Table 2.
(a) Overview of safety results, (b) adverse events of any grade in ≥10 % of patients, irrespective of relation to study treatment (safety population)
| (a) | Arm A CAP/BEV [N = 297; n (%)] |
Arm B CAP/BEV/VIN [N = 295; n (%)] |
P value | |||
|---|---|---|---|---|---|---|
| n | % | n | % | |||
| Any AE | 286 | 96.3 | 288 | 97.6 | 0.474 | |
| Related AE (investigator assessment) | 279 | 93.9 | 286 | 96.9 | 0.114 | |
| Any grade 3/4 | 173 | 58.2 | 216 | 73.2 | <0.001 | *** |
| Related grade 3/4 | 125 | 42.1 | 189 | 64.1 | <0.001 | *** |
| SAE | 112 | 37.7 | 146 | 49.5 | 0.005 | ** |
| AE leading to BEV discontinuation | 63 | 21.2 | 91 | 30.8 | 0.009 | ** |
| AE leading to CAP discontinuation | 65 | 21.9 | 89 | 30.2 | 0.025 | * |
| AE leading to VIN discontinuation | – | – | 100 | 33.9 | – | – |
| (b) | Arm A CAP/BEV [N = 297; n (%)] |
Arm B CAP/BEV/VIN [N = 295; n (%)] |
||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1/2 | Grade 3 | Grade 4 | Grade 5 | Grade 1/2 | Grade 3 | Grade 4 | Grade 5 | P value | ||||||||||
| n | % | n | % | n | % | n | % | n | % | n | % | n | % | n | % | |||
| Hand-foot syndrome1 | 125 | 42.1 | 70 | 23.6 | 77 | 26.1 | 43 | 14.6 | 0.006 | ** | ||||||||
| Nausea/vomiting | 100 | 33.7 | 8 | 2.7 | 127 | 43.1 | 18 | 6.1 | 1 | 0.3 | 0.031 | * | ||||||
| Infection | 78 | 26.3 | 25 | 8.4 | 2 | 0.7 | 90 | 30.5 | 31 | 10.5 | 3 | 1.0 | 3 | 1.0 | 0.347 | n.s. | ||
| Fatigue/malaise | 83 | 27.9 | 6 | 2.0 | 106 | 35.9 | 19 | 6.4 | 0.008 | ** | ||||||||
| Diarrhoea | 82 | 27.6 | 12 | 4.0 | 1 | 0.3 | 1 | 0.3 | 75 | 25.4 | 8 | 2.7 | 1 | 0.3 | 1 | 0.3 | 0.516 | n.s. |
| Hypertension | 65 | 21.9 | 21 | 7.1 | 2 | 0.7 | 60 | 20.3 | 9 | 3.1 | 0.017 | * | ||||||
| Mucosal inflammation | 49 | 16.5 | 8 | 2.7 | 60 | 20.3 | 8 | 2.7 | 1.000 | n.s. | ||||||||
| Peripheral neuropathia | 51 | 17.2 | 1 | 0.3 | 62 | 21.0 | 10 | 3.4 | 1 | 0.3 | 0.003 | ** | ||||||
| Haemorrhage/bleeding | 39 | 13.1 | 2 | 0.7 | 1 | 0.3 | 65 | 22.0 | 2 | 0.7 | 1 | 0.3 | 1.000 | n.s. | ||||
| Dyspnoea | 43 | 14.5 | 7 | 2.4 | 50 | 16.9 | 7 | 2.4 | 1 | 0.3 | 1.000 | n.s. | ||||||
| Neutropenia | 7 | 2.4 | 3 | 1.0 | 28 | 9.5 | 38 | 12.9 | 19 | 6.4 | <0.001 | *** | ||||||
| Decreased appetite | 36 | 12.1 | 3 | 1.0 | 39 | 13.2 | 7 | 2.4 | <0.001 | *** | ||||||||
| Alopecia2 | 20 | 6.7 | 59 | 20.0 | 0.221 | n.s. | ||||||||||||
| Leukopenia | 5 | 1.7 | 1 | 0.3 | 17 | 5.8 | 17 | 5.8 | 14 | 4.7 | 1 | 0.3 | <0.001 | *** | ||||
| General physical health deterioration | 12 | 4.0 | 8 | 2.7 | 1 | 0.3 | 1 | 0.3 | 15 | 5.1 | 10 | 3.4 | 4 | 1.4 | 0.821 | n.s. | ||
| Proteinuria | 20 | 6.7 | 3 | 1.0 | 18 | 6.1 | 1 | 0.3 | 0.624 | n.s. | ||||||||
| Thromboembolic event | 1 | 0.3 | 12 | 4.0 | 1 | 0.3 | 10 | 3.4 | 15 | 5.1 | 0.562 | n.s. | ||||||
| Pulmonary embolism | 4 | 1.3 | 1 | 0.3 | 4 | 1.4 | 5 | 1.7 | 9 | 3.1 | 4 | 1.4 | 0.017 | * | ||||
| Febrile neutropenia | 2 | 0.7 | 3 | 1.0 | 2 | 0.7 | 0.285 | n.s. | ||||||||||
AE adverse event; SAE serious adverse event
Arm A capecitabine/bevacizumab; Arm B capecitabine/bevacizumab/vinorelbine
1Palmar-plantar erythrodysaesthesia syndrome; ²Alopecia only grade 1/2, grade 3/4 N/A; significance: * 0.05. ** 0.01; *** 0.001; n.s. not significant