Sorafenib use for recurrent hepatocellular cancer after resection or transplantation: Observations from a US regional analysis of the GIDEON registry.
Treatment of unresectable recurrent hepatocellular carcinoma (HCC) in patients who recur after resection or orthotopic liver transplantation (OLT) remains a clinical challenge. One option is sorafenib, although little is known about its safety and tolerance in this unique patient population; therefore, we analyzed patients who underwent prior surgical resection and/or OLT and were treated with sorafenib in US cohort of GIDEON registry. In US, 645 patients were enrolled; 553 for intent to treat and 563 for safety. Data were analyzed in the safety population of 479 patients no surgery and 56 for resection or OLT. Forty-one patients underwent resection prior to the initiation of sorafenib, 15 patients had previously received an OLT, and 6 patients had both resection and OLT. Initial low starting doses (400 mg/day) were observed for more patients with prior OLT (71%) than prior resection (36%), resection and OLT (50%), concomitant OLT (25%), and no surgery (36%). Most AEs occurred in the first 4 weeks of treatment. Drug-related AEs were higher in patients with prior resection (87%), prior OLT (100%), or both (100%) than in patients with concomitant OLT (63%) or no surgery (70%). However, incidence of AEs resulting in permanent discontinuation were similar in all groups (19-38%).
University of Louisville, 315 E. Broadway, #312, Louisville, KY 40202, USA. Electronic address: robert.martin@louisville.edu.
Robert C G
RC
Martin
Department of Surgery, University of Louisville, Louisville, KY, USA.
Elizabeth
E
Bruenderman
Rocky Mountain Cancer Center - US Oncology, 1800 Williams Street, Denver, CO 80218, USA. Electronic address: allen.cohn@usoncology.com.
Allen
A
Cohn
Montefiore Medical Center, 200 Van Nest Avenue, Room 616, Bronx, NY 10461, USA. Electronic address: bpiperdi@montefiore.org.
Bilal
B
Piperdi
Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Shapiro 9, Boston, MA 02215, USA. Electronic address: rmiksad@bidmc.harvard.edu.
Rebecca
R
Miksad
Johns Hopkins University, Interventional Radiology Center, 1800 Orleans Street, Zayed 4203, Baltimore, MD 21287, USA. Electronic address: jfg@jhmi.edu.
Jean-Francois
JF
Geschwind
NYU Medical School, 157 E. 32nd Street, New York, NY 10016, USA. Electronic address: agoldenberg@mho-ny.com.
Alec
A
Goldenberg
Virginia Commonwealth University Medical Center, MCVH - West Hospital, 1200 E. Broad Street, W-14-W, Richmond, VA 23219, USA. Electronic address: asanyal@mcvh-vcu.edu.
Arun
A
Sanyal
Onyx Pharmaceuticals, An Amgen Subsidiary, 249 E Grand Ave, S San Francisco, CA 94080, USA. Electronic address: ezigmont@onyx.com.
Ellen
E
Zigmont
Bayer HealthCare Pharmaceuticals Inc., US Medical Affairs, Oncology, 100 Bayer Boulevard, PO Box 915, Whippany, NJ 07981-0915, USA. Electronic address: svetlana.babajanyan@bayer.com.
Svetlana
S
Babajanyan
Blue Ocean Pharma LLC, 4 Spring Hill Road, Annandale, NJ 08801, USA. Electronic address: pforeman@blueoceanpharma.com.
Pamela
P
Foreman
The Liver Institute at Methodist Dallas Medical Center, 1411 N. Beckley Avenue, Pavilion III, Suite 268, Dallas, TX 75203, USA. Electronic address: parvezmantry@mhd.com.
Parvez
P
Mantry
University of Alabama at Birmingham, 1530 Third Avenue South, MCLM 262, Birmingham, AL 35294-0005, USA. Electronic address: bmcguire@uab.edu.
Brendan
B
McGuire
Liver Center of Excellence, University Hospitals Case Medical Center, 2485 Wellington Road, Cleveland Heights, OH 44118, USA. Electronic address: pierre.gholam@case.edu.
Pierre
P
Gholam
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000628:therapy*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000401:mortality / Q000628:therapy*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D009536:Niacinamide / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000627:therapeutic use*; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D012042:Registries; D000077157:Sorafenib
D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D009536:Niacinamide; D000077157:Sorafenib
Hepatocellular cancer; Liver; Recurrence; Resection; Sorafenib; Transplantation; Treatment of recurrent cancer