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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.

EventITT population who entered follow-up studyITT 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 recurrence1 (2.4)3 (6.7)−4.2 (−12.9, 4.5)2 (4.4)7 (12.3)−8.0 (−18.4, 2.5)
 GL0 (0.0)0 (0.0)0 (0.0)0 (0.0)
 Death2 (4.9)4 (8.9)−4.0 (−14.6, 6.6)7 (13.8)7 (13.5)0.3 (−13.1, 13.7)
 AR/CR2 (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/death3 (7.3)7 (15.7)−8.4 (−21.8, 4.9)9 (17.0)10 (19.3)−2.2 (−17.2, 12.7)
 HCC recurrence1 (2.4)3 (6.7)−4.2 (−12.9, 4.5)2 (4.4)7 (12.3)−8.0 (−18.4, 2.5)
 GL0 (0.0)0 (0.0)0 (0.0)0 (0.0)
 Death2 (4.9)3 (6.7)−1.8 (−11.6, 8.0)7 (13.8)6 (11.4)2.4 (−10.5, 15.3)
 AR/CR2 (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/death3 (7.3)5 (11.1)−3.8 (−16.0, 8.4)9 (17.0)8 (14.8)2.2 (−11.8, 16.2)
 HCC recurrence1 (2.4)2 (4.4)−2.0 (−9.7, 5.6)2 (4.4)6 (10.2)−5.9 (−15.7, 3.9)
 GL0 (0.0)0 (0.0)0 (0.0)0 (0.0)
 Death0 (0.0)1 (2.2)−2.2 (−6.5, 2.1)5 (9.3)4 (7.2)2.2 (−8.2, 12.5)
 AR/CR2 (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/death2 (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.

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Annals of Transplantation eISSN: 2329-0358
Annals of Transplantation eISSN: 2329-0358