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1.
Int J Surg ; 2024 Sep 23.
Artículo en Inglés | MEDLINE | ID: mdl-39311927

RESUMEN

BACKGROUND AIMS: Self-expandable metallic stents (SEMSs) have been recommended for patients with unresectable malignant biliary obstruction while radiation-emitting metallic stents (REMSs) loaded with 125I seeds have recently been approved to provide longer patency and overall survival in malignant biliary tract obstruction. This trial is to evaluate the efficacy and safety of REMS plus hepatic arterial infusion chemotherapy (REMS-HAIC) versus SEMS plus HAIC (SEMS-HAIC) for unresectable perihilar cholangiocarcinoma (pCCA). METHODS: This multicenter randomized controlled trial recruited patients with unresectable Bismuth type III or IV pCCA between March 2021 and January 2023. Patients were randomly assigned (1:1 ratio) to receive either REMS-HAIC or SEMS-HAIC using permuted block randomization, with a block size of six. The primary endpoint was overall survival (OS). The secondary endpoints were time to symptomatic progression (TTSP), stent patency, relief of jaundice, quality of life, and safety. RESULTS: A total of 126 patients were included in the intent-to-treat population, with 63 in each group. The median OS was 10.2 months versus 6.7 months (P=0.002). The median TTSP was 8.6 months versus 5.4 months (P=0.003). The median stent patency was longer in the REMS-HAIC group than in the SEMS-HAIC group (P=0.001). The REMS-HAIC group showed better improvement in physical functioning scale (P<0.05) and fatigue symptoms (P<0.05) when compared to the SEMS-HAIC group. No significant differences were observed in relief of jaundice (85.7% vs. 84.1%; P=0.803) or the incidence of grade 3 or 4 adverse events (9.8% vs. 11.9%; P=0.721). CONCLUSION: REMS plus HAIC showed better OS, TTSP, and stent patency compared with SEMS plus HAIC in patients with unresectable Bismuth type III or IV pCCA with an acceptable safety profile.

2.
Adv Healthc Mater ; : e2402253, 2024 Sep 25.
Artículo en Inglés | MEDLINE | ID: mdl-39319494

RESUMEN

Drug-eluting bead transcatheter arterial chemoembolization (D-TACE) is one of the first-line treatment for intermediate hepatocellular carcinoma (HCC). However, the dual hypoxia microenvironment, due to inherent tumor hypoxia and TACE-induced hypoxia, triggers drug resistance in HCC. To address this challenge, the study develops multicavitary microspheres capable of encapsulating oxygen and harnessing magnetic hyperthermia to enhance oxygen permeability. The novel multicavitary oxygen-encapsulated magnetothermal drug-eluting microspheres (OTD-Ms) effectively reduce hypoxia-related proteins (HIF-1α, VEGF-A) and drug resistance (P-gp) both in vitro and in vivo. Moreover, these microspheres demonstrate improved TACE efficacy and enhance survival rates in a rabbit VX-2 tumor model, suggesting their potential for HCC treatment.

3.
EClinicalMedicine ; 72: 102622, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38745965

RESUMEN

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.

4.
APL Bioeng ; 8(2): 021501, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38572313

RESUMEN

Cancer, with high morbidity and high mortality, is one of the major burdens threatening human health globally. Intervention procedures via percutaneous puncture have been widely used by physicians due to its minimally invasive surgical approach. However, traditional manual puncture intervention depends on personal experience and faces challenges in terms of precisely puncture, learning-curve, safety and efficacy. The development of puncture interventional surgery robotic (PISR) systems could alleviate the aforementioned problems to a certain extent. This paper attempts to review the current status and prospective of PISR systems for thoracic and abdominal application. In this review, the key technologies related to the robotics, including spatial registration, positioning navigation, puncture guidance feedback, respiratory motion compensation, and motion control, are discussed in detail.

