Efficacy
tumor, extrahepatic, PD, BOR, tumors
DISEASE PROGRESSION, TUMOR, TUMORS
Treatment with IHP was assessed by central radiologic review, and there was an objective response in 17 patients (40% ORR) receiving IHP compared with two patients (4.5%) receiving control treatment (Treatments in the Control GroupWaterfall plots for the isolated hepatic perfusion and control group. Shown are the best percentage changes from baseline in the sum of the largest diameters of measurable tumors in patients for whom data from both baseline and postbaseline assessments of target lesions by independent central review were available: (A) 38 of 43 patients who received IHP and (B) 39 of 44 of patients who received control treatment. The upper dashed horizontal line indicates a 20% increase in tumor size in the patients who had disease progression, and the lower dashed line indicates a 30% decrease in tumor size (PR). IHP, isolated hepatic perfusion; PR, partial response.The estimated 6-month PFS rates were 58% for the IHP group compared with 8% in the control group. The median PFS was 7.4 months (95% CI, 5.2 to 11.6) in the IHP group compared with 3.3 months (95% CI, 2.9 to 3.7; Kaplan-Meier estimates of PFS and hPFS comparing isolated hepatic perfusion and control. Kaplan-Meier estimates of (A) PFS and (B) hPFS as assessed by blinded central review in the ITT population. The tick marks indicate censored data. hPFS, hepatic progression-free survival; IHP, isolated hepatic perfusion; ITT, intention-to-treat; PFS, progression-free survival.The estimated 6-month hPFS rates were 63% for the IHP group compared with 13% in the control group. The median hPFS was 9.1 months (95% CI, 5.6 to 13.4) in the IHP group compared with 3.3 months in the control group (95% CI, 2.9 to 4.0, The median DOR was 13.7 months (95% CI, 11.6 to 18.3) in the IHP group (n = 17) compared with 8.8 months (95% CI, 6.0 to not evaluable) in the control group (n = 2). In patients randomly assigned to IHP with a BOR of CR, PR, or SD who later progressed (n = 23), the site for progression was hepatic in 12 (52%), extrahepatic in six (26%), and simultaneous hepatic and extrahepatic progression in five (22%) patients. Among IHP patients who were primarily resistant to IHP (ie, BOR of PD, n = 13), 12 (92%) had primary progression in the liver, whereas only one patient (8%) had extrahepatic progression.