CRAFITY and AFP/PIVKA-II Kinetics Predict Prognosis in Hepatocellular Carcinoma on Immunotherapy

Area of Science:

• Oncology
• Biomarkers
• Hepatocellular Carcinoma Research

Background:

• The CRAFITY score (C-reactive protein and alpha-fetoprotein) is a prognostic biomarker for immunotherapy-treated hepatocellular carcinoma (HCC).
• Limitations exist due to many patients having non-elevated alpha-fetoprotein (AFP), impacting the CRAFITY score's accuracy.
• This study aimed to evaluate a composite model incorporating the CRAFITY score with AFP and PIVKA-II kinetic changes.

Purpose of the Study:

• To evaluate a novel composite model for prognostic stratification in unresectable HCC patients undergoing immunotherapy.
• To assess the performance of the CRAFITY-100 RULE, which combines the CRAFITY score with AFP/PIVKA-II kinetics, against the original CRAFITY score.
• To determine if the enhanced model improves prediction of objective response and overall survival.

Main Methods:

• Retrospective enrollment of 69 patients with unresectable HCC (BCLC stage B/C) receiving immunotherapy.
• Recording of baseline C-reactive protein (CRP), AFP, and PIVKA-II levels, along with their 4-week changes.
• Development and validation of the CRAFITY-100 RULE, assigning risk levels (I-III) based on CRAFITY score and biomarker kinetics.

Main Results:

• The CRAFITY score alone did not significantly stratify overall survival (OS).
• The CRAFITY-100 RULE demonstrated significantly different OS across risk levels (p=0.048), with median OS of 24, 15, and 7 months for levels I-III.
• The CRAFITY-100 RULE showed superior discrimination compared to the CRAFITY score at 6 and 12 months (AUROC 0.673 vs. 0.604 and 0.732 vs. 0.656, respectively).

Conclusions:

• The CRAFITY-100 RULE offers improved prognostic stratification and discrimination for HCC patients on immunotherapy.
• This simple composite model, integrating baseline and dynamic biomarkers, enhances clinical decision-making.
• The CRAFITY-100 RULE shows potential as a valuable tool for managing unresectable HCC in the context of immunotherapy.