Table 3.
Adverse events during chemotherapy and postoperative complications
| PeriOpCT group | Surgery group | ||
|---|---|---|---|
| Tolerance to preoperative chemotherapy (N=171) | |||
| Allergy grade 3* | 1 (1%) | .. | |
| Diarrhoea grade 3* | 14 (8%) | .. | |
| Nausea grade 3* | 6 (4%) | .. | |
| Vomiting | |||
| Grade 3 | 4 (3%) | .. | |
| Grade 4 | 1 (1%) | .. | |
| Stomatitis/pharyngitis grade 3* | 11 (7%) | .. | |
| Hand-foot skin syndrome grade 3* | 0 | .. | |
| Sensory neuropathy grade 3* | 4 (2%) | .. | |
| Cholinergic syndrome grade 3* | 1 (1%) | .. | |
| Dysaesthesia grade 3* | 4 (2%) | .. | |
| Other neurological toxicity grade 3* | 10 (6%) | .. | |
| Hepatic grade 3* | 5 (3%) | .. | |
| Cardiovascular grade 3* | 4 (2%) | .. | |
| Febrile neutropenia | |||
| Grade 3 | 1 (1%) | .. | |
| Grade 4 | 1 (1%) | .. | |
| Infection grade 3* | 5 (3%) | .. | |
| Catheter-related infection grade 3* | 0 | .. | |
| Leucopenia | |||
| Grade 3 | 9 (5%) | .. | |
| Grade 4 | 1 (1%) | .. | |
| Neutropenia | |||
| Grade 3 | 19 (11%) | .. | |
| Grade 4 | 12 (7%) | .. | |
| Thrombocytopenia grade 3* | 2 (1%) | ||
| Haemoglobin grade 3* | 1 (1%) | .. | |
| Postoperative complications | |||
| Number in group | 159 | 170 | |
| Reversible postoperative complications† | 40 (25%) | 27 (16%) | |
| Cardio-pulmonary failure | 3 (2%) | 2 (1%) | |
| Bleeding | 3 (2%) | 3 (2%) | |
| Biliary fistula | 13 (8%) | 7 (4%) | |
| Output >100 mL/day for >10 days | 9 (6%) | 2 (1%) | |
| Hepatic failure | 11 (7%) | 8 (5%) | |
| Bilirubin >100 mg/day for >3 days | 10 (6%) | 5 (3%) | |
| Wound infection | 5 (3%) | 4 (2%) | |
| Intra-abdominal infection | 11 (7%) | 4 (2%) | |
| Need for reoperation | 5 (3%) | 3 (2%) | |
| Urinary infection | 4 (3%) | 0 | |
| Pleural effusion | 3 (2%) | 1 (1%) | |
| Pulmonary embolism/deep-venous thrombosis | 2 (1%) | 1 (1%) | |
| Pneumopathy | 2 (1%) | 0 | |
| Neutropenia | 2 (1%) | 0 | |
| Ascites | 1 (1%) | 1 (1%) | |
| Ileus | 2 (1%) | 1 (1%) | |
| Cardiac arrhythmia | 0 | 1 (1%) | |
| Renal failure | 0 | 1 (1%) | |
| Other | 4 (3%) | 4 (2%) | |
| Postoperative death | 1 (1%) | 2 (1%) | |
| Tolerance to postoperative chemotherapy (N=115) | |||
| Allergy | |||
| Grade 3 | 4 (4%) | .. | |
| Grade 4 | 1 (1%) | .. | |
| Diarrhoea grade 3* | 6 (5%) | .. | |
| Nausea grade 3* | 5 (4%) | .. | |
| Vomiting grade 3* | 3 (3%) | .. | |
| Stomatitis/pharyngitis grade 3* | 0 | .. | |
| Hand-foot skin syndrom grade 3* | 1 (1%) | .. | |
| Sensory neuropathy grade 3* | 11 (10%) | .. | |
| Cholinergic syndrome grade 3* | 1 (1%) | .. | |
| Dysaesthesia grade 3* | 5 (4%) | .. | |
| Other neurological toxicity grade 3* | 14 (12%) | .. | |
| Hepatic grade 3* | 6 (5%) | .. | |
| Cardiovascular grade 3* | 1 (1%) | .. | |
| Febrile neutropenia grade 3* | 4 (4%) | .. | |
| Infection grade 3* | 2 (2%) | .. | |
| Catheter-related infection grade 3* | 5 (4%) | .. | |
| Leucopenia grade 3* | 14 (12%) | .. | |
| Neutropenia | |||
| Grade 3 | 32 (28%) | .. | |
| Grade 4 | 8 (7%) | .. | |
| Thrombocytopenia grade 3* | 8 (7%) | .. | |
| Haemoglobin grade 3* | 1 (1%) | ||
Data are n (%) unless otherwise stated. Patients may have several complications, therefore number of complications does not add up to the total number of patients. Common toxicity criteria10 version 2.0 was used. PeriOpCT=perioperative chemotherapy with fluorouracil or leucovorin and oxaliplatin
*
No grade 4 reported.
†
p=0·04.