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Ramucirumab in patients with previously treated advanced hepatocellular carcinoma: Impact of liver disease etiology |
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Liver Int. 2021 Jun 26. doi: 10.1111/liv.14994. Online ahead of print.
Peter R Galle 1, Masatoshi Kudo 2, Josep M Llovet 3 4 5, Richard S Finn 6, Mark Karwal 7, Denis Pezet 8, Tae-You Kim 9, Tsai-Sheng Yang 10, Sara Lonardi 11, Jiri Tomasek 12, Jean-Marc Phelip 13, Yann Touchefeu 14, Su-Jin Koh 15, Guido Stirnimann 16, Kun Liang 17, Kenyon D Ogburn 17, Chunxiao Wang 17, Paolo Abada 17, Ryan C Widau 17, Andrew X Zhu 18 19
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Author information
- 1University Medical Center, Mainz, Germany.
- 2Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.
- 3Mount Sinai Liver Cancer Program, Division of Liver Diseases, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
- 4Translational Research in Hepatic Oncology, Liver Unit, IDIBAPS, Hospital Clinic, University of Barcelona, Catalonia, Spain.
- 5Institució Catalana d'Estudis Avançats (ICREA), Barcelona, Catalonia, Spain.
- 6University of California, Los Angeles, California, USA.
- 7University of Iowa Hospitals and Clinics, University of Iowa Health Care, Iowa City, IA, USA.
- 8Estaing Hospital, Aubrac, Clermont-Ferrand, France.
- 9Seoul National University Hospital, Seoul, Korea.
- 10Chang Gung Memorial Hospital, Taoyuan, Taiwan, China.
- 11Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.
- 12Masaryk Memorial Cancer Institute, Masaryk University, Brno, Czech Republic.
- 13University Hospital Saint-Etienne North, Saint Etienne, France.
- 14CHU Hôtel-Dieu, Nantes, France.
- 15Division of Hematology and Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
- 16University Hospital Inselspital and University of Bern, Bern, Switzerland.
- 17Eli Lilly and Company, Indianapolis, IN, USA.
- 18Massachusetts General Hospital Cancer Center, Boston, MA, USA.
- 19Jiahui International Cancer Center, Jiahui Health, Shanghai, China.
Abstract
Background & aims: Hepatocellular carcinoma (HCC) is a common complication of chronic liver disease with diverse underlying etiologies. REACH/REACH-2 were global phase III studies investigating ramucirumab in advanced HCC (aHCC) following sorafenib treatment. We performed an exploratory analysis of outcomes by liver disease etiology and baseline serum viral load.
Methods: Meta-analysis was conducted in patients with aHCC and alpha-fetoprotein (AFP) ≥400 ng/mL (N=542) from REACH/REACH-2 trials. Individual patient-level data were pooled with results reported by etiology subgroup (hepatitis B [HBV] or C [HCV] and Other). Pretreatment serum HBV-DNA and HCV-RNA were quantified using Roche COBAS AmpliPrep/COBAS TaqMan. Overall survival (OS) and progression-free survival (PFS) were evaluated using the Kaplan-Meier method and Cox proportional hazard model (stratified by study).
Results: Baseline characteristics were generally balanced between arms in each subgroup (HBV: N=225, HCV: N=127, Other: N=190). No significant difference in treatment effect by etiology subgroup was detected (OS interaction p-value= 0.23). Median OS (ramucirumab vs placebo) in months was 7.7 versus 4.5 (HR 0.74; 95% CI 0.55-0.99) for HBV, 8.2 versus 5.5 (HR 0.82; 95% CI 0.55-1.23) for HCV, and 8.5 versus 5.4 (HR 0.56; 95% CI 0.40-0.79) for Other. Ramucirumab showed similar overall safety profiles across subgroups. Worst outcomes were noted in patients with a detectable HBV load. Use of HBV antiviral therapy, irrespective of viral load, was beneficial for survival, liver function, and liver-specific adverse events.
Conclusions: Ramucirumab improved survival across etiology subgroups with a tolerable safety profile, supporting its use in patients with aHCC and elevated AFP.
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