Development of a prognostic nomogram for liver toxicity in patients treated with pazopanib.

455Background: Potential liver toxicity associated with pazopanib treatment has provided a challenge for decision-making regarding patient selection and monitoring. The goal of this study was to develop a tool for predicting liver toxicity for patients receiving pazopanib. Methods: Data was pooled from several clinical trials in patients with renal cell carcinoma, soft tissue sarcoma, or ovarian carcinoma; the dataset consisted of 2,051 patients treated with pazopanib in these trials. Liver toxicity was defined as an ALT level > 3 times the upper limit of normal (ULN) and a bilirubin level > 2 times ULN. Predictors of hepatotoxicity included were age, gender, race, hypertension, performance status, indication (tumor type), prior antineoplastic treatment, concomitant treatment with CYP450, P-gp, or BCRP inhibitors, and baseline clinical characteristics of weight, ALT, AST, ALP, and bilirubin. The statistical modeling was performed using logistic regression. Continuous predictors were modeled with restricte...