22 November 2022: Original Paper
Long-Term Effects of Everolimus-Facilitated Tacrolimus Reduction in Living-Donor Liver Transplant Recipients with Hepatocellular Carcinoma
Gonzalo Sapisochin 1ADE** , Wei Chen Lee 2ABCDE , Dong Jin Joo 3ABD , Jae-Won Joh 4ABE , Koichiro Hata 56BCDE , Arvinder Singh Soin 7ACDE , Uday Kiran Veldandi 8ABCDEF , Shuhei Kaneko 9ACDE , Matthias Meier 10ACDEG , Denise Leclair 11DE , Gangadhar Sunkara 11CDEF , Long Bin Jeng 12AB**DOI: 10.12659/AOT.937988
Ann Transplant 2022; 27:e937988
Table 1 Demographics and baseline characteristics in ITT patients who followed to the H2406 study.
| Characteristics | EVR+rTACN=41 | sTACN=45 |
|---|---|---|
| Age (years), mean (SD) | 56.3 (7.58) | 56.5 (7.27) |
| Male gender, n (%) | 33 (80.5) | 35 (77.8) |
| Race, n (%) | ||
| Caucasian | 3 (7.3) | 4 (8.9) |
| Asian | 38 (92.7) | 41 (91.1) |
| eGFR at randomization (mL/min/1.73 m), mean (SD) | 86.2 (30.79) | 76.6 (23.34) |
| BMI (kg/m), mean (SD) | 22.7 (3.27) | 24.0 (3.55) |
| HCV-positive, n (%) | 6 (14.6) | 12 (26.7) |
| HBV-positive, n (%) | 24 (58.5) | 20 (44.4) |
| Primary disease leading to transplant, n (%) | ||
| Alcoholic cirrhosis | 4 (9.8) | 3 (6.7) |
| Hepatitis B | 4 (9.8) | 6 (13.3) |
| Hepatitis C | 1 (2.4) | 3 (6.7) |
| HCC | 32 (78.0) | 32 (71.1) |
| NASH | 0 | 1 (2.2) |
| Diabetes at baseline, n (%) | 10 (24.4) | 17 (37.8) |
| MELD score category, n (%) | ||
| ≤14 | 32 (78.0) | 36 (80.0) |
| 15~19 | 5 (12.2) | 4 (8.9) |
| 20~24 | 3 (7.3) | 4 (8.9) |
| 25~29 | 0 | 1 (2.2) |
| ≥30 | 1 (2.4) | 0 |
| HCC at transplantation | ||
| Milan criteria, n (%) | 31 (75.6) | 32 (71.1) |
| Yes | 10 (24.4) | 12 (26.7) |
| No | 0 | 1 (2.2) |
| Missing | ||
| Tumor lymph node metastasis stage n (%)* | ||
| Stage I | 13 (31.7) | 11 (24.4) |
| Stage II | 15 (36.6) | 19 (42.2) |
| Others** | 2 (4.9) | 3 (6.7) |
| Missing | 11 (26.8) | 12 (26.7) |
| Number of lesions, mean (SD) | 2.6 (3.59) | 2.4 (2.33) |
| Diameter of largest tumor (cm), mean (SD) | 2.5 (1.51) | 2.8 (1.73) |
| Total tumor diameter (cm), mean (SD) | 3.6 (3.20) | 4.5 (4.11) |
| AFP level (μg/mL), Median (Min–Max) | 14.4 (1.0–479.3) | 5.7 (0.1–37088.0) |
| TNM classification criteria, developed jointly by the American Joint Committee on Cancer and the International Union for Cancer Control, assesses primary tumor features, the presence or absence of nodal involvement and distant metastasis for tumor staging as per AJCC Cancer Staging Manual; 2017 Ed. * Collected pre-LT or at LT; ** includes TNM category IIIA–IVB. AFP – alpha fetoprotein; BMI – body mass index; eGFR – estimated glomerular filtration rate; EVR – everolimus; HBV – hepatitis B virus; HCC – hepatocellular carcinoma; HCV – hepatitis C virus; ITT – intent-to-treat; LT – liver transplantation; MELD – model for end-stage liver disease; n – number of subjects with event; N – the number of subjects in the treatment group; NASH – non-alcoholic steatohepatitis; sTAC – standard dose tacrolimus; SD – standard deviation; TNM – tumor lymph node metastasis. | ||