Table 4. Conventional-Dose Ipilimumab and Nivolumab vs Alternative-Dose Ipilimumab and Nivolumab in the Neoadjuvant Setting.
| Variable | Dose, No. (%) | OR (95% CI) | P value | |
|---|---|---|---|---|
| Conventional dosea | Alternative doseb | |||
| Total patients | 51 | 129 | NA | NA |
| Radiologic response evaluated | 49 | 129 | NA | NA |
| rCR | 3 (6.1) | 17 (13.2) | 0.43 (0.12-1.54) | .19 |
| rOOR | 31 (63.3) | 62 (48.1) | 1.86 (0.95-3.66) | .07 |
| rPD | 4 (8.2) | 15 (11.6) | 0.68 (0.21-2.15) | .51 |
| Pathologic response evaluated | 50 | 129 | NA | NA |
| pCR | 22 (44.0) | 65 (50.4) | 0.77 (0.40-1.49) | .44 |
| Adverse events | ||||
| Grade 3 or 4 irAE | 29 (56.9) | 28 (21.7) | 4.76 (2.38-9.52) | .001 |
| Unable to complete NAT | 13 (26.0) | 15 (11.6) | 2.6 (1.14-5.95) | .02 |
| Planned surgical resection | 51 (100) | 119 (92.2) | 9.05 (0.52-157.37) | .13 |
Abbreviations: irAE, immune-related adverse event; NA, not applicable; NAT, neoadjuvant therapy; OR, odds ratio; pCR, pathologic complete response; rCR, radiologic complete response; rOOR, radiologic overall objective response; rPD, radiologic progressive disease.
a
Conventional dose: 3-mg/kg dose of ipilimumab + 1-mg/kg dose of nivolumab.
b
Alternative dose: 1-mg/kg dose of ipilimumab + 3-mg/kg dose of nivolumab.