Systemic chemotherapy plus transarterial chemoembolization versus systemic chemotherapy alone for unresectable intrahepatic cholangiocarcinoma: a multicenter retrospective cohort study.

PURPOSE: Systemic chemotherapy (SYS) is the first-line treatment of unresectable intrahepatic cholangiocarcinoma (ICC). However, the survival benefit of SYS is still limited. This study compared the efficacy and safety of patients with unresectable ICC treated with transarterial chemoembolization (TACE) plus SYS to SYS alone. MATERIAL AND METHODS: The multicenter retrospective cohort study included patients aged ≥ 18 years old with pathologically diagnosed ICC. Patients with unmeasurable lesions, not receiving SYS treatment, Child-Pugh grade C, Eastern Cooperative Oncology Group performance status score of 3 or higher, prior liver resection, incomplete medical information, or discontinuation of the first SYS treatment were excluded. Data collection was mainly from the hospital system, and the survival outcome of patients was obtained through follow-up. Overall survival (OS) was estimated using the Kaplan-Meier method and compared using the log-rank test. Propensity score matching at a 1:1 ratio using the nearest neighbor matching algorithm was performed to reduce selection bias between the TACE plus SYS and SYS alone groups. The Cox proportional hazards model was used to identify prognostic factors associated with OS and to estimate their hazard ratios. Modified Response Evaluation Criteria in Solid Tumors criteria were utilized to evaluate the response of tumors to therapy. RESULTS: Between June 2016 and February 2023, 118 unresectable ICC patients from three hospitals were included in this study. Of them, 37 were in the TACE plus SYS group and 81 were in the SYS alone group. The median OS in the combination group was 11.3 months, longer than the 6.4 months in the SYS alone group (P = 0.011). A greater objective response rate (ORR) and disease control rate (DCR) were observed in the combination group than in the SYS alone group (ORR, 48.65 vs. 6.17%, P < 0.001; DCR, 89.19 vs. 62.96%, P = 0.004). There were 16 patients in each group after matching, and the matched results remained consistent regarding OS and tumor response. Adverse events (AEs) were similar in the two groups after matching. CONCLUSION: Compared to SYS alone, the combination treatment of TACE plus SYS was more effective than SYS alone in improving OS, ORR, and DCR without any significant increase in AEs. TACE plus SYS may be a viable treatment option for patients with unresectable ICC.

Heterogeneity Analysis of Chest CT Predict Individual Prognosis of COVID-19 Patients.

BACKGROUND: Ground-glass Opacity (GGO) and Consolidation Opacity (CLO) are the common CT lung opacities, and their heterogeneity may have potential for prognosis ofcoronavirus disease-19 (COVID-19) patients. OBJECTIVE: This study aimed to estimate clinical outcomes in individual COVID-19 patients using histogram heterogeneity analysis based on CT opacities. METHODS: 71 COVID-19 cases' medical records were retrospectively reviewed from a designated hospital in Wuhan, China, from January 24th to February 28th at the early stage of the pandemic. Two characteristic lung abnormity opacities, GGO and CLO, were drawn on CT images to identify the heterogeneity using quantitative histogram analysis. The parameters (mean, mode, kurtosis, and skewness) were derived from histograms to evaluate the accuracy of clinical classification and outcome prediction. Nomograms were built to predict the risk of death and median length of hospital stays (LOS), respectively. RESULTS: A total of 57 COVID-19 cases were eligible for the study cohort after excluding 14 cases. The highest lung abnormalities were GGO mixed with CLO in both the survival populations (26 in 42, 61.9%) and died population (10 in 15, 66.7%). The best performance heterogeneity parameters to discriminate severe type from mild/moderate counterparts were as follows: GGO_skewness: specificity= 66.67%, sensitivity=78.12%, AUC=0.706; CLO_mean: specificity=70.00%, sensitivity= 76.92%, and AUC=0.746. Nomogram based on histogram parameters can predict the individual risk of death and the prolonged median LOS of COVID-19 patients. C-indexes were 0.763 and 0.888 for risk of death and prolonged median LOS, respectively. CONCLUSION: Histogram analysis method based on GGO and CLO has the ability for individual risk prediction in COVID-19 patients.

