Gemcitabine and anthracyclines in platinum-resistant ovarian cancer

Background: Most of the patients with advanced ovarian cancer will recur after first-line platinum-based chemotherapy and need additional treatment. Gemcitabine (G) and Anthracyclines are active in this setting and their combination has shown synergistic antiproliferative activity in vitro, due to different mechanisms of action and non-overlapping toxicities. Patients and methods: In 2002 we began a phase II study with G 1000 mg/m(2) (day 1,8) combined to Epirubicin (E) 60 mg/m(2) (day 1), every 3 weeks for 6 cycles, in Platinum resistant/refractory ovarian carcinoma patients. Results: Among 30 patients enrolled so far (27 evaluable), receiving 149 cycles (median 6), 1 complete and 12 partial responses (48%), 9 stabilizations (33%) and 5 progressions (18%) were observed, with a good correlation with serological responses. Median time to progression was 8 months, while median time to response was 10 weeks and median duration 8 months. Grade 3-4 toxicities consisted of neutropenia (58%), thrombocytopenia (3%), anemia (10%), liver toxicity (13%), and mucositis (7%). Eight patients (27%) received G-CSF and 3 (10%) blood transfusions. No febrile neutropenia nor cardiotoxicity were observed. Conclusions: Although our results are preliminary, G/E combination appears particularly effective and safe in these platinum resistant/refractory patients.