Table 4.
Review of clinical data for regorafenib monotherapy in mCRC.
| ADVERSE EVENTS > GRADE 3 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NAME | STUDY | COUNTRY | NUMBER OF pts TREATED WITH REGORAFENIB | ≥4 LINES (%) | INITIATION DOSE REDUCTION (% pts) | DOSE ADAPTATION (% pts) | MEDIAN DURATION OF TREATMENT (mo) | MEDIAN OS (mo) | MEDIAN PFS (mo) | ADVERSE EVENTS (%) | AE (%) | HAND-FOOT SYNDROME % | HYPERTENSION % | FATIGUE % |
| Strumberg et al.27 | Phase I | Germany | 38 | 50.0 | 0 | 66.0 | 1.8 | NA | 3.5 | 84 | 58 | 32 | 11 | 11 |
| Grothey et al.15 | Phase III (CORRECT) | World | 500 | 49.0 | 0 | 76.0 | 1.7 | 6.4 | 1.9 | 93.0 | 54 | 17 | 7 | 10 |
| Li et al.16 | Phase III (CONCUR) | Asia | 136 | 38.0 | 0 | 75.0 | 2.4 | 8.8 | 3.2 | 97 | 54 | 16 | 11 | 3 |
| Van Cutsem et al.9 | Cohort study Phase IIIb (CONSIGN) | 25 countries | 2864 | 46 | 0 | 87 | 2.5 | NR | 2.7 | 91 | 57 | 14 | 15 | 13 |
| de la Fouchardiere et al.28 | Retrospective Cohort study (REBECCA) | France | 654 | NR | 20 | 50 | 2.2 | 5.6 | 2.7 | 80 | 43.7 | 9 | 4.6 | 14.5 |
| Komatsu et al.29 | Post marketing Surveillance | Japan | 796 | 24 | 34 | NR | 1.7 | 7 | NR | 89 | 51 | 18 | 14 | 2 |
| Tanaka et al.30 | Retrospective | Japan | 16 | NR | NR | 87.5 | 1.6* | 6.6 | 2.3 | NR | ND | 44 | 6 | 13 |
| Hirano et al.31 | Retrospective | Japan | 32 | 22 | 22 | 91.0 | 2.7* | 7.7 | 2.7 | NR | 50 | 22 | 9 | 13 |
| Kim et al.32 | Retrospective | Korean | 32 | NR | 0 | 50 | NR | NR | 4.2 | 90 | 37 | 0 | NR | 3 |
| Calcagno et al | Retrospective | France | 29 | 26 | 66 | 51 | 2.5 | 6 | NR | 86 | 24 | 7 | 3.5 | 3.5 |
Abbreviation: NR, not reported.