Table 2. Adverse events.
| Toxicity | G1 | G2 | G3 | G4 | All grades | G ≥ 3 | AE, G ≥ 3 in the R-CHOP arm from other trials | |||
|---|---|---|---|---|---|---|---|---|---|---|
| LNH03-6B (n = 295) [16] | CRUKE/03/019 (n = 534) [17] | LYM-2034 (n = 79) [15] | SWOG 0014 (n = 60) [1] | |||||||
| All toxicity | 8 (36.4%) | NA | 380 (71%) | 70 (89%) | 54 (90%) | |||||
| Hematologic | ||||||||||
| Leukopenia | 0 | 5 | 1 | 4 | 10 (45.5%) | 5 (22.7%) | NA | NA | 18 (23%) | NA |
| Neutropenia | 0 | 3 | 1 | 7 | 11 (50.0%) | 8 (36.4%) | 189 (64%) | 318 (60%) | 64 (81%) | 39 (65%) |
| Anemia | 4 | 5 | 0 | 0 | 9 (40.9%) | 0 | 51 (17%) | NA | 7 (9%) | 1 (2%) |
| Thrombocytopenia | 1 | 1 | 0 | 0 | 2 (9.1%) | 0 | 58 (20%) | 28 (5%) | 2 (3%) | 2 (3%) |
| Febrile neutropenia | 0 | 0 | 3 | 0 | 3 (13.6%) | 3 (13.6%) | 54 (18%) | 58 (11%) | 16 (20%) | 9 (15%) |
| Non-hematologic | ||||||||||
| Infection | ||||||||||
| (no neutropenia) | 3 | 0 | 0 | 0 | 3 (13.6%) | 0 | 13 (4%) | 125 (23%) | 4 (5%)* | 16 (27%) |
| Nausea | 1 | 0 | 0 | 0 | 1 (4.5%) | 0 | 3 (1%)† | 20 (4%) | NA | 17% |
| (all GI AE) | ||||||||||
| Vomiting | 0 | 0 | 0 | 0 | 0 | 0 | 17 (3%) | 1 (1%) | ||
| Diarrhea | 0 | 1 | 0 | 0 | 1 (4.5%) | 0 | 6 (2%) | NA | 1 (1%) | |
| Anorexia | 6 | 1 | 0 | 0 | 7 (31.8%) | 0 | NA | NA | NA | |
| Abdominal pain | 2 | 2 | 0 | 0 | 4 (18.2%) | 0 | NA | NA | NA | |
| Constipation | 2 | 0 | 0 | 0 | 2 (9.1%) | 0 | NA | NA | NA | |
| Mucositis | 0 | 0 | 0 | 0 | 0 | 0 | 10 (3%) | 10 (2%) | NA | NA |
| Fatigue | 2 | 1 | 0 | 0 | 3 (13.6%) | 0 | NA | NA | NA | NA |
| Cardiovascular | 0 | 0 | 0 | 0 | 0 | 0 | 25 (8%) | 2 (< 1%) | 1%‡ (n = 1) | 5 (8%) |
| Sensory neuropathy | 2 | 0 | 0 | 0 | 2 (9.1%) | 0 | 16 (5%) | 38 (7%) | 2 (3%) | 1 (2%) |
| Allergic reaction | 1 | 0 | 0 | 0 | 1 (4.5%) | 0 | 0 (0%) | NA | NA | NA |
| Skin rash | 1 | 1 | 0 | 0 | 2 (9.1%) | 0 | 1 (< 1%) | NA | NA | 1 (2%) |
| Treatment-related mortality | 0 | 14 (5%) | 3 (1%) | 3 (4%) | 1 (2%) | |||||
Abbreviation: AE, adverse events; G, grade; GI, gastrointestinal; NA, not available
SWOG 0014 was a single arm study of 3 cycles of R-CHOP and radiotherapy.
*pneumonia
†Nausea or vomiting
‡One on-study cardiac arrest