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. Issue 16 (1st June 2022)

• Record Type: Journal Article
• Authors: Oza, Bhavna; Eisen, Tim; Frangou, Eleni; Stewart, Grant D.; Bex, Axel; Ritchie, Alastair W.S.; Kaplan, Rick; Smith, Benjamin; Davis, Ian D.; Stockler, Martin R.; Albiges, Laurence; Escudier, Bernard; Larkin, James; Joniau, Steven; Hancock, Barry; Hermann, Gregers G.; Bellmunt, Joaquim; Parmar, Mahesh K.B.; Royston, Patrick; Meade, Angela
• Is Part Of: Journal of clinical oncology. Volume 40:Issue 16(2022)
• Page Start: 1772
• Page End: 1782
• Publication Date: 2022-06-01
• Subjects: Oncology -- Periodicals; Cancer -- Periodicals; Oncology; Medical Oncology; Cancérologie -- Périodiques; Cancer -- Périodiques; Cancérologie; Cancer; Oncology; Oncologia; Càncer; Periodicals; 616.994
• DOI: 10.1200/JCO.21.01090
• Languages: English
• ISSNs: 0732-183X

Abstract

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. Abstract : Read how we have shown that the 2003 Leibovich score demonstrates discriminative accuracy in contemporary clear-cell and non–clear-cell RCC patient cohorts, supporting its continued use to guide discussions on patient prognosis and risk-stratification in clinical trials.