Table 1. Baseline Demographics and Disease Characteristics.
Characteristic | No. (%) | |
---|---|---|
Chemotherapy plus radiotherapy (n=63) | Chemotherapy alone (n=63) | |
Sex | ||
Female | 10 (15.9) | 11 (17.5) |
Male | 53 (84.1) | 52 (82.5) |
Age, median (IQR), y | 46.0 (37.0-52.0) | 47.0 (39.0-52.0) |
Karnofsky performance status score | ||
90-100 | 58 (92.1) | 57 (90.5) |
70-80 | 5 (7.9) | 6 (9.5) |
Smoking status | ||
Smokers | 22 (34.9) | 20 (31.7) |
Nonsmokers | 41 (65.1) | 43 (68.3) |
Histologic findings | ||
Nonkeratinizing undifferentiated (type III) | 60 (95.2) | 61 (96.8) |
Nonkeratinizing differentiated (type II) | 2 (3.2) | 1 (1.6) |
Keratinizing (type I) | 1 (1.6) | 1 (1.6) |
T classification | ||
T1-T2 | 7 (11.1) | 8 (12.7) |
T3-T4 | 56 (88.9) | 55 (87.3) |
N classification | ||
N0-N1 | 14 (22.2) | 11 (17.5) |
N2-N3 | 49 (77.8) | 52 (82.5) |
Bone metastases | ||
No | 19 (30.2) | 16 (25.4) |
Yes | 44 (69.8) | 47 (74.6) |
Liver metastases | ||
No | 45 (71.4) | 44 (69.8) |
Yes | 18 (28.6) | 19 (30.2) |
Lung metastases | ||
No | 45 (71.4) | 46 (73.0) |
Yes | 18 (28.6) | 17 (27.0) |
Treatment responsea | ||
Complete | 3 (4.8) | 4 (6.3) |
Partial | 60 (90.4) | 59 (93.7) |
Metastatic lesionsa | ||
1-2 | 19 (30.1) | 20 (31.7) |
≥3 | 44 (69.8) | 43 (68.3) |
Abbreviation: IQR, interquartile range.
Treatment response and number of metastatic lesions were evaluated after 3 cycles of chemotherapy (at randomization), whereas remaining other clinical characteristics were evaluated before chemotherapy.