Table 4.
Radiological response assessment by central review (for patients without treatment changes and with available MRI scans): best response
| All patients | Group 1 ICI alone |
Group 2 SRT without or with non-ICI pharmacotherapy |
Group 3 ICI plus SRT |
|
| Best MRI response for SRT targets in groups 2 and 3 | (n=40)* | (n=15)* | (n=25)* | |
| Local assessment (n=52)† | ||||
| PD | 10 (19) | n.a. | 4 (20) | 6 (19) |
| SD | 20 (38) | 7 (35) | 13 (41) | |
| PR/CR | 18 (35) | 8 (40) | 10 (31) | |
| Data unavailable | 4 (8) | 1 (5) | 3 (9) | |
| RECIST V.1.1 (MRI only) (n=40) | ||||
| PD | 7 (17) | n.a. | 3 (20) | 4 (16) |
| SD | 8 (20) | 2 (13) | 6 (24) | |
| PR | 7 (17) | 4 (27) | 3 (12) | |
| CR | 6 (15) | 0 | 6 (24) | |
| Data unavailable | 12 (30) | 6 (40) | 6 (24) | |
| RANO (MRI, clinical, steroids) (n=40) | ||||
| PD | 9 (2) | n.a. | 4 (27) | 5 (20) |
| SD | 6 (15) | 2 (13) | 4 (16) | |
| PR | 7 (16) | 4 (27) | 3 (12) | |
| CR | 6 (15) | 0 | 6 (24) | |
| Data unavailable | 12 (30) | 5 (33) | 7 (28) | |
| iRANO (considering MRI only) (n=40) | ||||
| PD | 0 | n.a. | 0 | 0 |
| SD | 15 (37) | 6 (40) | 9 (36) | |
| PR | 8 (20) | 5 (33) | 3 (12) | |
| CR | 6 (15) | 0 | 6 (24) | |
| Data unavailable | 11 (27) | 4 (27) | 7 (28) | |
| iRANO (MRI, clinical, steroids) (n=40) | ||||
| PD | 3 (7) | n.a. | 2 (10) | 1 (4) |
| SD | 14 (35) | 5 (33) | 8 (32) | |
| PR | 7 (17) | 4 (27) | 3 (12) | |
| CR | 6 (15) | 0 | 6 (24) | |
| Data unavailable | 11 (27) | 4 (27) | 7 (28) | |
| Best MRI response for overall brain | (n=43) | (n=3) | (n=15) | (n=25) |
| Local assessment (n=62)† | ||||
| PD | 24 (39) | 6 (60) | 8 (40) | 10 (31) |
| SD | 15 (24) | 2 (20) | 4 (20) | 9 (28) |
| PR/CR | 19 (31) | 0 | 7 (35) | 12 (37) |
| Data unavailable | 4 (6) | 2 (20) | 1 (5) | 1 (3) |
| RECIST V.1.1 (MRI only) (n=43) | ||||
| PD | 13 (30) | 2 (66) | 5 (33) | 6 (24) |
| SD | 9 (21) | 0 | 3 (20) | 6 (24) |
| PR | 7 (16) | 0 | 4 (27) | 3 (12) |
| CR | 6 (14) | 0 | 0 | 6 (24) |
| Data incomplete | 8 (19) | 1 (33) | 3 (20) | 4 (16) |
| RANO (MRI, clinical, steroids) (n=43) | ||||
| PD | 13 (30) | 2 (67) | 5 (33) | 6 (24) |
| SD | 9 (1) | 0 | 3 (20) | 6 (24) |
| PR | 7 (16) | 0 | 4 (27) | 3 (12) |
| CR | 6 (14) | 0 | 0 (0) | 6 (24) |
| Data unavailable | 8 (19) | 1 (33) | 3 (20) | 4 (16) |
| iRANO (considering MRI only) (n=43) | ||||
| PD | 8 (13) | 2 (67) | 3 (20) | 3 (12) |
| SD | 13 (21) | 0 | 4 (27) | 9 (36) |
| PR | 8 (13) | 0 | 5 (33) | 3 (12) |
| CR | 6 (10) | 0 | 0 | 6 (24) |
| Data unavailable | 8 (19) | 1 (33) | 3 (20) | 4 (16) |
| iRANO (MRI, clinical, steroids) (n=43) | ||||
| PD | 8 (13) | 2 (67) | 3 (20) | 3 (12) |
| SD | 13 (30) | 0 | 4 (27) | 9 (36) |
| PR | 8 (19) | 0 | 5 (33) | 3 (12) |
| CR | 6 (14) | 0 | 0 | 6 (24) |
| Data unavailable | 8 (19) | 1 (33) | 3 (20) | 4 (16) |
| Pseudoprogression and radionecrosis | (n=43) | (n=0) | (n=15) | (n=25) |
| Pseudoprogression (n, %) | 7 (16) | 0 | 3 (20) | 4 (16) |
| Detected first on MRI at | ||||
| 3 months | 4 (57) | 0 | 3 (100) | 1 (25) |
| 6 months | 3 (43) | 0 | 0 | 3 (75) |
| 9 months | 0 | 0 | 0 | 0 |
| 12 months | 0 | 0 | 0 | 0 |
| Radionecrosis (n, %) | 7 (16) | 0 | 2 (13) | 5 (20) |
| Detected first on MRI at | ||||
| 3 months | 6 (86) | 0 | 1 (50) | 5 (100) |
| 6 months | 1 (14) | 0 | 1 (50) | 0 (0) |
| 9 months | 0 | 0 | 0 (0) | 0 (0) |
| 12 months | 0 | 0 | 0 (0) | 0 (0) |
*Number of MRI scans available for central review.
†Number of patients evaluated locally.
CR, complete response; ICI, immune checkpoint inhibition; iRANO, immunotherapy response assessment in neuro-oncology; n, number of patients; PD, progressive disease; PR, partial response; RANO, Response assessment in neuro-oncology; RECIST, Response Evaluation Criteria in Solid Tumours; SD, stable disease; SRT, stereotactic radiotherapy