Vinorelbine (N)-capecitabine (C) combination in advanced breast cancer (ABC): Long-term results of two multicentric phase II trials

Abstract

673 Background: Vinorelbine (Navelbine)-Fluoropyrimidine has demonstrated to be an active and safe combination for ABC. Two multi centric phase II trials were conducted by the CRG/CG to assess the efficacy and safety of Navelbine-Capecitabine combination (Navcap) and Navcap followed by Docetaxel (D) as sequential block regimen (NEXT). Methods: Eligible patients (pts) had ABC, measurable disease, no prior chemotherapy for ABC, WHO PS<2, adequate bone morrow, renal and hepatic functions and written informed consent. In the Navcap study, pts received N: 25 mg/m2 on day 1 & day 8 in combination with C: 825 mg/m2 twice a day from day 1 to day 14 every 3 weeks until progression or unacceptable toxicity, while in NEXT, pts received 4 cycles of the same schedule of Navcap followed by twelve consecutive weeks of D: 25 mg/m2/w. Results: Between april 01 and Sept 03, seventy-three consecutive pts were enrolled into these 2 trials. 73.5% of pts in Navcap and 78.5% of pts in NEXT had visceral involvement, 57% of pts in both trials received anthracycline in adjuvant setting. The efficacy results are displayed in table 1. Safety results were similar for both studies, WHO grade 3–4 neutropenia was reported in 13% of pts in Navcap and 14% in NEXT, however febrile neutropenia was more frequent in NEXT (8%/2% of pts). Non-haematological toxicity was mild, Grade 3 hand-foot syndrome and mucositis were reported by one pt each in Navcap. Asthenia, diarrhea, oedema and nail disorders were frequent in NEXT (Grade 1–2 in 3% of pts). Conclusions: Navcap and block sequential of Navcap followed by D demonstrated an interesting efficacy; however the tolerance profile was slightly better for the Navcap. A phase II randomized trial is planned in order to compare the Navcap regimen with sequential Navcap followed by weekly Docetaxel (NEXT) in the first line treatment of ABC breast cancer. No significant financial relationships to disclose.