Table 2. Treatment-related toxicities,* stratified by time.
| Overall incidence (N = 29) | Post-RE and | Post-sorafenib | ||||||||||
| Pre-sorafenib (N = 9) | Month 1 (N = 29) | Month 2 (N = 29) | Month 3(N = 27) | Month 4+ (N = 27) | ||||||||
| Grade, N (%) of patients | 1–2 | ≥3 | 1–2 | ≥3 | 1–2 | ≥3 | 1–2 | ≥3 | 1–2 | ≥3 | 1–2 | ≥3 |
| Any | 13 (45) | 15 (52) | 4 (14) | 1 (3) | 12 (41) | 7 (24) | 6 (21) | 3 (10) | 5 (19) | 3 (11) | 10 (37) | 4 (15) |
| Blood and lymph | ||||||||||||
| Anemia | 1 (3) | 1 (3) | ||||||||||
| Leukopenia | 1 (3) | 1 (3) | ||||||||||
| Thrombocytopenia | 1 (3) | 1 (4) | ||||||||||
| Gastrointestinal | ||||||||||||
| Abdominal distension | 1 (3) | 1 (3) | ||||||||||
| Ascites | 1 (3) | 1 (3) | ||||||||||
| Diarrhea | 9 (31) | 6 (21) | 1 (3) | 2 (8) | ||||||||
| Nausea | 2 (7) | 1 (3) | 1 (4) | |||||||||
| Upper GI hemorrhage | 1 (3) | 1 (4) | ||||||||||
| Vomiting | 3 (10) | 1 (3) | 3 (9) | 1 (3) | ||||||||
| General/administration site | ||||||||||||
| Lethargy | 1 (3) | 1 (3) | ||||||||||
| Mucosal inflammation | 1 (3) | 1 (4) | ||||||||||
| Pyrexia | 1 (3) | 1 (3) | 1 (3) | |||||||||
| Hepatobiliary | ||||||||||||
| Elevated ALP | 1 (3) | 1 (3) | 1 (3) | 1 (3) | ||||||||
| Elevated ALT | 1 (3) | 1 (3) | ||||||||||
| Elevated AST | 1 (3) | 2 (7) | 1 (3) | 1 (3) | 1 (4) | 1 (4) | ||||||
| Hepatitis | 1 (3) | 1 (4) | 1 (4) | |||||||||
| Hyperbilirubinemia | 3 (10) | 1 (3) | 1 (3) | 1 (3) | 1 (3) | 2 (7) | ||||||
| Hypoalbuminemia | 1 (3) | 1 (3) | ||||||||||
| Infections and infestations | ||||||||||||
| Sepsis | 1 (3) | 1 (3) | ||||||||||
| Viral infection | 1 (3) | 1 (3) | ||||||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Fall | 1 (3) | 1 (4) | ||||||||||
| Radiation skin injury | 1 (3) | 1 (3) | ||||||||||
| Skin toxicity | 1 (3) | 1 (3) | ||||||||||
| Metabolism and nutrition | ||||||||||||
| Decreased appetite | 1 (3) | 1 (3) | ||||||||||
| Renal and urinary | ||||||||||||
| Urinary tract infection | 1 (3) | 1 (3) | ||||||||||
| Reproductive system | ||||||||||||
| Scrotal pain | 1 (3) | 1 (3) | ||||||||||
| Respiratory, thoracic and mediastinal | ||||||||||||
| Chest discomfort | 1 (3) | |||||||||||
| Hemoptysis | 1 (3) | 1 (3) | ||||||||||
| Pneumonia | 1 (3) | 1 (3) | ||||||||||
| Pneumonitis | 1 (3) | 1 (3)† | 1 (4) | 1 (4)† | ||||||||
| Skin and subcutaneous | ||||||||||||
| Acne | 1 (3) | 1 (4) | ||||||||||
| Alopecia | 6 (21) | 2 (7) | 1 (3) | 3 (10) | ||||||||
| Hand-foot syndrome | 7 (24) | 5 (17) | 5 (17) | 2 (7) | 1 (3) | 1 (3) | 1 (4) | 3 (10) | 2 (7) | |||
| Rash | 5 (17) | 1 (3) | 3 (10) | 2 (7) | ||||||||
| Vascular | ||||||||||||
| Gingival bleeding | 1 (3) | 1 (4) | ||||||||||
| Hypertension | 2 (7) | 1 (4) | 2 (7) | |||||||||
* Treatment-related toxicities included all those assessed as either definitely, probably, possibly related to treatment and unlikely to be related to treatment (excluding only those events assessed as definitely unrelated to treatment); If a toxicity occurred multiple times to the same patient, it was counted once for that patient at the highest grade that was assessed.Post-RE: Post-radioembolization/Pre-sorafenib period of 14 days; N = number of patients alive at each time interval; National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.
Abbreviations: ALP: alkaline phosphatase; ALT: alanine transaminase; AST: aspartate aminotransferase GI: gastrintestinal.
†
This was a grade 5 event.