Table 1.
Demographics of enrolled patients*
Patient characteristic | Arm 1 (n = 195) | Arm 2 (n = 195) | Arm 3 (n = 187) | Total (n = 577) |
Age, No. (%) | ||||
<60,y | 82 (42) | 90 (46) | 72 (39) | 244 (42) |
≥60,y | 113 (58) | 105 (54) | 115 (62) | 333 (58) |
Median | 63 | 60 | 63 | 62 |
Range | 33–79 | 33–79 | 35–80 | 33–80 |
Sex, No. (%) | ||||
Men | 122 (63) | 125 (64) | 124 (66) | 371 (64) |
Women | 73 (37) | 70 (36) | 63 (34) | 206 (36) |
KPS, No. (%) | ||||
70–80 | 45 (23) | 47 (24) | 45 (24) | 137 (24) |
90–100 | 150 (77) | 148 (76) | 142 (76) | 440 (76) |
Histology, No. (%) | ||||
Squamous | 75 (38) | 75 (38) | 70 (37) | 220 (38) |
Adenocarcinoma | 53 (27) | 73 (37) | 52 (28) | 178 (31) |
Large Cell | 29 (15) | 27 (14) | 23 (12) | 79 (14) |
Combined | 2 (1) | 2 (1) | 8 (4) | 12 (2) |
Carcinoma NOS | 34 (17) | 18 (9) | 30 (16) | 82 (14) |
Other | 2 (1) | 0 (0) | 4 (2) | 6 (1) |
AJCC stage, No. (%) | ||||
II | 4 (2) | 3 (2) | 4 (2) | 11 (2) |
IIIA | 81 (42) | 84 (43) | 75 (40) | 240 (42) |
IIIB | 110 (56) | 108 (55) | 108 (58) | 326 (57) |
Race, No. (%) | ||||
White | 167 (86) | 171 (88) | 161 (86) | 499 (86) |
Hispanic | 3 (2) | 2 (1) | 2 (1) | 7 (1) |
Black or African American | 20 (10) | 19 (10) | 17 (9) | 56 (10) |
Asian | 3 (2) | 2 (1) | 5 (3) | 10 (2) |
Native American | 0 (0) | 1 (<1) | 1 (<1) | 2 (<1) |
Other | 2 (1) | 0 (0) | 1 (<1) | 3 (1) |
Arm 1 was the sequential arm. Arm 2 used the same chemotherapy regimen as arm 1 with 60 Gy thoracic radiotherapy beginning on day 1. Arm 3 used cisplatin at 50 mg/m2 on days 1, 8, 29, and 36 with oral etoposide at 50 mg twice daily for 10 weeks on days 1, 2, 5, and 6 with 69.6 Gy delivered as 1.2-Gy twice-daily fractions beginning on day 1. AJCC = American Joint Commission on Cancer staging; KPS = Karnofsky performance status; NOS = not otherwise specified.