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RESEARCH PRODUCT

Oral capecitabine and Vinorelbine in Metastatic Breast Cancer. A Retrospective Analysis of Tolerability and Activity

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ABSTRACT 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 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'07 to December'11 we analyzed 77 MBC pts. Median age was 52 years (range 34-73). 58 pts (75,3%) had a performance status (PS) ECOG 0; 13 pts (16,8%) PS1, 6 pts (7,8%) PS2. 5 pts (6,5%) had metastatic disease at time of diagnosis. 60 (77,9%) expressed estrogenic receptor; 74 (96,1%) were HER-2 negative; 18 pts (23,3%) had a triple negative disease. 54 pts (70,1%) received adjuvant (adj) hormonal therapies; 63 pts (81,8%) adj/neoadj chemotherapy. Median time to recurrence was 37 months (range 5-192). 58 pts (75,3%) received Cape + VNR as first metastatic line treatment. 58 pts (75,3%) had more than one metastatic site involved (range 2-4). 47 pts (61%) had bone metastases (mts); 29 (37,6%) hepatic mts; 20 (25,9%) pulmonary involvement; 25 pts (32,4%) had nodal mts; 3 pts (3,9%) pleural effusion; 5 pts (6,5%) skin mts; 3 (3,9%) brain mts. Median number of cycles administered was 7 (range 3-16). Regarding toxicity profile, 31 pts (40,2%) referred nausea G1; 21 pts (27,2%) experienced vomiting G1; 26 pts (33,7%) reported fatigue G1-G2; 15 pts (19,4%) had G1-G3 diarrhea.18 pts (23,3%) discontinued treatment for G1-G3 “hand and foot syndrome”. Hematological toxicity: neutropenia G1-G2 in 25 pts (32,4%) (3 (3,9%) requiring treatment discontinuation); 13 (16,8%) anemia G1 and 12 (15,5%) thrombocytopenia G1-G2. All 77 pts were evaluable for response. We had an objective response rate of 71,4% following RECIST criteria: 6 (7,8%) complete responses, 15 (19,4%) partial responses and 34 (44,1%) stable diseases. We observed 20 (25,9%) progression diseases. Median progression free survival was 7 months (range 2-15) and median overall survival 29,5 months (range 20-116). Conclusions Oral combination of Cape and VNR is a well-tolerated regimen and has an activity profile even in pre-treated MBC pts. Disclosure All authors have declared no conflicts of interest.