TY  - INPR
AV  - public
Y1  - 2022/02/25/
TI  - 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
N1  - 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/
PB  - American Society of Clinical Oncology (ASCO)
UR  - https://doi.org/10.1200/JCO.21.01090
N2  - 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.
ID  - discovery10144485
A1  - Oza, Bhavna
A1  - Eisen, Tim
A1  - Frangou, Eleni
A1  - Stewart, Grant D
A1  - Bex, Axel
A1  - Ritchie, Alastair WS
A1  - Kaplan, Rick
A1  - Smith, Benjamin
A1  - Davis, Ian D
A1  - Stockler, Martin R
A1  - Albiges, Laurence
A1  - Escudier, Bernard
A1  - Larkin, James
A1  - Joniau, Steven
A1  - Hancock, Barry
A1  - Hermann, Gregers G
A1  - Bellmunt, Joaquim
A1  - Parmar, Mahesh KB
A1  - Royston, Patrick
A1  - Meade, Angela
JF  - Journal of Clinical Oncology
ER  -