Acute pancreatitis after transarterial chemoembolization of hepatocellular carcinoma with drug-eluting beads.
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ABSTRACT:
SUBMITTER: Green TJ
PROVIDER: S-EPMC4346048 | biostudies-other | 2015 Mar
REPOSITORIES: biostudies-other
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Project description:PURPOSE To evaluate safety and efficacy of combined transarterial chemoembolization (TACE) with doxorubicin-eluting beads (DEB) and sorafenib in patients with advanced hepatocellular carcinoma (HCC). PATIENTS AND METHODS A prospective single-center phase II study was undertaken involving patients with unresectable HCC. The protocol involved sorafenib 400 mg twice per day combined with DEB-TACE. Safety and response were assessed. Results DEB-TACE in combination with sorafenib was successfully administered in 35 patients: mean age, 63 years; Child's A, 89%; Barcelona Clinic Liver Cancer stage C, 64%; Eastern Cooperative Oncology Group performance status of 0 and 1, 46% and 54%, respectively; and mean index tumor size, 7.7 cm (standard deviation, ± 4.2 cm). Patients underwent 128 cycles of therapy (sorafenib plus DEB-TACE, 60 cycles; sorafenib alone, 68 cycles). Median number of cycles per patient was two (range, one to five cycles); median number of days treated with sorafenib was 71 (range, 4 to 620 days). The most common toxicities during cycle one were fatigue (94%), anorexia (67%), alterations in liver enzymes (64%), and dermatologic adverse effects (48%). Although most patients experienced at least one grade 3 to 4 toxicity, most toxicities were minor (grade 1 to 2, 83% v grade 3 to 4, 17%). Toxicity during cycle two was decreased. Over the course of the study, there were 40 sorafenib dose interruptions and 25 sorafenib dose reductions. Sorafenib plus DEB-TACE was associated with a disease control rate of 95% (Response Evaluation Criteria in Solid Tumors Group)/100% (European Association for the Study of the Liver [EASL]), with an objective response of 58% (EASL). CONCLUSION The combination of sorafenib and DEB-TACE in patients with unresectable HCC is well tolerated and safe, with most toxicities related to sorafenib. Toxicity is manageable with dose adjustment of sorafenib. Preliminary efficacy data are promising.
| S-EPMC4829081 | biostudies-literature
Project description:Hepatocellular carcinoma (HCC) occurs in nearly three-quarters of all primary liver cancers, with the majority not amenable to curative therapies. We therefore aimed to re-evaluate the safety, efficacy, and survival benefits of treating patients with drug-eluting beads transcatheter arterial chemoembolization (DEB-TACE) compared to the conventional transcatheter arterial chemoembolization (C-TACE). Several databases were searched with a strict eligibility criterion for studies reporting on adult patients with unresectable or recurrent HCC. The pooled analysis included 34 studies involving 4841 HCC patients with a median follow-up of 1.5 to 18 months. There were no significant differences between DEB-TACE and C-TACE with regard to complete response, partial response and disease stability. However, disease control (OR: 1.42 (95% CI (1.03,1.96) and objective response (OR: 1.33 (95% CI (0.99, 1.79) were significantly more effective for DEB-TACE treatment with fewer severe complications and all-cause mortality. The pooled-analysis did not find superiority of DEB-TACE in complete or partial response, disease stability, controlling disease progression, and 30 day or end-mortality. However, results showed that DEB-TACE is associated with a better objective response, disease control, and lower all-cause mortality with severe complications compared to C-TACE treatment. Given that the safety outcomes are based on limited studies with a potential for bias, there was no clear improvement of DEB-TACE over C-TACE treatment.