5.
United European Gastroenterol J ; 12(2): 226-239, 2024 03.
Artículo en Inglés | MEDLINE | ID: mdl-38372444

RESUMEN

Hepatocellular carcinoma (HCC) is one of the most common cancers and a leading cause of cancer-related mortality. Locoregional therapies (LRTs) play a crucial role in HCC management and are selectively adopted in real-world practice across various stages. Choosing the best form of LRTs depends on technical aspects, patient clinical status and tumour characteristics. Previous studies have consistently highlighted the efficacy of combining LRTs with molecular targeted agents in HCC treatment. Recent studies propose that integrating LRTs with immune checkpoint inhibitors and molecular targeted agents could provide substantial therapeutic benefits, a notion underpinned by both basic and clinical evidence. This review summarised the current landscape of LRTs in HCC and discussed the anticipated outcomes of combinations with immunotherapy regimens.


Asunto(s)
Antineoplásicos , Carcinoma Hepatocelular , Neoplasias Hepáticas , Humanos , Resultado del Tratamiento , Inmunoterapia , Antineoplásicos/uso terapéutico
6.
Cardiovasc Intervent Radiol ; 47(3): 325-336, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38413420

RESUMEN

PURPOSE: While the role of drug-eluting beads transarterial chemoembolization (DEB-TACE) for hepatocellular carcinoma (HCC) is established, questions regarding appropriate bead size for use in patients remain. This trial evaluated the effectiveness and safety of DEB-TACE using small-size (≤ 100 µm) microspheres loaded with epirubicin. MATERIALS AND METHODS: This prospective, single-arm, multicenter study enrolled patients diagnosed with HCC who underwent DEB-TACE using 40 (range, 30-50), 75 (range, 60-90), or 100 (range, 75-125) µm epirubicin-loaded microspheres (TANDEM microspheres, Varian Medical). Bead size was at the discretion of treating physicians and based on tumor size and/or vascular structure. The primary outcome measure was 6-month objective response rate (ORR). Secondary outcome measures were 30-day and 3-month ORR, time to tumor progression and extrahepatic spread, proportion of progression-free survival and overall survival (OS) at one year, and incidence of treatment-associated adverse events. RESULTS: Data from 108 patients from ten centers was analyzed. Six-month ORR was 73.3 and 71.3% based on European association for the study of the liver (EASL) and modified response evaluation criteria in solid tumors (mRECIST) criteria, respectively. Thirty-day ORR was 79.6% for both EASL and mRECIST criteria with 3-month ORR being 80.0 and 81.0%, respectively, for each criteria. One-year PPF and OS rate were 60.3 and 94.3%. There was a total of 30 SAEs reported to be likely to definitely associated with microsphere (n = 9), epirubicin (n = 9), or procedure (n = 12) with none resulting in death. CONCLUSION: DEB-TACE using epirubicin-loaded small-sized (≤ 100 µm) microspheres demonstrates promising local tumor control and acceptable safety in patients with HCC. TRIAL REGISTRATION: Clinicaltrials.gov NCT03113955; registered April 14, 2017. Trial Registration Clinicaltrials.gov NCT03113955; registered April 14, 2017. LEVEL OF EVIDENCE: 2, Prospective, Non-randomized, Single-arm, study.


Asunto(s)
Carcinoma Hepatocelular , Quimioembolización Terapéutica , Neoplasias Hepáticas , Humanos , Carcinoma Hepatocelular/patología , Epirrubicina , Neoplasias Hepáticas/patología , Microesferas , Estudios Prospectivos , Resultado del Tratamiento , Quimioembolización Terapéutica/métodos , Doxorrubicina , Estudios Retrospectivos
7.
J Clin Transl Hepatol ; 12(1): 15-24, 2024 Jan 28.
Artículo en Inglés | MEDLINE | ID: mdl-38250466

