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Sorafenib Use After Prior Surgical Resection or Transplant in Hepatocellular Carcinoma: US Regional Analysis of Gideon
Robert C. Martin*1, Allen Cohn2, Jean-Francois Geschwind3, Alec Goldenberg4, Parvez S. Mantry5, Brendan M. Mcguire6, Rebecca Miksad7, Bilal Piperdi8, Arun J. Sanyal9, Alan Venook10, Ellen Zigmont11, Pierre M. Gholam12
1University of Louisville, Louisville, KY; 2Rocky Mountain Cancer Center - US Oncology, Denver, CO; 3Interventional Radiology Center, Johns Hopkins University, Baltimore, MD; 4NYU Medical School, New York, NY; 5The Liver Institute at Methodist Dallas Medical Center, Dallas, TX; 6University of Alabama at Birmingham, Birbingham, AL; 7Beth Israel Deaconess Medical Center, Boston, MA; 8Montefiore Medical Center, Bronx, NY; 9Virginia Commonwealth University Medical Center, Richmond, VA; 10University of California, San Francisco, San Francisco, CA; 11Onyx Pharmaceuticals, South San Francisco, CA; 12Liver Center of Excellence, University Hospitals Case Medical Center, Cleveland Heights, OH
Background: Experience using sorafenib (SOR) after prior surgical resection (PSR) or transplant (OLT) for recurrent hepatocellular carcinoma (HCC) is limited. GIDEON is a global, prospective, non-interventional study to evaluate SOR safety under real-life conditions. We aimed to examine US patients (pts) who received SOR for recurrent HCC after PSR or OLT. The GIDEON registry contains one of the largest data series collected in US pts.
Methods: Pts with unresectable HCC who were candidates for systemic therapy and for whom a decision was made to treat with SOR were eligible for inclusion; pts may have undergone PSR or OLT. Disease characteristics, safety, and treatment duration were evaluated. All results are descriptive.
Results: In the US, 563 pts were evaluable for safety. 53 had PSR, 27 had OLT, and 6 had both. Median time in months from PSR to start of SOR was 9.3 (range 0.7-61.3) and from OLT was 23.7 (range 1.2-78.3; data were missing for 7 [26%] pts). Median SOR doses were similar among all groups (Table). Grade 3/4 serious adverse events (SAEs) were 32%/8% for pts with PSR and 31%/6% without PSR; 4%/4% for pts with OLT and 14%/5% without OLT. Grade 3/4 drug-related SAEs (DRSAEs) were 42%/6% for pts with PSR and 20%/2% without PSR; 11%/4% for pts with OLT and 4%/1% without OLT. Treatment-emergent deaths occurred in 26% of PSR pts, 33% of pts without PSR, 22% of OLT pts, and 33% of pts without OLT. No drug-related deaths occurred in PSR or OLT patients (<1% overall). Median overall survival [95% confidence interval] in the ITT population (n=553) from start of SOR was 471 [284-689] days for PSR and 338 [234-910] days for OLT.
Conclusions: SOR after PSR or OLT was well tolerated in this real-life setting. PSR or OLT pts experienced a similar or reduced frequency of SAEs compared with those with no PSR or OLT. However, DRSAEs were more frequent. PSR and OLT pts had better preserved liver function and longer SOR treatment duration than those without. Safety profiles are consistent with SOR clinical trials with no new findings. Despite the small number of PSR and OLT pts, GIDEON represents the largest US experience currently available. | % (unless indicated otherwise) | Recurrent HCC After Resection n=53 | No Prior Resection n=510 | Recurrent HCC After OLT n=27 | No Prior OLT n=536 | | Etiology1: HBV/HCV/alcohol use | 25/40/17 | 13/57/42 | 22/63/44 | 14/54/54 | | BCLC stage at SOR initiation: A/B/C/D/NE | 8/15/42/4/32 | 10/12/36/13/292 | 4/4/37/11/44 | 10/13/36/12/293 | | Child-Pugh at SOR initiation: A/B/C/NE | 53/23/2/23 | 32/32/8/28 | 63/0/0/37 | 33/32/8/274 | | Max tumor size at SOR initiation: median (range) | 3.2 (0-13) | 5.2 (0-23) | 2.7 (0-10) | 5.0 (0-23) | | Extrahepatic spread at study entry | 40 | 29 | 70 | 28 | | AFP at SOR initiation: <400/≥400 | 60/195 | 49/346 | 59/117 | 49/348 | | Median average daily dose, mg (range) | 488 (200-800) | 546 (112-800) | 557 (209-800) | 526 (112-800) | | Median (range) treatment duration, months | 23 (1-110) | 12 (1-131) | 22 (1-112) | 12 (<1-131)9 | | 1May have more than 1; 2Missing for 1 pt; 3Missing for 1 pt; 4Missing for 1 pt; 5Unknown for 11 pts; 6Unknown for 86 pts; 7Unknown for 8 pts; 8Unknown for 90 pts; 9Missing for 12 pts. AFP, α-fetoprotein; BCLC, Barcelona Clinic Liver Cancer; HBV/HCV, hepatitis B/C virus; HCC, hepatocellular carcinoma; NE, not evaluable; OLT, orthotopic liver transplant; SOR, sorafenib. |
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