Table 2.
Staging data with comparison between TLPLDC versus placebo in the ITT and PT cohorts
| Category | ITT analysis | PT analysis | ||||
|---|---|---|---|---|---|---|
| TLPLDC | Placebo | p value | TLPLDC | Placebo | p value | |
| AJCC 7th edition overall stage | ||||||
| III | 80 (77.7) | 32 (78.0) | 0.961 | 52 (78.8) | 26 (81.3) | 0.777 |
| IV | 23 (22.3) | 9 (22.0) | 14 (21.2) | 6 (18.8) | ||
| AJCC 7th edition stage | ||||||
| IIIa | 9 (8.7) | 5 (12.2) | 0.013 | 6 (9.1) | 2 (6.2) | 0.211 |
| IIIb | 24 (23.3) | 19 (46.3) | 19 (28.8) | 16 (50.0) | ||
| IIIc | 47 (45.6) | 8 (19.5) | 27 (40.9) | 8 (25.0) | ||
| IV | 23 (22.3) | 9 (22.0) | 14 (21.2) | 6 (18.8) | ||
| T stage | ||||||
| T0 | 2 (1.9) | 0 (0) | 0.346 | 1 (1.5) | 0 (0) | 0.636 |
| Tis | 1 (1.0) | 0 (0) | 0 (0) | 0 (0) | ||
| T1 | 7 (6.8) | 7 (17.1) | 4 (6.1) | 4 (12.5) | ||
| T2 | 21 (20.4) | 4 (9.8) | 16 (24.2) | 3 (9.4) | ||
| T3 | 22 (21.4) | 8 (19.5) | 14 (21.2) | 7 (21.9) | ||
| T4 | 24 (23.3) | 7 (17.1) | 15 (22.7) | 7 (21.9) | ||
| TX | 11 (10.7) | 7 (17.1) | 7 (10.6) | 4 (12.5) | ||
| Unavailable | 15 (14.6) | 8 (19.5) | 9 (13.6) | 7 (21.9) | ||
| N stage | ||||||
| N1 | 18 (17.5) | 14 (34.1) | 0.168 | 13 (19.7) | 9 (28.1) | 0.595 |
| N2 | 26 (25.2) | 9 (22.0) | 17 (25.8) | 8 (25.0) | ||
| N3 | 32 (31.1) | 7 (17.1) | 22 (33.3) | 6 (18.8) | ||
| Unavailable | 27 (26.2) | 11 (26.8) | 14 (21.2) | 9 (28.1) | ||
| M stage | ||||||
| M0 | 75 (72.8) | 27 (65.9) | 0.868 | 48 (72.7) | 22 (68.8) | 0.714 |
| M1a | 5 (4.9) | 3 (7.3) | 3 (4.5) | 2 (6.3) | ||
| M1b | 4 (3.9) | 1 (2.4) | 3 (4.5) | 0 (0) | ||
| M1c | 5 (4.9) | 3 (7.3) | 3 (4.5) | 2 (6.3) | ||
| Unavailable | 14 (13.6) | 7 (17.1) | 9 (13.6) | 6 (18.8) | ||
Data are expressed as n (%)
TLPLDC tumor lysate, particle-loaded, dendritic cell, ITT intention-to-treat, PT per treatment, AJCC American Joint Committee on Cancer