Table 3.

Hepatic arterial infusion plus systemic chemotherapy in the adjuvant setting

Ref.	Numbers of patients	Setting	Randomized study	Regimes of therapy	Outcomes
					DFS	PFS	OS/DSS
Controlled studies
Ota et al[115], 1999	84 (37 vs 47)	Cohort study	NO	HAI/5-FU vs control group	5-yr DFS: 72.6% vs 29.8% (P = 0.0005)	-	5-yr OS:61.4% vs 28% (P = 0.0069)
Kemeny et al[112], 2005	156 (74 vs 82)	Phase III	YES	HAI/FUDR plus systemic 5-FU ± LV vs systemic 5-FU ± LV alone	-	Median PFS: 31.3 vs 17.2 mo (P = 0.02)	Median OS:68.4 vs 58.8 mo (P = 0.10)
House et al[113], 2011	250 (125 vs 125)	Cohort study	NO	HAI/FUDR plus systemic chemotherapy (5FU/LV + irinotecan or oxaliplatin) vs systemic chemotherapy alone	5-yr DFS: 48% vs 25% (P < 0.01)HR = 0.71 (95%CI: 0.48-0.96)	-	5-yr DSS:75% vs 55% (P < 0.01) HR = 0.39 (95%CI: 0.23-0.68)
Goéré et al[116], 2013	98 (44 vs 54)	Cohort study	NO	HAI/oxaliplatin plus systemic 5-FU/LV vs systemic irinotecan regimes or oxaliplatin regimes alone	3-yr DFS: 33% vs 5%(P < 0.0001) HR = 0.37 (95%CI: 0.23-0.60)	-	3-yr OS:75% vs 62% (P = 0.17) 5-yr OS:54% vs 52% (P = 0.34)
Non controlled studies
Alberts et al[114], 2010	55	Phase II single armed	NO	HAI/FUDR plus systemic capecitabine + oxaliplatin	2-yr DFS:59.7% Median DFS: 32.7 mo	-	2-yr OS:89.10%

DFS: Disease-free survival; PFS: Progression-free survival; OS: Overall survival; DSS: Disease-specific survival.