TABLE 2.
Arm A N = 6 |
Arm B N = 6 |
Arm C N = 6 |
Arm D N = 6 |
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Regimen |
Cisplatin Gemcitabine Nivolumab |
Cisplatin Pemetrexed Nivolumab |
Carboplatin Paclitaxel Bevacizumab Nivolumab |
Docetaxel Nivolumab |
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irAE grade or CS | Any | 3‐4 | CS | Any | 3‐4 | CS | Any | 3‐4 | CS | Any | 3‐4 | CS |
Any irAE | 6 (100) | 1 (16.7) | 2 (33.3) | 4 (66.7) | 0 (0.0) | 2 (33.3) | 6 (100) | 0 (0.0) | 2 (33.3) | 5 (83.3) | 1 (16.7) | 1 (16.7) |
Skin toxicity | 2 (33.3) | 0 (0.0) | 0 (0.0) | 4 (66.7) | 0 (0.0) | 0 (0.0) | 5 (83.3) | 0 (0.0) | 1 (16.7) | 2 (33.3) | 0 (0.0) | 0 (0.0) |
Rash maculopapular | 2 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Pruritus | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (50.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Rash erythematous | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Rash | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (50.0) | 0 (0.0) | 0 (0.0) | 5 (83.3) | 0 (0.0) | 1 (16.7) | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Urticarias | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Gastrointestinal toxicity | 1 (16.7) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Diarrhea | 1 (16.7) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Endocrine disorders | 1 (16.7) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Hypophysitis | 1 (16.7) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Hypothyroidism | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Blood thyroid‐stimulating hormone decreased | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) |
Hyperthyroidism | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Hepatotoxicity | 4 (66.7) | 1 (16.7) | 1 (16.7) | 3 (50.0) | 0 (0.0) | 0 (0.0) | 3 (50.0) | 0 (0.0) | 0 (0.0) | 3 (50.0) | 1 (16.7) | 0 (0.0) |
AST increased | 4 (66.7) | 1 (16.7) | 1 (16.7) | 3 (50.0) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 0 (0.0) | 3 (50.0) | 1 (16.7) | 0 (0.0) |
ALT increased | 4 (66.7) | 1 (16.7) | 1 (16.7) | 2 (33.3) | 0 (0.0) | 0 (0.0) | 3 (50.0) | 0 (0.0) | 0 (0.0) | 3 (50.0) | 0 (0.0) | 0 (0.0) |
Blood bilirubin increased | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Bilirubin conjugated increased | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Pulmonary toxicity | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 2 (33.3) | 1 (16.7) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Interstitial lung disease | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 2 (33.3) | 1 (16.7) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Renal toxicity | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Blood creatinine increased | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Hypersensitivity | 2 (33.3) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (50.0) | 0 (0.0) | 1 (16.7) | 2 (33.3) | 0 (0.0) | 1 (16.7) |
Hypersensitivity | 2 (33.3) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Infusion related reaction | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 1 (16.7) | 2 (33.3) | 0 (0.0) | 1 (16.7) |
Data are presented as n (%).
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase.