Identification of immune subtypes and prognosis of hepatocellular carcinoma based on immune checkpoint gene expression profile.

BACKGROUND CalliSpheres are drug-eluting beads used for tumor artery embolization, with clinical benefits in a number of cancer types. The aim of the study was to examine the clinical benefits and complications of patients with stage II-IV lung cancer treated with CalliSpheres drug-eluting beads for embolization versus conventional vascular interventional treatment. METHODS This was a prospective cohort study conducted from August 2018 to May 2019. The patients were grouped according to traditional bronchial arterial infusion chemotherapy (infusion group) or bronchial arterial chemoembolization with CalliSpheres drug-eluting beads loaded with adriamycin (CallisSphere group). Short-term effects, serum tumor markers, and adverse reactions during follow-up were compared between the two groups. RESULTS There were 60 participants enrolled into the study with 30 in each group including 54 men and six women, 42-78 years of age. In the CalliSphere group, compared with the infusion group, the disease control rate was 93.3% versus 73.3% (P = 0.080) and the objective remission rate (ORR) was 86.7% versus 60.0% (P = 0.039); the three- and six-month progression-free survival (PFS) and six-month overall survival (OS) were better in the CalliSphere group (three-month PFS: 96.7% vs. 73.3%, P = 0.026; six-month PFS: 87.5% vs. 57.1%, P = 0.045; six-month OS: 87.5% vs. 52.7%, P = 0.024); after treatment, the tumor markers in the CalliSphere group were lower (CEA: P < 0.001; CYFRA21-1: P = 0.014). There were no differences in adverse reactions between the two groups. CONCLUSIONS The clinical effect of bronchial arterial chemoembolization with drug-eluting beads on lung cancer is probably significant and could improve the short-term response, PFS, and OS in patients with stage IIIV lung cancer, without increasing severe adverse reactions. KEY POINTS SIGNIFICANT FINDINGS OF THE STUDY: The clinical effect of bronchial arterial chemoembolization with drug-eluting beads on lung cancer is probably significant and could improve the short-term response, PFS, and OS in patients with stage II-IV lung cancer, without increasing severe adverse reactions. WHAT THIS STUDY ADDS The ORR, PFS, OS was better in the CalliSphere group than that of infusion group; CEA and CYFRA21-1 were significant lower in CalliSphere group.

https://onlinelibrary.wiley.com/doi/pdf/10.1111/1759-7714.13522

Clinical effect of bronchial arterial infusion chemotherapy and CalliSpheres drug-eluting beads in patients with stage II-IV lung cancer: A prospective cohort study.

The purpose of this work was to investigate the plasma pharmacokinetics, intratumoral drug concentration, and tumor necrosis after transarterial chemoembolization (TACE) with doxorubicin-loaded CalliSpheres microspheres (CSMs). Sixty rabbits with liver VX2 tumors were assigned into five groups of 12 rabbits each, which received 4 mg of doxorubicin via intravenous injection (IV group), hepatic arterial infusion (IA group), conventional TACE (cTACE group), CSM-TACE (CSM low-dose group), and 8 mg of doxorubicin via CSM-TACE (CSM high-dose group), respectively. Doxorubicin concentrations in plasma, tumor, and adjacent hepatic parenchyma were measured at various timepoints after treatment, and tumor necrosis percentage and liver enzymes were also assessed. The peak plasma concentration of doxorubicin was significantly lower in the three TACE groups compared to IV and IA group (P < 0.05), while doxorubicin concentrations in tumor and adjacent hepatic parenchyma were higher in the two CSM groups compared with IV, IA, and cTACE groups at 3 days and 7 days after treatment (P < 0.05). The percentages of tumor necrosis at 3 and 7 days after treatment were significantly higher in three TACE groups (all higher than 50%) compared with IV group and IA group (both lower than 25%) (P < 0.05), and the highest tumor necrosis percentage was achieved in CSM high-dose group. The three TACE groups showed transient increases in transaminases levels after treatment, in which the peak transaminases levels were significantly lower in the two CSM groups than those in cTACE group (P < 0.05). CSM achieves an effective delivery of doxorubicin into liver cancer. High-dose doxorubicin improves tumoricidal capacity while not impairing the safety of the doxorubicin-loaded CSM.

Chemoembolization of liver cancer with doxorubicin-loaded CalliSpheres microspheres: plasma pharmacokinetics, intratumoral drug concentration, and tumor necrosis in a rabbit model

Objective: This study aimed to evaluate the efficacy and safety of doxorubicin-loaded drug-eluting beads transarterial chemoembolization (DEB-TACE) with CalliSpheres microspheres (CSM) in treating unresectable intrahepatic cholangiocarcinoma (ICC). Methods: 88 unresectable ICC patients who received DEB-TACE treatment with CSM were retrospectively enrolled in this study. Information about treatment response, survival and adverse events were collected. The Kaplan-Meier curve was used to evaluate progression-free survival (PFS) and overall survival (OS), and factors affecting OS were determined by Cox's proportional hazards regression model. Results: Tumor response of the whole sample of 88 patients was partial response (PR) in 58 (65.9%) patients, stable disease (SD) in 19 (21.6%) and progressive disease (PD) in 11 (12.5%) at one month after therapy, with no complete responses (CR). The median PFS and OS were 3.0 months and 9.0 months respectively. Cox's proportional hazards regression analysis disclosed that subsequent treatment was an independent favorable prognostic factor, while cholangiectasis, extensive intrahepatic tumor burden and extrahepatic metastasis were the three prognostic factors associated with poor survival in ICC patients. Besides, common adverse events included nausea/vomiting, abdominal pain and transient elevation of liver transaminase in patients treated by DEB-TACE with CSM. Conclusion: DEB-TACE with CSM is safe and well-tolerated for unresectable ICC patients, with a low complication rate and a relative benefit in terms of survival. Subsequent treatments including systemic/loco-regional treatments is an independent favorable prognostic factor, but cholangiectasis, extensive intrahepatic tumor burden and extrahepatic metastases are the three prognostic factors associated with poor survival.

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Drug-eluting beads transarterial chemoembolization with CalliSpheres microspheres for treatment of unresectable intrahepatic cholangiocarcinoma.

BACKGROUND We aimed to investigate treatment response, survival profiles, safety profiles, and predictive factors of drug-eluting beads-transarterial chemoembolization (DEB-TACE) with CalliSpheres® Microspheres (CSM) in treating Chinese hepatocellular carcinoma (HCC) patients. METHODS A total of 66 HCC patients about to receive DEB-TACE with CSM therapy were consecutively enrolled in this prospective cohort study. Treatment response was recorded. Besides, progression-free survival (PFS) and overall survival (OS) were also recorded. All adverse events including pain, nausea, vomiting, fever, and liver function damage were recorded during hospitalization. RESULTS 37.9% of patients achieved complete response (CR) and 81.8% of patients achieved an objective response rate (ORR). For survival, mean PFS and OS were 13.7 (11.7-15.8) months and 18.8 (95% CI: 16.3-21.2) months, respectively. Multivariate logistic regression analysis revealed that a number of nodules ≥2 was an independent factor for worse CR; moreover, multivariate Cox's regression analysis disclosed that largest sample size ≥5 cm was an independent factor for shorter PFS, and Child-Pugh B and BCLC stage B/C were independent predictive factors for unfavorable OS. As to AEs, numbers of patients suffered liver function damage, pain, nausea, vomiting, and fever were 29 (43.9%), 27 (40.9%), 22 (33.3%), 13 (19.7%), and 37 (56.1%), respectively. CONCLUSION Drug-eluting beads-transarterial chemoembolization with CSM is an effective and tolerated treatment for Chinese HCC patients, and number of nodules ≥2, largest nodule size ≥5 cm, Child-Pugh stage B, and BCLC stage B/C correlates with unfavorable prognosis.

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcla.22975

An investigation of efficacy, safety, and prognostic factors of drug-eluting beads-transarterial chemoembolization operation with CalliSpheres® Microspheres in treating Chinese hepatocellular carcinoma patients.

To assess the efficacy and safety of drug-eluting beads transarterial chemoembolization (DEB-TACE) in liver cancer patients with different times of previous conventional transarterial chemoembolization (cTACE) treatments. 367 liver cancer patients about to receive DEB-TACE treatment were enrolled in this prospective cohort study. All patients were divided into no previous cTACE group (NPC group), 1–2 times previous cTACE group (PC group) and triple or above previous cTACE group (TPC group) according to the times of previous cTACE treatments. There was no difference in complete response (CR) (P = 0.671) and objective response rate (ORR) (P = 0.062) among three groups. Additionally, no difference in overall survival (OS) among groups (P = 0.899) was found. As to liver function, most liver function indexes were deteriorative at 1 week after DEB-TACE operation, but returned to baseline at 1–3 months after DEB-TACE operation in all three groups, while percentage of abnormal total bile acid (TBA) patients was higher in TPC group than NPC and PC groups at 1–3 month post-DEB-TACE (P = 0.018). As for safety profiles, the incidence of pain during DEB-TACE operation was lower in TPC group compared to NPC and PC groups (P = 0.005), while no difference of other adverse events was found during and 1 month post-DEB-TACE treatment among three groups. DEB-TACE treatment was equally efficient and tolerated in liver cancer patients with different times of previous cTACE treatments.

CalliSpheres® drug-eluting beads (DEB) transarterial chemoembolization (TACE) is equally efficient and safe in liver cancer patients with different times of previous conventional TACE treatments: a result from CTILC study

Z.-C. Sun

Papers

CalliSpheres® drug-eluting beads (DEB) transarterial chemoembolization (TACE) is equally efficient and safe in liver cancer patients with different times of previous conventional TACE treatments: a result from CTILC study