PIB: A Score to Select Sorafenib Treatment Candidates for Hepatocellular Carcinoma in Resource-Limited Settings

Hepatocellular carcinoma (HCC) is the second leading cause of cancer-related death globally (1). Sorafenib, amulti-tyrosinekinaseinhibitor, remainsthestandardof care for patients with inoperable or advanced-stage HCC. In resource-limited settings without access to surgical or locoregionaltherapy,sorafenibmaybetheonlyoptionfor treating HCC. However, due to a modest survival benefit, aswellasthelimitingcostof sorafenibincertainregions, appropriate selection of patients for treatment is essential. Evaluationof BarcelonaClinicLiverCancer(BCLC)criteria in resource-limited settings is frequently unachievable due to a variety of reasons. Using a cohort from the South American liver research network (1336 HCC cases), we created a cost-effective prognostic scoring system to helpidentifypatientslikelytohaveasurvivalbenefitonsorafenibtreatment,usingsimplelaboratoryvariables(2).

InordertodesignthePlatelet-INR-Bilirubin(PIB)Score, we assigned each patient in the sorafenib cohort, with available laboratory and survival data, one point for each of the following: (1) total bilirubin ≤ 3.0 mg/dL, (2)
platelets≤250×109/L,(3)INR≤1.6,followingthemethodologypreviouslydescribedbyDiConstanzoetal. (3). Each of these variables showed a similar significant difference in predicting survival and therefore were chosen for this score. Our group previously identified these variables as prognostic factors for improved survival on sorafenib in a South American population (4). The PIB score has a hypothetical score range of 0 to 3. Measures of central tendency were expressed as medians (Q1 - Q3). Kaplan-Meyer survival curves were constructed to graphically compare scores. HazardratioswerederivedusingCoxproportional hazard regression with the Breslow method for ties. The log-rank test was used to assess the equality of survivor functions. A level of evidence of P ≤ 0.05 was taken as the criterion for significance. A biostatistician was consulted for review of our data analysis. Statistical analysis was performed using STATA V. 14.2 (Statacorp, College Station, TX). This study was approved by the Institutional Review Board (IRB) of Hennepin County Medical Center. In addition,eachcenterwasresponsibleforobtainingappropriateIRBapproval.

Of the total 1336 patients with HCC, 127 patients were treated with sorafenib. Of these, 86 had complete labora
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