Table 1 Trials of capecitabine in the adjuvant treatment of breast cancer

From: CREATE-X a role for capecitabine in early-stage breast cancer: an analysis of available data

Study

Eligibility

Treatment

Number of patients (events)

HR DFS (CI)

p-value

HR OS(CI)

p-value

Comments ……………

CREATEx

Her-2-negative

Post NAC

910

0.70 (0.53–0.93)

0.005

0.60 (0.40–0.92)

<0.01

94% of patients had prior A and T

Post NAC (2)

Residual disease post NAC

—

—

—

—

—

—

DMC recommended early release of positive result after enrollment completed

Hoffman-LaRoche (7)

T1-3, N1-2

AC-P vs. AC-PX

2611 (304)

0.84 (0.67–1.05)

NS

0.68

0.001 (0.51–0.92)

Primary analysis changed from event driven to time driven. Primary analysis 57% power

 

T > 2, N0

—

—

—

—

—

—

—

 

T > 1 N0 if ER and PR-negative

—

—

—

—

—

—

—

FINXX

Node pos

DX-CEX vs.

1500

0.70 (0.60–1.04)

NS

—

—

Updated 10 year results show OS benefit in TNBC

 

High-risk node neg

D-CEF

—

—

—

—

—

HR-0.55 (0.32–96)

MDACC (10)

Stage I-IIIC

wP-FEC vs. XP-FEC

601 (35)

1.02 (0.62–1.69)

NS

0.73

NS (0.6–1.04)

NOTE: breast cancer-free survival HR 0.64 (0.44–0.95 CI)

GEICAM

T1-3/N1-3

EC-D

1384 (297)

1.30 (1.03–1.64)

p = 0.03

1.13

0.46 (0.82–1.55)

FAVORS CONTROL in all subsets

2003–10 (11)

(Node pos)

EC-DX

—

—

—

—

—

—

  1. NAC neo-adjuvant chemotherapy, A anthracycline, T taxane, P paclitaxel, C cyclophosphamide, X capecitabine, D docetaxel, F 5-flurouracil, E epirubicin, wP weekly paclitaxel, DMC data monitoring committee, HR hazard ratio, OS overall survival, DFS disease-free survival
  2. Post NAC –X: post After Neo-adjuvant Chemotherapy Capecitabine 2500 mg/m2/day orally Day 1-14 every 3 weeks for 8 cycles. AC-T: Doxorubicin 600 mg/m2 plus cyclophosphamide 600 mg/m2 Day 1 every 3 weeks for 4 cycles followed by docetaxel 100mg/m2 Day 1 every 3 weeks for 4 cycles. AC-XT: Doxorubicin 600 mg/m2 plus cyclophosphamide 600 mg/m2 Day 1 every 3 weeks for 4 cycles followed by docetaxel 75 mg/m2 on day 1 plus 825 mg/m2 capecitabine twice daily x 14 days every 3 weeks for 4 cycles. TX-CEX: Capecitabine 900 mg/m2 orally twice per day for 14 days on Days 1 to 15 and docetaxel 60 mg/m day 1 of every 3-week cycle for 3 cycles followed by cyclophosphamide 600 mg/m2 and epirubicin 75 mg/m2 day 1 and oral capecitabine 900 mg/m2 given twice per day on days 1 to 15 every 3 weeks for 3 cycles. T-CEF: docetaxel 80 mg/m2 on day 1 every 3-weeks for 3 cycles followed by cyclophosphamide (600 mg/m2), epirubicin (75 mg/m2), and fluorouracil (600 mg/m2; CEF), on day 1 every 3 weeks for 3 cycles. wP-FEC: weekly paclitaxel 80 mg/m2 for 12 weeks followed by fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2 (FEC-100) every 3 weeks for four cycles. XP-FEC: docetaxel 75 mg/m2 on day 1 and capecitabine (XT) 1,500 mg/m2 on days 1 through 14 every 3 weeks for four cycles followed by fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2 (FEC-100) every 3 weeks for four cycles. EC-T: epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 on Day 1 every 3 weeks for four cycles), followed by docetaxel (100 mg/m2 four cycles. ET-X: epirubicin 90 mg/m2 plus docetaxel 75 mg/m2 on day 1 every 3 weeks for four cycles), followed by capecitabine (1,250 mg/m2 twice a day orally on days 1 to 14 fir our cycles)
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