Safety and efficacy of lenvatinib by starting dose based on body weight in patients with unresectable hepatocellular carcinoma in REFLECT.

"Declarations Conflict of interestTakuji Okusaka: reports research funding from Novartis Pharma, AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd, Bristol Myers K.K., and Baxter. Kenji Ikeda: reports no conflicts of interest. Masatoshi Kudo: reports advisory role for Eisai Co., Ltd, Ono, MSD, Bristol Myers Squibb, and Roche; honoraria from Eisai Co., Ltd, Bayer, MSD, Bristol Myers Squib, Lilly, and EA Pharma; grants from Gilead Sciences, Taiho, Sumitomo Dainippon Pharma, Takeda, Otsuka, EA Pharma, Abbvie, and Eisai Co., Ltd. Richard S. Finn: reports honoraria from Eisai and Merck. Shukui Qin reports no conflicts of interest. Kwang-Hyub Han: reports no conflicts of interest. Ann-Lii Cheng: reports honoraria from AstraZeneca, Bristol-Myers Squibb, Eisai, Merck Serono, Novartis, Ono Pharmaceutical, Exelixis, Nucleix, IPSEN Innovation, Bayer Healthcare, Merck Sharp & Dohme, Roche/Genentech, BeiGene, CSR Pharma Group, F. Hoffmann-La Roche, and IQVIA. Fabio Piscaglia: reports honoraria from Alkermes, AstraZeneca, Bayer, Bracco, Bristol Myers Squibb, Eisai, GE, Ipsen, La Force Guerbet, Roche, Siemens Healthcare, and Tiziana Life Sciences; research contract with Esaote. Masahiro Kobayashi: reports honoraria from Eisai Co., Ltd. Max W. Sung: reports honoraria from Eisai, AstraZeneca, Bayer. Minshan Chen: reports no conflicts of interest. Lucjan Wyrwicz: reports no conflicts of interest. Jung-Hwan Yoon: reports research grants from AstraZeneca, Bayer HealthCare Pharmaceuticals, Daewoong Pharmaceuticals, and Bukwang Pharmaceuticals. Zhenggang Ren: reports no conflicts of interest. Kalgi Mody: employee of Eisai Inc., Woodcliff, NJ, USA. Corina E. Dutcus: employee of Eisai Inc., Woodcliff, NJ, USA. Toshiyuki Tamai: employee of Eisai Co. Ltd, Tokyo, Japan. Min Ren: employee of Eisai Inc., Woodcliff, NJ, USA. Seiichi Hayato: employee of Eisai Co. Ltd, Tokyo, Japan. Hiromitsu Kumada: reports honoraria from MSD, Sumitomo Dainippon, AbbVie, Gilead Sciences, Inc., and Eisai. Conflict of interest Takuji Okusaka: reports research funding from Novartis Pharma, AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd, Bristol Myers K.K., and Baxter. Kenji Ikeda: reports no conflicts of interest. Masatoshi Kudo: reports advisory role for Eisai Co., Ltd, Ono, MSD, Bristol Myers Squibb, and Roche; honoraria from Eisai Co., Ltd, Bayer, MSD, Bristol Myers Squib, Lilly, and EA Pharma; grants from Gilead Sciences, Taiho, Sumitomo Dainippon Pharma, Takeda, Otsuka, EA Pharma, Abbvie, and Eisai Co., Ltd. Richard S. Finn: reports honoraria from Eisai and Merck. Shukui Qin reports no conflicts of interest. Kwang-Hyub Han: reports no conflicts of interest. Ann-Lii Cheng: reports honoraria from AstraZeneca, Bristol-Myers Squibb, Eisai, Merck Serono, Novartis, Ono Pharmaceutical, Exelixis, Nucleix, IPSEN Innovation, Bayer Healthcare, Merck Sharp & Dohme, Roche/Genentech, BeiGene, CSR Pharma Group, F. Hoffmann-La Roche, and IQVIA. Fabio Piscaglia: reports honoraria from Alkermes, AstraZeneca, Bayer, Bracco, Bristol Myers Squibb, Eisai, GE, Ipsen, La Force Guerbet, Roche, Siemens Healthcare, and Tiziana Life Sciences; research contract with Esaote. Masahiro Kobayashi: reports honoraria from Eisai Co., Ltd. Max W. Sung: reports honoraria from Eisai, AstraZeneca, Bayer. Minshan Chen: reports no conflicts of interest. Lucjan Wyrwicz: reports no conflicts of interest. Jung-Hwan Yoon: reports research grants from AstraZeneca, Bayer HealthCare Pharmaceuticals, Daewoong Pharmaceuticals, and Bukwang Pharmaceuticals. Zhenggang Ren: reports no conflicts of interest. Kalgi Mody: employee of Eisai Inc., Woodcliff, NJ, USA. Corina E. Dutcus: employee of Eisai Inc., Woodcliff, NJ, USA. Toshiyuki Tamai: employee of Eisai Co. Ltd, Tokyo, Japan. Min Ren: employee of Eisai Inc., Woodcliff, NJ, USA. Seiichi Hayato: employee of Eisai Co. Ltd, Tokyo, Japan. Hiromitsu Kumada: reports honoraria from MSD, Sumitomo Dainippon, AbbVie, Gilead Sciences, Inc., and Eisai."

