Table 3.
Grade 3–4 toxicities in our cohort compared to cohorts from landmark studies.
| H-RT + 1 ICI (this study) (n = 45) | Nivo, melanoma (1) (n = 665) | Nivo, RCC (2) (n = 406) | Nivo, NSCLC (3) (n = 287) | H-RT + Nivo/Ipi (this study) (n = 14) | Nivo + Ipi, melanoma (1) (n = 326) | Nivo 1 mg/kg Ipi 3 mg/kg, rSCLC (4) (n = 61) | Nivo 3 mg/kg Ipi 1 mg/kg, rSCLC (4) (n = 54) | |
|---|---|---|---|---|---|---|---|---|
| All AEs | 6 (13%) | 83 (12%) | 76 (19%) | 30 (10%) | 6 (43%) | 179 (55%) | 18 (30%) | 10 (19%) |
| Fatigue | 3 (7%) | 4 (0.6%)* | 10 (2%) | 3 (1%)* | 0 (0%) | 17 (5%) | 0 (0%) | 0 (0%) |
| Pruritus | 0 (0%) | 1 (0.2%) | 0 (0%) | 0 (0%) | 6 (2%) | 1 (2%) | 0 (0%) | |
| Fever | 0 (0%) | 0 (0%) | 0 (0%) | 4 (1%) | ||||
| Nausea | 1 (2%) | 0 (0%) | 1 (<1%) | 2 (1%) | 1 (7%) | 7 (2%) | 1 (2%) | 0 (0%) |
| Vomiting | 1 (2%) | 2 (0.3%) | 0 (0%) | 8 (2%) | 1 (2%) | 0 (0%) | ||
| Anorexia | 0 (0%) | 0 (0%) | 2 (<1%) | 0 (0%) | 0 (0%) | 3 (0.9%) | 0 (0%) | 0 (0%) |
| Transaminitis | 0 (0%) | 2 (14%) | 0 (0%)* | 1 (2%) | ||||
| Colitis | 0 (0%) | 1 (0.2%) | 1 (7%) | 32 (10%) | 1 (2%) | 1 (2%) | ||
| Diarrhea | 0 (0%) | 7 (1%) | 5 (1%) | 2 (1%) | 0 (0%) | 27 (8%) | 3 (5%) | 1 (2%) |
| Rash/dermatitis | 0 (0%) | 0 (0%) | 2 (<1%) | 0 (0%) | 11 (3%) | 2 (3%) | 0 (0%) | |
| Cough/SOB | 0 (0%) | 1 (0.2%) | 3 (1%) | 0 (0%) | 0 (0%) | 1 (2%) | 2 (4%) | |
| Pneumonitis | 2 (4%) | 1 (0.2%)* | 6 (1%) | 1 (7%) | 4 (1%) | 1 (2%) | 1 (2%) | |
| Hypo/hyper-thyroidism | 0 (0%) | 0 (0%) | 1 (2%) | 0 (0%) | ||||
| Hypophysitis | 0 (0%) | 0 (0%) | 0 (0%) | 5 (2%) | ||||
| AKI | 1 (2%) | 0 (0%) | 1 (2%) | 0 (0%) | ||||
| Electrolytes | 1 (2%) | 1 (7%) | ||||||
| Extremity edema | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | ||||
| Pancytopenia | 1 (2%) | 0 (0%) | ||||||
| Anemia | 1 (2%) | 1 (0.2%) | 7 (2%) | 1 (<1%) | 0 (0%) | 2 (0.6%) | 0 (0%) | 1 (2%) |
| Hyperglycemia | 0 (0%) | 5 (1%) | 1 (7%) | 1 (2%) | 0 (0%) | |||
| Adrenal insufficiency | 0 (0%) | 0 (0%) | 0 (0%) | 1 (2%) | ||||
| Pancreatitis | 0 (0%) | 0 (0%) | ||||||
| Uveitis | 0 (0%) | 0 (0%) |
Abbreviations: ICI, immune checkpoint inhibitor; H-RT, hypofractionated radiotherapy; RCC, renal cell carcinoma; Nivo, Nivolumab; Ipi, Ipilimumab; NSCLC, non-small cell lung cancer; rSCLC, recurrent small cell lung cancer; SOB, shortness of breath; AKI, acute kidney injury.
*denotes statistical significance with p-value<0.05 using Fisher's exact test. Columns 3, 4 and 5 compared to column 2; and columns 7, 8 and 9 compared to column 6.
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