RESUMEN

Background and Aims: Several first-line immune checkpoint inhibitor (ICI)-based combination therapies have been identified for unresectable hepatocellular carcinoma (uHCC). This network meta-analysis (NMA) aimed to provide the most updated evidence about the preferred first-line ICI-based regimens for uHCC. Methods: A comprehensive literature search was performed in various databases from database inception to May 2022. The phase 3 trials evaluating first-line single-agent ICIs, molecular-target agents (MTAs), or their combinations in uHCC were included. The main endpoints were overall survival (OS) and progression-free survival (PFS). Pooled effect estimates were calculated using a random effects model within the frequentist framework. Subgroup analyses based on etiology were also conducted. Results: Twelve trials at low risk of bias with 8,275 patients comparing 13 treatments were included. OS with atezolizumab plus bevacizumab was comparable to sintilimab plus IBI305 [hazard ratio (HR): 1.16; 95% confidence interval (CI): 0.80-1.68] and camrelizumab plus apatinib (HR: 1.06; 95% CI: 0.75-1.51). The combination therapies, apart from atezolizumab plus cabozantinib in OS and durvalumab plus tremelimumab in PFS, had higher P-score than single-agent MTAs or ICIs. The survival benefits were associated with a high risk of adverse events leading to treatment discontinuation. The proportion of patients with hepatitis B virus-related HCC receiving ICIs combinations might positively correlate with survival advantages (R2=0.8039, p=0.0155). Conclusion: This NMA demonstrated that atezolizumab plus bevacizumab remains the stand of care and confers comparable survival benefits to sintilimab plus IBI305 and camrelizumab plus apatinib in first-line therapy for uHCC. The optimal treatment algorithms should consider efficacy, safety, and etiology.

8.
Med Phys ; 51(1): 348-362, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37475484

RESUMEN

BACKGROUND: Leveraging the precision of its radiation dose distribution and the minimization of postoperative complications, low-dose-rate (LDR) permanent seed brachytherapy is progressively adopted in addressing hepatic malignancies. PURPOSE: The present study endeavors to devise a sophisticated treatment planning system (TPS) to optimize LDR brachytherapy for hepatic lesions. METHODS: Our TPS encompasses four integral modules: multi-organ segmentation, seed distribution initialization, puncture pathway selection, and inverse dose planning. By amalgamating an array of deep learning models, the segmentation module proficiently labels 17 discrete abdominal targets within the images. We introduce a knowledge-based seed distribution initialization methodology that discerns the most analogous tumor shape in the reference treatment plan from the knowledge base. Subsequently, the seed distribution from the reference plan is transmuted to the current case, thus establishing seed distribution initialization. Furthermore, we parameterize the puncture needles and seeds, while concurrently constraining the puncture needle angle through the employment of a virtual puncture panel to augment planning algorithm efficiency. We also presented a user interface that includes a range of interactive features, seamlessly integrated with the treatment planning generation function. RESULTS: The multi-organ segmentation module, which is trained by 50 cases of in-house CT scans and 694 cases of publicly available CT scans, achieved average Dice of 0.80 and Hausdorff distance of 5.2 mm in testing datasets. The results demonstrate that knowledge-based initialization exhibits a marked enhancement in expediting the convergence rate. Our TPS also demonstrates a dominant advantage in dose-volume-histogram criteria and execution time in comparison to commercial TPS. CONCLUSION: The study proposes an innovative treatment planning system for low-dose-rate permanent seed brachytherapy for hepatic malignancies. We show that the generated treatment plans meet clinical requirement.


Asunto(s)
Braquiterapia , Neoplasias Hepáticas , Humanos , Dosificación Radioterapéutica , Braquiterapia/métodos , Planificación de la Radioterapia Asistida por Computador/métodos , Algoritmos , Neoplasias Hepáticas/diagnóstico por imagen , Neoplasias Hepáticas/radioterapia
9.
Ann Vasc Surg ; 100: 39-46, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38104925

