Oral vinorelbine in combination with capecitabine in advanced breast cancer

Abstract

10586 Background: the availability of chemotherapeutic drugs given by oral route represents a step forward in the management of cancer patients (pts). Vinorelbine and capecitabine have demonstrated established efficacy in metastatic breast cancer (MBC) with distinct mechanism of action. Oral vinorelbine (OVRL) interacts with tubulin and capecitabine (XLD) acts through antimetabolite properties of 5FU. OVRL is rapidly absorbed (1.5- 3h) with elimination half-life around of 40h. No pharmacokinetic interaction was found between these two compounds and its metabolites according to a recent phase I trial. Methods: The treatment schedule was 60 mg/m2 of OVRL on day 1 and 8; XLD 1000 mg/ m2 bid from day 1 to 14 every 3 weeks. Cycles were repeated if ≥1000/mm3 neutrophils and ≥100000 platelets. In case of ≥ Grade (G) 3 haematological and non haematological toxicity dose adjustments were planned: OVRL from 60 mg/ m2 50 or 40 mg/ m2 and XLD from 1000 mg/ m2 to 900 mg/m2 or 750 mg/ m2 b.i.d. Results: Between June 2003 to December 2005, 29 advanced breast cancer pts were included in this trial. Median age: 64 years [range (42–85)]. PS0: 60, PS1: 40. Eight pts, 9 pts and 12 pts received the combination as 1st line, 2nd line and ≥3rd line treatment respectively. A median of 5 cycles [1–30] was given. No G 3/4 haematological toxicity was observed. One pt. suffered from G3 diarrhoea, G2 mild diarrhoea and abdominal pain was reported after ORVRL lasting 24 hours. No hand-foot syndrome has been observed.Out of 18 evaluable pts, 17 had clinical benefit: 1 CR, 4 PR and 12 SD (90% of tumour control). Conclusion: Oral vinorelbine and capecitabine combination is well tolerated and active in MCB pts allowing long-term treatment in ambulatory setting avoiding central venous line and infusions; therefore, this combination should be investigated in early lines of treatment. Final results will be presented during the meeting. [Table: see text]