Table 1:
Patient characteristics
| Phase I (n = 21) | Phase II (n=31) |
|||
|---|---|---|---|---|
| All Phase II Patients (N = 31) | CRT+ Veliparib (N=18) | CRT + Placebo (N=13) | ||
|
| ||||
| Age, median (range) | 70 (53 – 81) | 64.7(47.0–78.9) | 65.0(56.6–75.6) | |
|
| ||||
| Sex | ||||
| Male | 14 (67%) | 14(45%) | 7(39%) | 7(54%) |
| Female | 7 (33%) | 17(55%) | 11(61%) | 6(46%) |
|
| ||||
| Zubrod PS | ||||
| 0 | 11 (52%) | 10(32%) | 7(39%) | 3(23%) |
| 1 | 10 (48%) | 21(68%) | 11(61%) | 10(77%) |
|
| ||||
| Race | ||||
| White | 18 (86%) | 25(81%) | 13(72%) | 12(92%) |
| African American | 1 (5%) | 3(10%) | 2(11%) | 1(8%) |
| Asian | 1 (5%) | 2(6%) | 2(11%) | 0(0%) |
| Unknown | 1 (5%) | 1(3%) | 1(6%) | 0(0%) |
|
| ||||
| Stage | ||||
| IIIA | 16 (76%) | 12(39%) | 7(39%) | 5(38%) |
| IIIB | 5 (24%) | 19(61%) | 11(61%) | 8(62%) |
|
| ||||
| Histology | ||||
| Squamous cell | 8 (38%) | 15(48%) | 10(56%) | 5(38%) |
| Adenocarcinoma | 12 (57%) | 16(52%) | 8(44%) | 8(62%) |
| Other | 1(4.8%) | 0 | 0 | 0 |
|
| ||||
| Baseline LDH | ||||
| Normal | 15 (71%) | 25(81%) | 16(89%) | 9(69%) |
| Elevated | 3 (14%) | 5(16%) | 2(11%) | 3(23%) |
| Not reported | 3 (14%) | 1(3%) | 0(0%) | 1(8%) |
|
| ||||
| Smoking status | ||||
| Current smoker | 4 (19%) | 14(45%) | 8(44%) | 6(46%) |
| Former smoker Never | 13 (62%) | 16(52%) | 9(50%) | 7(54%) |
| smoker | 4 (19%) | 1(3%) | 1(6%) | 0(0%) |
|
| ||||
| Weight loss past 6 months | ||||
| < 5% | 15 (71%) | 24(71%) | 14(78%) | 8(62%) |
| 5–10% | 6 (29%) | 9(29%) | 4(22%) | 5(38%) |
PS, performance status; LDH, lactate dehydrogenase; CRT, concurrent chemoradiotherapy