First step of oral vinorelbine and capecitabine combination in advanced breast cancer patients: Feasability study

Abstract

1135 Background: The availability of chemotherapeutic drugs given by oral route represents a step forward in the management of cancer patients (pts). Vinorelbine and capectabine have 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 5 FU. OVRL is rapidly absorbed (1.5–3h) with elimination half-life around of 40h. No pharmacokinetic interaction was found between these 2 compounds and its metabolites. Methods: The treatment schedule was initial dose of 60 mg/m2 of OVRL on day 1 and 8; XLD 1000 mg/m2 bid/daily from day 1 to 14 every 3 weeks. Cycles were repeated if ≥1,000/mm3 neutrophils and ≥100,000 platelets and not other G3–4 toxicities. XLD was adjusted from 1,000 mg/m2 to 900 mg/m2 or 750 mg/m2 in case of hand-foot syndrome or severe diarrhoea. Results: Between June 2003 and May 2007, 25 metastatic breast cancer pts were included in this trial. Median age: 68 years-old [range 42 - 87]. PS: 0–2. 8 pts received the combination as 1st-line, 5 pts as 2nd-line, and 12 pts ≥ 3rd-line. A median of 11 cycles [1 - 48] were given. One patient had G4 febrile neutropenia. One pt suffered from G3 diarrhoea, G2 mild diarrhoea was reported in 1/3 of pts after ORVRL lasting 12 hours. G2 hand foot-syndrome was observed in 4 pts (16%). Out of 23 evaluable pts, 21 had clinical benefits: 2 CR, 4 PR and 15 SD (90% tumour control). Conclusions: Oral vinorelbine and capecitabine combination is well tolerated and active in MBC pts allowing long-term treatment in ambulatory setting avoiding central venous line and infusions. In our experience, this combination seems to be correctly tolerated in elder patients (≥ 75 yrs-old). This combination should be tried in early stages for the next step planned in our institution that is ongoing, and in combination with new target therapies: monoclonal antibodies as trastuzumab for HER2 positive pts, and bevacizumab for HER-2 negative pts. No significant financial relationships to disclose.