Table 4.
Sunitinib Schedule 4/2 and CDD schedule: most common treatment-emergent adverse events by grade (reported in ≥20 % of patients total; safety population)
| Adverse events, n (%) | Sunitinib Schedule 4/2 | Sunitinib CDD schedule | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
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| 37.5 mg/day (n = 12)a | 50 mg/day (n = 9) | 25 mg/day (MTD; n = 8) | 37.5 mg/day (n = 6) | |||||||||
|
|
|
|
|
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| G1/2 | G3 | G4b | G1/2 | G3 | G4 | G1/2 | G3 | G4b | G1/2 | G3 | G4b | |
| Neutropenia | 2 (16.7) | 5 (25.0) | 1 (8.3) | 1 (11.1) | 4 (44.4) | 3 (33.3) | 3 (37.5) | 4 (50.0) | 2 (25.0) | 0 | 2 (33.3) | 2 (33.3) |
| Fatigue | 4 (33.3) | 2 (16.7) | 0 | 4 (44.4) | 3 (33.3) | 0 | 4 (50.0) | 1 (12.5) | 0 | 4 (66.7) | 1 (16.7) | 0 |
| Thrombocytopenia | 6 (50.0) | 1 (8.3) | 0 | 5 (55.6) | 1 (11.1) | 0 | 3 (37.5) | 0 | 2 (25.0) | 3 (50.0) | 0 | 0 |
| Nausea | 6 (50.0) | 1 (8.3) | 0 | 5 (55.6) | 0 | 0 | 5 (62.5) | 0 | 0 | 4 (66.7) | 0 | 0 |
| Peripheral neuropathy | 5 (41.7) | 0 | 0 | 7 (77.8) | 0 | 0 | 3 (37.5) | 0 | 0 | 4 (66.7) | 0 | 0 |
| Vomiting | 4 (33.3) | 1 (8.3) | 0 | 5 (55.6) | 0 | 0 | 3 (37.5) | 0 | 0 | 4 (66.7) | 0 | 1 (16.7) |
| Anemia | 5 (41.7) | 1 (8.3) | 0 | 3 (33.3) | 0 | 0 | 1 (12.5) | 3 (37.5) | 0 | 2 (33.3) | 0 | 0 |
| Mucosal inflammation | 1 (8.3) | 2 (16.7) | 0 | 5 (55.6) | 0 | 0 | 2 (25.0) | 1 (12.5) | 0 | 2 (33.3) | 2 (33.3) | 0 |
| Abdominal pain | 0 | 3 (25.0) | 0 | 5 (55.6) | 0 | 0 | 2 (25.0) | 2 (25.0) | 0 | 2 (33.3) | 0 | 1 (16.7) |
| Pyrexia | 4 (44.4) | 1 (8.3) | 0 | 4 (44.4) | 0 | 0 | 3 (37.5) | 0 | 0 | 0 | 0 | 0 |
| Diarrhea | 2 (16.7) | 0 | 0 | 3 (33.3) | 2 (22.2) | 0 | 2 (25.0) | 0 | 0 | 0 | 1 (16.7) | 1 (16.7) |
| Decreased appetite | 2 (16.7) | 0 | 0 | 3 (33.3) | 1 (11.1) | 0 | 1 (12.5) | 1 (12.5) | 0 | 1 (16.7) | 2 (33.3) | 0 |
| Leukopenia | 3 (25.0) | 1 (8.3) | 0 | 1 (11.1) | 0 | 1 (11.1) | 2 (25.0) | 1 (12.5) | 0 | 0 | 1 (16.7) | 0 |
| Dysgeusia | 4 (33.3) | 0 | 0 | 2 (22.2) | 0 | 0 | 3 (37.5) | 0 | 0 | 1 (16.7) | 0 | 0 |
| Constipation | 5 (41.7) | 0 | 0 | 2 (22.2) | 0 | 0 | 1 (12.5) | 0 | 0 | 1 (16.7) | 0 | 0 |
| Dyspepsia | 5 (41.7) | 0 | 0 | 2 (22.2) | 0 | 0 | 0 | 0 | 0 | 2 (33.3) | 0 | 0 |
| Peripheral edema | 3 (25.0) | 0 | 0 | 3 (33.3) | 0 | 0 | 0 | 0 | 0 | 2 (33.3) | 0 | 0 |
| Epistaxis | 1 (8.3) | 0 | 0 | 3 (33.3) | 0 | 0 | 2 (25.0) | 1 (12.5) | 0 | 0 | 0 | 0 |
CDD continuous daily dosing, G grade, MTD maximum tolerated dose
a
MTD exceeded at 37.5 mg/day
b
Five grade 5 events were reported during the study and follow-up period due to disease progression (n = 1, sunitinib 37.5 mg/day Schedule 4/2; n = 2, sunitinib 37.5 mg/day CDD schedule); sepsis (n = 1, sunitinib 37.5 mg/day Schedule 4/2); and acute liver and renal failure secondary to disease progression (n = 1, sunitinib 25 mg/day CDD schedule). None of these events were assessed as related to treatment