Abstract
Background
Capecitabine is an approved standard therapy for anthracycline- and taxane-pretreated locally advanced or metastatic breast cancer (BC). Vinflunine has demonstrated single-agent activity in phase II studies in this setting, and activity and tolerability when combined with capecitabine. We compared the combination of vinflunine plus capecitabine (VC) with single-agent capecitabine. Patients and methods
Patients with locally recurrent/metastatic BC previously treated or resistant to an anthracycline and resistant to taxane therapy were randomly assigned to either vinflunine (280 mg/m2, day 1) plus oral capecitabine (825 mg/m2 twice daily [bid], days 1–14) every 3 weeks (q3w) or single-agent oral capecitabine (1250 mg/m2 bid, days 1–14) q3w. The primary end point was progression-free survival (PFS) assessed by an independent review committee. The study had 90% power to detect a 30% improvement in PFS. Results
Overall, 770 patients were randomised. PFS was significantly longer with VC than with capecitabine alone (hazard ratio 0.84, 95% confidence interval [CI] 0.71–0.99; log-rank P = 0.043; median 5.6 versus 4.3 months, respectively). Median overall survival was 13.9 versus 11.7 months with VC versus capecitabine alone, respectively (hazard ratio 0.98, 95% CI 0.83–1.15; log-rank P = 0.77). No difference in quality of life was observed between the two treatment arms. The most common adverse events in the combination arm were haematological and gastrointestinal. Grade 4 neutropenia was more frequent with VC (12% versus 1% with capecitabine alone); febrile neutropenia occurred in 2% versus 0.5%, respectively. Hand-foot syndrome was less frequent with VC (grade 3: 4% versus 19% for capecitabine alone). Peripheral neuropathy was uncommon in both arms (grade 3: 1% versus 0.3%). Conclusions
Vinflunine combined with capecitabine demonstrated a modest improvement in PFS and an acceptable safety profile compared with capecitabine alone in patients with anthracycline- and taxane-pretreated locally recurrent/metastatic breast cancer. ClinicalTrials.gov
NCT01095003
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