BACKGROUND: Lenvatinib has been recently approved as a first-line treatment option for patients with unresectable hepatocellular carcinoma (HCC) in Korea. We aimed to study the efficacy and safety of lenvatinib therapy in a real-world practice and to find prognostic factors related to survival and disease progression. METHODS: A hospital-based retrospective study was conducted on 111 consecutive patients who had unresectable HCC and were treated with lenvatinib at Samsung Medical Center from October 2018 to March 2020. Efficacy was determined using the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria in 111 patients who completed 1st tumor assessment. Safety was evaluated in 116 HCC patients including 5 patients who discontinued lenvatinib due to adverse events (AEs) before 1st tumor assessment using Common Terminology Criteria for AEs version 5.0. RESULTS: A total of 111 patients with a median age of 59 years were analyzed during a median follow-up duration of 6.2 (4.4-9.0) months. The Kaplan-Meier estimate of overall survival was 10.5 months, and the median progression-free survival was 6.2 months. Based on mRECIST criteria, the objective response rate was 18.9% and disease control rate was 75.7%. AEs developed in 86/116 (74.1%) patients, and grade ≥3 AEs developed in 16/116 (13.8%) patients. Diarrhea, hand-foot skin rash, abdominal pain, hypertension, and anorexia were identified as the AEs with the highest frequencies of any grade. REFLECT eligibility criteria including tumor extent ≥50% liver occupation or inadequate bone marrow function and occurrence of anorexia were prognostic factors for survival, and occurrence of diarrhea was a favorable factor for disease progression. CONCLUSION: Lenvatinib therapy showed a favorable efficacy and safety in a real-world practice. The REFLECT eligibility criteria and specific AEs could be one of the prognostic markers.
BACKGROUND: Lenvatinib has been recently approved as a first-line treatment option for patients with unresectable hepatocellular carcinoma (HCC) in Korea. We aimed to study the efficacy and safety of lenvatinib therapy in a real-world practice and to find prognostic factors related to survival and disease progression. METHODS: A hospital-based retrospective study was conducted on 111 consecutive patients who had unresectable HCC and were treated with lenvatinib at Samsung Medical Center from October 2018 to March 2020. Efficacy was determined using the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria in 111 patients who completed 1st tumor assessment. Safety was evaluated in 116 HCC patients including 5 patients who discontinued lenvatinib due to adverse events (AEs) before 1st tumor assessment using Common Terminology Criteria for AEs version 5.0. RESULTS: A total of 111 patients with a median age of 59 years were analyzed during a median follow-up duration of 6.2 (4.4-9.0) months. The Kaplan-Meier estimate of overall survival was 10.5 months, and the median progression-free survival was 6.2 months. Based on mRECIST criteria, the objective response rate was 18.9% and disease control rate was 75.7%. AEs developed in 86/116 (74.1%) patients, and grade ≥3 AEs developed in 16/116 (13.8%) patients. Diarrhea, hand-foot skin rash, abdominal pain, hypertension, and anorexia were identified as the AEs with the highest frequencies of any grade. REFLECT eligibility criteria including tumor extent ≥50% liver occupation or inadequate bone marrow function and occurrence of anorexia were prognostic factors for survival, and occurrence of diarrhea was a favorable factor for disease progression. CONCLUSION: Lenvatinib therapy showed a favorable efficacy and safety in a real-world practice. The REFLECT eligibility criteria and specific AEs could be one of the prognostic markers.
Authors: Josep M Llovet; Sergio Ricci; Vincenzo Mazzaferro; Philip Hilgard; Edward Gane; Jean-Frédéric Blanc; Andre Cosme de Oliveira; Armando Santoro; Jean-Luc Raoul; Alejandro Forner; Myron Schwartz; Camillo Porta; Stefan Zeuzem; Luigi Bolondi; Tim F Greten; Peter R Galle; Jean-François Seitz; Ivan Borbath; Dieter Häussinger; Tom Giannaris; Minghua Shan; Marius Moscovici; Dimitris Voliotis; Jordi Bruix Journal: N Engl J Med Date: 2008-07-24 Impact factor: 91.245
Authors: Sabrina Welland; Catherine Leyh; Fabian Finkelmeier; André Jefremow; Kateryna Shmanko; Maria A Gonzalez-Carmona; Arne Kandulski; Petia Jeliazkova; Jan Best; Thorben W Fründt; Angela Djanani; Maria Pangerl; Andreas Maieron; Richard Greil; Christina Fricke; Disorn Sookthai; Rainer Günther; Andreas Schmiderer; Henning Wege; Marino Venerito; Ursula Ehmer; Martina Müller; Christian P Strassburg; Arndt Weinmann; Jürgen Siebler; Oliver Waidmann; Christian M Lange; Anna Saborowski; Arndt Vogel Journal: Liver Cancer Date: 2022-01-14 Impact factor: 12.430
Authors: Kurvi Patwala; David Stephen Prince; Yael Celermajer; Waafiqa Alam; Eldho Paul; Simone Irene Strasser; Geoffrey William McCaughan; Paul Gow; Siddharth Sood; Elise Murphy; Stuart Roberts; Elliot Freeman; Elizabeth Stratton; Scott Anthony Davison; Miriam Tania Levy; McCawley Clark-Dickson; Vi Nguyen; Sally Bell; Amanda Nicoll; Ashley Bloom; Alice Unah Lee; Marno Ryan; Jessica Howell; Zina Valaydon; Alexandra Mack; Ken Liu; Anouk Dev Journal: Hepatol Int Date: 2022-08-25 Impact factor: 9.029
Authors: Bo Hyun Kim; Su Jong Yu; Wonseok Kang; Sung Bum Cho; Soo Young Park; Seung Up Kim; Do Young Kim Journal: J Gastroenterol Hepatol Date: 2021-11-17 Impact factor: 4.369