| S-EPMC8699068 | biostudies-literature
Project description::Objective: To describe the responses, toxicities and outcomes of HCC patients treated by transarterial chemoembolization (TACE) using idarubicin-loaded TANDEM beads. Materials and Methods: Seventy-two consecutive patients (mean age: 71 years (58-84 years)) with HCC were treated by TACE using idarubicin-loaded TANDEM in a first line, over a five-year period. Most patients (89%) had liver cirrhosis classified as Child-Pugh A (90%). BCLC B classification applied in 85% of cases. Baseline tumor burden was limited to one to three nodules in 92% of cases, unilobar in 88% cases, with a median tumor diameter of 55 mm (range: 13-150 mm). Toxicity was assessed using NCI CTC AE v4.0. Response was assessed using mRECIST criteria. Time-to-treatment failure (TTTF) and overall survival (OS) were also calculated based on Kaplan-Meier method. Result: Of 141 TACE sessions performed with bead sizes of 100 and 75 µm in 42 (29.8%) and 99 (70.2%) sessions, respectively. In 78% of all TACE sessions, the full dose of idarubicin-loaded beads was injected. Grade 3-4 AE were observed after 73 (52%) sessions, most of them being biological. Multi-organ failure was observed three days after the first TACE in a Child B patients, unfortunately leading to death. Overall, the best objective response rate (ORR) was 65%. Median follow-up lasted 14.3 months (95% CI: 11.2-18.8 months). Median TTTF and OS were 14.4 months (95% CI: 7.2-24.6 months) and 34.6 months (95% CI: 24.7-not reached) respectively. Conclusion: In this retrospective study involving well-selected HCC patients, high ORR and long TTTF and OS are observed after TACE using idarubicin-loaded TANDEM. A randomized trial is needed.
| S-EPMC6678754 | biostudies-literature
Project description:Transarterial chemoembolization has proven benefit in the treatment of unresectable hepatocellular carcinoma (HCC). Commonly reported symptoms following chemoembolization with or without drug-eluting beads include abdominal pain, nausea, and low-grade fever, which typically limited resolve within a few days. A recent study comparing traditional chemoembolization versus chemoembolization with drug-eluting beads demonstrated similar survival between the two techniques, but improved tolerability when the drug-eluting beads were used. This case report describes a patient with unresectable HCC undergoing chemoembolization with drug-eluting beads. The postprocedure course was complicated by interstitial pneumonitis secondary to shunting of the drug-eluting beads containing doxorubicin to both lungs via tumor vasculature. This case highlights the relationship between the number and size of the tumors to be treated, arteriovenous shunting within the liver/tumors, and the size of the embolization particles.
| S-EPMC3193323 | biostudies-other
Project description:BackgroundThis study aimed to compare the therapeutic effectiveness including progression-free survival (PFS), overall survival (OS), and safety of conventional transarterial chemoembolization (cTACE) and drug-eluting bead transarterial chemoembolization (DEB-TACE) in a superselective fashion for the patients with nodular hepatocellular carcinoma (HCC) (n ⩽ 5) and Child-Pugh class A.MethodsA total of 198 consecutive patients with nodular HCCs (n ⩽ 5) and Child-Pugh class A liver function who were initially treated with cTACE (n = 125) or DEB-TACE (n = 57) were included retrospectively. The primary endpoint was PFS. Secondary endpoints included time-to-target lesion progression (TTTLP), OS, and safety.ResultsThe median follow up was 62 months (range, 1-87 months). The PFS was significantly longer in the cTACE group than in the DEB-TACE group (median, 18 months versus 7 months; hazard ratio [HR] = 0.658, log-rank p = 0.031), whereas OS was comparable (log-rank p = 0.299). TTTLP was significantly longer in the cTACE group than in the DEB-TACE group (median, 34 months versus 11 months; log-rank p < 0.001). In the stratification analysis based on tumor size, the cTACE group showed significantly longer TTTLP than the DEB-TACE group in the 1.0-2.0 cm and 2.1-3.0 cm subgroups (HR = 0.188, log-rank p < 0.001 and HR = 0.410, p = 0.015, respectively) but not in the 3.1-5.0 cm and 5.1-10.0 cm subgroups (all p > 0.05). Postembolization syndrome occurred more frequently in the cTACE group than in the DEB-TACE group (p = 0.006).ConclusionsDEB-TACE is followed by significantly shorter PFS than cTACE in patients with nodular HCCs (n ⩽ 5) and Child-Pugh class A, although OS is comparable. Postembolization syndrome occurs more frequently in cTACE than in DEB-TACE.
