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Purpose Selective internal radiation therapy or radioembolization (RE) shows efficacy in unresectable hepatocellular carcinoma (HCC) limited to the liver. This study compared the safety and efficacy of RE and sorafenib in patients with locally advanced HCC. Patients and Methods SIRveNIB (selective internal radiation therapy v sorafenib), an open-label, investigator-initiated, phase III trial, compared yttrium-90 (90Y) resin microspheres RE with sorafenib 800 mg/d in patients with locally advanced HCC in a two-tailed study designed for superiority/detriment. Patients were randomly assigned 1:1 and stratified by center and presence of portal vein thrombosis. Primary end point was overall survival (OS). Efficacy analyses were performed in the intention-to-treat population and safety analyses in the treated population. Results A total of 360 patients were randomly assigned (RE, 182; sorafenib, 178) from 11 countries in the Asia-Pacific region. In the RE and sorafenib groups, 28.6% and 9.0%, respectively, failed to receive assigned therapy without significant cross-over to either group. Median OS was 8.8 and 10.0 months with RE and sorafenib, respectively (hazard ratio, 1.1; 95% CI, 0.9 to 1.4; P = .36). A total of 1,468 treatment-emergent adverse events (AEs) were reported (RE, 437; sorafenib, 1,031). Significantly fewer patients in the RE than sorafenib group had grade ≥ 3 AEs (36 of 130 [27.7%]) v 82 of 162 [50.6%]; P < .001). The most common grade ≥ 3 AEs were ascites (five of 130 [3.8%] v four of 162 [2.5%] patients), abdominal pain (three [2.3%] v two [1.2%] patients), anemia (zero v four [2.5%] patients), and radiation hepatitis (two [1.5%] v zero [0%] patients). Fewer patients in the RE group (27 of 130 [20.8%]) than in the sorafenib group (57 of 162 [35.2%]) had serious AEs. Conclusion In patients with locally advanced HCC, OS did not differ significantly between RE and sorafenib. The improved toxicity profile of RE may inform treatment choice in selected patients.
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Braquiterapia/métodos , Carcinoma Hepatocelular/tratamento farmacológico , Carcinoma Hepatocelular/radioterapia , Neoplasias Hepáticas/tratamento farmacológico , Neoplasias Hepáticas/radioterapia , Sorafenibe/administração & dosagem , Radioisótopos de Ítrio/administração & dosagem , Antineoplásicos/administração & dosagem , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Microesferas , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
Hepatocellular carcinoma (HCC) is the 6th most common cancer in the world, but the second most common cause of cancer death. There is no universally accepted consensus practice guidelines for HCC owing to rapid developments in new treatment modalities, the heterogeneous epidemiology and clinical presentation of HCC worldwide. However, a number of regional and national guidelines currently exist which reflect practice relevant to the epidemiology and collective experience of the consensus group. In 2014, clinicians at the multidisciplinary Comprehensive Liver Cancer Clinic (CLCC) at the National Cancer Centre Singapore (NCCS) reviewed the latest published scientific data and existing international and regional practice guidelines, such as those of the National Comprehensive Cancer Network, American Association for the Study of Liver Diseases and the Asian Pacific Association for the Study of the Liver, and modified them to reflect local practice. These would serve as a template by which treatment outcomes can be collated and benchmarked against international data. The NCCS Consensus Guidelines for HCC have been successfully implemented in the CLCC since their publication online on 26(th) September 2014, and the guidelines allow outcomes of treatment to be compared to international data. These guidelines will be reviewed periodically to incorporate new data.
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BACKGROUND: To obtain descriptive data on Singaporean thyroid cancer patients treated with radioiodine and to assess gender, race, and age at diagnosis as risk factors for metastasis or recurrence. METHODS: This is a retrospective study of all thyroid cancer patients treated with radioiodine of any prescribed activity at our institution. Data collected included: age at diagnosis, gender, race, histopathological type, duration of follow-up, and metastasis at diagnosis (locoregional or distant) or recurrence at any time. Gender, race, and age at diagnosis were analyzed for possible associations with metastasis or recurrence. RESULTS: A total of 1,657 thyroid cancer patients were treated with radioiodine across a 40-year period; mean follow-up 6.4 ± 6.9 years (median 4.2 years). 656 (39.6%) patients had metastasis or recurrence over the duration of their follow-up. Male gender (odds ratio (OR) 1.38; p = 0.006), Malay race (OR 1.71; p < 0.0001), and age at diagnosis of > 46 years (OR 1.31; p = 0.007) were significantly associated with metastasis or recurrence. CONCLUSION: Male gender, Malay race, and age at diagnosis of > 46 years were significant risk factors for metastasis or recurrence in Singaporean thyroid cancer patients treated with radioiodine.
