Table 6.
Summary of selected clinical trials of systemic therapy in advanced HCC patients
| Study | Regimen | Study type | N | RR% | SD% | MS (months) |
|---|---|---|---|---|---|---|
| Current study | TAC-101 | Phase II | 21/28 | 0% | 57.1%/42.9% | 19.2/12.7a |
| Abou-Alfa et al. (2006) | Sorafenib | Phase II | 137 | 8 | 33.6 | 9.2 |
| Llovet et al. (2007) | Sorafenib vs. placebo | Phase III | 602 (299/303) | 2.3% | 10.7 vs. 7.9 (p = 0.00058) | |
| Zhu et al. (2006) | GEMOX-bevacizumab | Phase II | 33 | 20 | 27 | 9.6 |
| Gish (Gish et al. 2007) | Nolatrexed vs. doxorubicin | Phase III | 446 | 1.4 vs. 4.0 | NA | 4.8 vs. 7.1 |
| Boige et al. (2006) | Irinotecan | Phase II | 25 | 0% | 52 | 7.4 |
| Yeo et al. (2005) | Doxorubicin vs. PIAF | Phase III | 86/91 | 10.5 vs. 20.9 | 43 vs. 38 | 6.8 vs. 8.7 (p = 0.83) |
| Posey et al. (2005) | T138067 vs. doxorubicin | Phase II/III | 169/170 | 2 vs. 4 | 43 vs. 43 | 5.7 vs. 5.6 |
| Ikeda et al. (2005) | 5FU, mitoxantrone, cisplatin | Phase II | 50 | 27 | 53 | 11.6 |
| Barbare et al. (2005) | Tamoxifen vs. BSC | Phase II | 210/210 | NA | NA | 4.8 vs. 4.0 |
| Philip et al. (2005) | Erlotinib | Phase II | 38 | 9 | 50 | 13 |
| Patt et al. (2005) | Thalidomide | Phase II | 37 | 6 | 31 | 6.8 |
| Lee et al. (2004) | Doxorubicin and cisplatin | Phase II | 37 | 18.9 | 16.2 | 7.3 |
| Guan et al. (2003) | Gemcitabine, std. vs. fixed-dose | Phase II, | 25/23 | 4 vs. 0 | NA | 3.2 vs. 3.2 |
| Fuchs et al. (2002) | Gemcitabine | Phase I | 30 | 0 | 30 | 6.9 |
| Leung et al. (2002a, b) | PIAF | Phase II | 149 | 16.8 | NA | 7.1 |
| Mok et al. (1999) | Nolatrexed vs. doxorubicin | Phase II | 32/12 | 0 | 21.8 vs. 16.7 | 4.6 vs. 3.5 |
| Meyskens et al. (1998) | B-all-trans-retinoic acid | Phase II | 18 | 0 | NA | 4.0 |
GEMOX gemcitabine, oxaliplatin; PIAF cisplatin, interferon, Adriamycin, 5FU; NA not available
aMS 19.2 months for 21 evaluable pts; 12.7 months for all pts treated at MTD