Table 3a.
TEAEs leading to dose reduction, interruption, or discontinuation in the concurrent nivolumab cohort.
| Parameter, n (%) | Concurrent Cohort (n = 22) | |||
|---|---|---|---|---|
| nab-Paclitaxel | Carboplatin | Nivolumab | nab-Paclitaxel/carboplatin/nivolumab | |
| Patients with ≥1 TEAE leading to dose reduction or interruptiona | 20 (90.9) | 14 (63.6) | 14 (63.6) | 21 (95.5) |
| Patients with ≥1 TEAE leading to withdrawal of study drug | 4 (18.2) | 1 (4.5) | 4 (18.2) | 7 (31.8) |
| Most common TEAEs leading to dose reduction and/or interruptionb Neutropenia |
9 (40.9) | 7 (31.8) | 4 (18.2) | 9 (40.9) |
| Neutrophil count decreased | 6 (27.3) | 3 (13.6) | 1 (4.5) | 6 (27.3) |
| Thrombocytopenia | 5 (22.7) | 3 (13.6) | 2 (9.1) | 5 (22.7) |
| Platelet count decreased | 4 (18.2) | 3 (13.6) | 2 (9.1) | 4 (18.2) |
| WBC count decreased | 2 (9.1) | 1 (4.5) | 3 (13.6) | 3 (13.6) |
| Fatigue | 1 (4.5) | 0 | 1 (4.5) | 2 (9.1) |
| Anemia | 2 (9.1) | 1 (4.5) | 1 (4.5) | 2 (9.1) |
| ALT increased | 1 (4.5) | 1 (4.5) | 2 (9.1) | 2 (9.1) |
| Dehydration | 2 (9.1) | 0 | 2 (9.1) | 2 (9.1) |
| Pneumonitis | 0 | 0 | 2 (9.1) | 2 (9.1) |
| Vomiting | 1 (4.5) | 1 (4.5) | 2 (9.1) | 2 (9.1) |
| Most common TEAEs leading to withdrawal of study drugb Neutrophil count decreased |
2 (9.1) | 0 | 0 | 2 (9.1) |
ALT, alanine aminotransferase; TEAE, treatment-emergent adverse event; WBC, white blood cell.
a
For nivolumab, because dose reductions were not allowed, the numbers represent patients with dose interruption.
b
Occurring in >1 patient in any group, presented in descending order of incidence in the nab-paclitaxel/carboplatin/nivolumab group.