Table 1: Summary of data in the (neo)adjuvant setting.

Author (year)Setting/type of trialDrug(s)Number of patientsResults

Pruneri et al. [6]Adj/Phase IIICTX 50 mg/day orally continuously for 1 year and MTX 2.5 mg/twice a day orally, days 1 and 2 of every week for 1 year
versus
no maintenance chemotherapy
647BCFI risk reduction: 13%
DFS risk reduction: 11%
DFRI risk reduction: 16%
OS risk reduction: 17%
(for every 10% increase of TILs)

Nasr et al. [7]Adj/Phase IIGroup 1158 (whole population)
78
mDFS
28 versus 24 months
mOS
37 versus 29
Distant mets recurrence rate 26% versus 37%
FEC-100 × 3 cycles
Docetaxel 80 mg/m2 + Carboplatin AUC 5
Followed by
CTX 50 mg/day + MTX 2,5 mg bid, days 1 and 2 every week

Masuda et al. [8] (Neo)adj/Phase IImPTX 80 mg/m2 days 1, 8, and 15pCR 47.5%
cORR 90%
CTX 50 mg/day
CAPE 1200 mg/m2, daily40
Followed by
FEC100

Shawky and Galal [9]Adj/Phase IImCAPE 650 mg/m2, twice every day, after standard adjuvant chemotherapy for 1 year192 ys-DFS rate 88.8%
3 ys-DFS rate 82.05%

Alagizy et al. [10]Adj/Phase IICAPE 500 mg twice daily continuously for 6 months after finishing six cycles of adjuvant FEC10041Mean DFS 42.4 months

EPI = epirubicin; CDDP = cisplatin; 5FU = 5-fluorouracil; PTX = paclitaxel; CTX = Cyclophosphamide; CAPE = capecitabine; mCAPE = metronomic capecitabine; FEC100 = 5FU + EPI 100 mg/m2 + CTX; MTX = methotrexate; cCR = clinical complete response; cPR = clinical partial response; pCR = pathologic complete response; DFS = disease free survival; BCFI = breast cancer free interval; DFRI = distant recurrence free interval; OS = overall survival.