Table 2.
Toxicity by grade and treatment arm
| Toxicity | All patients N (%) (n=32) | Arm A N (%) (n=12) | Arm B N (%) (n=11) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Grade 1/2 | Grade 3 | Grade 4 | Grade 1/2 | Grade 3 | Grade 4 | Grade 1/2 | Grade 3 | Grade 4 | |
| Hypersensitivity reaction | 4 (17.3) | 1 (4.3) | – | 3 (25) | 1 (8.3) | – | 1 (9.1) | – | – |
| Hematologic | |||||||||
| Neutropenia | 8 (34.7) | 1 (4.3) | – | 2 (16.7) | 1 (8.3) | – | 6 (54.5) | – | – |
| Infection with neutropenia | 1 (4.3) | – | – | – | – | – | 1 (9.1) | – | – |
| Infection without neutropenia | 7 (30.4) | 2 (8.7) | – | 3 (25) | 1 (8.3) | – | 4 (36.3) | 1 (9.1) | – |
| Thrombocytopenia | 8 (34.7) | 1 (4.3) | – | 2 (16.7) | – | – | 6 (54.5) | 1(9.1) | – |
| Vascular | |||||||||
| Hemorrhage | 10 (43.5) | – | – | 6 (50.0) | – | – | 4 (36.4) | – | – |
| DVT | – | 2 (8.7) | 1 (4.3) | – | – | – | – | 2 (18.1) | 1 (9.1) |
| Hypertension | 8 (34.8) | – | – | 6 (50.0) | – | – | 2 (18.2) | – | – |
| Constitutional symptoms | |||||||||
| Edema | 3 (13.0) | – | – | 2 (16.7) | – | – | 1 (9.1) | – | – |
| Fatigue | 22 (95.6) | – | – | 11 (91.6) | – | – | 11 (100) | – | – |
| Pain | 16 (69.5) | 2 (8.7) | – | 8 (66.6) | 1 (8.3) | – | 8 (72.7) | 1 (9.1) | – |
| Fever | 6 (26.0) | – | – | 2 (16.7) | – | – | 4 (36.3) | – | – |
| Skin changes | |||||||||
| Alopecia | 1 (4.3) | – | – | – | – | – | 1 (9.1) | – | – |
| Dry/cracked | 7 (30.4) | – | – | 3 (25) | – | – | 4 (36.3) | – | – |
| Fissures | 9 (39.1) | 1 (4.3) | – | 7 (58.3) | – | – | 2 (18.1) | 1 (9.1) | – |
| Nail changes | 4 (17.3) | 1 (4.3) | – | 2 (16.7) | – | – | 2 (18.1) | 1 (9.1) | – |
| Paronychia | 11 (47.8) | 1 (4.3) | – | 5 (41.6) | – | – | 6 (54.5) | 1 (9.1) | – |
| Rash | 17 (73.9) | 5 (21.7) | – | 9 (75) | 2 (16.7) | – | 8 (72.7) | 3 (27.2) | – |
| Hand-foot syndrome | 5 (21.7) | – | – | 1 (8.3) | – | – | 4 (36.4) | – | – |
| Gastrointestinal | |||||||||
| Constipation | 11 (47.8) | 2 (8.7) | – | 5 (41.7) | 2 (16.7) | – | 6 (54.5) | – | – |
| Diarrhea | 12 (52.1) | 8 (34.8) | – | 5 (41.6) | 4 (33.3) | – | 7 (63.6) | 4 (36.3) | – |
| Nausea | 16 (69.5) | – | – | 9 (75) | – | – | 7 (63.6) | – | – |
| Vomiting | 7 (30.4) | – | – | 5 (41.6) | – | – | 2 (18.1) | – | – |
| Metabolic | |||||||||
| Weight loss | 5 (21.7) | 1 (4.3) | – | 3 (25) | – | – | 2 (18.1) | 1 (9.1) | – |
| Hypomagnesemia | 8 (34.7) | 3 (13.0) | 1 (4.3) | 4 (33.3) | 1 (8.3) | 1 (8.3) | 4 (36.3) | 2 (18.1) | – |
| Hyperglycemia | 14 (60.8) | – | – | 6 (50.0) | – | – | 8 (72.2) | – | – |
| Hypoalbuminemia | 7 (30.4) | – | – | 2 (16.7) | – | – | 5 (45.5) | – | – |
| Hypokalemia | 3 (13.0) | 2 (8.7) | – | 1 (8.3) | – | – | 2 (18.1) | 1 (9.1) | – |
| Neurologic | |||||||||
| Parasthesias | 17 (73.9) | – | – | 8 (66.6) | – | – | 8 (72.2) | – | – |
| Parasthesias/pain | 2 (8.7) | – | – | 1 (8.3) | – | – | 1 (9.1) | – | – |
| Sensory neuropathy | 11 (47.8) | – | – | 5 (41.6) | – | – | 6 (54.5) | – | – |
| Insomnia | 6 (26.0) | – | – | 3 (25) | – | – | 3 (27.2) | – | – |