative involvement
No, clinically non palpable nodes	480 (49)	1		1		1
Yes, by sentinel node or elective node dissection	490 (51)	0.59 (0.47 0.75)	<0.001	0.63 (0.46 0.86)	0.004	0.63 (0.46 0.86)	0.004
Breslow thickness, mm
1.51 to 3.00	598 (62)	1		1		1
.01 to 3.01 – 4.00	175 (18)	1.44 (1.05 1.97)	0.02	1.35 (0.88 2.06)	0.16	1.35 (0.88 2.06)	0.16
>4.0	197 (20)	2.83 (2.18 3.67)	<0.001	2.59 (1.83 3.66)	<0.001	2.59 (1.83 3.66)	<0.001
Ulceration of primary
No	581 (60)	1		1		1
Yes	389 (40)	2.19 (1.73 2.76)	<0.001	2.76 (2.01 3.80)	<0.001	2.77 (2.01 3.80)	<0.001
GM2-KLH/QS-21 Vaccine
No	491 (51)	1		1		1
Yes	479 (49)	0.95 (0.76 1.20)	0.67	1.07 (0.78 1.45)	0.68	1.07 (0.78 1.45)	0.68