Table 5.
Author(s) | Rini et al. (2009) | Rixe et al. (2007) | Tomita et al. (2011) | |||
---|---|---|---|---|---|---|
Previous therapy | Sorafenib refractory ± other* (N = 62) |
Cytokine refractory (N = 52) |
Cytokine refractory (N = 64) |
|||
Axitinib dose/schedule | 5.0 mg BID, dose escalation |
5.0 mg BID, dose escalation |
5.0 mg BID, dose escalation |
|||
Adverse event | All Gr (%) | ≥ Gr 3 (%) | All Gr (%) | ≥ Gr 3 (%) | All Gr (%) | ≥ Gr 3 (%) |
Diarrhea | 60 | 10 | 61 | 15 | 64 | 5 |
Hypertension | 58 | 15 | 45 | 16 | 84 | 70 |
Fatigue | 52 | 8 | 77 | 16 | 48 | 5 |
Nausea | 44 | 0 | 44 | 7 | 25 | 0 |
Dysphonia | NS | Ns | 37 | 0 | 53 | 0 |
Hand–foot syndrome | NS | NS | 36 | 16 | 75 | 22 |
Anorexia | 35 | 2 | 48 | 0 | 36 | 5 |
Weight loss | 27 | 0 | 31 | 5 | 30 | 3 |
Dyspepsia | 23 | 0 | NS | NS | NS | NS |
Vomiting | 21 | 0 | 32 | 5 | 16 | 0 |
Headache | NS | NS | 29 | 0 | 23 | 0 |
Arthralgia | NS | NS | 27 | 3 | 19 | 3 |
BID, twice daily; Gr, grade.
*Previous therapy may also have included bevacizumab, sunitinib, temsirolimus, cytokines, chemotherapy, and/or other.