Comprehensive predictive factors for CalliSpheres® microspheres (CSM) drug-eluting bead-transarterial chemoembolization and conventional transarterial chemoembolization on treatment response and survival in hepatocellular carcinoma patients.

BACKGROUND: Transarterial chemoembolization (TACE) is widely applied in hepatocellular carcinoma (HCC) patients who are not suitable for surgical treatment. We aimed to investigate the treatment outcomes and comprehensive prognostic factors of CalliSpheres® microspheres (CSM) drug-eluting bead TACE (DEB-TACE) treatment and conventional TACE (cTACE) treatment in HCC patients. METHODS: Three hundred and thirty-five HCC patients received DEB-TACE or cTACE treatment were consecutively enrolled in multi-center, retrospective cohort study. Treatment response was conducted at M1, M3 or M6 after treatment. Progression free survival (PFS) and overall survival (OS) were recorded. Thirty-seven baseline factors including demographic characteristics, clinical features, biochemical indexes and previous treatment histories were selected. RESULTS: In total patients, history of drink and largest nodule size≥7cm independently predicted worse ORR, DEB-TACE predicted better OS, while largest nodule size≥7cm, increased Child-Pugh stage, ALB abnormal, ALP abnormal or AFP abnormal predicted worse survival. For DEB-TACE group, previous cTACE and ANC abnormal independently predicted worse ORR, and hepatic vein invasion, increased Child-Pugh stage or AFP abnormal independently predicted poor survival. For cTACE group, largest nodule size≥7cm independently predicted poor ORR, and multifocal disease as well as ALB abnormal predicted poor OS. CONCLUSIONS: History of drink, largest nodule size≥7cm, DEB-TACE, increased Child-Pugh stage, abnormal ALB, ALP or AFP are potential prognostic factors in total patients, previous cTACE and ANC abnormal, hepatic vein invasion, increased Child-Pugh stage or AFP abnormal are potential prognostic factors in DEB-TA group, and largest nodule size≥7cm, multifocal disease and ALB abnormal are potential prognostic factors in cTACE group.

Comparison of chemoembolization with CalliSpheres® microspheres and conventional chemoembolization in the treatment of hepatocellular carcinoma: a multicenter retrospective study.

PURPOSE: This study aimed to compare the efficacy and safety between transarterial chemoembolization (TACE) with CalliSpheres® microspheres (CSM-TACE) and conventional TACE (cTACE) in patients with hepatocellular carcinoma (HCC). PATIENTS AND METHODS: Three hundred and thirty-five HCC patients receiving CSM-TACE or cTACE were consecutively enrolled in this multi-center, retrospective cohort study, and then divided into CSM-TACE group and cTACE group accordingly. Complete response (CR), objective response (ORR) and disease control response (DCR) was assessed according to mRECIST criteria at 1 month (M1), 3 months(M3) and 6 months(M6) after treatment. Progression-free survival (PFS) and overall survival (OS) were assessed. Liver function indexes and adverse events (AEs) were also evaluated. RESULTS: CR at M3 (P=0.020) and ORR at M1 (P<0.001), M3 (P<0.001) and M6 (P=0.017) after treatment were significantly higher in the CSM-TACE compared with cTACE group. DCRs, PFS (25.3 months vs 24.2 months, P=0.503) and OS (27.8 months vs 25.3 months, P=0.203) were similar between the two groups. CSM-TACE was independently correlated with higher ORR at M1 (P=0.002) and longer OS (P=0.023). Abnormal alkaline phosphatase (ALP) (P=0.049) was independently associated with lower ORR at M3, and history of alcohol intake (P=0.019) and largest nodule size ≥7 cm (P=0.015) independently correlated with lower ORR at M6 (P=0.015). Largest nodule size ≥7 cm (P=0.029) and abnormal albumin (ALB) (P=0.046) were independently associated with shorter PFS. Child-Pugh stage B/C (P=0.023), abnormal ALB (P=0.001), ALP (P=0.008) and alpha-fetoprotein (AFP) (P=0.005) were independently associated with shorter OS. Most liver function indexes and AEs were similar between the two groups (P>0.05), except that ALP (P=0.005), total bilirubin (P=0.031), pain during procedure (P=0.034) and occurrence of fever post(treatment (P=0.017) were significantly elevated in the CSM-TACE compared with cTACE group. CONCLUSION: CSM-TACE presents with a better treatment response and similar survival profile compared with cTACE in HCC patients.

