eprintid: 10144485 rev_number: 7 eprint_status: archive userid: 699 dir: disk0/10/14/44/85 datestamp: 2022-03-02 15:04:19 lastmod: 2022-03-02 15:04:19 status_changed: 2022-03-02 15:04:19 type: article metadata_visibility: show sword_depositor: 699 creators_name: Oza, Bhavna creators_name: Eisen, Tim creators_name: Frangou, Eleni creators_name: Stewart, Grant D creators_name: Bex, Axel creators_name: Ritchie, Alastair WS creators_name: Kaplan, Rick creators_name: Smith, Benjamin creators_name: Davis, Ian D creators_name: Stockler, Martin R creators_name: Albiges, Laurence creators_name: Escudier, Bernard creators_name: Larkin, James creators_name: Joniau, Steven creators_name: Hancock, Barry creators_name: Hermann, Gregers G creators_name: Bellmunt, Joaquim creators_name: Parmar, Mahesh KB creators_name: Royston, Patrick creators_name: Meade, Angela title: 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 ispublished: inpress divisions: UCL divisions: J38 divisions: D65 divisions: B02 note: 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/ 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. date: 2022-02-25 date_type: published publisher: American Society of Clinical Oncology (ASCO) official_url: https://doi.org/10.1200/JCO.21.01090 oa_status: green full_text_type: pub language: eng primo: open primo_central: open_green verified: verified_manual elements_id: 1941868 doi: 10.1200/JCO.21.01090 medium: Print-Electronic lyricists_name: Kaplan, Richard lyricists_name: Parmar, Mahesh lyricists_name: Meade, Angela lyricists_name: Oza, Bhavna lyricists_name: Frangou, Eleni lyricists_id: RKAPL47 lyricists_id: MKBPA56 lyricists_id: AMMEA04 lyricists_id: BOZAX54 lyricists_id: EFRAN76 actors_name: Kalinowski, Damian actors_id: DKALI47 actors_role: owner full_text_status: public publication: Journal of Clinical Oncology event_location: United States citation: Oza, Bhavna; Eisen, Tim; Frangou, Eleni; Stewart, Grant D; Bex, Axel; Ritchie, Alastair WS; Kaplan, Rick; ... Meade, Angela; + view all <#> Oza, Bhavna; Eisen, Tim; Frangou, Eleni; Stewart, Grant D; Bex, Axel; Ritchie, Alastair WS; 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 KB; Royston, Patrick; Meade, Angela; - view fewer <#> (2022) 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. Journal of Clinical Oncology 10.1200/JCO.21.01090 <https://doi.org/10.1200/JCO.21.01090>. (In press). Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/10144485/1/Oza_External%20Validation%20of%20the%202003%20Leibovich%20Prognostic%20Score%20in%20Patients%20Randomly%20Assigned%20to%20SORCE%2C%20an%20International%20Phase%20III%20Trial%20of%20Adjuvant%20Sorafenib%20in%20Renal%20Cell%20Cancer_AOP.pdf