RESUMEN

BACKGROUND: To evaluate the safety and efficacy of endovascular denervation (EDN) as an adjunct to percutaneous vascular intervention (PVI) for peripheral artery disease (PAD). METHODS: From August 2019 to April 2021, 38 eligible patients with PAD enrolled in this study were randomly and equally assigned into 2 groups: the PVI group and the PVI + EDN group treated with EDN at the iliac and femoral arteries before PVI. The primary endpoint was the improvement in the ankle brachial index at 6 months after the procedure. The secondary endpoints were transcutaneous oxygen pressure (TcPO2), Rutherford category, numerical rating scale score, and safety. RESULTS: The technical success rates of PVI and EDN were 100%, and no device-related or procedure-related major adverse events occurred in either group. Compared with PVI alone, PVI + EDN demonstrated a significant improvement in limb hemodynamics at 6 months (Δ ankle brachial index 0.44 ± 0.31 vs. 0.24 ± 0.15, P = 0.018). Microcirculatory perfusion of PAD was significantly better at 6 months in the PVI + EDN group (ΔTcPO2, 15.68 ± 16.72 vs. 4.95 ± 13.43, P = 0.036). The Rutherford category was significantly improved in the PVI + EDN group in comparison with the PVI group at the 3-month follow-up (100.00% vs. 68.42%, P = 0.02). The decrease in the numerical rating scale score in the PVI + EDN group was greater than that in the PVI group at 1 week following the procedure (3 [2-5] vs. 4 [4-6], P = 0.022). CONCLUSIONS: In this single-center pilot analysis of a heterogeneous cohort of patients with PAD, PVI with EDN demonstrated a significant improvement in limb ischemia at 6 months compared with PVI alone.


Asunto(s)
Procedimientos Endovasculares , Enfermedad Arterial Periférica , Humanos , Microcirculación , Resultado del Tratamiento , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/cirugía , Isquemia/diagnóstico por imagen , Isquemia/cirugía , Desnervación , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/métodos , Factores de Riesgo
10.
IEEE Trans Med Imaging ; 43(5): 1727-1739, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38153820

RESUMEN

The augmented intra-operative real-time imaging in vascular interventional surgery, which is generally performed by projecting preoperative computed tomography angiography images onto intraoperative digital subtraction angiography (DSA) images, can compensate for the deficiencies of DSA-based navigation, such as lack of depth information and excessive use of toxic contrast agents. 3D/2D vessel registration is the critical step in image augmentation. A 3D/2D registration method based on vessel graph matching is proposed in this study. For rigid registration, the matching of vessel graphs can be decomposed into continuous states, thus 3D/2D vascular registration is formulated as a search tree problem. The Monte Carlo tree search method is applied to find the optimal vessel matching associated with the highest rigid registration score. For nonrigid registration, we propose a novel vessel deformation model based on manifold regularization. This model incorporates the smoothness constraint of vessel topology into the objective function. Furthermore, we derive simplified gradient formulas that enable fast registration. The proposed technique undergoes evaluation against seven rigid and three nonrigid methods using a variety of data - simulated, algorithmically generated, and manually annotated - across three vascular anatomies: the hepatic artery, coronary artery, and aorta. Our findings show the proposed method's resistance to pose variations, noise, and deformations, outperforming existing methods in terms of registration accuracy and computational efficiency. The proposed method demonstrates average registration errors of 2.14 mm and 0.34 mm for rigid and nonrigid registration, and an average computation time of 0.51 s.


Asunto(s)
Algoritmos , Imagenología Tridimensional , Método de Montecarlo , Humanos , Imagenología Tridimensional/métodos , Angiografía por Tomografía Computarizada/métodos , Angiografía de Substracción Digital/métodos
11.
J Diabetes ; 15(8): 665-673, 2023 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-37438984

RESUMEN

The rising prevalence of metabolic disorders such as obesity and type 2 diabetes mellitus (T2DM) poses a major challenge to global health. Existing therapeutic approaches have limitations, and there is a need for new, safe, and less invasive treatments. Interventional metabolic therapy is a new addition to the treatment arsenal for metabolic disorders. This review focuses on two interventional techniques: bariatric arterial embolization (BAE) and endovascular denervation (EDN). BAE involves embolizing specific arteries feeding ghrelin-producing cells to suppress appetite and promote weight loss. EDN targets nerves that regulate metabolic organs to improve glycemic control in T2DM patients. We describe the current state of these techniques, their mechanisms of action, and the available safety and effectiveness data. We also propose a new territory called "Interventional Metabology" to encompass these and other interventional approaches to treating metabolic disorders.


