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A Simple Score to Select Sorafenib Treatment Candidates: A Report from the South American Liver Research Network.

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  1. A Simple Score to Select Sorafenib Treatment Candidates: A Report from the South American Liver Research Network James S. Leathers1, Domingo Balderramo2, Jhon Prieto3, Fernando Diehl2, Esteban Gonzalez-ballerga4, Melina R. Ferreiro4, Enrique Carrera5, Fernando Barreyro6, Javier Diaz-ferrer7, Dupinder Singh10, Angelo Z. Mattos8, Flair Carrilho9, Jose D. Debes10 1Vanderbilt University School Of Medicine,USA2Hospital Privado Universitario de Córdoba, Argentina.3Organización Sanitas Colombia, Centro de Enfermedades Hepáticas Y Digestivas, Colombia.4Hospital Clinicas, Buenos Aires, Argentina. 5Hospital Eugenio Espejo, Quito, Ecuador. 6Consejo Nacional de Investigaciones Científicas Y Técnicas, Posadas, Argentina. 7Hospital Nacional Edgardo Rebagliati Martins (HNERM), Lima, Peru8Federal University Of Health Sciences Of Porto Alegre; Pontifical Catholic University Of Rio Grande Do Sul. Rio Grande, Brazil. 9University Of São Paulo School Of Medicine, São Paulo, Brazil. 10University Of Minnesota, Hennepin County Medical Center, MN, USA.

  2. Disclosures • Will not discuss off-label use of pharmaceuticals • No conflicts of interest to disclose

  3. Background • Hepatocellular carcinoma (HCC) is the 2nd leading cause of cancer-related death worldwide • Sorafenib, most widely used chemotherapeutic agent for late-stage HCC • Sorafenib response has been shown to be affected by multiple factors (underlying liver disease, geographical region, etc.)

  4. Objectives 1) To evaluate treatment efficacy and predictors of survival, in patients with HCC treated with sorafenib in South America 2) To design a simple score for the selection of sorafenib treatment candidates for use in resource-limited settings

  5. Methods • Retrospective cohort study of HCC cases treated with sorafenib in South America between January 2010 and June 2017 • Eight medical centers in five different countries (Argentina, Brazil, Colombia, Ecuador, Peru) • Risk factors for decreased OS were identified using Cox proportional hazard regression and log-rank tests

  6. Results • Of 1336 HCC patients in the network, 127 were treated with sorafenib and thus included in the study • Median age 65 years (IQR 55-71), 70% male • The most common etiology of HCC was hepatitis C (HCV) infection (38%) • BCLC stages: • A: 2% | B: 24% | C: 57% | D: 1% | Unknown: 16% • Median survival was 8 months (IQR 2-17)

  7. Platelet-INR-Bilirubin (PIB) Score • Three laboratory variables associated with survival were selected to be included in PIB score • One point was assigned for each of the following: • P – Platelets <250,000 mm3 • I– INR <1.6 IU • B– Bilirubin (total) <3 mg/dL • Hypothetical score range: 0-3

  8. Platelet-INR-Bilirubin Score: Kaplan Meyer Survival Analysis

  9. Conclusions • Overall survival under sorafenib was 8 months • Platelets, INR, total bilirubin and BCLC stage were associated with survival on sorafenib • The PIB score may be useful for the selection of sorafenib treatment candidates in resource-limited settings • Future Steps: Validation of score in larger, prospective study

  10. Acknowledgments • South American Liver Research Network (SALRN) • Doris Duke Charitable Foundation • Robert Wood Johnson Foundation

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