Table 2. Cumulative incidence of toxicity.
|
During G/D scheme |
During mP6 |
|||
|---|---|---|---|---|
| Toxicity | All grades | Grades 3–4 | All grades | Grades 3–4 |
|
Haematology | ||||
| Anaemia | 8 | 0 | 64 | 41 |
| Absolute neutrophil count decreased | 12 | 9 | 55 | 51 |
| Platelet count decreased | 7 | 4 | 57 | 52 |
|
Chemistry | ||||
| ALT increase | 9 | 4 | 10 | 2 |
| AST increase | 7 | 4 | 9 | 2 |
| Hypoalbuminemia | 0 | 0 | 1 | 0 |
| Hypokalaemia | 0 | 0 | 7 | 1 |
| Hyponatremia | 1 | 0 | 16 | 2 |
|
Gastrointestinal disorders | ||||
| Diarrhoea | 9 | 1 | 13 | 0 |
| Constipation | 5 | 0 | 22 | 1 |
| Nausea | 8 | 0 | 28 | 3 |
| Vomiting | 6 | 0 | 33 | 2 |
| Mucositis | 6 | 0 | 40 | 9 |
| Dyspepsia | 0 | 0 | 3 | 0 |
| Enterocolitis | 0 | 0 | 1 | 1 |
|
Infections | ||||
| Febrile neutropenia | 2 | 1 | 48 | 48 |
| Urinary tract infection | 2 | 1 | 2 | 1 |
| Skin/subcutaneous infection | 2 | 1 | 9 | 4 |
| Upper airway infection | 0 | 0 | 1 | 0 |
| Chicken pox | 1 | 0 | 1 | 1 |
| Lip infection | 1 | 1 | 2 | 0 |
| Lung infection | 2 | 1 | 3 | 2 |
| Otitis media | 0 | 0 | 1 | 0 |
| Pharyngitis | 0 | 0 | 1 | 1 |
| Sepsis | 0 | 0 | 2 | 2 |
| Oral candidiasis | 1 | 0 | 2 | 0 |
|
Skin tissue disorders | ||||
| Rash | 1 | 0 | 5 | 0 |
| Palmar-plantar syndrome | 0 | 0 | 2 | 0 |
|
Immune system disorders | ||||
| Allergic reaction | 4 | 0 | 0 | 0 |
|
General disorders | ||||
| Oedema limbs | 4 | 0 | 4 | 0 |
| Pain | 15 | 3 | 42 | 4 |
|
Vascular disorders | ||||
| Phlebitis | 0 | 0 | 3 | 0 |
|
Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 3 | 0 | 5 | 0 |
| Dyspnoea | 1 | 0 | 2 | 0 |
| Epistaxis | 3 | 0 | 2 | 0 |
| Respiratory failure | 0 | 0 | 1 | 1 |
|
Injury, poisoning and procedural complications | ||||
| Fracture | 2 | 2 | 1 | 1 |
|
Neoplasms benign, malignant and unspecified | ||||
| Leukaemia secondary to oncology chemotherapy | 1 | 1 | 1 | 1 |
|
Renal and urinary disorders | ||||
| Cystitis non infected | 0 | 0 | 1 | 1 |
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; G/D=Gemcitabine and Docetaxel.
National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Toxicities of the G/D scheme refer to those reported both during the window cycles and maintenance.