Table 3.
Treatment Adjustments Due to Adverse Events
| Standard dose n (%*) | Extended interval dosing n (%*) | |
|---|---|---|
| Total number of treatment adjustments | 23 (26.1) | 31 (26.5) |
| - Treatment reduced to single dose | - | 8 (6.8) |
| • By treatment schedule | ||
| Chemotherapy + ICI | - | - |
| Pembrolizumab monotherapy | - | 4 |
| Nivolumab monotherapy | - | 2 |
| Durvalumab adjuvant | - | 2 |
| • By PD-L1 expression | ||
| PD-L1 ≥ 50% | - | 4 |
| PD-L1 < 50% | - | 1 |
| PD-L1 not assessed | - | 2 |
| Treatment interrupted | 12 (13.6) | 18 (15.4) |
| • By treatment schedule | ||
| Chemotherapy + ICI | 3 | 4c |
| Pembrolizumab monotherapy | 5a | 10d |
| Nivolumab monotherapy | 4b | 3 |
| Durvalumab adjuvant | - | 1e |
| • By PD-L1 expression | ||
| PD-L1 ≥ 50% | 5 | 12 |
| PD-L1 < 50% | 7 | 5 |
| PD-L1 not assessed | - | 1 |
| Treatment discontinued | 11 (12.5) | 5 (4.3) |
| • By treatment schedule | ||
| Chemotherapy + ICI | 1 | - |
| Pembrolizumab monotherapy | 5a | - |
| Nivolumab monotherapy | - | 2 |
| Durvalumab adjuvant | 5 | 3 |
| • By PD-L1 expression | ||
| PD-L1 ≥ 50% | 5 | 1 |
| PD-L1 < 50% | 3 | 3 |
| PD-L1 not assessed | 3 | 1 |
Percent of all patients in the standard dose (nSD = 88) and the EI dosing cohort (nEI = 117). Each cohort includes patients receiving pembrolizumab monotherapy (nSD = 30 and nEI = 35), pembrolizumab consolidation therapy (nSD = 11 and nEI = 15), nivolumab monotherapy (nSD = 30 and nEI = 18), and adjuvant durvalumab (nSD = 17 and nEI = 49).
One patient had two occurrences of the same toxicity on pembrolizumab monotherapy (hepatitis).
One patient had two occurrences of same toxicity on nivolumab monotherapy (colitis).
Therapy was interrupted in one patient receiving chemotherapy-ICI combination (hepatitis and endocrinopathy).
Therapy was interrupted in two patients treated with pembrolizumab monotherapy, patient 1: pneumonitis and endocrinopathy; patient 2: two occurrences of skin toxicity.
Patient with two different toxicities: fatigue leading to dose reduction and skin toxicity leading to treatment interruption.