Table 1.
Baseline characteristics of intention-to-treat population
| Characteristics | Cilengitide 240 mg/m2 n = 35 | Cilengitide 400 mg/m2 n = 35 | Cilengitide 600 mg/m2 n = 36 | Docetaxel 75 mg/m2 n = 34 | Total n = 140 |
|---|---|---|---|---|---|
| Male/female, n (%) | 25/10 (71/29) | 25/10 (71/29) | 22/14 (61/39) | 22/12 (65/35) | 94/46 (67/33) |
| Mean age (range), yrs | 62.5 (45.0–80.0) | 57.8 (33.0–77.0) | 59.3 (41.0–76.0) | 61.2 (42.0–79.0) | 60.2 (33.0–80.0) |
| Karnofsky PS n (%) | |||||
| 100 % | 4 (11) | 5 (14) | 5 (14) | 5 (15) | 19 (14) |
| 90 % | 8 (23) | 14 (40) | 12 (33) | 10 (29) | 44 (31) |
| 80 % | 17 (49) | 12 (34) | 12 (33) | 12 (35) | 53 (38) |
| 70 % | 6 (17) | 4 (11) | 7 (19) | 7 (21) | 24 (17) |
| Tumor stage, n (%) | |||||
| IIIB | 1 (3) | 2 (6) | 0 | 3 (9) | 6 (4) |
| IV | 34 (97) | 33 (94) | 36 (100) | 31 (91) | 134 (96) |
| Histologya, n (%) | |||||
| Adenocarcinoma | 14 (40) | 12 (34) | 12 (33) | 9 (26) | 47 (34) |
| Squamous | 2 (6) | 4 (12) | 4 (12) | 8 (24) | 18 (13) |
| Other | 4 (11) | 2 (6) | 2 (6) | 2 (6) | 10 (7) |
| Unknown | 15 (43) | 17 (49) | 18 (50) | 15 (44) | 65 (46) |
| Prior chemotherapy, n (%) | |||||
| Platinum based | 25 (71) | 25 (71) | 28 (78) | 23 (68) | 101 (72) |
| Non-platinum | 10 (29) | 10 (29) | 8 (22) | 11 (32) | 39 (28) |
| Prior radiation, n (%) | 12 (34) | 12 (34) | 11 (31) | 15 (44) | 50 (36) |
| Tumor-related surgery, n (%) | 6 (17) | 8 (23) | 14 (39) | 12 (35) | 40 (29) |
aGiven the date of the study, histology was not performed as rigorously as would be the case in current trials
Karnofsky PS, Karnofsky performance status