Table 2.
Summary of adverse events, interruptions and discontinuations relating to treatment
| Parameters | Pembrolizumab monotherapy (n = 20) | Sequential therapy (n = 20) | Concurrent therapy (n = 20) |
|---|---|---|---|
| All TRAE, n (%) | 17 (85) | 19 (95) | 20 (100) |
| Grade 3/grade 4 TRAE, n (%) | 1 (5) | 5 (25) | 11 (55) |
| Treatment-related death, n (%) | 0 | 0 | 0 |
| During neoadjuvant therapy, n | 20 | 20 | 20 |
| All TRAE, n (%) | 15 (75) | 16 (80) | 20 (100) |
| Grade 3/grade 4 TRAE, n (%) | 1 (5) | 1 (5) | 8 (40) |
| Treatment discontinuation due to TRAEa | 0 | 0 | 7 (35) |
| Dabrafenib plus trametinib | – | 0 | 7 |
| Pembrolizumab | 0 | 0 | 1 |
| Treatment interruption due to TRAEa | 0 | 3 (15) | 19 (95) |
| Dabrafenib plus trametinib | – | 3 | 19 |
| Pembrolizumab | 0 | 0 | 0 |
| During adjuvant pembrolizumab, n | 12 | 17 | 16 |
| Treatment discontinuation due to TRAEb | 1 | 4 | 4 |
| During adjuvant dabrafenib plus trametinib, nc | 3 | 1 | 1 |
| Treatment discontinuation due to TRAE | 1 | 0 | 0 |
Summary of TRAEs, treatment interruptions and treatment discontinuations during neoadjuvant and adjuvant therapy.
aAll interruptions and discontinuations during neoadjuvant therapy were due to TRAE.
bSix patients discontinued adjuvant pembrolizumab for reasons other than TRAE (recurrence, n = 6).
cDabrafenib plus trametinib could be given as adjuvant therapy at the investigator’s discretion in any patient with a pNR.