Background: Capecitabine (C) is an established agent in MBC & is being evaluated in anthracycline/taxane-based adjuvant (adj) & neoadjuvant (neoadj) regimens.

Methods: We summarise available data for C from randomised phase III studies in EBC.

Results: Significant efficacy benefits were reported with two C-based regimens in EBC: recurrence-free survival (RFS) was significantly improved when C was added to an adj regimen in the FinXX trial (3-year RFS: 93% vs 89% control; HR 0.66 [95% CI: 0.47-0.94]; p=0.02) [Lancet Oncol 2009;10:1145-51]. Pathological complete response (pCR) was significantly higher when C was integrated into a standard neoadj regimen in the ABCSG-24 study (24.3% vs 16.0% control; p=0.02) [ECCO-ESMO 2009; Abst 4BA]. Two studies were negative: one adj [Muss et al. NEJM 2009;360:2055-65] & one neoadj [GeparQuattro JCO 2010;2024-31].

D=docetaxel; Cyc=cyclophosphamide; E=epirubicin; F=5-FU; A=doxorubicin; P=paclitaxel; bev=bevacizumab; G=gemcitabine; M=methotrexate; DFS=disease-free survival; EFS=event-free survival

Safety data are available from 3 other adj studies: in the GEICAM trial, ED→C was generally well tolerated and associated with significantly better hair recovery than control (incomplete hair recovery: 28% ECyc→D vs 11% ED→C; p=0.0004); in the GAIN study, haematological toxicities were more common in the E→P→Cyc arm & discontinuations more frequent with ECyc→CP; in the ICE study in pts aged >65 yrs, a low incidence of grade 3/4 AEs was reported with C & significantly higher global QoL scores were attained with C vs control (week 20, p=0.008). Several phase III trials are ongoing (table): US Oncology is conducting a study in high-risk EBC, which will report efficacy data shortly; CIBOMA collaborative group is conducting a trial of C maintenance therapy after adj anthracycline/taxane in triple-negative EBC; the TACT2 study has a 2x2 factorial design in resected/operable EBC; safety data are expected from both studies: MINDACT is an EORTC/collaborative group study in node-negative EBC and compares a 70-gene signature with traditional methods of risk evaluation; pts with high-risk disease receive anthracyclines or CD.

Conclusions: The ongoing evaluation of C in EBC encompasses >20,000 pts. Following initial positive data for C in EBC, further results of these trials are eagerly awaited to define the clinical utility of C-based therapy in this setting.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-10-11.