Continuous regional chemotherapy for metastatic colorectal cancer using a totally implantable infusion pump. A feasibility study in 50 patients

A new concept in continuous regional chemotherapy for metastatic liver disease was introduced with the availability of a totally implantable drug infusion pump. This device is powered by charged freon, has a chamber capacity of 50 ml, and a fixed rate of 3 ml/day. The pump is silent, small (10 by 3 cm), and lightweight (180 g). It is refilled and automatically recharged by a simple percutaneous injection through the skin every 2 weeks. The pump is connected to a Silastic catheter placed in the gastroduodenal artery up to the lumen of the hepatic artery. We have implanted the Infusaid drug infusion pump in 50 consecutive patients with metastatic colorectal carcinoma of the liver. The median follow-up has been more than 6 months. Patients returned to the clinic every 2 weeks to receive floxuridine chemotherapy at 0.3 mg/kg per day, alternating with injections of saline solution. There were no technical problems with the pump or the hepatic artery catheter with a cumulative experience of over 6,750 days. An objective remission was induced in 83 percent of evaluable patients as evidenced by a decrease in their carcinoembryonic antigen levels by a mean value of 80 per cent (range 35 to 97 percent). These remissions were confirmed by liver sonogram which showed either stable or decreased tumor volume. Tumor progression later developed in the livers of only two patients who had good response, whereas seven patients have had relapse, so far in extrahepatic sites (lung, pelvis, or bone). Four patients have died at 4, 5, 10, and 11 months postoperatively. The toxicity to floxuridine chemotherapy has been relatively tolerable, but increased in frequency with prolonged drug administration. Transient jaundice from chemical hepatitis developed in one third of the patients. There has been little or no systemic toxicity (no vomiting, diarrhea, marrow suppression, etc.). Although these results are preliminary, it appears that this implantable drug infusion pump system is technically feasible, safe, and capable of inducing a remission in most patients with colorectal metastases. Furthermore, this approach using continuous floxuridine regional chemotherapy is associated with an acceptable level of drug toxicity in most patients.