Pilot study of regional, hepatic intra-arterial paclitaxel in patients with breast carcinoma metastatic to the liver

BACKGROUND. Approximately 25% of patients with metastatic breast carcinoma develop hepatic involvement during the course of their disease that further affects their survival. Systemic paclitaxel is safe and has demonstrated good antitumor activity against breast carcinoma. The objective of this prospective study was to determine the safety and antitumor activity of hepatic intra-arterial paclitaxel therapy. METHODS. Ten patients with breast carcinoma and dominant liver metastases received monthly, inpatient, 24-hour, continuous hepatic infusions of paclitaxel at 200 mg/m(2) through an intra-arterial catheter, which was placed using a percutaneous transfemoral approach. RESULTS. The mean patient age at the time of treatment was 51 years. Fifty-six courses of paclitaxel were delivered. The most common treatment-related toxicities were leukopenia, fatigue, nausea, and vomiting. No procedure-related complications were observed. Three patients (30%) attained partial responses that, lasted for 6 months, 7 months, and 48 months; and 4 other patients had stable disease for 5 months to 9 months. One patient underwent liver resection after receiving hepatic arterial infusions of paclitaxel and remained disease free for 48 months. Eight patients had received prior systemic taxane therapy alone or with other cytotoxic agents. However, no association between previous taxane exposure and the efficacy of the current regimen was established. CONCLUSIONS. Hepatic intra-arterial therapy with paclitaxel at the dose level and on the schedule used in this study was safe and well tolerated and had reasonable antitumor activity against breast carcinoma involving the liver. Previous taxane exposure did not hamper the potential benefit of this approach. This regimen alone or in combination with targeted therapies deserves further investigation in patients with dominant liver metastases from breast carcinoma.