P L Blinman1, I D Davis2, A Martin3, S Troon4, S Sengupta5, E Hovey6, X Coskinas7, R Kaplan8, A Ritchie9, A Meade8, T Eisen10, M R Stockler11. 1. Concord Cancer Centre, Concord Repatriation General Hospital, Concord, Australia; ANZUP Cancer Trials Group, Camperdown, Australia. Electronic address: prunella.blinman@health.nsw.gov.au. 2. ANZUP Cancer Trials Group, Camperdown, Australia; Eastern Health Clinical School, Monash University, Box Hill, Australia; Eastern Health, Box Hill, Australia. 3. ANZUP Cancer Trials Group, Camperdown, Australia; Eastern Health Clinical School, Monash University, Box Hill, Australia; NHMRC Clinical Trials Centre, Camperdown, Australia. 4. ANZUP Cancer Trials Group, Camperdown, Australia; Department of Medical Oncology, Royal Perth Hospital, Perth, Australia. 5. ANZUP Cancer Trials Group, Camperdown, Australia; Austin Health, Heidelberg, Australia. 6. ANZUP Cancer Trials Group, Camperdown, Australia; Nelune Cancer Centre, Prince of Wales Hospital, Randwick, Australia. 7. ANZUP Cancer Trials Group, Camperdown, Australia; NHMRC Clinical Trials Centre, Camperdown, Australia. 8. MRC Clinical Trials Unit at UCL, London, UK. 9. Gloucestershire Royal Hospital, Gloucester, UK. 10. Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK. 11. Concord Cancer Centre, Concord Repatriation General Hospital, Concord, Australia; ANZUP Cancer Trials Group, Camperdown, Australia; NHMRC Clinical Trials Centre, Camperdown, Australia.
Abstract
Background: We sought to determine the survival benefits that patients judged sufficient to warrant adjuvant therapy with sorafenib for 1 year, or for 3 years after resection of renal cell carcinoma in the SORCE trial. Methods: SORCE participants from all sites in Australia and New Zealand, and selected sites in the UK, completed a validated preferences questionnaire at months 0, 3, 15, and 42 to elicit the minimum survival benefits they judged sufficient to warrant adjuvant sorafenib for 1 year (versus observation), or for 3 years (versus 1 year). The questionnaires used reference survival times of 5 and 15 years; and reference survival rates at 5 years of 65% and 85%. Results: The 233 participants had a median age of 57 years (range 29-78) and 71% were male. For 1 year of sorafenib versus no adjuvant therapy, the median benefits in survival times judged sufficient to warrant treatment were an extra 9 months beyond 5 years and an extra 1 year beyond 15 years; the median benefit in survival rates were an extra 4% beyond 65% and an extra 3% beyond 85% at 5 years. For 3 years of sorafenib versus 1 year of sorafenib, the median benefit in survival time judged sufficient to warrant extended treatment was an extra 1 year beyond both 5 and 15 years. Participants randomly allocated to treatment with sorafenib judged larger benefits necessary than those allocated to placebo. Participants' preferences were not associated with their baseline characteristics or the interval from randomisation. Conclusion: Most participants judged an extra year of survival necessary to warrant 1 year of adjuvant sorafenib worthwhile, and an additional year of survival to warrant extending the duration of sorafenib from 1 to 3 years. Patients' preferences are important in shared decision making. SORCE trial clinical trials number: NCT00492258.
RCT Entities:
Background: We sought to determine the survival benefits that patients judged sufficient to warrant adjuvant therapy with sorafenib for 1 year, or for 3 years after resection of renal cell carcinoma in the SORCE trial. Methods: SORCE participants from all sites in Australia and New Zealand, and selected sites in the UK, completed a validated preferences questionnaire at months 0, 3, 15, and 42 to elicit the minimum survival benefits they judged sufficient to warrant adjuvant sorafenib for 1 year (versus observation), or for 3 years (versus 1 year). The questionnaires used reference survival times of 5 and 15 years; and reference survival rates at 5 years of 65% and 85%. Results: The 233 participants had a median age of 57 years (range 29-78) and 71% were male. For 1 year of sorafenib versus no adjuvant therapy, the median benefits in survival times judged sufficient to warrant treatment were an extra 9 months beyond 5 years and an extra 1 year beyond 15 years; the median benefit in survival rates were an extra 4% beyond 65% and an extra 3% beyond 85% at 5 years. For 3 years of sorafenib versus 1 year of sorafenib, the median benefit in survival time judged sufficient to warrant extended treatment was an extra 1 year beyond both 5 and 15 years. Participants randomly allocated to treatment with sorafenib judged larger benefits necessary than those allocated to placebo. Participants' preferences were not associated with their baseline characteristics or the interval from randomisation. Conclusion: Most participants judged an extra year of survival necessary to warrant 1 year of adjuvant sorafenib worthwhile, and an additional year of survival to warrant extending the duration of sorafenib from 1 to 3 years. Patients' preferences are important in shared decision making. SORCE trial clinical trials number: NCT00492258.
Authors: Nicola J Lawrence; Andrew Martin; Ian D Davis; Simon Troon; Shomik Sengupta; Elizabeth Hovey; Xanthi Coskinas; Richard Kaplan; Benjamin Smith; Alastair Ritchie; Angela Meade; Tim Eisen; Prunella Blinman; Martin R Stockler Journal: Kidney Cancer Date: 2018-08-01
Authors: Ovidio Fernández; Martín Lázaro-Quintela; Guillermo Crespo; Diego Soto de Prado; Álvaro Pinto; Laura Basterretxea; Alfonso Gómez de Liaño; Olatz Etxaniz; Sara Blasco; Clara Gabás-Rivera; Susana Aceituno; Virginia Palomar; Carlos Polanco-Sánchez Journal: Front Oncol Date: 2022-01-07 Impact factor: 6.244
Authors: Hiba El Masri; Treasure M McGuire; Mieke L van Driel; Helen Benham; Samantha A Hollingworth Journal: Patient Prefer Adherence Date: 2022-09-20 Impact factor: 2.314
Authors: Tim Eisen; Eleni Frangou; Bhavna Oza; Alastair W S Ritchie; Benjamin Smith; Rick Kaplan; Ian D Davis; Martin R Stockler; Laurence Albiges; Bernard Escudier; James Larkin; Axel Bex; Steven Joniau; Barry Hancock; Gregers G Hermann; Joaquim Bellmunt; Elizabeth Hodgkinson; Grant D Stewart; Jim Barber; Janet Brown; Rhona McMenemin; Paul Nathan; Lisa M Pickering; Mahesh K B Parmar; Angela Meade Journal: J Clin Oncol Date: 2020-10-14 Impact factor: 44.544
Authors: Prunella Blinman; Andrew Martin; Michael Jefford; David Goldstein; David Boadle; Michelle Morris; Niall Tebbutt; Christine Aiken; Andrea Harkin; Eva Segelov; Andrew Haydon; Tim Iveson; Martin R Stockler Journal: JNCI Cancer Spectr Date: 2020-11-28