Comparison of liver function and safety in hepatocellular cancer patients treated with DEB-TACE and cTACE: a multi-center, retrospective cohort study.

BACKGROUND: This study aimed to compare the live function change and adverse events (AEs) between drug-eluting beads (DEB) transarterial chemoembolization (TACE) with CalliSpheres® microspheres (CSM) and conventional TACE (cTACE) in treating hepatocellular carcinoma (HCC) patients. METHODS: Three hundred and thirty-five HCC patients underwent DEB-TACE with CSM (n=171, DEB-TACE group) or cTACE (n=164, cTACE group) were consecutively enrolled in this multi-center, retrospective cohort study. Liver function indexes were reviewed before treatment (W0), at 1 week (W1) and 1 month (M1) post treatment. Moreover, AEs during operation and hospitalization were retrieved as well. RESULTS: The changes of albumin (ALB) [-3.55 (-6.25 to -0.43) vs. -2.20 (-4.63-0.00), P=0.043] and total protein (TP) [-4.62 (-10.18-0.43) vs. -2.50 (-7.08-1.08), P=0.013] from W1 to W0 were lower in DEB-TACE group compared to cTACE group, while no difference was observed referring to the change of alanine aminotransferase (ALT) (P=0.494), aspartate aminotransferase (AST) (P=0.747), alkaline phosphatase (ALP) (P=0.895), total bilirubin (TBIL) (P=0.059), total bile acid (TBA) (P=0.491) from W1 to W0. And the changes of these seven indexes from M1 to W0 were all similar between DEB-TACE group and cTACE group (all P>0.05). Besides, the occurrence of pain during treatment (19.3% vs. 11.0%, P=0.034) and the occurrence of fever during hospitalization (18.1% vs. 9.1%, P=0.017) were both increased in DEB-TACE group compared to cTACE group. CONCLUSIONS: DEB-TACE with CSM is non-inferior to cTACE in terms of liver function change, while DEB-TACE with CSM leads to higher incidences of pain and fever.

Comparison of treatment efficacy and safety between drug-eluting bead transarterial chemoembolization with CalliSpheres® microspheres and conventional transarterial chemoembolization as first-line treatment in hepatocellular carcinoma patients.

We aimed to compare the treatment response, survivals and safety of drug-eluting bead (DEB) transarterial chemoembolization (TACE) with CalliSpheres® microspheres (CSM) and conventional TACE (cTACE) as first-line treatment in Chinese HCC patients. 192 HCC patients from multiple centers received DEB-TACE with CSM or cTACE treatment as first-line treatment were included and assigned to DEB-TACE group (N=94) or cTACE group (N=98) accordingly. Treatment response was assessed at 1 month (M1), M3 and M6 after treatment. Progression-free survival (PFS) and overall survival (OS) was evaluated. Liver function indexes and adverse events were recorded. Complete response (CR) and objective response rate (ORR) were higher, while disease control rate (DCR) rate was similar in DEB-TACE group compared with cTACE group, and further multivariate logistic regression analysis validated that DEB-TACE vs cTACE independently predicted higher ORR. For survivals, no difference in PFS or OS was observed between DEB-TACE and cTACE groups, and multivariate Cox's proportional hazards regression revealed that DEB-TACE vs cTACE was not correlated with PFS or OS either. Additionally, no difference in liver function indexes at M1 or changes of liver function indexes from M0 to M1 between DEB-TACE and cTACE groups after treatment was observed, whereas DEB-TACE resulted in higher incidence of pain and fever during treatment or hospitalization. DEB-TACE with CSM discloses better treatment response, similar survival profiles and equal liver function injury but increased incidence of short-term adverse events than cTACE as the first-line therapy in treating HCC patients.