Ramucirumab in patients with previously treated advanced hepatocellular carcinoma: Impact of liver disease aetiology
| Autor: | Josep M. Llovet, Peter R. Galle, Paolo Abada, Sara Lonardi, Jiri Tomasek, Su Jin Koh, Guido Stirnimann, Richard S. Finn, Masatoshi Kudo, Jean-Marc Phelip, Tae-You Kim, Ryan C. Widau, Mark Karwal, Tsai Sheng Yang, Kenyon D. Ogburn, Denis Pezet, Andrew X. Zhu, Yann Touchefeu, Chunxiao Wang, Kun Liang |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Carcinoma Hepatocellular 610 Medizin 610 Medicine & health Chronic liver disease Antibodies Monoclonal Humanized Gastroenterology Ramucirumab 03 medical and health sciences Liver disease 0302 clinical medicine 610 Medical sciences Internal medicine Medicine Humans 030304 developmental biology 0303 health sciences Hepatology business.industry Liver Neoplasms Hepatitis C Hepatitis B medicine.disease digestive system diseases 3. Good health Clinical Trials Phase III as Topic 030220 oncology & carcinogenesis Hepatocellular carcinoma Liver function business Viral load |
| Zdroj: | Galle, Peter R; Kudo, Masatoshi; Llovet, Josep M; Finn, Richard S; Karwal, Mark; Pezet, Denis; Kim, Tae-You; Yang, Tsai-Sheng; Lonardi, Sara; Tomasek, Jiri; Phelip, Jean-Marc; Touchefeu, Yann; Koh, Su-Jin; Stirnimann, Guido; Liang, Kun; Ogburn, Kenyon D; Wang, Chunxiao; Abada, Paolo; Widau, Ryan C and Zhu, Andrew X (2021). Ramucirumab in patients with previously treated advanced hepatocellular carcinoma: Impact of liver disease aetiology. Liver international, 41(11), pp. 2759-2767. Wiley 10.1111/liv.14994 |
| Popis: | BACKGROUND & AIMS Hepatocellular carcinoma (HCC) is a common complication of chronic liver disease with diverse underlying aetiologies. 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 aetiology 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 aetiology subgroup (hepatitis B [HBV] or C [HCV] and Other). Pre-treatment 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 aetiology subgroup was detected (OS interaction P-value = .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 aetiology subgroups with a tolerable safety profile, supporting its use in patients with aHCC and elevated AFP. |
| Databáze: | OpenAIRE |
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