Background: Only 5-10% of colorectal cancer patients (pts) with liver metastases are eligible for surgical resection. Regional and systemic chemotherapy represents the best therapeutic options for unresectable metastases.
Materials and methods: In a randomized phase II trial 123 pts were enrolled with a minimum follow-up of 3 years. In Arm A 58 pts were submitted to intraarterial continuous infusion of cisplatin (CDDP), 24 mg/m2/day, while the other 65 were included in Arm B (bolus of CDDP, 24 mg/m2/day). All the pts were also given i.v. escalating doses of fluorouracil. Response was evaluated after a minimum of 3 cycles.
Results: Toxicity > or = G3 was lower in Arm B. The objective response rate was 52% in all the series, the complete responses being 17.3% (17.6% vs. 17% in Arms A and B, respectively). The overall median survival was 18 months rising to 28 months in the responders.
Conclusion: CDDP HAI provided similar results as FUdR in terms of response to treatment. Moreover, long-term survivors were unexpectedly observed.