J King1, D H Palmer2, P Johnson2, P Ross3, R A Hubner4, K Sumpter5, S Darby6, C Braconi7, C Iwuji8, D Swinson9, P Collins10, K Patel11, J Nobes12, I Muazzam13, C Blesing14, A Kirkwood15, S Nash15, T Meyer16. 1. Department of Oncology, Royal Free London NHS Foundation Trust, London, UK. 2. University of Birmingham, Birmingham, UK; University of Liverpool, Liverpool, UK; Clatterbridge Cancer Centre, Wirral, UK. 3. King's College Hospital, London, UK. 4. The Christie NHS Foundation Trust, Manchester, UK. 5. The Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, UK. 6. Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK. 7. University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK. 8. Leicester Royal Infirmary, Leicester, UK. 9. Leeds Teaching Hospitals NHS Trust, Leeds, UK. 10. University Hospitals Bristol NHS Foundation Trust, Bristol, UK. 11. Oxford University Hospitals NHS Trust, Oxford, UK. 12. Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK. 13. Hull and East Yorkshire Hospitals NHS Trust, Hull, UK. 14. Great Western Hospital NHS Trust, Swindon, UK. 15. Cancer Research UK & UCL Cancer Trials Centre, London, UK. 16. Department of Oncology, Royal Free London NHS Foundation Trust, London, UK; UCL Cancer Institute, London, UK. Electronic address: t.meyer@ucl.ac.uk.
Abstract
AIMS: Sorafenib is the current standard treatment for advanced hepatocellular carcinoma. We carried out a national audit of UK patients treated with sorafenib as standard-of-care and those treated with systemic therapy in first-line trials. MATERIALS AND METHODS: Sorafenib-treated and trial-treated patients were identified via the Cancer Drugs Fund and local databases. Data were collected retrospectively from medical records according to a standard case report form. The primary outcome measure was overall survival, estimated by the Kaplan-Meier method. RESULTS: Data were obtained for 448 sorafenib-treated patients from 15 hospitals. The median age was 68 years (range 17-89) and 75% had performance status ≤ 1. At baseline, 77% were Child-Pugh A and 16.1% Child-Pugh B; 38% were albumin-bilirubin grade 1 (ALBI-1) and 48% ALBI-2; 23% were Barcelona Clinic Liver Classification B (BCLC-B) and 72% BCLC-C. The median time on sorafenib was 3.6 months, with a mean daily dose of 590 mg. The median overall survival for 448 evaluable sorafenib-treated patients was 8.5 months. There were significant differences in overall survival comparing Child-Pugh A versus Child-Pugh B (9.5 versus 4.6 months), ALBI-1 versus ALBI-2 (12.9 versus 5.9 months) and BCLC-B versus BCLC-C (13.0 versus 8.3 months). For trial-treated patients (n=109), the median overall survival was 8.1 months and this was not significantly different from the sorafenib-treated patients. CONCLUSION: For Child-Pugh A patients with good performance status, survival outcomes were similar to those reported in global randomised controlled trials. Patients with ALBI grade > 1, Child-Pugh B or poor performance status seem to derive limited benefit from sorafenib treatment.
AIMS: Sorafenib is the current standard treatment for advanced hepatocellular carcinoma. We carried out a national audit of UK patients treated with sorafenib as standard-of-care and those treated with systemic therapy in first-line trials. MATERIALS AND METHODS:Sorafenib-treated and trial-treated patients were identified via the Cancer Drugs Fund and local databases. Data were collected retrospectively from medical records according to a standard case report form. The primary outcome measure was overall survival, estimated by the Kaplan-Meier method. RESULTS: Data were obtained for 448 sorafenib-treated patients from 15 hospitals. The median age was 68 years (range 17-89) and 75% had performance status ≤ 1. At baseline, 77% were Child-Pugh A and 16.1% Child-Pugh B; 38% were albumin-bilirubin grade 1 (ALBI-1) and 48% ALBI-2; 23% were Barcelona Clinic Liver Classification B (BCLC-B) and 72% BCLC-C. The median time on sorafenib was 3.6 months, with a mean daily dose of 590 mg. The median overall survival for 448 evaluable sorafenib-treated patients was 8.5 months. There were significant differences in overall survival comparing Child-Pugh A versus Child-Pugh B (9.5 versus 4.6 months), ALBI-1 versus ALBI-2 (12.9 versus 5.9 months) and BCLC-B versus BCLC-C (13.0 versus 8.3 months). For trial-treated patients (n=109), the median overall survival was 8.1 months and this was not significantly different from the sorafenib-treated patients. CONCLUSION: For Child-Pugh A patients with good performance status, survival outcomes were similar to those reported in global randomised controlled trials. Patients with ALBI grade > 1, Child-Pugh B or poor performance status seem to derive limited benefit from sorafenib treatment.
Authors: Wojciech Straś; Joanna Gotlib; Piotr Małkowski; Dariusz Wasiak; Andrzej Śliwczyński; Mariusz Panczyk; Olga Tronina; Melania Brzozowska Journal: Med Sci Monit Date: 2021-08-31
Authors: Alexa Childs; Nekisa Zakeri; Yuk Ting Ma; Joanne O'Rourke; Paul Ross; Essam Hashem; Richard A Hubner; Kimberley Hockenhull; Chinenye Iwuji; Sam Khan; Daniel H Palmer; Joanna Connor; Daniel Swinson; Suzanne Darby; Chiara Braconi; Tom Roques; Dominic Yu; Tu Vinh Luong; Tim Meyer Journal: Br J Cancer Date: 2021-09-15 Impact factor: 7.640