Table 1.
Summary of data in the (neo)adjuvant setting.
| Author (year) | Setting/type of trial | Drug(s) | Number of patients | Results |
|---|---|---|---|---|
| Pruneri et al. [6] | Adj/Phase III | CTX 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 |
647 | BCFI 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 II | Group 1 | 158 (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 II | mPTX 80 mg/m2 days 1, 8, and 15 | pCR 47.5% cORR 90% |
|
| CTX 50 mg/day | ||||
| CAPE 1200 mg/m2, daily | 40 | |||
| Followed by | ||||
| FEC100 | ||||
|
| ||||
| Shawky and Galal [9] | Adj/Phase II | mCAPE 650 mg/m2, twice every day, after standard adjuvant chemotherapy for 1 year | 19 | 2 ys-DFS rate 88.8% 3 ys-DFS rate 82.05% |
|
| ||||
| Alagizy et al. [10] | Adj/Phase II | CAPE 500 mg twice daily continuously for 6 months after finishing six cycles of adjuvant FEC100 | 41 | Mean 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.