Table 1. Patient characteristics.
|
Phase I
|
||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Phase II | |
| N | 3 | 7 | 3 | 35 |
| Median age (range) | 65 (65–73) | 67 (46–69) | 66 (53–69) | 65 (41–75) |
| Male/female | 1/2 | 5/2 | 2/1 | 26/8 |
| Stage IIIb/IV/recurrence | 0/0/3 | 0/1/6 | 0/1/2 | 0/26/8 |
| ECOG PS 0/1 | 3/0 | 7/0 | 2/1 | 28/6 |
| Histology, adeno/squamous/other | 2/1/0 | 7/0/0 | 3/0/0 | 27/5/2 |
| EGFR mutation, positive/negative/unknown | 0/0/3 | 1/2/4 | 2/1/0 | 4/14/16 |
| Prior chemotherapy regimen, 1/2/3a | 3/0/0 | 3/4/0 | 1/1/1 | 22/8/4 |
| Median no. of course (range) | 6 (2–18) | 4 (1–24) | 5 (5–12) | 6 (2–18) |
Abbreviations: ECOG PS=Eastern Cooperative Oncology Group performance status; EGFR=epidermal growth factor receptor; TKI=tyrosine kinase inhibitor.
In the phase I portion, the dose of S-1 (80 mg m−2 per day) was fixed at a dose of 80 mg m−2 per day for 7 consecutive days, and doses of docetaxel were escalated to be 30 mg m−2 in level 1, 35 mg m−2 in level 2, and 40 mg m−2 in level 3 on days 1 and 15. The treatment was repeated every 2 weeks.
a
The number of prior chemotherapy regimens contains EGFR–TKI treatment.