Transarterial chemoembolisation (TACE) with gemcitabine: Phase II study in patients with liver metastases of breast cancer

Objective

Evaluation of the efficacy and tolerability of transarterial chemoembolization with gemcitabine in patients with inoperable liver metastases of breast cancer.

Materials and methods

Open-label, prospective non-randomized single-center study design; patients had previous chemotherapy including anthracyclines and/or taxanes in the metastatic setting, adequate bone marrow reserve, sufficient liver/renal function, no centralnervous system metastases, Karnovsky-performance-status >70%, and life expectancy >12 weeks. Forty-three patients were enrolled (median 58 years, range 48–71). A suspension of gemcitabine 1.200 mg/m², 2–10 ml/m² of Lipiodol, and 5 ml of a degradable starch microsphere (Embocept) suspension, were administered intra-arterially up to 3 times with a 4-weaks-interval. Dose-limiting toxicit is defined as grade 4 thrombocytopenia, neutropenia, or nonhematologic toxicity > grade 3. Tumor response was evaluated by magnetic resonance (MRI) and computed tomography (CT) imaging.

Results

All patients tolerated the treatment well; with no dose limiting toxicities. Imaging follow-up according to the RECIST-criteria (Response Evaluation Criteria in Solid Tumors) revealed a partial response in 3 patients, stable disease in 16 patients and progression in 22 patients. The progression free survival was 3.3 months.A significant correlation exists only with the factor vascularization: strongly vascularized tumors show a significantly lowered response. Patients with complete or partial response and the main fraction of the stable disease group showed in the MRI and angiography only a moderate vascularization.The resulting estimate of the total survival rate amounts to a median of 10.2 months.

Conclusion

Transarterial chemoembolization with gemcitabine is well tolerated and provides an alternative treatment method for patients with liver metastases of breast cancer.