Table 1.
Patient Characteristics
| Characteristic | Total Cohort (N=50) |
Arm A (NIVO/IPI) (N=25) |
ArmB (NIVO/IPI/SBRT) (N=25) |
P Value |
|---|---|---|---|---|
| Age median [IQR] | 73 [67-81] | 74 [66-81] | 73 [68-76] | 0.81 |
| Gender, No. (%) | ||||
| Female | 11 (22) | 5 (20) | 6 (24) | 0.99 |
| Male | 39 (78) | 20 (80) | 19 (76) | |
| Race: White, No. (%) | 50 (100) | 25 (100) | 25 (100) | 0.99 |
| ECOG Performance Status, No. (%) | 0.99 | |||
| 0 | 23 (46) | 11 (44) | 12 (48) | |
| 1 | 27 (54) | 14 (56) | 13 (52) | |
| Stage, No. (%) | 0.32 | |||
| IIIB | 12 (24) | 4(16) | 8 (32) | |
| IV | 38 (76) | 21 (84) | 17 (68) | |
| Primary Tumor Site, No. (%) | 0.48 | |||
| Head and Neck | 16 (32) | 11 (44) | 5 (20) | |
| Trunk | 2 (4) | 1 (4) | 1 (4) | |
| Extremities | 26 (52) | 11 (44) | 15 (60) | |
| Unknown Primary | 6 (12) | 2 (8) | 4 (16) | |
| M Stage, No. (%) | 0.26 | |||
| MO | 12 (24) | 4 (16) | 8 (32) | |
| M1a | 19 (38) | 12 (48) | 7 (28) | |
| M1b | 0 (0) | 0 (0) | 0 (0) | |
| M1c | 19 (38) | 9 (36) | 10 (40) | |
| #Distant Metastastic Sites, No. (%) | ||||
| 0 | 12 (24) | 4 (16) | 8 (32) | 0.81 |
| 1-2 | 16 (32) | 9 (36) | 7 (28) | |
| 3-4 | 14 (28) | 9 (36) | 5 (20) | |
| >5 | 7 (14) | 3 (12) | 4 (16) | |
| LDH, No. (%) | ||||
| Normal | 26 (52) | 10 (40) | 16 (64) | 0.16 |
| Elevated | 24 (48) | 15 (60) | 9 (36) | |
| Prior Immunotherapy Status, No. (%) | 0.78 | |||
| ICI Naïve | 24 (48) | 13 (52) | 11 (44) | |
| Prior ICI | 26 (52) | 12 (48) | 14 (56) | |
| Prior Chemotherapy Status, No. (%) | 0.99 | |||
| Chemotherapy-Naïve | 45 (90) | 23 (92) | 22 (88) | |
| Prior Chemotherapy | 5 (10) | 2 (8) | 3 (12) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; ICI, immune-checkpoint inhibitor; IQR, interquartile range; NIVO, nivolumab; IPI, ipilimumab; SBRT, stereotactic body radiation therapy; LDH, lactate dehydrogenase.