Table 1.
Trials of capecitabine in the adjuvant treatment of breast cancer
| 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 | — | — | — | — | — | — |
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
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)