BACKGROUND: We report long-term outcomes and side effects after transplantation for hepatocellular carcinoma (HCC) using de novo, sirolimus-based immunosuppression (IS). METHODS: A total of 70 patients with HCC (mean age: 54.4+/-7 years, female/male: 12/58) were transplanted and included in the study. Immunosuppression included de novo sirolimus, low-dose calcineurin inhibitor for 6 to 12 months, with short-course (3 months) or no steroids. RESULTS: After 49 months-median follow-up, eight patients have experienced an HCC recurrence, 2 of 34 when Milan criteria were respected (6%) and 6 of 36 when beyond Milan criteria (17%). One- and 4-year tumor-free survivals were 85 and 73%, when Milan criteria were respected and 82% and 75% when they were not, respectively. (P=0.9). After recurrence, mean survival was 23+/-28 months. Half (35 of 70) of the patients experienced a rejection. Incisional hernia (24 of 70, 34%), wound infection (12 of 70, 17%), anemia (39 of 70, 56%), leucopenia (39 of 70, 56%), high triglyceride (43 of 70, 61%), and cholesterol (28 of 70, 40%) levels and mouth ulcers (20 of 70, 29%) were among the most frequent complications. No hepatic artery thrombosis was observed. CONCLUSIONS: These data suggest that de novo sirolimus-based immunosuppression is associated with satisfactory outcomes after transplantation, even in selected patients beyond Milan criteria. The protocol has proven safe, with an acceptable side-effect profile. This study supports the conduct of larger randomized trials investigating sirolimus after transplantation for HCC.
BACKGROUND: We report long-term outcomes and side effects after transplantation for hepatocellular carcinoma (HCC) using de novo, sirolimus-based immunosuppression (IS). METHODS: A total of 70 patients with HCC (mean age: 54.4+/-7 years, female/male: 12/58) were transplanted and included in the study. Immunosuppression included de novo sirolimus, low-dose calcineurin inhibitor for 6 to 12 months, with short-course (3 months) or no steroids. RESULTS: After 49 months-median follow-up, eight patients have experienced an HCC recurrence, 2 of 34 when Milan criteria were respected (6%) and 6 of 36 when beyond Milan criteria (17%). One- and 4-year tumor-free survivals were 85 and 73%, when Milan criteria were respected and 82% and 75% when they were not, respectively. (P=0.9). After recurrence, mean survival was 23+/-28 months. Half (35 of 70) of the patients experienced a rejection. Incisional hernia (24 of 70, 34%), wound infection (12 of 70, 17%), anemia (39 of 70, 56%), leucopenia (39 of 70, 56%), high triglyceride (43 of 70, 61%), and cholesterol (28 of 70, 40%) levels and mouth ulcers (20 of 70, 29%) were among the most frequent complications. No hepatic artery thrombosis was observed. CONCLUSIONS: These data suggest that de novo sirolimus-based immunosuppression is associated with satisfactory outcomes after transplantation, even in selected patients beyond Milan criteria. The protocol has proven safe, with an acceptable side-effect profile. This study supports the conduct of larger randomized trials investigating sirolimus after transplantation for HCC.
Authors: M Sherman; K Burak; J Maroun; P Metrakos; J J Knox; R P Myers; M Guindi; G Porter; J R Kachura; P Rasuli; S Gill; P Ghali; P Chaudhury; J Siddiqui; D Valenti; A Weiss; R Wong Journal: Curr Oncol Date: 2011-10 Impact factor: 3.677
Authors: Anna Rossetto; Umberto Baccarani; Gian Luigi Adani; Dario Lorenzin; Vittorio Bresadola; Giovanni Terrosu Journal: Updates Surg Date: 2010-12-22
Authors: Francesco Bellissimo; Marilia Rita Pinzone; Bruno Cacopardo; Giuseppe Nunnari Journal: World J Gastroenterol Date: 2015-11-14 Impact factor: 5.742
Authors: Andreas A Schnitzbauer; Carl Zuelke; Christian Graeb; Justine Rochon; Itxarone Bilbao; Patrizia Burra; Koert P de Jong; Christophe Duvoux; Norman M Kneteman; Rene Adam; Wolf O Bechstein; Thomas Becker; Susanne Beckebaum; Olivier Chazouillères; Umberto Cillo; Michele Colledan; Fred Fändrich; Jean Gugenheim; Johann P Hauss; Michael Heise; Ernest Hidalgo; Neville Jamieson; Alfred Königsrainer; Philipp E Lamby; Jan P Lerut; Heikki Mäkisalo; Raimund Margreiter; Vincenzo Mazzaferro; Ingrid Mutzbauer; Gerd Otto; Georges-Philippe Pageaux; Antonio D Pinna; Jacques Pirenne; Magnus Rizell; Giorgio Rossi; Lionel Rostaing; Andre Roy; Victor Sanchez Turrion; Jan Schmidt; Roberto I Troisi; Bart van Hoek; Umberto Valente; Philippe Wolf; Heiner Wolters; Darius F Mirza; Tim Scholz; Rudolf Steininger; Gunnar Soderdahl; Simone I Strasser; Karl-Walter Jauch; Peter Neuhaus; Hans J Schlitt; Edward K Geissler Journal: BMC Cancer Date: 2010-05-11 Impact factor: 4.430