TABLE 2.
Treatment Summary (n = 88)
| Gemcitabine/ Cisplatin (n = 28) |
Gemcitabine/ Cisplatin + Cetuximab (n = 60) |
|
|---|---|---|
| Eligible, n | 28 | 60 |
| Toxicity evaluable, n | 28 | 59a |
| Efficacy evaluable, n | 28 | 57b |
| Number of chemotherapy cycles, n (%)c | ||
| <4 | 4 (14) | 15 (25) |
| 4 | 3 (11) | 13 (22) |
| 5 | 1 (4) | 3 (5) |
| 6 | 20 (71) | 28 (47) |
| Dose intensity per cycle, mg/m2d | ||
| Gemcitabine | 2267 ± 459.8 | 2066 ± 602.5 |
| Cisplatin | 65 ± 8.1 | 65 ± 10.8 |
| Patients on cetuximab maintenance, n (%) | 26 (44) | |
| Cycles, ne | NA | 3 (1–36) |
| Patients crossed over to cetuximab, n | 1f | — |
| Patients off therapy because of toxicity/change in condition at any time during study, n (%) | 3 (10.7) | 10 (16.9) |
Abbreviation: NA, not applicable.
a
One patient withdrew consent before treatment was started.
b
Two patients withdrew consent before they had completed 4 weeks of therapy.
c
There were 87 evaluable patients.
d
The data are presented as means and standard deviations.
e
The data are presented as medians and ranges.
f
Thirty-two cycles of cetuximab.