Table I.
Characteristics of included studies: an overview of comparative studies
| First author (year) | Enrolment period | Countries | Study design | Patients | Comparison groups | No. total patients | End-point |
|---|---|---|---|---|---|---|---|
| Giorgio (2011) | NA | Italy | RCT (abstract) | HCC, liver cirrhosis, Child-Pugh A, PVTT | Sorafenib alone vs. sorafenib + RFA | 79 | 3-year survival rate |
| Kasai (2013) | NA | Japan | Retrospective study (abstract) | HCC, PVTT | Sorafenib alone vs. HAIC of 5-fluorouracil + systemic pegylated interferon α2b | 40 | Early response rate; cumulative survival rate |
| Lee (2014) | 01.2000–12.2012 | South Korea | Retrospective study (abstract) | HCC, PVTT | Sorafenib alone vs. hepatic resection vs. TACE | 173 | Survival time; 1-, 2-, and 3-year overall survival rate |
| Nakazawa (2014) | 07.2009–11.2011 | Japan | Retrospective propensity score analysis (full text) | Unresectable HCC, PVTT in the main trunk or the first branch | Sorafenib alone vs. radiotherapy | 97 | The primary end point was all-cause mortality |
| Sinclair (2014) | Ongoing | Multi-national | Phase III, two-arm, open-label, RCT (abstract) | Unresectable HCC, PVTT | Sorafenib alone vs. yttrium-90 glass microspheres | 328 | Primary endpoint: overall survival from the time of randomisation until time of event (death). Secondary endpoint: time to progression/symptomatic progression, time to worsening of PVT, tumour response, patient-reported outcome assessments, and adverse events |
| Song (2014) | 02.2008–05.2013 | South Korea | Retrospective study (full text) | Advanced HCC, PVTT | Sorafenib alone vs. HAIC | 110 | Disease control rate; objective response rate; overall survival; time to progression |
| Yang (2012) | 07.2008–07.2010 | China | RCT (full text) | HCC, Child-Pugh A or B, PVTT | Sorafenib alone vs. sorafenib + cryotherapy | 104 | Primary end-point: overall survival. Secondary end-point: time to progression, tolerability |
| Yoon (2013) | Ongoing | South Korea | Phase II RCT (abstract) | HCC, major branch of portal vein invasion, Child-Pugh score ≤ 7 | Sorafenib alone vs. TACE | 40 | Primary end-point: time to progression. Secondary end-point: overall survival, objective tumour response/control rate, progression-free survival, change of perfusion parameter, α fetoprotein responsiveness |
HAIC – Hepatic arterial infusion chemotherapy, HCC – hepatocellular carcinoma, PVTT – portal vein tumour thrombus, RCT – randomised controlled trial, RFA – radiofrequency ablation, TACE – transarterial chemoembolisation.