Immune checkpoint inhibitors and anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors with or without transarterial chemoembolization as first-line treatment for advanced hepatocellular carcinoma (CHANCE2201): a target trial emulation study.

Background: The role of transarterial chemoembolization (TACE) in the treatment of advanced hepatocellular carcinoma (HCC) is unconfirmed. This study aimed to assess the efficacy and safety of immune checkpoint inhibitors (ICIs) plus anti-vascular endothelial growth factor (anti-VEGF) antibody/tyrosine kinase inhibitors (TKIs) with or without TACE as first-line treatment for advanced HCC. Methods: This nationwide, multicenter, retrospective cohort study included advanced HCC patients receiving either TACE with ICIs plus anti-VEGF antibody/TKIs (TACE-ICI-VEGF) or only ICIs plus anti-VEGF antibody/TKIs (ICI-VEGF) from January 2018 to December 2022. The study design followed the target trial emulation framework with stabilized inverse probability of treatment weighting (sIPTW) to minimize biases. The primary outcome was overall survival (OS). Secondary outcomes included progression-free survival (PFS), objective response rate (ORR), and safety. The study is registered with ClinicalTrials.gov, NCT05332821. Findings: Among 1244 patients included in the analysis, 802 (64.5%) patients received TACE-ICI-VEGF treatment, and 442 (35.5%) patients received ICI-VEGF treatment. The median follow-up time was 21.1 months and 20.6 months, respectively. Post-application of sIPTW, baseline characteristics were well-balanced between the two groups. TACE-ICI-VEGF group exhibited a significantly improved median OS (22.6 months [95% CI: 21.2-23.9] vs 15.9 months [14.9-17.8]; P < 0.0001; adjusted hazard ratio [aHR] 0.63 [95% CI: 0.53-0.75]). Median PFS was also longer in TACE-ICI-VEGF group (9.9 months [9.1-10.6] vs 7.4 months [6.7-8.5]; P < 0.0001; aHR 0.74 [0.65-0.85]) per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. A higher ORR was observed in TACE-ICI-VEGF group, by either RECIST v1.1 or modified RECIST (41.2% vs 22.9%, P < 0.0001; 47.3% vs 29.7%, P < 0.0001). Grade ≥3 adverse events occurred in 178 patients (22.2%) in TACE-ICI-VEGF group and 80 patients (18.1%) in ICI-VEGF group. Interpretation: This multicenter study supports the use of TACE combined with ICIs and anti-VEGF antibody/TKIs as first-line treatment for advanced HCC, demonstrating an acceptable safety profile. Funding: National Natural Science Foundation of China, National Key Research and Development Program of China, Jiangsu Provincial Medical Innovation Center, Collaborative Innovation Center of Radiation Medicine of Jiangsu Higher Education Institutions, and Nanjing Life Health Science and Technology Project.

Recurrent Hemoptysis After Bronchial Artery Embolization: Prediction Using a Nomogram and Artificial Neural Network Model.

OBJECTIVE. The purpose of this study was to develop an effective nomogram and artificial neural network (ANN) model for predicting recurrent hemoptysis after bronchial artery embolization (BAE). MATERIALS AND METHODS. The institutional ethics review boards of the two participating hospitals approved this study. Patients with hemoptysis who were treated with BAE were allocated to either the training cohort (Hospital A) or the validation cohort (Hospital B). The predictors of recurrent hemoptysis were identified by univariable and multivariable analyses in the training cohort. A nomogram and ANN model were then developed, and the accuracy was validated by the Harrell C statistic and ROC curves in both the training and validation cohorts. RESULTS. A total of 242 patients (training cohort, 141; validation cohort, 101) were enrolled in this study. The univariable and multivariable analyses revealed that age of 60 years old or older (hazard ratio [HR], 3.921; 95% CI, 1.267-12.127; p = 0.018), lung cancer (HR, 18.057; 95% CI, 4.124-79.068; p < 0.001), bronchial-pulmonary shunts (HR, 11.981; 95% CI, 2.593-55.356; p = 0.001), and nonbronchial systemic artery involvement (HR, 4.194; 95% CI, 1.596-11.024; p = 0.004) were predictors of recurrent hemoptysis. The developed nomogram and ANN model had high accuracy, with a Harrell C statistic of 0.849 (95% CI, 0.778-0.919) internally (for the training cohort) and 0.799 (95% CI, 0.701-0.897) externally (for the validation cohort). The optimal cutoff value of the recurrent hemoptysis risk was 0.16. CONCLUSION. The nomogram and ANN model could effectively predict the risk for recurrent hemoptysis after BAE. Further interventions should be considered for patients with a high suspicion of risk (> 0.16) according to the nomogram.

Prognostic nomogram for the combination therapy of percutaneous catheter drainage and antibiotics in pyogenic liver abscess patients.

PURPOSE: To identify the predictors for recovery of pyogenic liver abscess (PLA) patients treated with percutaneous catheter drainage (PCD) and antibiotics, and then develop an effective nomogram to predict the recovery time. MATERIALS AND METHODS: The retrospective study included consecutive PLA patients treated with PCD and antibiotics. We defined the overall recovery time (ORT) as the time from the PCD procedure to the time of clinical success or failure. Based on the ORT, its predictors were identified with univariate and multivariate analyses. Then, a nomogram was developed to predict the ORT, and was internally validated by using Harrell's c statistic. RESULTS: A total of 116 patients and 142 PCD procedures with a median ORT of 15.0±10.6 days were included. Gas-formation (GF; HR: 0.486 [95% CI 0.312-0.757]; P = 0.001), diabetes mellitus (DM; HR: 0.455 [95% CI 0.303-0.682]; P<0.001), and preinterventional septic shock (PSS; HR: 0.276 [95% CI 0.158-0.483]; P < 0.001) were identified as predictors for the ORT of combination therapy after univariate and multivariate analyses, which indicated a significantly longer ORT than those patients without. The prognostic analyses demonstrated that the more predictors (GF, DM, and PSS) a patient exhibited, the longer ORT for the combination therapy. A nomogram was developed to predict the ORT and revealed high accuracy, with Harrell's c statistic of 0.73. CONCLUSION: GF, DM, and PSS were predictors for the recovery of PLA patients treated with PCD and antibiotics. The nomogram was effective in predicting the ORT of combination therapy.