Asunto(s)
Cirugía Bariátrica , Bariatria , Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/terapia , Obesidad/metabolismo , Pérdida de Peso , Desnervación
12.
Eur Radiol ; 33(12): 8669-8681, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37368105

RESUMEN

OBJECTIVES: This study aimed to investigate the efficacy and safety of transarterial chemoembolization (TACE) plus camrelizumab, a monoclonal antibody targeting programmed death-1, and apatinib for patients with intermediate and advanced hepatocellular carcinoma (HCC) in a real-world setting. METHODS: A total of 586 HCC patients treated with either TACE plus camrelizumab and apatinib (combination group, n = 107) or TACE monotherapy (monotherapy group, n = 479) were included retrospectively. Propensity score matching analysis was used to match patients. The overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety in the combination group were described in comparison to monotherapy. RESULTS: After propensity score matching (1:2), 84 patients in the combination group were matched to 147 patients in the monotherapy group. The median age was 57 years and 71/84 (84.5%) patients were male in the combination group, while the median age was 57 years with 127/147 (86.4%) male in the monotherapy group. The median OS, PFS, and ORR in the combination group were significantly higher than those in the monotherapy group (median OS, 24.1 vs. 15.7 months, p = 0.008; median PFS, 13.5 vs. 7.7 months, p = 0.003; ORR, 59.5% [50/84] vs. 37.4% [55/147], p = 0.002). On multivariable Cox regression, combination therapy was associated with significantly better OS (adjusted hazard ratio [HR], 0.41; 95% confidence interval [CI], 0.26-0.64; p < 0.001) and PFS (adjusted HR, 0.52; 95% CI, 0.37-0.74; p < 0.001). Grade 3 or 4 adverse events occurred in 14/84 (16.7%) and 12/147 (8.2%) in the combination and monotherapy groups, respectively. CONCLUSIONS: TACE plus camrelizumab and apatinib showed significantly better OS, PFS, and ORR versus TACE monotherapy for predominantly advanced HCC. CLINICAL RELEVANCE STATEMENT: Compared with TACE monotherapy, TACE plus immunotherapy and molecular targeted therapy showed better clinical efficacy for predominantly advanced HCC patients, with a higher incidence of adverse events. KEY POINTS: • This propensity score-matched study demonstrates that TACE plus immunotherapy and molecular targeted therapy have a longer OS, PFS, and ORR compared with TACE monotherapy in HCC. • Grade 3 or 4 adverse events occurred in 14/84 (16.7%) patients treated with TACE plus immunotherapy and molecular targeted therapy compared with 12/147 (8.2%) patients in the monotherapy group, while no grade 5 adverse events were observed in all cohorts.


Asunto(s)
Antineoplásicos , Carcinoma Hepatocelular , Quimioembolización Terapéutica , Neoplasias Hepáticas , Humanos , Masculino , Persona de Mediana Edad , Femenino , Carcinoma Hepatocelular/tratamiento farmacológico , Carcinoma Hepatocelular/patología , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Hepáticas/patología , Antineoplásicos/uso terapéutico , Quimioembolización Terapéutica/efectos adversos , Puntaje de Propensión , Estudios Retrospectivos
13.
Int J Surg ; 109(5): 1188-1198, 2023 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-37038986

RESUMEN

BACKGROUND AND AIM: Treatment strategy for hepatocellular carcinoma (HCC) and Vp4 [main trunk] portal vein tumor thrombosis (PVTT) remains limited due to posttreatment liver failure. We aimed to assess the efficacy of irradiation stent placement with 125 I plus transcatheter arterial chemoembolization (TACE) (ISP-TACE) compared to sorafenib plus TACE (Sora-TACE) in these patients. METHODS: In this multicenter randomized controlled trial, participants with HCC and Vp4 PVTT without extrahepatic metastases were enrolled from November 2018 to July 2021 at 16 medical centers. The primary endpoint was overall survival (OS). The secondary endpoints were hepatic function, time to symptomatic progression, patency of portal vein, disease control rate, and treatment safety. RESULTS: Of 105 randomized participants, 51 were assigned to the ISP-TACE group, and 54 were assigned to the Sora-TACE group. The median OS was 9.9 months versus 6.3 months (95% CI: 0.27-0.82; P =0.01). Incidence of acute hepatic decompensation was 16% (8 of 51) versus 33% (18 of 54) ( P =0.036). The time to symptomatic progression was 6.6 months versus 4.2 months (95% CI: 0.38-0.93; P =0.037). The median stent patency was 7.2 months (interquartile range, 4.7-9.3) in the ISP-TACE group. The disease control rate was 86% (44 of 51) versus 67% (36 of 54) ( P =0.018). Incidences of adverse events at least grade 3 were comparable between the safety populations of the two groups: 16 of 49 (33%) versus 18 of 50 (36%) ( P =0.73). CONCLUSION: Irradiation stent placement plus TACE showed superior results compared with sorafenib plus TACE in prolonging OS in patients with HCC and Vp4 PVTT.


