Abstract
1061 Background: High activity of intravenous vinorelbine (VNR) plus trastuzumab (T) has been demonstrated in previous clinical trials performed in HER2-overexpressing MBC patients (pts). The present phase II study evaluates a new regimen investigating the combination of oral and intravenous vinorelbine plus trastuzumab. Methods: This phase II trial investigated HER2-overexpressing MBC pts (IHC 3+ or FISH+) who received VNR at an intravenous dose of 25mg/m2 on day 1 followed by oral VNR applied at a dose of 60mg/m2 on days 8 and 15 of a 3-week cycle. Trastuzumab was given at 3-week intervals with a starting dose of 8mg/kg on day 1 of the first cycle, and a maintenance dose of 6mg/kg in all subsequent cycles. Overall response rate was evaluated as a primary endpoint, while progression-free survival (PFS), overall survival (OS), and safety were analysed as secondary endpoints. Results: 42 pts were recruited. Median age was 60 years (range 34 - 75 years), and median baseline Karnofsky performance status was 100% (range 70–100%). 67% of pts were hormone receptor positive. A HER2 IHC score of 3+ was determined in 95% of pts, while 5% of pts had an IHC score of 2+, but were FISH positive. 27 pts (64%) had received previous (neo)-adjuvant therapy (21 anthracycline-based, 8 taxane-based). Visceral metastasis was evident in 69% of pts. A median of 8 cycles (range 1–18) were applied. Hematological toxicity was generally low with grade 3–4 neutropenia of 19%. Complete remission was observed in 8 pts (19%), partial remission in 18 pts (43%), and stable disease in 8 pts (19%) for an ORR of 62%. Median remission duration was 7.5 months, median PFS was 7.9 months. The median of OS has not been reached so far. Conclusions: The combination or oral plus intravenous vinorelbine and trastuzumab has shown high antitumor efficacy and excellent tolerability in 1st-line treatment of HER2 overexpressing MBC. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Pierre Fabre Pharma Pierre Fabre Pharma
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