BRAF status as a predictive factor for response in isolated limb perfusion

Figures & data

Table 1. Patient and tumor characteristics.

	BRAF wild type n = 66	BRAF V600E/K n = 32	p-value
Gender
Female	30 (46%)	17 (53%)	.48
Male	36 (54%)	16 (47%)
Median age (range)	72 (40 - 93)	66 (41 - 91)	.09
Stage
N2c	38 (58%)	13 (40%)	.13
N3	21 (32%)	17 (53%)
M1	7 (10%)	2 (6%)
Vascular access
Brachial	13 (20%)	2 (6%)	.206
External Iliac	4 (6%)	3 (9%)
Femoral	49 (74%)	27 (85%)
Chemotherapy
Melphalan	61 (92%)	32 (100%)	.110
TNF + Melphalan	5 (8%)	0 (%)
Largest tumor diameter
≤ 30 mm	50 (79%)	30 (94%)	.069
> 30 mm	13 (21%)	2 (6%)
Missing	3
Number of lesions
≤ 10	47 (72%)	20 (63%)	.326
> 10	18 (28%)	12 (38%)
Missing	1

Table 2. Response rates based on BRAF mutational status.

Response (WHO)	BRAF wild type n = 66	BRAF V600E/K n = 32	p-value
CR	34 (51%)	15 (47%)	0.81
PR	17 (26%)	7 (21%)
SD	7 (11%)	5 (16%)
PD	8 (12%)	5 (16%)

Notes: CR: complete response; PR: partial response; SD: stable disease; PD: progressive disease

Table 3. Univariate and multivariate logistic regression for complete response.

	Univariate analysis			Multivariate analysis
	OR	95% CI	p-value	OR	95% CI	p-value
Age (year)	1.0	0.9–1.1	.4	1.0	0.9–1.0	.6
Gender
Female* vs. Male	0.7	0.3–1.5	.3	0.6	0.2–1.4	.2
Stage
N2c* vs. N3	10.4	1.2–87.5	.03	1.7	0.6–4.6	.3
N2c* vs. M1	13.0	1.5–111.8	.02	0.2	0.1–2.5	.2
Numbers of tumors
≤10* vs. >10	0.5	0.2–1.1	.1	0.6	0.2–1.6	.3
Tumor size
≤30 mm* vs. >30 mm	0.2	0.1–0.8	.02	0.4	0.8–1.7	.2
Chemotherapy
M-ILP* vs. TM-ILP	0.2	0.1–2.0	.2	0.8	0.1–13.8	.9
Mutational Status
BRAF wild type* vs.  BRAF V600E/K	0.8	0.3–1.9	.7	0.6	0.2–1.6	.3

Note: Bold values represents the statistical significant p < 0.05.

Table 4. Prognostic factors for survival.

	Univariate analysis			Multivariate analysis
	HR	95% CI	p-value	HR	95% CI	p-value
Age (per year)	1.03	1.0–1.1	.03	1.03	1.0–1.1	.02
Sex
Female* vs. Male	1.1	0.6–1.9	.7	0.8	0.4–1.5	.5
Stage (AJCC 7)
N2c* vs. N3	2.0	1–0–3.6	.4	2.6	1.3–5.6	.008
N2c* vs. M1	7.8	3.5–17.1	<.001	18.4	6.5–51–0	<.001
Numbers of tumors
<10* vs. >10	1.2	0.7–2.2	.5	1.5	0.7–3–1	.3
Tumor size
<30* vs. >30	2.1	1.0–4.2	.04	1.3	0.6–2.9	.5
Chemotherapy
M-ILP* vs. TM-ILP	1.8	0.6–5.8	.3	1.3	0.2–7.7	.7
Mutational Status
BRAF wild type* vs. BRAF V600E/K	0.9	0.5–1.7	.7	0.8	0.4–1.6	.5

Figure 1. Overall survival. There was no significant difference in overall survival depending on if the patients were BRAF V600E/K or BRAF wild type (p = 0.61). Median survival for BRAF wild type patients was 44 months, while for patients with BRAF V600E/K mutation, the median survival was not reached.