Table 1.
Author/ yearreference | Phase of CT | Primary site | Carry out country | Number in intervention/control group | ECOG-PS | Type of treatment | ADE-related outcomes included in analysis |
---|---|---|---|---|---|---|---|
Grothey / 2013 19 | III | CRC | 16 countries in North America, Europe, Asia, and Australia | 500/253 | 0,1 | Oral regorafenib 160 mg once daily on days 1–21 each 28-day cycle + BSC versus placebo + BSC | Dose reductions Dose interruptions Permanent discontinuation |
Demetri / 2013 20 | III | GIST | 17 countries in North America, Europe, and Asia | 132/66 | 0,1 | Oral regorafenib 160 mg once daily on days 1–21 each 28-day cycle + BSC versus placebo + BSC | Dose reductions Permanent discontinuation |
Li / 2015 21 | III | CRC | China, Hong Kong, South Korea, Taiwan, and Vietnam | 136/68 | 0,1 | Oral regorafenib 160 mg once daily on days 1–21 each 28-day cycle + BSC versus placebo + BSC | Dose reductions Dose interruptions Permanent discontinuation |
Pavlakis / 2016 22 | II | GC / GEJ | Australia, New Zealand, Canada, Korea | 56/29 | 0,1 | Oral regorafenib 160 mg daily on days 1–21 each 28-day cycle + BSC versus oral placebo + BSC | Permanent discontinuation |
Mir / 2016 23 | II | STS | France, Austria | 26/12 | 0,1 | Oral regorafenib 160 mg once daily on days 1–21 each 28-day cycle versus placebo | Dose reductions Dose interruptions Permanent discontinuation |
Bruix / 2017 24 | III | HCC | 21 countries in North America, South America, Europe, Asia, and Australia | 379/194 | 0,1 | Oral regorafenib 160 mg once daily on days 1–21 each 28-day cycle + BSC versus placebo + BSC | Dose reductions Permanent discontinuation |
Duffaud / 2019 25 | II | Osteosarcoma | France | 89/92 | 0,1 | Oral regorafenib 160 mg once daily on days 1–21 each 28-day cycle + BSC versus placebo + BSC | Dose reductions Dose interruptions Permanent discontinuation |
ADE, adverse drug event; BSC, best supportive care; CRC, colorectal cancer; CT, clinical trial; ECOG-PS, Eastern Cooperative Oncology Group performance status; GC, gastric cancer; GEJ, gastroesophageal junction; GIST, gastrointestinal stromal tumour; HCC, hepatocellular carcinoma; STS, soft tissue sarcoma.