{"title":"CRAFITY and AFP/PIVKA-II Kinetics Predict Prognosis in Hepatocellular Carcinoma on Immunotherapy.","authors":"Shou-Wu Lee, Yi-Jie Huang, Ying-Cheng Lin, Hsin-Ju Tsai, Chia-Chang Chen, Chung-Hsin Chang, Teng-Yu Lee, Yen-Chun Peng","doi":"10.3390/cancers17183058","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The CRAFITY score, integrating baseline C-reactive protein (CRP) and alpha-fetoprotein (AFP), has been validated as a prognostic biomarker in hepatocellular carcinoma (HCC) treated with immunotherapy, but many patients present with non-elevated AFP, limiting its accuracy. This study evaluated a composite model incorporating the CRAFITY score with AFP/PIVKA-II kinetic changes.</p><p><strong>Methods: </strong>We retrospectively enrolled 69 patients with unresectable HCC (BCLC stage B/C) receiving immunotherapy between September 2021 and June 2023. Baseline CRP, AFP, and PIVKA-II, as well as 4-week changes, were recorded. The CRAFITY-100 RULE combined CRAFITY (0-2) with AFP/PIVKA-II kinetics (0-3), yielding three risk levels (I-III). Clinical outcomes included objective response (OR) and overall survival (OS).</p><p><strong>Results: </strong>Of the cohort, 10 (14.5%), 29 (42%), and 30 (43.5%) patients had CRAFITY scores 0, 1, and 2, respectively, but this score did not clearly stratify OS (median 24, 12, and 15 months; <i>p</i> = 0.267). In contrast, the CRAFITY-100 RULE classified 5 (7.3%), 35 (50.7%), and 29 (42%) patients into levels I-III, respectively, with significantly different survival (median OS 24, 15, and 7 months; <i>p</i> = 0.048). OR rates were lowest at level III (17%). Time-dependent ROC analysis confirmed superior discrimination of CRAFITY-100 RULE over CRAFITY scores at 6 months (AUROC 0.673 vs. 0.604) and 12 months (0.732 vs. 0.656).</p><p><strong>Conclusions: </strong>The CRAFITY-100 RULE provided clearer stratification and higher discrimination. This simple model integrating baseline and dynamic biomarkers may assist clinical decision-making in unresectable HCC treated with immunotherapy.</p>","PeriodicalId":9681,"journal":{"name":"Cancers","volume":"17 18","pages":""},"PeriodicalIF":4.4000,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12468996/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancers","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3390/cancers17183058","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: The CRAFITY score, integrating baseline C-reactive protein (CRP) and alpha-fetoprotein (AFP), has been validated as a prognostic biomarker in hepatocellular carcinoma (HCC) treated with immunotherapy, but many patients present with non-elevated AFP, limiting its accuracy. This study evaluated a composite model incorporating the CRAFITY score with AFP/PIVKA-II kinetic changes.
Methods: We retrospectively enrolled 69 patients with unresectable HCC (BCLC stage B/C) receiving immunotherapy between September 2021 and June 2023. Baseline CRP, AFP, and PIVKA-II, as well as 4-week changes, were recorded. The CRAFITY-100 RULE combined CRAFITY (0-2) with AFP/PIVKA-II kinetics (0-3), yielding three risk levels (I-III). Clinical outcomes included objective response (OR) and overall survival (OS).
Results: Of the cohort, 10 (14.5%), 29 (42%), and 30 (43.5%) patients had CRAFITY scores 0, 1, and 2, respectively, but this score did not clearly stratify OS (median 24, 12, and 15 months; p = 0.267). In contrast, the CRAFITY-100 RULE classified 5 (7.3%), 35 (50.7%), and 29 (42%) patients into levels I-III, respectively, with significantly different survival (median OS 24, 15, and 7 months; p = 0.048). OR rates were lowest at level III (17%). Time-dependent ROC analysis confirmed superior discrimination of CRAFITY-100 RULE over CRAFITY scores at 6 months (AUROC 0.673 vs. 0.604) and 12 months (0.732 vs. 0.656).
Conclusions: The CRAFITY-100 RULE provided clearer stratification and higher discrimination. This simple model integrating baseline and dynamic biomarkers may assist clinical decision-making in unresectable HCC treated with immunotherapy.
期刊介绍:
Cancers (ISSN 2072-6694) is an international, peer-reviewed open access journal on oncology. It publishes reviews, regular research papers and short communications. Our aim is to encourage scientists to publish their experimental and theoretical results in as much detail as possible. There is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced.