Table 2.
Summary of adverse effects of regorafenib and TAS-102 in refractory metastatic colorectal cancer
| Adverse event % | Regorafenib (n=146) | TAS-102 (n=54) | P-value | ||
|---|---|---|---|---|---|
|
| |||||
| Grade 1/2 | Grade 3/4 | Grade 1/2 | Grade 3/4* | ||
|
| |||||
| Hematologic | |||||
| Neutropenia | 14 | 3 | 26 | 37 | <0.0001 |
| Leukopenia | 17 | 2 | 41 | 19 | 0.0001 |
| Anemia | 66 | 9 | 57 | 24 | 0.008 |
| Thrombocytopenia | 53 | 8 | 33 | 4 | 0.52 |
|
| |||||
| Nonhematologic | |||||
| Nausea | 17 | 0 | 67 | 6 | 0.02 |
| Vomiting | 10 | 0 | 35 | 2 | 0.27 |
| Diarrhea | 23 | 2 | 28 | 4 | 0.61 |
| Fatigue | 67 | 1 | 78 | 0 | 1.00 |
| Anorexia | 55 | 5 | 69 | 11 | 0.21 |
| Mucositis | 27 | 1 | 31 | 0 | 1.00 |
| Hand–foot syndrome | 50 | 21 | 6 | 0 | <0.0001 |
| Rash | 17 | 4 | 11 | 0 | 0.19 |
| AST increased | 60 | 13 | 39 | 0 | 0.002 |
| ALT increased | 43 | 10 | 17 | 0 | 0.01 |
| Bilirubin increased | 40 | 8 | 22 | 0 | 0.04 |
| Creatinine increased | 25 | 3 | 11 | 0 | 0.33 |
| Febrile neutropenia | NA | 0 | NA | 6 | 0.02 |
| Fever | 32 | 0 | 19 | 0 | NA |
Note:
*
Patients also randomized within each treatment arm to receive preemptive or reactive clobetasol for HFSR.
Abbreviations: ALT, alanine aminotransferase; AST, aspartate transaminase; NA, not available.