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.
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Embargo End Date
ICR Authors
Authors
Oza, B
Eisen, T
Frangou, E
Stewart, GD
Bex, A
Ritchie, AWS
Kaplan, R
Smith, B
Davis, ID
Stockler, MR
Albiges, L
Escudier, B
Larkin, J
Joniau, S
Hancock, B
Hermann, GG
Bellmunt, J
Parmar, MKB
Royston, P
Meade, A
Eisen, T
Frangou, E
Stewart, GD
Bex, A
Ritchie, AWS
Kaplan, R
Smith, B
Davis, ID
Stockler, MR
Albiges, L
Escudier, B
Larkin, J
Joniau, S
Hancock, B
Hermann, GG
Bellmunt, J
Parmar, MKB
Royston, P
Meade, A
Document Type
Journal Article
Date
2022-06-01
Date Accepted
2022-01-20
Abstract
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.
Citation
Journal of Clinical Oncology, 2022, 40 (16), pp. 1772 - 1782
Source Title
Journal of Clinical Oncology
Publisher
LIPPINCOTT WILLIAMS & WILKINS
ISSN
0732-183X
eISSN
1527-7755
1527-7755
1527-7755