Table 2.
Summary of AEs
| Regimen M Afatinib (20 mg) + TMZ + RT N = 7 | Regimen M Afatinib (30 mg) + TMZ + RT N = 6 | Regimen M Afatinib (40 mg) + TMZ + RT N = 7 | Regimen M Afatinib (total) + TMZ + RT N = 20 | |
|---|---|---|---|---|
| Any AE, n (%) | 7 (100) | 6 (100) | 7 (100) | 20 (100) |
| DLTsa, n (%) | 4 (57) | 1 (17) | 3 (43) | 8 (40) |
| Treatment-related AEs, n (%) | 7 (100) | 6 (100) | 6 (86) | 19 (95) |
| AEs leading to discontinuation of afatinib, n (%) | 4 (57) | 0 | 5 (71) | 9 (45) |
| AEs leading to discontinuation of TMZ, n (%) | 1 (14) | 0 | 2 (29) | 3 (15) |
| SAEsb, n (%) | 4 (57) | 5 (83) | 3 (43) | 12 (60) |
| Maximum CTCAE grade, n (%) | ||||
| Grade 1 | 0 | 0 | 1 (14) | 1 (5) |
| Grade 2 | 0 | 2 (33) | 1 (14) | 3 (15) |
| Grade 3 | 4 (57) | 4 (67) | 4 (57) | 12 (60) |
| Grade 4 | 3 (43) | 0 | 1 (14) | 4 (20) |
| Grade 5 | 0 | 0 | 0 | 0 |
| Regimen U afatinib (20 mg) + RT N = 3 | Regimen U afatinib (40 mg) + RT N = 13 | Regimen U afatinib (total) + RT N = 16 | |
|---|---|---|---|
| Any AE, n (%) | 3 (100) | 13 (100) | 16 (100) |
| DLTsa, n (%) | 2 (67) | 4 (31) | 6 (38) |
| Treatment-related AEs, n (%) | 3 (100) | 12 (92) | 15 (94) |
| AEs, regardless of causality, leading to discontinuation of afatinib, n (%) | 1 (33) | 9 (69) | 10 (63) |
| SAEsb, n (%) | 2 (67) | 10 (77) | 12 (75) |
| Maximum CTCAE grade, n (%) | |||
| Grade 1 | 0 | 1 (8) | 1 (6) |
| Grade 2 | 1 (33) | 2 (15) | 3 (19) |
| Grade 3 | 2 (67) | 5 (38) | 7 (44) |
| Grade 4 | 0 | 2 (15) | 2 (13) |
| Grade 5 | 0 | 3 (23) | 3 (19) |
AE adverse event, CTCAE Common Terminology Criteria for Adverse Events, DLT dose-limiting toxicity, RT radiotherapy, SAE serious adverse event, TMZ temozolomide
aDLTs occurring in the overall treatment period, as determined by the investigator
bA patient may have experienced more than one SAE