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

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%) ach...