Table 1. Summary of baseline demographic and disease characteristics.
| Characteristic | Dose-escalation phase (n=45) | Expansion phase (n=25) |
|---|---|---|
| Median age, years (range) | 56 (37–73) | 58 (37–72) |
|
Gender, n (%) | ||
| Male | 26 (58) | 13 (52) |
| ECOG PS, n (%) | ||
| 0 | 14 (31) | 11 (44) |
| 1 | 31 (69) | 14 (56) |
|
Tumour type,
n
(%) | ||
| Colorectal | 9 (20) | — |
| NSCLC | 6 (13) | 18 (72) |
| Ovary | 6 (13) | — |
| Breast | 5 (11) | — |
| Melanoma | 4 (9) | — |
| HNSCC | 3 (7) | — |
| Pancreas | 2 (4) | 7 (28) |
| Endocrine | 2 (4) | — |
| Othera | 8 (18) | — |
|
Lines of previous systemic anticancer therapyb | ||
| 1 | 3 (7) | 2 (8) |
| 2 | 4 (9) | 4 (16) |
| 3 | 4 (9) | 8 (32) |
| At least 4 | 33 (73) | 11 (44) |
|
Afatinib administration,
n
(%) | ||
| Continuous | 26 (58) | 25 (100) |
| Intermittent | 19 (42) | — |
Abbreviations: ECOG PS=Eastern Cooperative Oncology Group performance status; HNSCC=head and neck squamous cell carcinoma; NSCLC=non-small cell lung cancer.
a
Other tumour types include one patient each with soft tissue sarcoma, cancer of unknown primary, biliary tree, bladder, pleura, thyroid, oesophagus and kidney.
b
One patient in the dose-escalation phase did not receive previous systemic therapy.