Marasco Giovanni, Poggioli Francesco, Colecchia Antonio, Cabibbo Giuseppe, Pelizzaro Filippo, Giannini Edoardo Giovanni, Marinelli Sara, Rapaccini Gian Ludovico, Caturelli Eugenio, Di Marco Mariella, Biasini Elisabetta, Marra Fabio, Morisco Filomena, Foschi Francesco Giuseppe, Zoli Marco, Gasbarrini Antonio, Svegliati Baroni Gianluca, Masotto Alberto, Sacco Rodolfo, Raimondo Giovanni, Azzaroli Francesco, Mega Andrea, Vidili Gianpaolo, Brunetto Maurizia Rossana, Nardone Gerardo, Alemanni Luigina Vanessa, Dajti Elton, Ravaioli Federico, Festi Davide, Trevisani Franco, Italian Liver Cancer Ita Li Ca Group On Behalf Of The
Division of Internal Medicine and Digestive Pathophysiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.
Department of Medical and Surgical Science, University of Bologna, 40138 Bologna, Italy.
Cancers (Basel). 2021 May 29;13(11):2677. doi: 10.3390/cancers13112677.
Among scores and staging systems used for HCC, none showed a good prognostic ability in patients with advanced HCC treated with Sorafenib. We aimed to evaluate predictive factors of overall survival (OS) and drug response in HCC patients undergoing Sorafenib included in the Italian Liver Cancer (ITA.LI.CA.) multicenter cohort. Patients in the ITA.LI.CA database treated with Sorafenib and updated on 30 June 2019 were included. Demographic and clinical data before starting Sorafenib treatment were considered. For the evaluation of predictive factors for OS, a time-dependent Cox proportional hazard model was used. A total of 1107 patients were included in our analysis. The mean age was 64.3 years and 81.7% were male. Most patients were staged as BCLC B (205, 18.9%) or C (706, 65.1%). The median time of Sorafenib administration was 4 months (interquartile range (IQR) 2-12), and the median OS was 10 months (IQR: 4-20). A total of 263 patients (33.8%) out of 780 with available evaluation experienced objective tumoral response to Sorafenib. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (hazard ratio (HR) 1.284), maximum tumoral diameter (HR 1.100), plasma total bilirubin (HR 1.119), aspartate amino transferase assessed as multiple of the upper normal value (HR 1.032), alpha-fetoprotein ≥200 ng/mL (HR 1.342), hemoglobin (HR 0.903) and platelet count (HR 1.002) were associated with OS at multivariate Cox regression analysis. Drug response was predicted by maximum tumoral diameter and platelet count. A novel prognostic nomogram for patients undergoing Sorafenib is hereby proposed. The novelty introduced is the comprehensive patient's assessment using common markers of patient's general status, liver damage and function and HCC biology. Further studies are required to test its accuracy and provide external validation.
在用于肝细胞癌（HCC）的多种评分和分期系统中，对于接受索拉非尼治疗的晚期HCC患者，没有一种显示出良好的预后能力。我们旨在评估意大利肝癌（ITA.LI.CA.）多中心队列中接受索拉非尼治疗的HCC患者的总生存期（OS）和药物反应的预测因素。纳入ITA.LI.CA数据库中接受索拉非尼治疗并于2019年6月30日更新的患者。考虑开始索拉非尼治疗前的人口统计学和临床数据。为了评估OS的预测因素，使用了时间依赖性Cox比例风险模型。我们的分析共纳入1107例患者。平均年龄为64.3岁，男性占81.7%。大多数患者分期为BCLC B期（205例，18.9%）或C期（706例，65.1%）。索拉非尼给药的中位时间为4个月（四分位间距（IQR）2 - 12），中位OS为10个月（IQR：4 - 20）。在780例可进行评估的患者中，共有263例（33.8%）对索拉非尼有客观肿瘤反应。东部肿瘤协作组（ECOG）体能状态（PS）（风险比（HR）1.284）、最大肿瘤直径（HR 1.100）、血浆总胆红素（HR 1.119）、以正常上限值倍数评估的天冬氨酸氨基转移酶（HR 1.032）、甲胎蛋白≥200 ng/mL（HR 1.342）、血红蛋白（HR 0.903）和血小板计数（HR 1.002）在多因素Cox回归分析中与OS相关。药物反应由最大肿瘤直径和血小板计数预测。在此提出一种用于接受索拉非尼治疗患者的新型预后列线图。引入的新颖之处在于使用患者一般状况、肝损伤和功能以及HCC生物学的常见标志物对患者进行全面评估。需要进一步研究来检验其准确性并提供外部验证。
