Table 2.
Short-term toxicity in the SIOPEL-4 trial
|
Reported toxicity in cycles A1–A3 |
Number of patients with reported toxicity in cycle B | Number of patients with reported toxicity in cycle C | ||
|---|---|---|---|---|
| Number of patients | Number of cycles | |||
| Haemoglobin | ||||
| Grade 1 | 6 (10%) | 8 (4%) | .. | 1 (3%) |
| Grade 2 | 27 (44%) | 40 (22%) | 3 (23%) | 7 (19%) |
| Grade 3 | 53 (85%) | 105 (58%) | 7 (54%) | 18 (49%) |
| Grade 4 | 11 (18%) | 12 (7%) | 2 (15%) | 6 (16%) |
| Neutrophils | ||||
| Grade 1 | 2 (3%) | 3 (2%) | .. | 1 (3%) |
| Grade 2 | 6 (10%) | 7 (4%) | .. | 2 (5%) |
| Grade 3 | 20 (32%) | 27 (15%) | .. | 5 (14%) |
| Grade 4 | 53 (85%) | 105 (58%) | 12 (92%) | 25 (68%) |
| Platelets | ||||
| Grade 1 | 21 (34%) | 25 (14%) | 1 (8%) | 3 (8%) |
| Grade 2 | 9 (15%) | 9 (5%) | .. | 2 (5%) |
| Grade 3 | 29 (47%) | 38 (21%) | 2 (15%) | 6 (16%) |
| Grade 4 | 39 (63%) | 66 (36%) | 9 (69%) | 19 (51%) |
| Febrile neutropenia | ||||
| Grade 1 | 1 (2%) | 1 (1%) | .. | 1 (3%) |
| Grade 2 | 2 (3%) | 4 (2%) | .. | 1 (3%) |
| Grade 3 | 41 (66%) | 7 (4%) | 8 (62%) | 16 (43%) |
| Grade 4 | 3 (5%) | 3 (2%) | .. | 2 (5%) |
| Infection (documented) | ||||
| Grade 2 | 7 (11%) | 8 (4%) | 1 (8%) | .. |
| Grade 3 | 17 (27%) | 18 (10%) | 2 (15%) | 5 (14%) |
| Grade 4 | .. | .. | .. | 1 (3%) |
| Fever | ||||
| Grade 1 | 15 (24%) | 19 (10%) | 1 (8%) | 3 (8%) |
| Grade 2 | 13 (21%) | 15 (8%) | 1 (8%) | 1 (3%) |
| Grade 3 | 2 (3%) | 3 (2%) | .. | .. |
| Vomiting | ||||
| Grade 1 | 20 (32%) | 21 (12%) | 1 (8%) | 3 (8%) |
| Grade 2 | 29 (47%) | 46 (25%) | 1 (8%) | 5 (14%) |
| Grade 3 | 4 (6%) | 4 (2%) | .. | 1 (3%) |
| Anorexia | ||||
| Grade 1 | 11 (18%) | 12 (7%) | 2 (15%) | 3 (8%) |
| Grade 2 | 10 (16%) | 12 (7%) | 2 (15%) | 3 (8%) |
| Grade 3 | 22 (35%) | 36 (20%) | 2 (15%) | 5 (14%) |
| Mucositis | ||||
| Grade 1 | 13 (21%) | 16 (9%) | 1 (8%) | 3 (8%) |
| Grade 2 | 7 (11%) | 9 (5%) | 3 (23%) | 1 (3%) |
| Grade 3 | 7 (11%) | 11 (6%) | 1 (8%) | .. |
| Diarrhoea | ||||
| Grade 3 | 2 (3%) | 2 (1%) | .. | 2 (5%) |
| Hypertension | ||||
| Grade 4 | 1 (2%) | 1 (1%) | .. | .. |
| Haemorrhage or bleeding | ||||
| Grade 4 | 1 (2%) | 1 (1%) | 1 (8%) | .. |
| Allergy | ||||
| Grade 3 | 1 (2%) | 1 (1%) | .. | .. |
| Left ventricular systolic dysfunction | ||||
| Grade 3 | 1 (2%) | 1 (1%) | .. | .. |
| Glomerular filtration rate | ||||
| Grade 1 | 7 (11%) | 7 (4%) | .. | 3 (8%) |
| Grade 2 | 2 (3%) | 2 (1%) | 1 (8%) | 2 (5%) |
| Grade 3 | 1 (2%) | 1 (1%) | ||
| Aspartate aminotransferase | ||||
| Grade 1 | 31 (50%) | 47 (26%) | 3 (23%) | 9 (24%) |
| Grade 2 | 13 (21%) | 13 (7%) | .. | 2 (5%) |
| Grade 3 | 7 (11%) | 7 (4%) | .. | 2 (5%) |
| Grade 4 | 1 (2%) | 1 (1%) | ||
| Alanine aminotransferase | ||||
| Grade 1 | 25 (40%) | 36 (20%) | 2 (15%) | 7 (19%) |
| Grade 2 | 6 (10%) | 6 (3%) | 1 (8%) | 2 (5%) |
| Grade 3 | 5 (8%) | 5 (3%) | .. | 3 (8%) |
| Grade 4 | .. | 1 (3%) | ||
| Hypomagnesaemia | ||||
| Grade 1 | 23 (37%) | 34 (19%) | 2 (15%) | 5 (14%) |
| Grade 2 | 10 (16%) | 16 (9%) | .. | 1 (3%) |
| Grade 3 | 4 (6%) | 4 (2%) | .. | 1 (3%) |
| Hypophosphataemia | ||||
| Grade 3 | 2 (3%) | 2 (1%) | .. | .. |
| Grade 4 | 1 (2%) | |||
| Hypokalaemia | ||||
| Grade 4 | 1 (2%) | .. | .. | .. |
| Hyperbilirubinaemia | ||||
| Grade 1 | 11 (18%) | 11 (6%) | .. | 2 (5%) |
| Grade 2 | 2 (3%) | 2 (1%) | .. | 2 (5%) |
| Grade 3 | 3 (5%) | 3 (2%) | .. | .. |
Data are n (%). Cycles A1–A3 were given to 62 patients (in total 182 cycles), additional preoperative chemotherapy (cycle B) to 13 patients, and postoperative chemotherapy (cycle C) to 37 patients.