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 3 Efficacy results for patients in ITT population.
Event | ITT population who entered follow-up study | ITT population in core study | ||||
---|---|---|---|---|---|---|
EVR+rTACN=41n (KM rate%) | sTACN=45n (KM rate%) | EVR+rTAC vs sTAC(Difference [%], 95% CI) | EVR+rTACN=56n (KM rate%) | sTACN=61n (KM rate%) | EVR+rTAC vs sTAC(Difference [%], 95% CI) | |
HCC recurrence | 1 (2.4) | 3 (6.7) | −4.2 (−12.9, 4.5) | 2 (4.4) | 7 (12.3) | −8.0 (−18.4, 2.5) |
GL | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
Death | 2 (4.9) | 4 (8.9) | −4.0 (−14.6, 6.6) | 7 (13.8) | 7 (13.5) | 0.3 (−13.1, 13.7) |
AR/CR | 2 (4.9) | 3 (7.1) | −2.2 (−12.4, 8.0) | 4 (7.6) | 3 (6.2) | 1.4 (−8.6, 11.3) |
AR/CR/GL/death | 3 (7.3) | 7 (15.7) | −8.4 (−21.8, 4.9) | 9 (17.0) | 10 (19.3) | −2.2 (−17.2, 12.7) |
HCC recurrence | 1 (2.4) | 3 (6.7) | −4.2 (−12.9, 4.5) | 2 (4.4) | 7 (12.3) | −8.0 (−18.4, 2.5) |
GL | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
Death | 2 (4.9) | 3 (6.7) | −1.8 (−11.6, 8.0) | 7 (13.8) | 6 (11.4) | 2.4 (−10.5, 15.3) |
AR/CR | 2 (4.9) | 2 (4.4) | 0.4 (−8.5, 9.4) | 4 (7.6) | 2 (3.5) | 4.0 (−4.5, 12.6) |
AR/CR/GL/death | 3 (7.3) | 5 (11.1) | −3.8 (−16.0, 8.4) | 9 (17.0) | 8 (14.8) | 2.2 (−11.8, 16.2) |
HCC recurrence | 1 (2.4) | 2 (4.4) | −2.0 (−9.7, 5.6) | 2 (4.4) | 6 (10.2) | −5.9 (−15.7, 3.9) |
GL | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
Death | 0 (0.0) | 1 (2.2) | −2.2 (−6.5, 2.1) | 5 (9.3) | 4 (7.2) | 2.2 (−8.2, 12.5) |
AR/CR | 2 (4.9) | 2 (4.4) | 0.4 (−8.5, 9.4) | 4 (7.6) | 2 (3.5) | 4.0 (−4.5, 12.6) |
AR/CR/GL/death | 2 (4.9) | 3 (6.7) | −1.8 (−11.6, 8.0) | 8 (14.9) | 6 (10.6) | 4.3 (−8.2, 16.7) |
KM rate and 95% CI for each treatment are obtained using KM estimates and standard error derived based on Greenwood’s formula; 95% CI for difference from z-test statistic for no difference. AR – acute rejection; CI – confidence interval; CR – chronic rejection; D – death, EVR – everolimus; GL – graft loss; HCC – hepatocellular carcinoma; ITT – intent-to-treat; KM – Kaplan Meier; n – number of patients with event; N – the total number of patients in the treatment group; rTAC – reduced-dose tacrolimus; sTAC – standard-dose tacrolimus. |