Table 2.
Results and adverse events within included studies for IAS.
| Investigators | ORR (EG or EG vs CG) | DCR (EG or EG vs CG) | PFS (EG or EG vs CG) | Median OS (EG or EG vs CG) | Adverse events (grade III/IV) |
|---|---|---|---|---|---|
| Inaba (43) | 7.7% (95% CI, 0.2–36.0%) | 69% (95% CI, 38.6–90.9%) | N/A | 389 d (95% CI, 158–620) | Neutropenia (n = 2), elevated GGT (n = 1), elevated AST (n = 1), elevated ALT (n = 1), elevated bilirubin plus PVTT (n = 1) |
| Ghiringhell (44) | 66.6% (95% CI, 29–100%) | 91% (95% CI 45–100%) | 9.2 mo (95% CI, 5.1–29.4) | 20.3 mo (95% CI, 13.2–49.7) | Neutropenia (n = 2), thrombocytopenia (n = 2), oxaliplatin allergy (n = 2) |
| Kasai (45) | 60% | 90% | 8.0 mo (95% CI, 3.1–14.5) | 14.6 mo (95% CI, 5.5–16.8) | Leukopenia (n = 2), thrombocytopenia (n = 2), anemia (n = 2) |
| Konstantinidis (46) | 59 vs 39%, P = 0.11 | N/A | N/A | 30.8 vs 18.4 mo (P <.001) | None |
| Cercek (38) | 58% | 84% | 11.8 mo (1-sided 90% CI, 11.1) | 25.0 mo (95% CI, 20.6–not reached) | 4 patients (11%) had grade 4 toxic effects: portal hypertension (n = 1), gastroduodenal artery aneurysm (n = 2), infection in the pump pocket (n = 1) |
| Wang (47) | 67.60% | 89.20% | 12.2 mo (95% CI, 6.60–17.83) | 20.5 mo (95% CI, 11.12–29.88) | Severe anemia (16.2%), leukopenia (10.8%), thrombocytopenia (13.5%), Grades 3 and 4 liver enzyme elevation (8.1%), severe abdominal pain (5.4%) |
| Kiefer (48) | 11% | 76% | 8 mo | 20 mo | Pulmonary edema and elevated cardiac enzymes (n = 1), pulmonary infarct (n = 1), severe postembolization syndrome (n = 1), hyperglycemia (n = 1), acute renal failure and dehydration (n = 1) |
| Li (49) | N/A | N/A | 22.0 vs 14.3 mo | 27.6 vs 20.4 mo | None |
| Wang (50) | N/A | N/A | 50 vs 10 mo, P = 0.022 | 63.0 vs 18.0 mo, P = 0.041 | None |
| Zheng (52) | N/A | N/A | 10.5 mo | 20.0 mo | Biliary hemorrhage and cholangitis |
| Aliberti (55) | 15% | 95% | N/A | 14.53 mo (95% CI, 9.17–15.23) | Nausea/vomiting (24%), fever (7%), pain (7%) |
| Poggi (56) | 44% | 100% | 8.4 vs 2.9 mo, P = 0.1 | 30 vs 12.7 mo, P = 0.004 | Abdominal pain (24%; 28/67), cholangitis G3 (3%; 2/67), hypertensive crisis G3 (3%; 2/67) |
| Luo (57) | 67.60% | 91.90% | N/A | 376 d (95% CI, 341–412 d) | None |
| Zhou (58) | 65.90% | 87.50% | 3 (95% CI, 2.5–3.5) | 9 (95% CI, 7.0–11.0) | None |
| Ibrahim (62) | 27% | 95% | N/A | 14.9 mo | Albumin toxicities (17%) |
| Bilirubin toxicity (4%) | |||||
| Hoffmann (63) | 36.40% | 87.90% | 9.8 mo | 22 mo | No clinical relevant acute or delayed toxicities |
ORR, overall response rate; DCR, disease control rate; PFS, progression-free survival; OS, overall survival; CG, control group; EG, experimental group; 95% CI, 95% confidence interval; GGT, gamma-glutamyl transpeptidase; AST, aspartate aminotransferase; ALT, alanine aminotransferase; PVTT, portal vein tumor thrombosis.