Table 1.
Patient Characteristics
| Variable | No ICB | Durvalumab | Durvalumab + Tremelimumab | Total | P-value |
|---|---|---|---|---|---|
|
| |||||
| Randomized Patients | |||||
|
| |||||
| Number of patients | 4 | 9 | 11 | 24 | |
|
| |||||
| Age, year | 58.8 ± 13.4 | 67.9 ± 6.1 | 63.4 ± 9.5 | 64.3 ± 9.3 | 0.246 |
|
| |||||
| Gender | 0.440 | ||||
| Male | 2 (50 %) | 7 (78%) | 9 (82%) | 18 (75%) | |
| Female | 2 (50 %) | 2 (22%) | 2 (18%) | 6 (25%) | |
|
| |||||
| Asbestos exposure | 2 (50%) | 5 (62.5%) | 6 (75%) | 13 (54%) | 0.874 |
|
| |||||
| PFT | |||||
| FVC | 2.1 ± 0.2 | 2.4 ± 0.5 | 2.6 ± 0.8 | 2.4 ± 0.6 | 0.385 |
| %FVC | 60 ± 12 | 59 ± 17 | 60 ± 21 | 60 ± 17 | 0.992 |
| FEV1 | 1.8 ± 0.2 | 1.9 ± 0.4 | 1.9 ± 0.5 | 1.9 ± 0.4 | 0.937 |
| %FEV1 | 69 ± 15 | 62 ± 15 | 57 ± 18 | 61 ± 16 | 0.496 |
| FEV1/FVC | 89 ± 13 | 82 ± 9 | 83 ± 15 | 83 ± 12 | 0.647 |
|
| |||||
| Clinical stage | 0.967 | ||||
| I | 3 (75%) | 7 (78%) | 8 (73%) | 18 (75%) | |
| II | 1 (25%) | 2 (22%) | 3 (27%) | 6 (25%) | |
|
| |||||
| Histology | 0.531 | ||||
| Epithelioid | 3 (75%) | 5 (56%) | 8 (73%) | 16 (67%) | |
| Biphasic | 1 (25%) | 1 (11%) | 2 (18%) | 4 (17%) | |
| Sarcomatoid | 0 | 3 (33%) | 1 (9%) | 4 (17%) | |
|
| |||||
| PD-L1 (%) | 0.313 | ||||
| 0–5% | 3 (75%) | 3 (33%) | 7 (64%) | 13 (54%) | |
| 5–50% | 1 (25%) | 4 (44%) | 1 (9%) | 6 (25%) | |
| 50–100% | 0 (0%) | 2 (23%) | 3 (27%) | 5 (21%) | |
|
| |||||
| SUVmax | 5.3 ± 2.7 | 11.0 ± 8.1 | 5.7 ± 3.1 | 7.8 ± 6.1 | 0.123 |
|
| |||||
| Prior chemotherapy | 2 (50%) | 0 (0%) | 1 (9.1%) | 3 (12.5%) | 1.0* |
|
| |||||
| irAEs (all grades) | - | 7 (78%) | 7 (64%) | 14 (70%) | 0.642* |
|
| |||||
| Interval from ICB to surgery (days) | 25 ± 7 (N=8) | 28 ± 14 (N=9) | 22 ± 14 (N=17) | 0.554* | |
|
| |||||
| Patients undergoing Thoracotomy | |||||
|
| |||||
| Number of patients | 4 | 8 | 9 | 21 | |
|
| |||||
| Procedure | 0.219 | ||||
| EPP | 3 (75%) | 2 (25%) | 1 (11%) | 6 (29%) | |
| P/D | 1 (25%) | 4 (50%) | 5 (56%) | 10 (48%) | |
| Partial P/D | 0 (0%) | 1 (12.5%) | 2 (22%) | 3 (14%) | |
| ET | 1 (12.5%) | 1 (11%) | 2 (9%) | ||
|
| |||||
| Operation time (minutes) | 419± 165 | 362±153 | 347±129 | 367± 141 | 0.720 |
|
| |||||
| Estimate Blood Loss (L) | 0.8 ± 0.6 | 1.6 ± 1.0 | 1.1 ± 0.8 | 1.2 ± 0.9 | 0.399 |
|
| |||||
| Intraoperative transfusion | 4 (100%) | 6 (75%) | 4 (44%) | 14 (67%) | 0.119 |
|
| |||||
| HIOC | 4 (100%) | 4 (50%) | 3 (33.3%) | 11 (52%) | 0.084 |
|
| |||||
| Macroscopic complete resection | 4 (100%) | 6 (75%) | 6 (67%) | 16 (76%) | 0.817 |
|
| |||||
| Length of stay (days) | 13.3 ± 2.1 | 11.4 ± 7.5 | 11.4 ± 6.5 | 11.8 ± 6.1 | 0.873 |
|
| |||||
| Histology | 0.651 | ||||
| Epithelioid | 3 (75%) | 4 (50%) | 6 (67%) | 13 (62%) | |
| Non-epithelioid | 1 (25%) | 4 (50%) | 3 (33%) | 8 (38%) | |
|
| |||||
| Pathologic stage | pstage | ypstage | ypstage | 0.986 | |
| 0 | 0 | 1 (12.5%) | 1 (11.1%) | ||
| I | 4 (100%) | 4 (50%) | 4 (44.5%) | ||
| II | 0 | 0 (0%) | 0 (0%) | ||
| III | 0 | 2 (25%) | 3 (33.3%) | ||
| IV | 0 | 1 (12.5%) | 1 (11.1%) | ||
|
| |||||
| Adjuvant chemotherapy | 2 (50%) | 3 (38%) | 5 (56%) | 10 (48%) | 0.754 |
|
| |||||
| Adjuvant radiotherapy | 1 (25%) | 1 (12.5%) | 0 | 2 (9.5%) | 0.343 |
*
P-values are generated from the comparison of durvalumab to durvalumab + tremelimumab.
EPP, extrapleural pneumonectomy; ET, exploratory thoracotomy; HIOC, heated intraoperative chemotherapy; irAE. immunotherapy-related adverse events; P/D, pleurectomy/decortication; PD-L1, programmed cell death 1 ligand 1; SUVmax, maximum standardized uptake value.