| S-EPMC6689910 | biostudies-literature
Project description:The present study aimed to compare the efficacy and safety of drug-eluting beads-transarterial chemoembolization (DEB-TACE) plus microwave ablation (MWA) versus (vs.) surgery in treating patients with hepatocellular carcinoma (HCC) adjacent to gallbladder. Totally 54 patients with HCC adjacent to gallbladder were included and divided into two groups: DEB-TACE plus MWA group (n = 24) and surgery group (n = 30). Treatment response, relapse-free survival (RFS), progression-free survival (PFS), overall survival (OS) and adverse events were assessed and documented. For DEB-TACE plus MWA group, complete response rate, objective response rate and disease control rate were 79.2%, 95.8% and 100.0% after one-month post treatment, respectively. In terms of survival profiles, DEB-TACE plus MWA group presented similar RFS (28.2 (95% CI: 12.5-43.9) months vs. 26.6 (95% CI: 19.2-34.1) months) (P = 0.930), PFS (21.2 (95% CI: 1.6-40.8) months vs. 26.6 (95% CI: 19.2-34.1) months) (P = 0.541), and OS (41.4 (95% CI: 35.0-47.9) months vs. 59.7 (95% CI: 51.7-67.7) months) (P = 0.138) compared with surgery group, and further multivariate Cox's regression analysis validated that, after adjustment of confounding factors, DEB-TACE plus MWA group exhibited no difference of RPS, PFS or OS compared with surgery group. Regarding safety, the intraoperative adverse event incidence was higher in DEB-TACE plus MWA group compared with surgery group (P = 0.008), while two groups exhibited no difference of postoperative adverse event incidence (P = 0.618). In conclusion, DEB-TACE plus MWA presents to be an optional treatment strategy in patients with HCC adjacent to gallbladder.
| S-EPMC8340149 | biostudies-literature
Project description:OBJECTIVES:Our study sought to compare the overall survival in patients with hepatocellular carcinoma (HCC) and portal venous thrombosis (PVT), treated with either conventional trans-arterial chemoembolization (cTACE) or drug-eluting beads (DEB) TACE. METHODS:This retrospective analysis included a total of 133 patients, treated without cross-over and compared head-to-head by means or propensity score weighting. Mortality was compared using survival analysis upon propensity score weighting. Adverse events and liver toxicity grade ?3 were recorded and reported for each TACE. In order to compare with historical sorafenib studies, a sub-group analysis was performed and included patients who fulfilled the SHARP inclusion criteria. RESULTS:The median overall survival (MOS) of the entire cohort was 4.53 months (95 % CI, 3.63-6.03). MOS was similar across treatment arms, no significant difference between cTACE (N?=?95) and DEB-TACE (N?=?38) was observed (MOS of 5.0 vs. 3.33 months, respectively; p?=?0.157). The most common adverse events after cTACE and DEB- TACE, respectively, were as follows: post-embolization syndrome [N?=?57 (30.0 %) and N?=?38 (61.3 %)], diarrhea [N?=?3 (1.6 %) and N?=?3 (4.8 %)], and encephalopathy [N?=?11 (5.8 %) and N?=?2 (3.2 %)]. CONCLUSION:Our retrospective study could not reveal a difference in toxicity and efficiency between cTACE and DEB-TACE for treatment of advanced stage HCC with PVT. KEY POINTS:• Conventional TACE (cTACE) and drug-eluting-beads TACE (DEB-TACE) demonstrated equal safety profiles. • Survival rates after TACE are similar to patients treated with sorafenib. • Child-Pugh class and tumor burden are reliable predictors of survival.
