Z Gastroenterol 2018; 56(01): E2-E89
DOI: 10.1055/s-0037-1612809
Poster Visit Session IV Tumors, Liver Surgery and Transplantation – Saturday, January 27, 2018, 8:30am – 9:15am, Foyer area West Wing
Georg Thieme Verlag KG Stuttgart · New York

Regorafenib after progression on Sorafenib for advanced HCC

J von Felden
1   Universitätsklinikum Hamburg-Eppendorf, 1. Medizinische Klinik und Poliklinik, Hamburg
,
K Schulze
1   Universitätsklinikum Hamburg-Eppendorf, 1. Medizinische Klinik und Poliklinik, Hamburg
,
H Ittrich
2   Universitätsklinikum Hamburg-Eppendorf, Diagnostische und Interventionelle Radiologie, Hamburg
,
I Gil-Ibanez
1   Universitätsklinikum Hamburg-Eppendorf, 1. Medizinische Klinik und Poliklinik, Hamburg
,
T Fründt
1   Universitätsklinikum Hamburg-Eppendorf, 1. Medizinische Klinik und Poliklinik, Hamburg
,
J Krause
1   Universitätsklinikum Hamburg-Eppendorf, 1. Medizinische Klinik und Poliklinik, Hamburg
,
K Karkmann
1   Universitätsklinikum Hamburg-Eppendorf, 1. Medizinische Klinik und Poliklinik, Hamburg
,
A Lohse
1   Universitätsklinikum Hamburg-Eppendorf, 1. Medizinische Klinik und Poliklinik, Hamburg
,
H Wege
1   Universitätsklinikum Hamburg-Eppendorf, 1. Medizinische Klinik und Poliklinik, Hamburg
› Author Affiliations
Further Information

Publication History

Publication Date:
03 January 2018 (online)

Also available at
 

Background/Aim:

Advanced hepatocellular carcinoma (HCC) with distant metastasis or macrovascular invasion (BCLC stage C) has a dismal prognosis. Especially treatment after progression on first-line Sorafenib (SOR) remains challenging. Recently, the RESORCE trial tested Regorafenib (REG) superior to placebo as second-line treatment in terms of overall survival (OS, 10.6 vs. 7.8 months) and progression free survival (PFS, 3.1 vs. 1.5 months), despite a high prevalence of treatment-emergent adverse events (AE) (Bruix et al, Lancet 2017). The aim of our single center study was to investigate the real-life outcomes of REG treatment after progression on SOR in patients with advanced HCC.

Methods:

Eight patients with advanced HCC (BCLC stage C) who started REG after progression on SOR at the University Medical Center Hamburg-Eppendorf between September 2016 and June 2017 were prospectively followed. Primary endpoint was efficacy assessed with OS and PFS according to mRECIST. The secondary endpoint was safety.

Results:

The cohort contained 62.5% male patients. 50% of patients had liver cirrhosis. All patients progressed on first-line SOR with a median PFS of 9 months. Two patients received subsequent treatment with intravenous Doxorubicin-Transdrug within a clinical trial (NCT01655693) prior to REG. At start of REG, all patients had compensated liver function and were ECOG 0 – 1, median AFP was 258 kIU/l (range 2 – 5282). All patients were initially titrated to a maximum REG dose of 160 mg/d (three weeks on treatment followed by one week off). Median OS was not reached (median follow-up 7.8 months, range 1.0 – 11.3). Median PFS on REG was 5.7 months, with two patients still on treatment (duration to date 3.1 and 10.1 months, respectively). 88% of patients had ≥1 AE, predominantly hand-foot skin reaction (50%), hypertension (25%), diarrhea (25%), stomatitis (25%) and fatigue (13%), ranging from CTCAE grade 1 – 3. One death on treatment occurred. Dose-adjustments of REG due to AE were necessary in three patients (38%).

Conclusions:

In this single center real-life cohort, REG showed good efficacy (median OS not reached, PFS 5.7 months vs. 3.1 months in the RESORCE trial) and acceptable safety with highly frequent (88%), but mostly low-grade AE. Despite one death, no cessation of treatment due to AE was necessary.