Prospective randomized clinical trial of two drug delivery pathway in the treatment of inoperable advanced pancreatic carcinoma.

Abstract

Objectives: Evaluate the effect of an implanted percutaneous left subclavian artery port-catheter drug delivery system for regional chemotherapy of inoperable pancreatic carcinoma.

Methods: One hundred and forty patients with inoperable pancreatic carcinoma were enrolled and randomized into two groups to receive the FAM regimen on a 6-day cycle at 1-month intervals: 70 patients in the regional interventional chemotherapy group in which treatment was infused directly into the common hepatic artery, and 70 patients who received the same chemotherapy regimen via the peripheral vein.

Result: In the interventional chemotherapy group, there were 5 cases of complete remission (CR) and 49 cases of partial remission (PR), giving a response rate (CR+PR) of 77.1%; pain control was effective in 95.7% cases; survival time was 3-34 months (median 13.5). There was no case of CR in the systemic chemotherapy group, and 25 cases of PR, giving a response rate of 35.7%; pain control was effective in 35.7%, and survival time was 1-13 months (median 6.2). The differences between the two groups in response rate and survival were statistically significant (P < 0.005). Nausea and vomiting occurred in 48.6% of the interventional chemotherapy group and 41.3% of the systemic chemotherapy group (NS). There were three cases of serious myelosuppression in the systemic chemotherapy group and one case died. There was a significant difference between the two groups in white blood cell count after the chemotherapy, indicating that the myelosuppressive effect was serious in the systemic chemotherapy group.

Conclusion: Interventional arterial infusion chemotherapy could significantly improve quality of life and prolong the survival of patients with inoperable pancreatic carcinoma.