Asunto(s)
Carcinoma Hepatocelular , Quimioembolización Terapéutica , Neoplasias Hepáticas , Trombosis de la Vena , Humanos , Carcinoma Hepatocelular/complicaciones , Carcinoma Hepatocelular/terapia , Sorafenib , Neoplasias Hepáticas/complicaciones , Neoplasias Hepáticas/terapia , Vena Porta/patología , Quimioembolización Terapéutica/efectos adversos , Quimioembolización Terapéutica/métodos , Resultado del Tratamiento , Trombosis de la Vena/terapia , Stents , Estudios Retrospectivos
15.
Eur Radiol ; 32(11): 7335-7343, 2022 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-35776182

RESUMEN

OBJECTIVES: To investigate the efficacy and safety of dicycloplatin as chemotherapeutic regimen in transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). METHODS: In this randomized, open-label, phase II trial, patients with unresectable HCC who were TACE treatment-naïve or experienced recurrence after surgical resection or ablation were enrolled at 7 centers in China from March 2019 to November 2019. Participants were randomly assigned (1:1:1) to receive TACE with chemotherapeutic regimen of dicycloplatin alone (group A1), dicycloplatin plus epirubicin (group A2), or epirubicin alone (group B). The primary endpoint was objective response rate (ORR). The secondary endpoints included disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and safety. RESULTS: The ORR at 6 months in group A1 (n = 22) was significantly better than that in group B (p = 0.093; 90% confidence interval [CI], 1.03-9.45). The DCR in group A1 was significantly higher than that in group B (p = 0.045; 90% CI, 1.29-12.88). There was no significant difference in DOR among the groups (p = 0.271). The median PFS were 6.00 and 3.05 months in groups A2 (n = 25) and B (n = 24), respectively (p = 0.061). Grade 3 or worse adverse events were similar among groups in the safety population (p = 0.173). CONCLUSION: TACE with dicycloplatin was comparably safe and well tolerable as epirubicin alone in patients with unresectable HCC. Compared with epirubicin alone, significant improvement in ORR and DCR when dicycloplatin was applied, as well as prolonged PFS when dicycloplatin plus epirubicin was applied, was generated. KEY POINTS: • To our knowledge, this is the first multicenter randomized trial to assess the efficacy and safety of TACE with dicycloplatin in patients with unresectable HCC. • This phase II trial showed that TACE with dicycloplatin alone or plus epirubicin was comparably safe and well tolerable as epirubicin alone. • Significant improvements in ORR, DCR when dicycloplatin was applied, and prolonged PFS when dicycloplatin plus epirubicin was applied were recorded compared with epirubicin alone.


Asunto(s)
Carcinoma Hepatocelular , Quimioembolización Terapéutica , Neoplasias Hepáticas , Humanos , Carcinoma Hepatocelular/tratamiento farmacológico , Carcinoma Hepatocelular/patología , Quimioembolización Terapéutica/efectos adversos , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Hepáticas/patología , Epirrubicina/uso terapéutico , Resultado del Tratamiento
16.
Int J Surg ; 102: 106094, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35662438

