Table 3.
Toxicities (treatment-related AEs) to cetuximab plus paclitaxel treatment.
| Event; n (%) | Grade ≥ 3 | Leading to CP discontinuation | TTCC-2019-02 N = 531 |
|
|---|---|---|---|---|
| Blood system disorders | Overall | 12 (2.3) | 4 (0.8) | 34 (6.4) |
| Neutrophil count decreased | 7 (1.3) | 1 (0.2) | 16 (3) | |
| Febrile neutropenia | 5 (0.9) | 2 (0.4) | 9 (1.7) | |
| Anemia | 2 (0.4) | 2 (0.4) | 11 (2.1) | |
| Leukocytosis | 0 (0) | 0 (0) | 1 (0.2) | |
| Metabolism and nutrition disorders | Overall | 3 (0.6) | 1 (0.2) | 9 (1.7) |
| Hypomagnesemia | 1 (0.2) | 0 (0) | 1 (0.2) | |
| Hypocalcemia | 0 (0) | 0 (0) | 1 (0.2) | |
| Anorexia | 0 (0) | 0 (0) | 3 (0.6) | |
| General disorders | Overall | 12 (2.3) | 15 (2.8) | 33 (6.2) |
| Fatigue | 11 (2.1) | 9 (1.7) | 26 (4.9) | |
| Infusion-related reactions | 1 (0.2) | 5 (0.9) | 5 (0.9) | |
| Muscle alterations | 0 (0) | 0 (0) | 1 (0.2) | |
| Flushing | 0 (0) | 1 (0.2) | 1 (0.2) | |
| Skin and subcutaneous tissue disorders | Overall | 52 (9.8) | 19 (3.6) | 119 (22.4) |
| Rash acneiform | 47 (8.9) | 18 (3.4) | 108 (20.3) | |
| Dry skin | 1 (0.2) | 0 (0) | 5 (0.9) | |
| Pruritus | 0 (0) | 0 (0) | 1 (0.2) | |
| Palmo-plantar erythrodysesthesia syndrome | 0 (0) | 1 (0.2) | 3 (0.6) | |
| Nail toxicity | 6 (1.2) | 0 (0) | 11 (2.1) | |
| Alopecia | 0 (0) | 0 (0) | 5 (0.9) | |
| Hypertrichosis | 0 (0) | 0 (0) | 2 (0.4) | |
| Investigations | Overall | 4 (0.8) | 4 (0.8) | 9 (1.7) |
| Alkaline phosphatase increased | 1 (0.2) | 0 (0) | 1 (0.2) | |
| GGT increased | 0 (0) | 1 (0.2) | 1 (0.2) | |
| Transaminase increased | 4 (0.8) | 2 (0.4) | 7 (1.3) | |
| Creatinine increased | 0 (0) | 2 (0.4) | 2 (0.4) | |
| Gastrointestinal disorders | Overall | 10 (1.9) | 9 (1.7) | 54 (10.2) |
| Oral mucositis | 8 (1.5) | 8 (1.5) | 36 (6.8) | |
| Esophagitis | 1 (0.2) | 0 (0) | 1 (0.2) | |
| Emesis | 0 (0) | 0 (0) | 10 (1.9) | |
| Diarrhea | 1 (0.2) | 1 (0.2) | 13 (2.5) | |
| Infections and infestations | Overall | 10 (1.9) | 5 (0.9) | 18 (3.4) |
| Urinary tract infection | 1 (0.2) | 0 (0) | 2 (0.8) | |
| Respiratory infection | 4 (0.8) | 2 (0.4) | 7 (1.3) | |
| Sepsis | 2 (0.4) | 2 (0.4) | 2 (0.4) | |
| Abdominal infection | 1 (0.2) | 1 (0.2) | 1 (0.2) | |
| Eye infection | 2 (0.4) | 0 (0) | 6 (1.1) | |
| Non-infectious respiratory events | Overall | 3 (0.6) | 4 (0.8) | 6 (1.1) |
| Pulmonary toxicity | 3 (0.6) | 3 (0.6) | 5 (0.9) | |
| Cough | 0 (0) | 1 (0.2) | 1 (0.2) | |
| Tumor-related events | Overall | 0 (0) | 1 (0.2) | 3 (0.6) |
| Pain | 0 (0) | 0 (0) | 2 (0.4) | |
| Fistula | 0 (0) | 1 (0.2) | 1 (0.2) | |
| Others | Overall | 5 (0.9) | 12 (2.3) | 25 (4.7) |
| Peripheral sensory neuropathy | 5 (0.9) | 12 (2.3) | 25 (4.7) | |
| Bone fracture | 0 (0) | 0 (0) | 1 (0.2) | |
The study collected only those AEs that were grade ≥3, led to discontinuation or dosage reduction of paclitaxel and/or cetuximab, or met criteria for serious AE (SAE).
CP, cetuximab plus paclitaxel; GGT, gamma glutamyl transferase.