Table 3.
Agent | Trial | Phase | Number | Patient | Therapy | Dosing | Results a vs. b |
---|---|---|---|---|---|---|---|
Cetuximab | Gruenwald et al. (2007) [109] | II | 27 | Prior therapy | a. Cetuximab (n = 27) | Cetuximab 400 mg/m2 follow by weekly 250 mg/m2 | TTP: 8.0 weeks; DCR: 44.4% |
Zhu et al. (2007) [108] | II | 30 | Prior therapy | a. Cetuximab (n = 30) | Cetuximab 400 mg/m2 follow by weekly 250 mg/m2 | OS: 9.6 months; PFS: 1.4 months; TTP: 4.2 months; DCR: 17% | |
Erlotinib | Philip et al. (2005) [114] | II | 38 | Maximum 1 prior line of therapy | a. Erlotinib (n = 38) | Erlotinib 150 mg daily | OS: 13 months; TTP: 3.8 months; ORR: 9%; DCR:50% |
Thomas et al. (2007) [115] | II | 40 | No prior systemic therapy | a. Erlotinib (n = 40) | Erlotinib 150 mg daily | OS: 10.75 months; PFS: 43% at 16 weeks; TTP: 13.3 weeks; DCR: 43% | |
Zhu et al. (2015) [116] | III | 720 | No prior systemic therapy | a. Sorafenib/Erlotinib (n = 362); b. Placebo (n = 358) |
Sorafenib 400 mg BID; Erlotinib 150 mg daily | OS: 9.5 months vs. 8.5 months, HR 0.929, p = 0.408; TTP: 3.2 vs. 4.0 months, HR 1.135, p = 0.18; ORR: 6.6% vs. 3.9%, p = 0.102; DCR: 52.5% vs. 43.9%, p = 0.021 | |
Govindarajan et al. (2013) [117] | II | 21 | No prior systemic therapy | a. Bevacizumab/Erlotinib (n = 21) | Bevacizumab 15 mg/kg every 3 weeks; Erlotinib 150 mg daily | OS: 8.33 months; PFS: 28% at 27 weeks; TTP: 2.57 months | |
Yau et al. (2012) [118] (study halted) | II | 10 | Failed sorafenib | a. Bevacizumab/Erlotinib (n = 10) | Bevacizumab 10 mg/kg every 2 weeks; Erlotinib 150 mg daily | OS: 4.37 months; TTP: 1.81 months; DCR: 0% | |
Hsu et al. (2013) [119] | II | 51 | No prior systemic therapy | a. Bevacizumab/Erlotinib (n = 51) | Bevacizumab 5 mg/kg every 2 weeks; Erlotinib 150 mg daily | OS: 10.7 months; PFS: 2.9 months; ORR: 6%; DCR: 53% | |
Philip et al. (2012) [120] | II | 27 | Maximum 1 prior line of therapy | a. Bevacizumab/Erlotinib (n = 27) | Bevacizumab 10 mg/kg every 2 weeks; Erlotinib 150 mg daily | OS 9.5 months; TTP: 3.0 months; ORR: 5% | |
Kaseb et al. (2012) [121] | II | 59 | Maximum 1 prior line of therapy | a. Bevacizumab/Erlotinib (n = 59) | Bevacizumab 10 mg/kg every 2 weeks; Erlotinib 150 mg daily | OS: 13.7 months; PFS: 7.2 months; ORR: 24%; DCR: 80% | |
Lapatinib | Bekaii-Saab et al. (2009) [123] | II | 26 | Maximum 1 prior line of therapy | a. Lapatinib (n = 26) | Lapatinib 1500 mg daily | OS: 12.6 months; PFS 1.9 months; ORR: 40% |
Ramanathan et al. (2009) [124] | II | 40 | Maximum 1 prior line of therapy | a. Lapatinib (n = 40) | Lapatinib 1500 mg daily | OS: 6.2 months; PFS: 2.3 months; ORR: 5%; DCR: 40% |
OS: median overall survival; PFS: median progression free survival; TTP: median time to progression; ORR: objective response rate, DCR: disease control rate.