Table 2. Treatment Outcomes.
| Outcome | No. (%) | P value | ||
|---|---|---|---|---|
| All (N = 74) | ECOG PS score | |||
| 0-1 (n = 45) | ≥2 (n = 29) | |||
| Objective responsea | ||||
| ORR | 17 (23.9) | 12 (27.9) | 5 (17.9) | .40 |
| CR | 2 (2.8) | 2 (4.6) | 0 | |
| PR | 15 (21.1) | 10 (23.3) | 5 (17.9) | |
| Disease controla | ||||
| DCR | 53 (74.6) | 38 (88.4) | 15 (53.6) | .002 |
| SD | 36 (50.7) | 26 (60.5) | 10 (35.7) | |
| Immune-related adverse events | ||||
| Any grade | 33 (44.6) | 24 (53.3) | 9 (31.0) | .09 |
| Grade ≥3 | 11 (14.9) | 6 (13.3) | 5 (17.2) | .74 |
| Steroid use | 15 (20.3) | 10 (22.2) | 5 (17.2) | .77 |
| Treatment discontinuation | 7 (9.5) | 3 (6.7) | 4 (13.8) | .42 |
| Death | 1 (1.4) | 1 (2.2) | 0 | >.99 |
| Progression free survival, median, (95% CI), mo | 4.8 (2.9-7.9) | 7.9 (4.6-15.4) | 2.3 (1.8-4.8) | .004 |
| Progression free survival 2, median (95% CI), mo | 8.9 (6.6-11.9) | 11.9 (8.6-23.9) | 4.1 (2.1-6.9) | <.001 |
| Overall survival, median (95% CI), mo | 9.9 (6.7-23.2) | 23.2 (14.0-35.7) | 4.1 (2.1-6.9) | <.001 |
| Death on home hospice | ||||
| Yes | 29 (39.2) | 15 (33.3) | 14 (48.3) | .59 |
| No | 14 (18.9) | 7 (15.6) | 7 (24.1) | |
| Not known | 2 (2.7) | 0 | 2 (6.9) | |
| Not applicable | 29 (39.2) | 23 (51.1) | 6 (20.7) | |
Abbreviations: CR, complete response; DCR, disease control rate; ECOG PS, Eastern Cooperative Oncology Group performance status; ORR, overall response rate; PR, partial response; SD, stable disease.
a
Objective response and disease control rates available for 71 patients (43 [60.6%] with ECOG PS 0-1; 28 [39.4%] with ECOG PS ≥2).