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New model predicts survival in Italian, Taiwanese with HCC

Researchers recently developed the ITA.LI.CA prognostic system, which accurately predicted survival of Italian and Taiwanese patients with hepatocellular carcinoma, using data from the Italian Liver Cancer database. Further, the system may also serve as a potential use for designating treatment.

According to the researchers, other score models — Model to Estimate Survival in Ambulatory HCC Patients (MESIAH), Cancer of the Liver Italian Program (CLIP) and Japanese Integrated Staging (JIS) — are not accurate for the determination of scores of various populations or define tumor stages for clinicians to easily use in clinical practice. Therefore, they prospectively collected and evaluated data of 5,290 patients with HCC from one of 19 institutions (n = 3,628) enrolled in the Italian Liver Cancer (ITA.LI.CA) study group to develop and validate a new prognostic system for patients with HCC.

An internal validation cohort of 1,555 patients with HCC from Italy and external validation cohort of 2,651 patients with HCC from Taiwan were used to develop the ITA.LI.CA prognostic system. The researchers first determined ITA.LI.CA stages (0, A, B1, B2, B3, C) using only tumor characteristics, ie, largest tumor diameter, number of nodules, intrahepatic and extrahepatic macroscopic vascular invasion. These were then used to create a parametric multivariable survival model using the relative prognostic value of ITA.LI.CA tumor stage, Eastern Cooperative Oncology Group performance status, Child–Pugh score and alpha-fetoprotein, for the prediction of individual survival. The system was based on a scale of 0 to 13 points and was compared with other systems, such as Barcelona Clinic Liver Cancer and Hong Kong Liver Cancer sets.

The median follow-up was 58 months for Italian patients and 39 months for Taiwanese patients. In addition, researchers performed a subgroup analysis for the same period to evaluate and overcome potential time-related biases.

Median overall survival was lower in the Italian patients compared with Taiwanese patients (32 vs. 57 months; P < .001). For the Italian patients, overall survival was 80% at 1 year, 48% at 3 years and 29% at 5 years. For the Taiwanese patients, the overall survival was 78% at 1 year, 61% at 3 years and 49% at 5 years.

The ITA.LI.CA prognostic score showed optimal discrimination and calibration abilities in Italian patients, according to the research. The median survival in the training and internal validation sets was 57 and 61 months in quartile 1 (ITA.LI.CA score less than 1), 43 and 38 months in quartile 2 (score between 2 and 3), 23 months for both in quartile 3 (score between 4–5) and 9 and 8 months in quartile 4 (score greater than 5).

“Observed and predicted median survival in the training and internal validation sets largely coincided. Although observed and predicted survival estimations were significantly lower in Italian than in Taiwanese patients, the ITA.LI.CA score maintained very high discrimination and calibration features also in the external validation cohort,” the researchers wrote.

The concordance index (C-index) of the ITA.LI.CA score was 0.71 in the internal cohort and 0.78 in the external. The ITA.LI.CA score’s prognostic ability was better compared with Barcelona Clinic Liver Cancer (0.64 vs. 0.73), CLIP score (0.68 vs. 0.75), JIS score (0.67 vs. 0.70), MESIAH score (0.69 vs. 0.77) and Hong Kong Liver Cancer set (0.68 vs. 0.75; P < .001 for all). The main limitations of this study are its retrospective nature and the intrinsically significant differences between the Taiwanese and Italian groups, according to the researchers.

“The ITA.LI.CA prognostic system demonstrated the best ability of the compared systems to predict the survival of Italian and Taiwanese patients. Moreover, it allows a simple but accurate clinical description of each HCC patient, with the potential to be used for deciding treatment or designing clinical trials,” the researchers concluded.

In a press release about the new system, Neehar Parikh, MD, of University of Michigan Health System, and Amit Singal, MD, MS, assistant professor of internal medicine at University of Texas Southwestern and Medical Director of the Parkland Liver Tumor Clinic, said: “This system is an important iteration in the evolution of staging for HCC, and, while it enters a crowded field, the ITA.LI.CA staging system is a worthy entrant.” – by Melinda Stevens

Disclosure: Farinati reports no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.