TABLE 1.
Adjuvant Therapies After LT for HCC: Nonrandomized Studies
| Study | Treatment | Patients Outside the Milan Criteria/Total Patients (n/N) | Study Design | Disease-Free Survival (%)* | Overall Survival (%)* | Results of Proposed Adjuvant Therapy | Level of Evidence |
|---|---|---|---|---|---|---|---|
| Stone et al.10 (1993) | Doxorubicin before, during, and after LT | 17/20 (HCC diameter > 5 cm) | Single arm prospective study with no control group | 54 (3 years) | 59 (3 years); 39 (5-year update) | The treatment may provide a benefit. | 4 |
| Olthoff et al.14 (1995) | Doxorubicin, fluorouracil, and cisplatin | 15/25 | Prospective with historical controls | 46 (3 years) | 46 versus 5.8 (3 years)† | The treatment may provide a benefit. | 4 |
| Cherqui et al.11 (1994) | TACE and radiotherapy before LT and mitoxantrone after LT | 14/14 | Single arm and prospective with no control group | 47 (5 years) | 54 (5 years) | The treatment may provide a benefit. | 4 |
| Roayaie et al.12 (2002) | TACE before LT and doxorubicin during and after LT | 43/43 | Prospective with no control group | 48 (5 years) | 44 (5 years) | The treatment may provide a benefit. | 4 |
| Zhang et al.15 (2005) | Doxorubicin, fluorouracil, and cisplatin after LT | 10/10 | Retrospective case series | —‡ | NA | The treatment may provide a benefit. | 4 |
| Chen et al.16 (2004) | Individualized chemotherapy based on the adenosine triphosphate tumor chemosensitivity assay | Unknown/21 cases and 52 controls | Retrospective case series with controls | 60.0 versus 37.8 (2 years)§ | 74 versus 70 (2 years)|| | The treatment may provide a benefit. | 4 |
| Sun et al.17 (2007) | TACE before LT and doxorubicin, fluorouracil, and cisplatin after LT | Unknown/20 cases (pTNM stages III and IVa) and 16 controls | Retrospective case series with controls | 40.5 versus 15.6 (2 years) | 47.1 versus 20.5 (2 years) | The treatment may provide a benefit. | 4 |
| Hsieh et al.13 (2008) | Gemcitabine and cisplatin | 15/30 | Retrospective case series | 56 (2 years) | 72 (3 years) | Efficacy is suggested in patients beyond the Milan criteria | 4 |
*
The follow-up period is shown in parentheses.
†
Statistically significant (P < 0.001).
‡
Three of 10 patients experienced recurrence.
§
Statistically significant (P < 0.05).
||
Not statistically significant.