The effect of perfusate buffering on toxicity and response in isolated hepatic perfusion for uveal melanoma liver metastases

Figures & data

Table 1. Patient and treatment characteristics.

	Buffer	No-buffer	p Values
Sex			0.759
Female	23 (64%)	9 (56%)
Male	13 (36%)	7 (44%)
Median age (range)	62.6 (17.8–76.4)	58.1 (27.7–77.2)	0.552
Largest diameter (cm, SD)	2.5 ± 1.7	2.1 ± 1.9	0.814
Tumour numbers			0.492
1–4	6 (17%)	6 (38%)
5–10	16 (44%)	5 (31%)
11–100	8 (22%)	4 (25%)
>100	3 (8%)	1 (6%)
Missing	3 (8%)	0 (0%)
Mean temperature
Perfusion circuit (°C ± SD)	39.8 ± 0.2	39.5 ± 0.6	0.045
Left liver (°C ± SD)	39.9 ± 0.4	39.8 ± 0.2	0.059
Right liver (°C ± SD)	39.6 ± 1.4	40.1 ± 0.2	0.064
Hospital stay	8.4 ± 4.0	8.5 ± 2.4	0.167
Baseline LFT values
ALT (μkat/L ± SD)	0.4 ± 0.1	0.6 ± 0.5	0.490
AST (μkat/L ± SD)	0.5 ± 0.2	0.5 ± 0.2	0.263
PK (INR ± SD)	1.0 ± 0.1	1.0 ± 0.1	0.989
ALP (μkat/L ± SD)	1.3 ± 0.3	1.5 ± 0.6	0.298
Bilirubine (μmol/L ± SD)	6.2 ± 2.9	10.9 ± 4.7	0.001

Figure 1. Kinetics of liver functions tests 7 d after IHP with or without buffering of the perfusate. Legend: *p < 0.05, **p < 0.01 and ***p < 0.001.

Table 2. Distribution of response according to treatment with or without buffering.

Response	Buffer n = 36 (%)	No buffer n = 16 (%)	p Values
ORR	21 (58%)	14 (88%)	0.055
CR	4 (11%)	7 (44%)	0.023
PR	17 (47%)	7 (44%)	1.000
SD	7 (20%)	2 (12%)	0.704
PD	8 (22%)	0 (0%)	0.047

ORR: overall response rate; CR: complete response; PR: partial response; SD: stable disease; PD: progressive disease.

Table 3. Univariate and multivariate analyses for time to local progression.

	Univariate			Multivariate
Time to local progression	HR	CI	p Values	HR	CI	p Values
Age (years)	1.0	1.0–1.0	0.833	1.0	0.9–1.0	0.667
Sex
Female	1.0			1.0
Male	0.7	0.3–1.3	0.264	1.4	0.5–3.7	0.563
Largest tumour  diameter (cm)	1.2	1.0–1.4	0.013	1.3	1.1–1.5	0.013
Number of tumours
1–4	1.0			1.0
5–10	2.3	1.0–5.6	0.060	3.1	0.9–10.0	0.052
11–100	2.1	0.8–5.6	0.135	4.1	1.0–15.9	0.045
>100	5.9	1.6–22	0.007	6.6	1.1–41.0	0.043
Overall response
No-response	1.0			1.0
Response	0.3	0.2–0.8	0.007	0.4	0.1–1.3	0.136
Buffering
No-buffer	1.0			1.0
Buffer	1.7	0.9–3.5	0.100	1.8	0.8–4.4	0.163
Perfusion  circuit temperature (°C)	0.8	0.4–1.4	0.442	0.7	0.3–1.6	0.389

HR: hazard ratio; CI: confidence interval.

Table 4. The univariate and multivariate analyses performed for survival.

	Univariate			Multivariate
Survival	HR	CI	p Values	HR	CI	p Values
Age	1.0	1.0–1.0	0.863	1.0	0.9–1.0	0.654
Sex
Female	1.0			1.0
Male	0.9	0.5–1.6	0.883	1.7	0.7–4.2	0.267
Largest tumour  diameter (cm)	1.3	1.1–1.4	0.001	1.3	1.1–1.6	0.002
Number of tumours
1–4	1.0			1.0
5–10	2.0	0.9–4.4	0.094	2.8	1.0–8.2	0.060
11–100	2.3	0.9–5.5	0.072	5.0	1.5–16.4	0.007
>100	5.0	1.5–17.0	0.010	9.3	1.4–60.1	0.019
Overall response
No-response	1.0			1.0
Response	2.4	1.2–4.7	0.011	2.9	1.0–8.4	0.047
Buffering
No-buffer	1.0			1.0
Buffer	1.3	0.7–2.4	0.428	1.6	0.7–3.8	0.264
Perfusion circuit  temperature (°C)	0.8	0.4–1.4	0.410	0.5	0.2–1.2	0.138

HR: hazard ratio; CI: confidence interval; ORR: overall response rate.

Figure 2. Overall survival with or without buffering of the perfusate.