Six of the Best, Colorectal 21

Abstract

Aims: Intrahepatic arterial (IHA) therapy should deliver higher doses of drug to the liver with reduced overall systemic exposure. An IHA regimen was designed which used the same drugs and schedule, and achieved similar toxicity and steady-state venous 5FU levels as the standard de Gramont IV regimen. Patients with advanced colorectal liver metastases were randomized to either IV or IHA. Methods: In total 290 patients were randomized from 16 centres in 6 years. The median age was 62 years, 70 per cent were male, 68 per cent had colon cancer. Of the 145 patients allocated to IV, 14 per cent did not receive any allocated therapy, but 78 per cent received six cycles of chemotherapy. Of the 145 IHA patients, 37 per cent did not start and only 35 per cent received six cycles. The additional problems in the IHA group were inability to insert the catheter, or infected, leaking, or blocked catheters. Of the patients who did not receive six cycles of IHA therapy, 52 per cent switched to IV therapy. Similar levels of toxicity and quality of life were reported in both arms. Results: There was no clear evidence of a difference in progression-free survival (HR 0.90, 95 per cent CI: 0.71–1.16; P = 0.42) or overall survival (HR 1.03, 95 per cent CI: 0.79–1.33; P = 0.85). From randomization median, and estimated 1- and 2-year survival were 14.1 months in both groups, and 60 and 57 per cent, and 26 and 22 per cent for IV and IHA, respectively. Conclusions: This trial suggests that there is no obvious role for this IHA regimen in the management of hepatic metastatic colorectal cancer.