"This study was funded by Eisai Inc., Woodcliff, NJ, USA, and also by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Medical writing support was provided by Heather A. Mitchell, PhD, Oxford PharmaGenesis Inc., Newtown, PA, USA, and was funded by Eisai Inc., Woodcliff, NJ, USA, and also by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Declarations: Conflict of interestTakuji Okusaka: reports research funding from Novartis Pharma, AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd, Bristol Myers K.K., and Baxter. Kenji Ikeda: reports no conflicts of interest. Masatoshi Kudo: reports advisory role for Eisai Co., Ltd, Ono, MSD, Bristol Myers Squibb, and Roche; honoraria from Eisai Co., Ltd, Bayer, MSD, Bristol Myers Squib, Lilly, and EA Pharma; grants from Gilead Sciences, Taiho, Sumitomo Dainippon Pharma, Takeda, Otsuka, EA Pharma, Abbvie, and Eisai Co., Ltd. Richard S. Finn: reports honoraria from Eisai and Merck. Shukui Qin reports no conflicts of interest. Kwang-Hyub Han: reports no conflicts of interest. Ann-Lii Cheng: reports honoraria from AstraZeneca, Bristol-Myers Squibb, Eisai, Merck Serono, Novartis, Ono Pharmaceutical, Exelixis, Nucleix, IPSEN Innovation, Bayer Healthcare, Merck Sharp & Dohme, Roche/Genentech, BeiGene, CSR Pharma Group, F. Hoffmann-La Roche, and IQVIA. Fabio Piscaglia: reports honoraria from Alkermes, AstraZeneca, Bayer, Bracco, Bristol Myers Squibb, Eisai, GE, Ipsen, La Force Guerbet, Roche, Siemens Healthcare, and Tiziana Life Sciences; research contract with Esaote. Masahiro Kobayashi: reports honoraria from Eisai Co., Ltd. Max W. Sung: reports honoraria from Eisai, AstraZeneca, Bayer. Minshan Chen: reports no conflicts of interest. Lucjan Wyrwicz: reports no conflicts of interest. Jung-Hwan Yoon: reports research grants from AstraZeneca, Bayer HealthCare Pharmaceuticals, Daewoong Pharmaceuticals, and Bukwang Pharmaceuticals. Zhenggang Ren: reports no conflicts of interest. Kalgi Mody: employee of Eisai Inc., Woodcliff, NJ, USA. Corina E. Dutcus: employee of Eisai Inc., Woodcliff, NJ, USA. Toshiyuki Tamai: employee of Eisai Co. Ltd, Tokyo, Japan. Min Ren: employee of Eisai Inc., Woodcliff, NJ, USA. Seiichi Hayato: employee of Eisai Co. Ltd, Tokyo, Japan. Hiromitsu Kumada: reports honoraria from MSD, Sumitomo Dainippon, AbbVie, Gilead Sciences, Inc., and Eisai."

"Clinincal trial: Trial registration ID: ClinicalTrials.gov # NCT01761266"