@article{10902/35160,
year = {2024},
url = {https://hdl.handle.net/10902/35160},
abstract = {Introduction: In REFLECT, lenvatinib was noninferior to sorafenib in terms of overall survival (OS) in patients with unresectable hepatocellular carcinoma (uHCC; median 13.6 vs. 12.3 months; HR 0.92, 95% CI 0.79-1.06). The objective response rate (ORR) with lenvatinib was 18.8% by blinded independent imaging review (IIR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1); permodified RECIST (mRECIST), the ORR was 40.6%. We sought to further characterize these tumor responses and explore ORR's importance among outcomes for patients with HCC. 
Methods: Efficacy assessments included all patients randomly assigned to receive lenvatinib treatment (if bodyweight 60 kg, 12 mg/day; if <60 kg, 8 mg/ day). Time to first objective response (TTR) and duration of response (DOR) included patients who achieved a partial or complete tumor response. Tumors were assessed by IIR per RECIST v1.1 or mRECIST. 
Results: Four hundred seventy-eight patients were randomly assigned to receive lenvatinib. By IIR, 90 patients (18.8%) achieved an objective response per RECIST v1.1, and 194 (40.6%) had an objective response per mRECIST. Median TTR/DOR were 2.8 months/7.4 months in responders per RECIST v1.1, and 1.9 months/7.3 months in responders per mRECIST, respectively. Per baseline disease characteristics, ORRs by Child-Pugh score (A5/A6) were 21.2%/11.2% per RECIST v1.1 and 42.9%/33.6% per mRECIST, respectively. By baseline alphafetoprotein level (<400/400 ng/mL), ORRs were 21.4%/15.4% per RECIST v1.1 and 45.6%/33.8% per mRECIST, respectively. Incidences of treatment-related treatment-emergent adverse events were 98.9% in responders per RECIST v1.1 and 97.9% in responders per mRECIST. 
Conclusions: Responses were seen even in those patients with more severe disease at baseline. Tumor responses occurred early and were durable.},
organization = {This study was sponsored by Eisai Inc., Nutley, NJ, USA, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Medical writing support was provided by Michael Venditto, PharmD, of Oxford PharmaGenesis Inc., Newtown, PA, USA, and was funded by Eisai Inc., Nutley, NJ, USA, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.},
publisher = {S. Karger},
publisher = {Liver Cancer, 2024, 13, 537-547},
title = {Characterization of tumor responses in patients with unresectable hepatocellular carcinoma treated with lenvatinib in the phase 3 randomized trial: REFLECT},
author = {Finn, Richard S. and Qin, Shukui and Piscaglia, Fabio and Evans, Thomas R. Jeffry and Knox, Jennifer J. and López López, Carlos and Ramji, Zahra and Ren, Min and Mody, Kalgi and Vogel, Arndt and Kudo, Masatoshi},
}