RESUMEN

BACKGROUND: Hepatocellular carcinoma (HCC) is subject to different management approaches and guidelines according to Eastern and Western therapeutic algorithms. Use of selective internal radiation therapy (SIRT) with resin yttrium 90 microspheres for HCC has increased in Asia in recent years, without clearly defined indications for its optimal application. The objective of this systematic review and expert consensus statement is to provide guidance and perspectives on the use of SIRT among patients with HCC in Asia. MATERIALS AND METHODS: A systematic literature review identified current publications on HCC management and SIRT recommendations. A group of 10 experts, representing stakeholder specialties and countries, convened between August 2020 and March 2021 and implemented a modified Delphi consensus approach to develop guidelines and indications for use of SIRT for HCC in Asia. Final recommendations were organized and adjudicated based on the level of evidence and strength of recommendation, per approaches outlined by the American College of Cardiology/American Heart Association and Oxford Centre for Evidence-Based Medicine. RESULTS: The experts acknowledged a general lack of evidence relating to use of SIRT in Asia and identified as an unmet need the lack of phase 3 randomized trials comparing clinical outcomes and survival following SIRT versus other therapies for HCC. Through an iterative process, the expert group explored areas of clinical relevance and generated 31 guidance statements and a patient management algorithm that achieved consensus. CONCLUSION: These recommendations aim to support clinicians in their decision-making and to help them identify and treat patients with HCC using SIRT in Asia. The recommendations also highlight areas in which further clinical trials are needed to define the role of SIRT in management of HCC among Asian populations.


Asunto(s)
Braquiterapia , Carcinoma Hepatocelular , Neoplasias Hepáticas , Humanos , Carcinoma Hepatocelular/patología , Neoplasias Hepáticas/patología , Microesferas , Radioisótopos de Itrio/uso terapéutico
17.
Cardiovasc Intervent Radiol ; 45(6): 808-813, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35316381

RESUMEN

PURPOSE: To evaluate the efficacy and safety of computed tomography-guided radioactive iodine-125 (125I) seed implantation for oligo-recurrence soft tissue sarcomas following surgical resection. MATERIALS AND METHODS: Patients with oligo-recurrence soft tissue sarcomas after curative surgical resection between June 2013 and December 2020 were included. The primary outcome measure was objective response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). The secondary outcomes included progression-free survival, overall survival, and safety profiles. RESULTS: Twenty-nine patients receiving computed tomography-guided 125I seed implantation were included in the study. The objective response rates at 2-, 6- and 12-month follow-up were 48.3%, 65.5% and 40.9%, respectively. The median progression-free survival was 11.3 months. The median overall survival was 25.1 months, with a 1- and 2-year overall survival rate of 81.5% and 50.0%, respectively. No severe treatment-related adverse effects occured. CONCLUSION: 125I seed implantation has the potential to be an effective and safe treatment for oligo-recurrence soft tissue sarcomas after surgical resection.


Asunto(s)
Braquiterapia , Sarcoma , Neoplasias de los Tejidos Blandos , Neoplasias de la Tiroides , Braquiterapia/efectos adversos , Humanos , Radioisótopos de Yodo/uso terapéutico , Recurrencia Local de Neoplasia/radioterapia , Estudios Retrospectivos , Sarcoma/diagnóstico por imagen , Sarcoma/radioterapia , Sarcoma/cirugía , Neoplasias de los Tejidos Blandos/diagnóstico por imagen , Neoplasias de los Tejidos Blandos/radioterapia , Neoplasias de los Tejidos Blandos/cirugía , Resultado del Tratamiento
18.
Hepatobiliary Surg Nutr ; 10(5): 661-671, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-34760969

RESUMEN

IMPORTANCE: Transarterial chemoembolization (TACE) has been associated with a wide range of practice variations for hepatocellular carcinoma (HCC) between the East and the West. This considerable ambiguity may lead to the heterogeneous quality in treatment and have a negative impact on the role of TACE in the overall multidisciplinary HCC treatment system. OBJECTIVE: It may be a good start to establish a guideline worldwide to have this consensus from experts who represent east and west, although it does not cover all aspects of TACE. EVIDENCE REVIEW: An international expert panel on TACE is convened to cluster the expert's opinions and summary a standard consensus. This panel committee consist of leading physicians in TACE on HCC from USA, France, Japan, Singapore, Korea, China, and so on. The first-round face-to-face consensus meeting was held during in Nanjing, China in October 2019. The second-round conference for revision of the consensus was held during the Annual Meeting of Chinese College of Interventionalists in August 2020 by a hybrid format of a Webinar and roundtable meeting. After several on-line revisions, the final manuscript was approved by all members of the panel in June 2021. FINDINGS: The consensus statements were organized into the following categories: patients' selection, performing the procedure, TACE outcomes, repeat TACE, TACE failure/refractory, and TACE-based combination treatments. CONCLUSIONS AND RELEVANCE FOR REVIEWS: More and more evidences have showed the better outcomes with strategy of combined TACE with other local therapies such as ablations. The most-recently developing strategy of combined TACE with PD-1/PD-L1 plus tyrosine kinase inhibitor (TKI) agents has shined a light to the HCC patients, especially to those with high risk of tumor recurrence after treatment or TACE failure/refractory.

