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@article{1673183, author = {Kudo, M. and Galle, P. R. and Llovet, J. M. and Finn, R. S. and Vogel, A. and Motomura, K. and Assenat, E. and Merle, P. and Brandi, G. and Daniele, B. and Okusaka, T. and Tomášek, Jiří and Borg, C. and Dadduzio, V. and Morimoto, M. and Pracht, M. and Jen, M. H. and Ubreva, N. D. and Widau, R. C. and Shinozaki, K. and Yoshikawa, R. and Zhu, A. X.}, article_location = {Hoboken}, article_number = {8}, doi = {http://dx.doi.org/10.1111/liv.14462}, keywords = {alpha-fetoprotein (AFP); elderly; hepatocellular carcinoma; ramucirumab; sorafenib intolerance; VEGFR2}, language = {eng}, issn = {1478-3223}, journal = {Liver International}, title = {Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2}, url = {https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/liv.14462}, volume = {40}, year = {2020} }
TY - JOUR ID - 1673183 AU - Kudo, M. - Galle, P. R. - Llovet, J. M. - Finn, R. S. - Vogel, A. - Motomura, K. - Assenat, E. - Merle, P. - Brandi, G. - Daniele, B. - Okusaka, T. - Tomášek, Jiří - Borg, C. - Dadduzio, V. - Morimoto, M. - Pracht, M. - Jen, M. H. - Ubreva, N. D. - Widau, R. C. - Shinozaki, K. - Yoshikawa, R. - Zhu, A. X. PY - 2020 TI - Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2 JF - Liver International VL - 40 IS - 8 SP - 2008-2020 EP - 2008-2020 PB - John Viley & Sons SN - 14783223 KW - alpha-fetoprotein (AFP) KW - elderly KW - hepatocellular carcinoma KW - ramucirumab KW - sorafenib intolerance KW - VEGFR2 UR - https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/liv.14462 L2 - https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/liv.14462 N2 - Background & Aims Limited data on treatment of elderly patients with hepatocellular carcinoma (HCC) increase the unmet need. REACH and REACH-2 were global phase III studies of ramucirumab in patients with HCC after prior sorafenib, where patients with alpha-fetoprotein (AFP) >= 400 ng/mL showed an overall ssurvival (OS) benefit for ramucirumab. These post-hoc analyses examined efficacy and safety of ramucirumab in patients with HCC and baseline AFP >= 400 ng/mL by three prespecified age subgroups (<65, >= 65 to <75 and >= 75 years). Methods Individual patient data were pooled from REACH (baseline AFP >= 400 ng/mL) and REACH-2. Kaplan-Meier and Cox proportional hazards regression methods (stratified by study) assessed OS, progression-free survival (PFS), time to progression (TTP) and patient-reported outcomes (Functional Hepatobiliary System Index-8 [FHSI-8] score). Results A total of 542 patients (<65 years: n = 302; >= 65 to <75 years: n = 160; >= 75 years: n = 80) showed similar baseline characteristics between ramucirumab and placebo. Older subgroups had higher hepatitis C and steatohepatitis incidences, and lower AFP levels, than the <65 years subgroup. Ramucirumab prolonged OS in patients <65 years (hazard ratio [HR], 0.753; 95% CI 0.581-0.975), >= 65 to <75 years (0.602; 0.419-0.866) and >= 75 years (0.709; 0.420-1.199), PFS and TTP irrespective of age. Ramucirumab showed similar overall safety profiles across subgroups, with a consistent median relative dose intensity >= 97.8%. A trend towards a delay in symptom deterioration in FHSI-8 with ramucirumab was observed in all subgroups. Conclusions In this post-hoc analysis, ramucirumab showed a survival benefit across age subgroups with a tolerable safety profile, supporting its use in advanced HCC with elevated AFP, irrespective of age, including >= 75 years. ER -
KUDO, M., P. R. GALLE, J. M. LLOVET, R. S. FINN, A. VOGEL, K. MOTOMURA, E. ASSENAT, P. MERLE, G. BRANDI, B. DANIELE, T. OKUSAKA, Jiří TOMÁŠEK, C. BORG, V. DADDUZIO, M. MORIMOTO, M. PRACHT, M. H. JEN, N. D. UBREVA, R. C. WIDAU, K. SHINOZAKI, R. YOSHIKAWA a A. X. ZHU. Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2. \textit{Liver International}. Hoboken: John Viley \&{} Sons, 2020, roč.~40, č.~8, s.~2008-2020. ISSN~1478-3223. Dostupné z: https://dx.doi.org/10.1111/liv.14462.
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