Table 2:
PHASE III | PHASE II/III | |||||
---|---|---|---|---|---|---|
|
||||||
IMRT (n=13) | PET-BMS-IMRT (n=16) | P | IMRT (n=55) | PET-BMS-IMRT (n=46) | P | |
TOXICITY | ||||||
Neutropenia | ||||||
Grade ≥ 2 | 9 (69%) | 8 (50%) | 0.30 | 31 (56%) | 22 (48%) | 0.39 |
Grade ≥ 3 | 7 (54%) | 3 (19%) | 0.048* | 19 (35%) | 6 (13%) | 0.01* |
Lymphopenia | ||||||
Grade ≥ 2 | 4 (31%) | 5 (31%) | 0.98 | 17 (31%) | 16 (35%) | 0.68 |
Grade ≥ 3 | 1 (8%) | 1 (6%) | 0.88 | 6 (11%) | 4 (9%) | 0.75 |
Thrombocytopenia | ||||||
Grade ≥ 2 | 1 (8%) | 2 (13%) | 0.36 | 6 (11%) | 7 (15%) | 0.56 |
Grade ≥ 3 | 0 (0%) | 1 (6%) | 0.67 | 4 (7%) | 1 (2%) | 0.37 |
Anemia | ||||||
Grade ≥ 2 | 6 (46%) | 10 (63%) | 0.38 | 23 (42%) | 21 (46%) | 0.70 |
Grade ≥ 3 | 1 (8%) | 3 (19%) | 0.39 | 1 (2%) | 3 (7%) | 0.33 |
Leukopenia | ||||||
Grade ≥ 2 | 8 (62%) | 12 (75%) | 0.44 | 41 (75%) | 31 (67%) | 0.43 |
Grade ≥ 3 | 5 (38%) | 7 (44%) | 0.77 | 21 (38%) | 14 (30%) | 0.42 |
Any Hematologic Toxicity | ||||||
Grade ≥ 2 | 10 (77%) | 14 (88%) | 0.45 | 47 (85%) | 38 (83%) | 0.70 |
Grade ≥ 3 | 7 (54%) | 9 (56%) | 0.90 | 25 (45%) | 17 (37%) | 0.39 |
Gastrointestinal Toxicity | ||||||
Grade ≥ 2 | 3 (23%) | 2 (13%) | 0.44 | 17 (31%) | 17 (37%) | 0.51 |
Grade ≥ 3 | 0 (0%) | 0 (0%) | - | 1 (2%) | 2 (4%) | 0.59 |
Variable was unbalanced (P<.05) between groups.