Hepatic intra-arterial chemotherapy with gemcitabine: An ongoing phase II study in patients with liver metastases of breast cancer

Abstract

738 Background: Purpose: To evaluate the efficacy and tolerability of hepatic intra-arterial chemoembolization with gemcitabine as a cytostatic agent in pts with inoperable liver metastases of breast cancer. Methods: Ongoing, open-label, single-center study design; pts had histologically confirmed breast cancer with inoperable liver metastases, adequate bone marrow reserve, sufficient liver/renal function, no active CNS metastases, KPS >70%, and life expectancy > 12 weeks. A suspension of gemcitabine 1,200 mg/m2, 10 ml/m2 of iodised oil (Lipiodol), and 5 ml of a degradable starch microsphere (Spherex) suspension, is administered intra-arterially up to 3 times every 4 wks. Dose-limiting toxicity (DLT) is defined as grade 4 thrombocytopenia, neutropenia, or nonhematologic toxicity > grade 3. Tumor response is evaluated by magnetic resonance (MRT) and computed tomography (CT) imaging. Results: 15 pts enrolled (median 58 yrs, range 48–65). All pts tolerated the treatment well, with no DLTs. Five pts (33%) achieved a partial response, 8 stable disease, and 2 progressed. Conclusions: These first results indicate that hepatic intra-arterial chemotherapy with gemcitabine is well tolerated and achieved encouraging response rates in pts with liver metastases of breast cancer. (This study is supported in part by Eli Lilly Oncology.) No significant financial relationships to disclose.