Abstract
Background and AimsResponse to sorafenib is highly variable in hepatocellular carcinoma (HCC). Baseline inflammatory parameters and treatment toxicities may improve survival prediction in patients on sorafenib therapy.Results442 patients with advanced stage HCC on sorafenib were recruited (follow-up 5096 person-months at risk). 88% had BCLC stage B or greater HCC and 72.3% had Child-Pugh A cirrhosis. On Cox multivariate regression, previously-treated HCC (HR 0.579, 95% CI 0.385-0.872, p=0.009), Cancer of Liver Italian Program (CLIP) score (HR 1.723, 95% CI 1.462-2.047, p<0.0001), baseline red cell distribution width (RDW; HR 1.234, 95% CI 1.115-1.290, p<0.0001) and neutrophil to lymphocyte ratio (NLR; HR 1.218, 95% CI 1.108-1.322, p<0.0001) were significant independent risks for shorter survival, whilst sorafenib-related diarrhoea was associated with prolonged survival (HR 0.533, 95% CI 0.373-0.763, p=0.001). The combination of RD-CLIP score (CLIP score multiplied by RDW) ≥ 70 and no treatment-related diarrhoea had good utility for predicting 3-month survival (AUC of 0.808 (95% CI 0.734-0.882), positive predictive value of 86.4% and negative predictive value of 83.3%), compared with CLIP (AUC=0.642) or BCLC score alone (AUC=0.579). RD-CLIP score ≥ 35 and no treatment-related diarrhoea had an AUC of 0.787 for predicting 12-month survival.MethodsPatients with HCC were consecutively recruited from three tertiary centres (Japan, Italy and UK) and clinical data were prospectively collected. The primary study endpoint was overall survival (OS) after commencing sorafenib.ConclusionThe novel prognostic index of CLIP score combined with inflammatory marker RDW and treatment-related diarrhoea has good accuracy for predicting overall, 3 month and 12 month survival in patients on sorafenib.
Highlights
Hepatocellular carcinoma (HCC) is the sixth most common malignancy worldwide and the third most common cause of cancer-related death) [1]
The novel prognostic index of Cancer of Liver Italian Program (CLIP) score combined with inflammatory marker red cell distribution width (RDW) and treatment-related diarrhoea has good accuracy for predicting overall, 3 month and 12 month survival in patients on sorafenib
We developed a novel prognostic index of baseline RDW multiplied by CLIP score (RD-CLIP), combined with sorafenib-related diarrhoea in a logistic regression model
Summary
Hepatocellular carcinoma (HCC) is the sixth most common malignancy worldwide and the third most common cause of cancer-related death) [1]. Despite major advances in the diagnosis and therapy of HCC, incidence of HCC is increasing worldwide and mortality remains high despite the global trend of falling cancer death rates over the last decade [1, 2]. In the clinical setting overall response rates to sorafenib are highly heterogeneous [3], due to the fact that mortality from HCC is not solely influenced by tumour stage, and by underlying liver function impairment and patient performance status. There are currently no validated stratifying biomarkers to predict sorafenib treatment efficacy. Baseline inflammatory parameters and treatment toxicities may improve survival prediction in patients on sorafenib therapy
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