%0 Journal Article
%A Oza, Bhavna
%A Eisen, Tim
%A Frangou, Eleni
%A Stewart, Grant D
%A Bex, Axel
%A Ritchie, Alastair WS
%A Kaplan, Rick
%A Smith, Benjamin
%A Davis, Ian D
%A Stockler, Martin R
%A Albiges, Laurence
%A Escudier, Bernard
%A Larkin, James
%A Joniau, Steven
%A Hancock, Barry
%A Hermann, Gregers G
%A Bellmunt, Joaquim
%A Parmar, Mahesh KB
%A Royston, Patrick
%A Meade, Angela
%D 2022
%F discovery:10144485
%I American Society of Clinical Oncology (ASCO)
%J Journal of Clinical Oncology
%T External Validation of the 2003 Leibovich Prognostic Score in Patients Randomly Assigned to SORCE, an International Phase III Trial of Adjuvant Sorafenib in Renal Cell Cancer
%U https://discovery.ucl.ac.uk/id/eprint/10144485/
%X PURPOSE: The 2003 Leibovich score guides prognostication and selection to adjuvant clinical trials for patients with locally advanced renal cell carcinoma (RCC) after nephrectomy. We provide a robust external validation of the 2003 Leibovich score using contemporary data from SORCE, an international, randomized trial of sorafenib after excision of primary RCC. METHODS: Data used to derive the 2003 Leibovich score were compared with contemporary data from SORCE. Discrimination and calibration of the metastasis-free survival outcome were assessed in data from patients with clear-cell RCC, using Cox proportional hazards regression, Kaplan-Meier curves, and calculation of Harrell's c indexes. Secondary analyses involved three important SORCE groups: patients with any non-clear-cell subtype, papillary, and chromophobe carcinomas. RESULTS: Four hundred seven recurrences occurred in 982 patients in the Leibovich cohort and 520 recurrences were recorded in 1,445 patients in the primary SORCE cohort. Clear discrimination between intermediate-risk and high-risk SORCE cohorts was shown; hazard ratio 2.74 (95% CI, 2.29 to 3.28), c-index 0.63 (95% CI, 0.61 to 0.65). A hazard ratio of 0.61 (95% CI, 0.53 to 0.70) confirmed poor calibration of the two cohorts. Discrimination was observed in secondary populations, with c-indexes of 0.64 (95% CI, 0.59 to 0.69) for non-clear-cell RCC, 0.63 (95% CI, 0.56 to 0.69) for papillary RCC, and 0.65 (95% CI, 0.55 to 0.76) for chromophobe RCC. CONCLUSION: The 2003 Leibovich score discriminates between intermediate-risk and high-risk clear-cell and non-clear-cell RCC groups in contemporary data, supporting its use for risk stratification in adjuvant clinical trials. Over time, metastasis-free survival for patients with locally advanced RCC has improved. Contemporary data from adjuvant RCC trials should be used to improve prognostication for patients with RCC.
%Z This is an Open Access article made available under a Creative Commons Attribution Non-Commercial 4.0 License. See: https://creativecommons.org/licenses/by-nc/4.0/