19.
J Clin Transl Hepatol ; 9(4): 521-527, 2021 Aug 28.
Artículo en Inglés | MEDLINE | ID: mdl-34447681

RESUMEN

BACKGROUND AND AIMS: The recognition of transarterial chemoembolization (TACE) failure/refractoriness among Chinese clinicians remains unclear. Using an online survey conducted by the Chinese College of Interventionalists (CCI), the aim of this study was to explore the recognition of TACE failure/refractoriness and review TACE application for hepatocellular carcinoma (HCC) treatment in clinical practice. METHODS: From 27 August 2020 to 30 August 2020 during the CCI 2020 annual meeting, a survey with 34 questions was sent by email to 264 CCI clinicians in China with more than 10 years of experience using TACE for HCC treatment. RESULTS: A total of 257 clinicians participated and responded to the survey. Most participants agreed that the concept of "TACE failure/refractoriness" has scientific and clinical significance (n=191, 74.3%). Nearly half of these participants chose TACE-based combination treatment as subsequent therapy after so-called TACE failure/refractoriness (n=88, 46.1%). None of the existing TACE failure/refractoriness definitions were widely accepted by the participants; thus, it is necessary to re-define this concept for the treatment of HCC in China (n=235, 91.4%). Most participants agreed that continuing TACE should be performed for patients with preserved liver function, presenting portal vein tumor thrombosis (n=242, 94.2%) or extrahepatic spread (n=253, 98.4%), after the previous TACE treatment to control intrahepatic lesion(s). CONCLUSIONS: There is an obvious difference in the recognition of TACE failure/refractoriness among Chinese clinicians based on existing definitions. Further work should be carried out to re-define TACE failure/refractoriness.

20.
Front Oncol ; 11: 602700, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34026598

RESUMEN

PURPOSE: Given that the novel coronavirus disease (COVID-19) pandemic has disrupted operations globally, an institution's ability to repeat transarterial chemoembolization (TACE) for patients with hepatocellular carcinoma (HCC) has also been affected. The aim of this study was to evaluate the impact of the COVID-19 on the intervals and outcomes of TACE in HCC patients. MATERIALS AND METHODS: This retrospective study included 154 HCC patients who underwent follow-up after TACE treatment from January 2020 to March 2020 (n = 71, study group) and January 2019 to March 2019 (n = 83, control group) at two institutions in China. The endpoints included the follow-up interval and overall response rate (ORR). Multivariate logistic regression analyses were performed to identify independent risk factors for a worse ORR. The cut-off point was determined to divide follow-up durations into long- and short-intervals. RESULTS: The median follow-up interval was 82.0 days (IQR, 61-109) in the study group, which was significantly longer than 66.0 days (IQR, 51-94) in the control group (P = 0.004). The ORR was 23.9 and 39.8% in the study and control group, respectively (P = 0.037). The cut-off value was 95 days. The grouping (OR, 2.402; 95% CI, 1.040-5.546; P = 0.040), long interval (OR, 2.573; 95% CI, 1.022-6.478; P = 0.045), and China liver cancer staging system (OR, 2.500; 95% CI, 1.797-3.480; P <0.001) were independent predictors for the efficacy of TACE treatment. CONCLUSIONS: The COVID-19 pandemic causes a longer follow-up interval in general, which may further lead to a lower ORR in HCC patients. Those with a follow-up interval of >95 days tend to have a worse prognosis.

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