Jordi Rimola1, Álvaro Díaz-González2, Anna Darnell1, María Varela3, Fernando Pons4, Manuel Hernandez-Guerra5, Manuel Delgado6, Javier Castroagudin7, Ana Matilla8, Bruno Sangro9, Carlos Rodriguez de Lope10, Margarita Sala11, Carmen Gonzalez12, Carlos Huertas13, Beatriz Minguez14, Carmen Ayuso1, Jordi Bruix2, María Reig2. 1. Barcelona Clinic Liver Cancer Group, Servicio de Radiodiagnóstico, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain. 2. Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Universitat de Barcelona, Barcelona, Spain. 3. Liver Unit, Hospital Universitario Central de Asturias, Oviedo, Spain. 4. Servicio de Digestivo, Hospital Universitario Puerta de Hierro, Madrid, Spain. 5. Liver Unit, Hospital Universitario de las Islas Canarias, Canary Islands, Spain. 6. Servicio de Digestivo, Hospital Universitario La Coruña, La Coruña, Spain. 7. Servicio de Digestivo, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain. 8. Servicio de Digestivo, Hospital General Universitario Gregorio Marañón, Madrid, Spain. 9. Servicio de Hepatología, Clínica Universidad de Navarra, Pamplona, Spain. 10. Servicio de Digestivo, Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Marqués de Valdecilla, Santander, Spain. 11. Unidad Hepatología, CIBERehd, Servicio de Aparato Digestivo, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain. 12. Servicio de Digestivo-Sección Hepatologia Hospital General Universitario Valencia, Valencia, Spain. 13. Servicio de Digestivo. Hospital Universitari Dr. Josep Trueta, Girona, Spain. 14. Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut of Research, CIBERehd. Universitat Autonoma de Barcelona, Barcelona, Spain.
Abstract
The clinical benefit of sorafenib in patients with hepatocellular carcinoma (HCC) has been undervalued due to the absence of complete responses, even though patients who develop early dermatologic reactions have shown to have a positive outcome. In addition, sorafenib is described as an antiangiogenic drug, but it also acts on immunological cells. Thus, the goal of this study was to assess the complete response rate in a retrospective cohort of HCC patients treated with sorafenib and to describe the profile of the patients who achieve complete response for identifying factors related to this event and their connection with the immunological profile of sorafenib. Ten Spanish centers submitted cases of complete response under sorafenib. The baseline characteristics, development of early dermatologic reactions, and cause of treatment discontinuation were annotated. Radiological images taken before starting sorafenib, at first control, after starting sorafenib, at the time of complete response, and at least 1 month after treatment were centrally reviewed. Of the 1119 patients studied, 20 had been classified as complete responders by the centers, but eight of these patients were excluded after central review. Ten patients had complete disappearance of all tumor sites, and two had just a small residual fibrotic scar. Thus, 12 patients were classified as complete responders (58% HCV, median age 59.7 years, 83.4% Child-Pugh class A, Eastern Cooperative Oncology Group performance status 0 91.7%, and Barcelona Clinic Liver Cancer stage C 83.3%). The median overall survival and treatment duration were 85.8 and 40.1 months, respectively. All but one patient developed early dermatologic reactions, and seven patients discontinued sorafenib after achieving complete response due to adverse events, patient decision, or liver decompensation. Conclusion: Complete response affects 1% of patients with HCC who are treated with sorafenib. The association of complete response with early dermatologic reactions supports the role of a specific immune/inflammatory patient profile in the improved response to sorafenib. (Hepatology 2018;67:612-622).
The clinical benefit of sorafenib in patients with hepatocellular carcinoma (HCC) has been undervalued due to the absence of complete responses, even though patients who develop early dermatologic reactions have shown to have a positive outcome. In addition, sorafenib is described as an antiangiogenic drug, but it also acts on immunological cells. Thus, the goal of this study was to assess the complete response rate in a retrospective cohort of HCC patients treated with sorafenib and to describe the profile of the patients who achieve complete response for identifying factors related to this event and their connection with the immunological profile of sorafenib. Ten Spanish centers submitted cases of complete response under sorafenib. The baseline characteristics, development of early dermatologic reactions, and cause of treatment discontinuation were annotated. Radiological images taken before starting sorafenib, at first control, after starting sorafenib, at the time of complete response, and at least 1 month after treatment were centrally reviewed. Of the 1119 patients studied, 20 had been classified as complete responders by the centers, but eight of these patients were excluded after central review. Ten patients had complete disappearance of all tumor sites, and two had just a small residual fibrotic scar. Thus, 12 patients were classified as complete responders (58% HCV, median age 59.7 years, 83.4% Child-Pugh class A, Eastern Cooperative Oncology Group performance status 0 91.7%, and Barcelona Clinic Liver Cancer stage C 83.3%). The median overall survival and treatment duration were 85.8 and 40.1 months, respectively. All but one patient developed early dermatologic reactions, and seven patients discontinued sorafenib after achieving complete response due to adverse events, patient decision, or liver decompensation. Conclusion: Complete response affects 1% of patients with HCC who are treated with sorafenib. The association of complete response with early dermatologic reactions supports the role of a specific immune/inflammatory patient profile in the improved response to sorafenib. (Hepatology 2018;67:612-622).
Authors: Gonçalo Nunes; Cristina Fonseca; Marta Patita; Mario João Aleixo; Miguel Ramalho; Jorge Fonseca Journal: Turk J Gastroenterol Date: 2020-02 Impact factor: 1.852
Authors: Anna Tutusaus; Milica Stefanovic; Loreto Boix; Blanca Cucarull; Aynara Zamora; Laura Blasco; Pablo García de Frutos; Maria Reig; Jose C Fernandez-Checa; Montserrat Marí; Anna Colell; Jordi Bruix; Albert Morales Journal: Oncotarget Date: 2018-03-30