Table 2. Cycle 3 Patient-Reported Outcomes by Arm.
| PRO measure | No. | Observed mean (95% CI) | Fitted difference (95% CI) | ||
|---|---|---|---|---|---|
| Baseline | Cycle 3 | Pembrolizumab vs ipilimumab/HDI | P value | ||
| FACT-BRM | |||||
| Trial outcome index | |||||
| Ipilimumab/HDI | 267 | 91.9 (90.5-93.4) | 80.6 (78.4-82.9) | NA | NA |
| Pembrolizumab | 565 | 92.1 (91.0-93.2) | 90.3 (89.2-91.5) | 9.6 (7.9-11.3) | <.001 |
| Total score | |||||
| Ipilimumab/HDI | 267 | 135.6 (133.5-137.6) | 124.4 (121.5-127.2) | NA | NA |
| Pembrolizumab | 563 | 135.7 (134.3-137.2) | 134.9 (133.3-136.4) | 10.4 (8.1-12.6) | <.001 |
| Physical subscale | |||||
| Ipilimumab/HDI | 271 | 24.4 (24.0-24.8) | 21.2 (20.6-21.8) | NA | NA |
| Pembrolizumab | 575 | 24.4 (24.1-24.6) | 23.7 (23.4-24.0) | 2.5 (2.0-3.0) | <.001 |
| Cognitive/emotional subscale | |||||
| Ipilimumab/HDI | 271 | 19.4 (19.0-19.9) | 17.9 (17.3-18.5) | NA | NA |
| Pembrolizumab | 575 | 19.2 (18.9-19.5) | 19.2 (18.8-19.5) | 1.5 (1.0-2.0) | <.001 |
| FACT-G | |||||
| Total score | |||||
| Ipilimumab/HDI | 269 | 91.8 (90.3-93.2) | 85.5 (83.6-87.3) | NA | NA |
| Pembrolizumab | 566 | 92.1 (91.1-93.1) | 91.9 (90.8-93.0) | 6.2 (4.6-7.8) | <.001 |
| Physical well-being | |||||
| Ipilimumab/HDI | 270 | 25.8 (25.5-26.2) | 21.5 (20.8-22.2) | ||
| Pembrolizumab | 571 | 26.1 (25.9-26.3) | 24.8 (24.5-25.1) | 3.2 (2.6-3.7) | <.001 |
| Social/family well-being | |||||
| Ipilimumab/HDI | 273 | 24.9 (24.4-25.4) | 24.3 (23.8-24.9) | NA | NA |
| Pembrolizumab | 578 | 24.7 (24.4-25.1) | 24.4 (24.0-24.8) | 0.1 (−0.4-0.7) | .61 |
| Emotional well-being | |||||
| Ipilimumab/HDI | 273 | 18.7 (18.3-19.2) | 19.3 (18.9-19.8) | NA | NA |
| Pembrolizumab | 576 | 18.8 (18.5-19.1) | 20.0 (19.7-20.2) | 0.6 (0.2-1.0) | .01 |
| Functional well-being | |||||
| Ipilimumab/HDI | 273 | 22.3 (21.7-22.9) | 20.2 (19.4-20.9) | NA | NA |
| Pembrolizumab | 577 | 22.4 (22.0-22.8) | 22.6 (22.1-23.0) | 2.3 (1.7-2.9) | <.001 |
| FACIT-D | |||||
| Trial outcome index | |||||
| Ipilimumab/HDI | 132 | 91.0 (89.7-92.4) | 83.5 (81.3-85.6) | NA | NA |
| Pembrolizumab | 289 | 91.3 (90.4-92.3) | 89.6 (88.4-90.7) | 5.8 (4.0-7.6) | <.001 |
| Total score | |||||
| Ipilimumab/HDI | 132 | 134.9 (132.8-137.0) | 127.3 (124.4-130.3) | NA | NA |
| Pembrolizumab | 287 | 134.8 (133.3-136.3) | 134.2 (132.6-135.9) | 6.8 (4.3-9.4) | <.001 |
| Diarrhea subscale | |||||
| Ipilimumab/HDI | 136 | 43.0 (42.6-43.3) | 41.9 (41.3-42.5) | NA | NA |
| Pembrolizumab | 292 | 42.8 (42.5-43.1) | 42.5 (42.1-42.9) | 0.7 (0.0-1.4) | .05 |
| EQ-5D-3L | |||||
| Index score | |||||
| Ipilimumab/HDI | 250 | 0.89 (0.88-0.91) | 0.86 (0.84-0.88) | NA | NA |
| Pembrolizumab | 546 | 0.90 (0.89-0.91) | 0.90 (0.89-0.91) | 0.04 (0.02-0.06) | <.001 |
| Global Health score | |||||
| Ipilimumab/HDI | 264 | 83.6 (81.9-85.2) | 77.1 (74.8-79.3) | NA | NA |
| Pembrolizumab | 565 | 84.9 (83.8-86.0) | 84.6 (83.6-85.6) | 6.7 (4.9-8.5) | <.001 |
Abbreviations: FACT, Functional Assessment of Cancer Therapy; FACT-BRM, FACT Biological Response Modifiers; FACIT-D, Functional Assessment of Chronic Illness Therapy diarrhea; FACT-G, FACT general; HDI, high-dose interferon α 2b; PROs, patient-reported outcomes.