Table 1.
Characteristics of liver recipients with hepatocellular carcinoma, and outcomes following transplantation, stratified by sirolimus use
| Characteristic | Sirolimus Exposed Recipients (N=234) |
Sirolimus Unexposed Recipients (N=3702) |
p-value |
|---|---|---|---|
| Sex, N (%) | 0.97 | ||
| Female | 54 (23%) | 858 (23%) | |
| Male | 180 (77%) | 2844 (77%) | |
| Race, N (%) | 0.73 | ||
| White | 190 (81%) | 3026 (82%) | |
| Black | 25 (11%) | 344 (9%) | |
| Other | 19 (8%) | 332 (9%) | |
| Ethnicity, N (%) | 0.02 | ||
| Hispanic | 40 (17%) | 446 (12%) | |
| Non-Hispanic | 194 (83%) | 3256 (88%) | |
| Age at transplantation in years, median (IQR) | 57 (53–62) | 57 (53–62) | 0.96 |
| Prior renal failure, N (%) | 0.16 | ||
| Yes | 1 (0%) | 59 (2%) | |
| No | 233 (100%) | 3643 (98%) | |
| Type of donor, N (%) | 0.17 | ||
| Living | 1 (0%) | 57 (2%) | |
| Deceased | 233 (100%) | 3645 (98%) | |
| Calendar year at transplantation, median (IQR) | 2009 (2007–2011) | 2008 (2005–2011) | <0.001 |
| Transplant center volumea | <0.001 | ||
| <150 | 70 (30%) | 1078 (29%) | |
| 299-150 | 20 (9%) | 1737 (47%) | |
| ≥300 | 144 (62%) | 887 (24%) | |
| Total tumor volume, median (IQR) | 7.7 (4.2–15.7) | 7.2 (2.9–15.6) | 0.13 |
| Met Milan criteria, N (%) | <0.001 | ||
| Yes | 209 (89%) | 3526 (95%) | |
| No | 25 (11%) | 176 (5%) | |
| AFP in ng/mL, median (IQR)b | 13 (5–55) | 11 (5–40) | 0.33 |
| AFP <500 ng/mL, N (%)b | 0.54 | ||
| Yes | 210 (94%) | 3219 (95%) | |
| No | 13 (6%) | 166 (5%) | |
| Allocation MELD score, median (IQR)c | 25 (22–25) | 24 (22–28) | 0.12 |
| Calculated MELD score, median (IQR)c | 13 (10–16) | 12 (9–16) | 0.04 |
| Serum creatinine in mg/dL, median (IQR)c | 0.9 (0.7–1.1) | 0.9 (0.7–1.1) | 0.95 |
| Bilirubin in mg/dL, median (IQR)c | 1.8 (1.2–2.8) | 1.6 (1.0–2.7) | 0.08 |
| INR, median (IQR)c | 1.4 (1.2–1.5) | 1.3 (1.1–1.5) | 0.002 |
| Anti-IL2 induction therapy | |||
| Yes | 168 (72%) | 1821 (49%) | |
| No | 66 (28%) | 1881 (51%) | <0.001 |
| Polyclonal antibody induction therapy | |||
| Yes | 16 (7%) | 294 (8%) | |
| No | 218 (93%) | 3408 (92%) | 0.54 |
| Days from transplant to first sirolimus claim, median (IQR) | 6 (5–15) | - | |
| Outcomes following transplantation | |||
| Deaths, N | 47 | 832 | |
| Rate per 100 person-years (95% CI) | 6.43 (4.73–8.56) | 6.03 (5.63–6.45) | |
| Cancer-Specific Deaths, N | 13 | 271 | |
| Rate per 100 person-years (95% CI) | 1.78 (0.95–3.04) | 1.96 (1.74–2.21) | |
| Recurrences, N | 11 | 231 | |
| Rate per 100 person-years (95% CI) | 1.54 (0.77–2.75) | 1.71 (1.50–1.95) | |
Chi-squared tests were used to calculate p-values for categorical variables. Wilcoxon rank-sum tests were used to calculate p-values for continuous variables.
a
Transplant center volume was measured as the number of liver transplants done for recipients with a hepatocellular carcinoma diagnosis between 2002 and 2012
b
328 recipients (8.3%) did not have information on AFP.
c
Values were based on most recent measurement/score prior to liver transplantation.
IQR=interquartile range, AFP=alpha-fetoprotein, MELD=Model for End-Stage Liver Disease, INR=international normalized ratio