Gemcitabine in combination with capecitabine in metastatic breast carcinoma: A phase I-II study

870 Background: Gemcitabine (G) and Capecitabine (C) are both actives in metastatic breast cancer (MBC). Methods: To define the maximum tolerated dose of this combination we designed a phase I study with escalating dose of G (from 750 mg/m2 up to 1500 mg/m2 with increments of 250 mg/m2) at day 1 and 8 every 3 weeks combined with C 2000 mg/m2/die on days 1 to 14. To better investigate the activity and toxicity at the recommended doses, a phase II study has been subsequently performed in patients (pts) pre-treated with anthracyclines and taxanes. Results: 12 pts have been enrolled in the phase I study. Dose escalation of G reached the maximum dose planned without observing dose-limiting toxicities. In fact, only 6 pts experienced a grade 2 (WHO) toxicity (anaemia, neutropenia, N/V, mucositis). So far, 21 pts have received G at the recommended dose of 1500 mg/m2 and C 2000 mg/m2/die for a total of 125 cycles with a median of 6 cycles for pt (range1–12). Main characteristics included: median age 51 (range 35–...