Table 2.
Differences and similarities between regorafenib and TAS-102 trials.
| Regorafenib | TAS-102 | |
|---|---|---|
| Drug | ||
| Pharmaceutical | Bayer | Taiho |
| Mechanism of action | Multi-TKI | Antimetabolic |
| Route | Oral | Oral |
| Dose | 160 mg daily, 3 weeks of each 4-week cycle | 35 mg/m² twice a day on days 1–5 and 8–12 every 4 weeks |
| Study | CORRECT | RECOURSE |
| Reference | [Grothey et al. 2013] | [Yoshino et al. 2014] |
| Trial phase | III | III |
| Primary objective (targeted HR) | OS (0.70) | OS (0.75) |
| Randomization ratio | 2:1 | 2:1 |
| Comparator | Placebo | Placebo |
| No of patients (investigational / placebo) | 505 / 255 | 534 / 266 |
| Recruitment | Early stop for positive results | Full |
| Prior antiangiogenic agent | 100% | 100% |
| Efficacy results | ||
| OS, HR (absolute median difference) | 0.77 (+1.4) | 0.68 (+1.8) |
| PFS, HR (absolute median difference) | 0.49 (+0.2) | 0.48 (+0.3) |
| DCR, % (absolute difference) | 41 (+26) | 44 (+28) |
| Safety profile | ||
| Neutropenia, any grade (grade ¾) | Not reported | 67 (38) |
| Anemia | 7 (3) | 76 (18) |
| Nausea | 14 (<1) | 48 (2) |
| Stomatitis | 27 (3) | 8 (<1) |
| Diarrhea | 34 (8) | 32 (3) |
| Hand-and-foot syndrome | 47 17) | 2 (0) |
| Asthenia | 63 (10) | 35 (4) |
| HRQoL | No change | Not done |
| Predictive biomarkers | None | TK1-high expression? |
| FDA/EMA approval | Yes | Not yet |
Abbreviations: TKI, tyrosine kinase inhibitor; RECOURSE, Refractory Colorectal Cancer Study; HR, hazard ratio; OS, overall survival ; PFS, progression-free survival ; DCR, disease control rate; HRQoL, heath-related quality of life; FDA, Food and Drug Administration; EMA, European Medical Agency.