Table 3.
Adverse events. The adverse events were categorised into haematological, non-haematological, and biochemical. Each category was further divided into two severity grades: Grades 1 & 2 and Grades 3 & 4. NS, not significant; SGOT, Aspartate transaminase; SGPT, Alanine transaminase
| Group A (Neoadjuvant chemotherapy) (n = 146) | Group B (Standard-of-care) (n = 138) | P value | Group A (Neoadjuvant chemotherapy) (n = 146) | Group B (Standard-of-care) (n = 138) | P value | ||
|---|---|---|---|---|---|---|---|
| Adverse events | Grades 1 & 2 | Grades 3 & 4 | |||||
| Haematological | Leukopenia | 58 (40%) | 66 (48%) | NS | 3 (2%) | 5 (4%) | NS |
| Neutropenia | 38 (26%) | 43 (31%) | NS | 9 (6%) | 15 (11%) | NS | |
| Febrile neutropenia | 0 (0%) | 1 (1%) | NS | 0 (0%) | 0 (0%) | NS | |
| Thrombocytopenia | 41 (28%) | 52 (37%) | NS | 0 (0%) | 0 (0%) | NS | |
| Anaemia | 85 (58%) | 94 (68%) | NS | 0 (0%) | 0 (0%) | NS | |
| Non-haematological | Nausea | 41 (28%) | 42 (30%) | NS | 2 (1%) | 3 (2%) | NS |
| Vomiting | 8 (5%) | 11 (8%) | NS | 0 (0%) | 0 (0%) | NS | |
| Peripheral sensory neuropathy | 92 (63%) | 88 (64%) | NS | 17 (12%) | 28 (20%) | NS | |
| Palmar-plantar erythrodysesthesia | 11 (8%) | 17 (12%) | NS | 2 (1%) | 5 (4%) | NS | |
| Constipation | 15 (10%) | 17 (12%) | NS | 0 (0%) | 0 (0%) | NS | |
| Biochemical | Elevated SGOT | 43 (29%) | 46 (33%) | NS | 2 (1%) | 1 (1%) | NS |
| Elevated SGPT | 47 (32%) | 45 (32%) | NS | 1 (1%) | 1 (1%) | NS | |
| Elevated Bilirubin | 3 (2%) | 4 (3%) | NS | 0 (0%) | 0 (0%) | NS | |
| Elevated Creatinine | 14 (10%) | 15 (11%) | NS | 2 (1%) | 2 (1%) | NS | |