| S-EPMC5470590 | biostudies-literature
Project description:The purpose of this study was to investigate the efficacy and safety of drug-eluting beads transarterial chemoembolization (DEB-TACE) treatment in Chinese hepatocellular carcinoma (HCC) patients and the prognostic factors for treatment response as well as survival. A total of 275 HCC patients were included in this prospective study. Treatment response was assessed by modified Response Evaluation Criteria in Solid Tumors (mRECIST), and progression-free survival (PFS) as well as overall survival (OS) were determined. Liver function and adverse events (AEs) were assessed before and after DEB-TACE operation. Complete response (CR), partial response (PR), and objective response rate (ORR) were 22.9%, 60.7%, and 83.6%, respectively. The mean PFS was 362 (95% CI: 34.9-375) days, the 6-month PFS rate was 89.4?±?2.1%, while the mean OS was 380 (95% CI: 370-389) days, and the 6-month OS rate was 94.4?±?1.7%. Multivariate logistic regression revealed that portal vein invasion (p?=?0.011) was an independent predictor of worse clinical response. Portal vein invasion (p?=?0.040), previous cTACE treatment (p?=?0.030), as well as abnormal serum creatinine level (BCr) (p?=?0.017) were independent factors that predicted worse ORR. In terms of survival, higher Barcelona Clinic Liver Cancer (BCLC) stage (p?=?0.029) predicted for worse PFS, and abnormal albumin (ALB) (p?=?0.011) and total serum bilirubin (TBIL) (p?=?0.009) predicted for worse OS. The number of patients with abnormal albumin, total protein (TP), TBIL, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) were augmented at 1 week posttreatment and were similar at 1-3 months compared with baseline. The most common AEs were pain, fever, nausea, and vomiting, and no severe AEs were observed in this study. DEB-TACE was effective and tolerable in treating Chinese HCC patients, and portal vein invasion, previous cTACE treatment, abnormal BCr, ALB, and TBIL appear to be important factors that predict worse clinical outcome.
| S-EPMC7851504 | biostudies-literature
Project description:There are currently two methods widely used in clinical practice to perform transarterial chemoembolization (TACE). One is based on mixing an aqueous drug with an iodized oil (Lipiodol) and creating an emulsion that is delivered intraarterially, followed by embolization with a particulate agent. The other is based on a one-step TACE using Drug-eluting Beads (DEBs) loaded with drug. It is not recommended to mix Lipiodol with DEBs due to incompatibility. For the first time, novel DEB: Lipiodol: doxorubicin (Dox) emulsions are identified using lyophilized polyvinyl alcohol (PVA) hydrogels (non-iodinated or iodinated) DEBs.Methods15 DEB emulsions (50mg Dox) were assessed for stability and deliverability in vitro and in vivo in a swine model. Dox release from selected formulations was measured in vitro using a vascular flow model and in vivo in a VX2 rabbit tumor model.ResultsBoth DEB formats were shown to be able to form emulsions, however only Iodinated DEBs consistently met defined handling criteria. Those based on the non-iodinated DEB achieved >99%+ Dox loading in <5 minutes but were generally less stable. Those prepared using iodinated DEBs, which are more hydrophobic, were able to form stable Pickering-like emulsions (separation time ≥ 20 minutes) and demonstrated handling, administration and imaging observations more akin to Lipiodol™ TACE emulsions in both embolization models. Controlled Dox release and hence beneficial in vivo pharmacokinetics associated with DEB-TACE were maintained.ConclusionsThis study demonstrates that it is possible to formulate novel DEB emulsions suitable for TACE that combine positive elements of both Lipiodol™ based and DEB-TACE procedures.
| S-EPMC6735388 | biostudies-literature
Project description: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.
| S-EPMC6943446 | biostudies-literature