Combination of oral capecitabine and vinorelbine in metastatic breast cancer: A retrospective analysis of activity and tolerability profile.

Abstract

e11049 Background: The purpose of this study was to retrospectively analyze toxicity profile and activity of an all-oral combination schedule of capecitabine (Cape) and vinorelbine (VNR) in metastatic breast cancer (MBC) patients (pts). Methods: All 60 pts treated had a histological confirmed diagnosis of breast cancer (BC). Each 3-week cycle of treatment consisted of 500 mg/m2 cape twice daily (2 weeks on, 1 week off), and 60 mg/m2 VNR on days 1 and 8. Results: From June 2007 to December 2010 we treated 60 MBC pts. Median age was 49 years (range 33-73). 42 pts (70%) had a performance status (PS) ECOG 0; 12 pts (20%) PS 1, 6 pts (10%) PS 2. 12 pts (20%) had metastatic disease at time of diagnosis. 52 (86,5%) expressed estrogenic receptor (ER); 10 pts (16,6%) had a HER2-positive disease; 38 (63,3%) HER-2 negative; 4 pts (6,66%) had a triple negative disease. 38 pts (63,3%) received adjuvant (adj) hormonal therapies (HT); 44 pts (73,3%) adj/neoadj chemotherapy (CT). Median time to recurrence was 37 months (range 5-192). 12 pts (20%) received Cape + VNR as first metastatic line treatment. 56 pts (93,3%) had more than one metastatic site involved (range 2-4). 42 pts (70%) had bone metastases (mts); 34 (56,6%) hepatic mts; 30 (50%) mts to lung; 18 pts (30%) nodal mts; 8 (13,3%) pleural effusion; 6 (10%) skin mts; 6 (10%) brain mts. Median number of cycles administered was 6 (range 3-16). Tolerability: 36 pts (59,7%) referred nausea G1; 14 pts (23,2%) had vomiting G1; 28 pts (46,5%) reported asthenia G1-G2; 22 pts (36,5%) diarrhea. We observed neutropenia G1-G2 in 24 pts (39,8%) (1 (1,6%) requiring treatment discontinuation) and 1 (1,6%) alopecia G1. 50 pts (83,3%) were evaluable for response. We had an objective response rate of 60% (ORR) following RECIST criteria: 3 (6%) complete responses (CR) and 27 (54%) stable diseases (SD). We observed 20 (40%) progression diseases (PD). After a median follow-up of 20 months (range 4-42), median progression free survival (PFS) was 10 months (range 3-20) and median overall survival (OS) was 55 months (range 20-116). Conclusions: Oral combination of Cape and VNR is a well-tolerated regimen and has an activity profile in pre-treated MBC pts.