Table 2.
Characteristics of the included studies
| Authors | Study type | Intervention | Comparator | Location(s) |
|---|---|---|---|---|
| Sanoff et al. [4] (NCT01298570)a | RCT | REG 160 mg daily on days 4–10 and days 18–24 of every 28-day cycle + FOLFIRI (irinotecan 180 mg/m2, leucovorin 400 mg/m2, and 5-FU 400 mg/m2 followed by 2400 mg/m2 over 46 h) on days 1 and 2 and days 15 and 16 (n = 120) | Placebo + FOLFIRI (irinotecan 180 mg/m2, leucovorin 400 mg/m2, and 5-FU 400 mg/m2 followed by 2400 mg/m2 over 46 h) on days 1 and 2 and days 15 and 16 (n = 61) | USA and Ireland |
| Hsieh et al. [25]a | Observational | TFD/TPI 35 mg/m2 twice daily for 5 days a week with 2 days of rest for 2 consecutive weeks, followed by 14 days of rest. Repeated every 4 weeks. Monotherapy or combination with anti-VEGF, anti-EGFR, irinotecan, or oxaliplatin (n = 50) | REG 160 mg daily on days 1–21 with 7 days of rest. Repeated every 4 weeks. Monotherapy or in combination with anti-VEGF, anti-EGFR, irinotecan, or oxaliplatin (n = 75) | Taiwan |
| Moriwaki et al. [26] (REGOTAS)a | Observational | TFD/TPI (n = 327) | REG (n = 223) | Japan |
| Nakashima et al. [27]a | Cohort | TFD/TPI (n = 3777) | REG (n = 1501) | Japan |
| Patel et al. [28]a | Cohort | TFD/TPI (n = 126) | REG (n = 95) | USA |
| Vitale et al. [29]a | Observational | TFD/TPI 35 mg/m2 twice daily on days 1–5 and 8–12 every 28-day cycle (n = 76) | REG 160 mg daily on days 1–21 of every 28-day cycle (n = 64) | Italy and Spain |
| Xu et al. [30] (TERRA, NCT01955837)a | RCT | TFD/TPI 35 mg/m2 twice daily, 5 days a week, 2 days of rest, for 2 weeks, followed by a 14-day rest period in 28-day treatment cycles (n = 271) | Placebo twice daily, 5 days a week, 2 days of rest, for 2 weeks, followed by a 14-day rest period in 28-day treatment cycles (n = 135) | China, Republic of Korea, and Thailand |
| Xu et al. [31] (CONCUR, NCT01584830)a | RCT | REG 160 mg daily for the first 3 weeks of each 4-week cycle (n = 112) | Placebo daily for the first 3 weeks of each 4-week cycle (n = 60) | China, Hong Kong and Taiwan |
| Seidensticker et al. [32] | Observational | SIRT (n = 29) | BSC (n = 29) | Germany |
| Hendlisz et al. [33] (NCT00199173) | Open-label RCT | SIRT + 5-fluorouracil (n = 21) | 5-Fluorouracil with crossover to SIRT upon progression at investigator discretion (n = 23) | Belgium |
| Bester et al. [34] | Non-randomised interventional | SIRT (n = 224) | BSC (n = 29) | Australia |
| Grothey et al. [35] (CORRECT, NCT01103323) | RCT | REG at 160 mg/day (n = 505) | Placebo (n = 255); cross-over not permitted | North America, Western Europe, Israel, Australia, Asia, and Eastern Europe |
| Li et al. [36] (CONCUR, NCT01584830) | RCT | REG at 160 mg/day (n = 136) | Placebo (n = 68) | China, Hong Kong, South Korea, Taiwan, and Vietnam |
| Mayer et al. [37] (RECOURSE, NCT01607957) | RCT | TFD/TPI at 35 mg/m2 twice daily (n = 534) | Placebo (n = 266); cross-over not permitted | Japan, USA, Europe, and Australia |
| Yoshino et al. [38] (JapicCTI-090880) | RCT | TFD/TPI at 35 mg/m2 twice daily (n = 112) | Placebo (n = 57); cross-over not permitted | Japan |
BSC Best supportive care, RCT randomised controlled trial, REG regorafenib, SIRT selective internal radiation therapy, TFD/TPI trifluridine–tipiracil
aNew studies added to the results reported by Walter et al. [11]