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Carcinoma/mortalidade , Carcinoma/secundário , Recidiva Local de Neoplasia/mortalidade , Recidiva Local de Neoplasia/prevenção & controle , Neoplasias da Glândula Tireoide/mortalidade , Neoplasias da Glândula Tireoide/radioterapia , Adolescente , Adulto , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Carcinoma/prevenção & controle , Criança , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Grupos Raciais/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , Distribuição por Sexo , Singapura/etnologia , Taxa de Sobrevida , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: The safety and tolerability of sequential radioembolization-sorafenib therapy is unknown. An open-label, single arm, investigator-initiated Phase II study (NCT0071279) was conducted at four Asia-Pacific centers to evaluate the safety and efficacy of sequential radioembolization-sorafenib in patients with hepatocellular carcinoma (HCC) not amenable to curative therapies. METHODS: Sorafenib (400 mg twice-daily) was initiated 14 days post-radioembolization with yttrium-90 (90Y) resin microspheres given as a single procedure. The primary endpoints were safety and tolerability and best overall response rate (ORR) using RECIST v1.0.Secondary endpoints included: disease control rate (complete [CR] plus partial responses [PR] and stable disease [SD]) and overall survival (OS). RESULTS: Twenty-nine patients with Barcelona Clinic Liver Cancer (BCLC) stage B (38%) or C (62%) HCC received a median of 3.0 GBq (interquartile range, 1.0) 90Y-microspheres followed by sorafenib (median dose/day, 600.0 mg; median duration, 4.1 months). Twenty eight patients experienced ≥1 toxicity; 15 (52%) grade ≥3. Best ORR was 25%, including 2 (7%) CR and 5 (18%) PR, and 15 (54%) SD. Disease control was 100% and 65% in BCLC stage B and C, respectively. Two patients (7%) had sufficient response to enable radical therapy. Median survivals for BCLC stage B and C were 20.3 and 8.6 months, respectively. CONCLUSIONS: This study shows the potential efficacy and manageable toxicity of sequential radioembolization-sorafenib. TRIAL REGISTRATION: ClinicalTrials.gov NCT00712790.
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Carcinoma Hepatocelular/tratamento farmacológico , Carcinoma Hepatocelular/radioterapia , Neoplasias Hepáticas/tratamento farmacológico , Neoplasias Hepáticas/radioterapia , Niacinamida/análogos & derivados , Compostos de Fenilureia/uso terapêutico , Idoso , Carcinoma Hepatocelular/fisiopatologia , Carcinoma Hepatocelular/cirurgia , Progressão da Doença , Relação Dose-Resposta a Droga , Embolização Terapêutica/efeitos adversos , Feminino , Humanos , Neoplasias Hepáticas/fisiopatologia , Neoplasias Hepáticas/cirurgia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Niacinamida/efeitos adversos , Niacinamida/uso terapêutico , Compostos de Fenilureia/efeitos adversos , Qualidade de Vida , Sorafenibe , Fatores de Tempo , Radioisótopos de Ítrio/uso terapêuticoRESUMO
High resolution yttrium-90 ((90)Y) imaging of post-radioembolization microsphere biodistribution may be achieved by conventional positron emission tomography with integrated computed tomography (PET/CT) scanners that have time-of-flight capability. However, reconstructed (90)Y PET/CT images have high background noise, making non-target activity detection technically challenging. This educational article describes our image assessment technique for non-target activity detection by (90)Y PET/CT, which qualitatively overcomes the problem of background noise. We present selected case examples of non-target activity in untargeted liver, stomach, gallbladder, chest wall, and kidney, supported by angiography and (90)Y bremsstrahlung single-photon emission computed tomography with integrated computed tomography (SPECT/CT) or technetium-99m macroaggregated albumin SPECT/CT.
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Radioembolization is an effective locoregional therapy for patients with intermediate or advanced stage hepatocellular carcinoma (HCC). It has been shown that radioembolization is safe in patients with portal vein thrombosis. This case report describes safe radioembolization after portal vein embolization in a patient with multifocal HCC.
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Carcinoma Hepatocelular/terapia , Embolização Terapêutica/métodos , Neoplasias Hepáticas/terapia , Veia Porta , Idoso , Angiografia Digital , Biomarcadores Tumorais/sangue , Carcinoma Hepatocelular/diagnóstico por imagem , Humanos , Testes de Função Hepática , Neoplasias Hepáticas/diagnóstico por imagem , Masculino , Álcool de Polivinil/uso terapêutico , Interpretação de Imagem Radiográfica Assistida por Computador , Tomografia Computadorizada por Raios XRESUMO
Radiopharmaceutical therapy, once touted as the "magic bullet" in radiation oncology, is increasingly being used in the treatment of a variety of malignancies; albeit in later disease stages. With ever-increasing public and medical awareness of radiation effects, radiation dosimetry is becoming more important. Dosimetry allows administration of the maximum tolerated radiation dose to the tumor/organ to be treated but limiting radiation to critical organs. Traditional tumor dosimetry involved acquiring pretherapy planar scans and plasma estimates with a diagnostic dose of intended radiopharmaceuticals. New advancements in single photon emission computed tomography and positron emission tomography systems allow semi-quantitative measurements of radiation dosimetry thus allowing treatments tailored to each individual patient.
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Superfície Corporal , Neoplasias Hepáticas , Fígado , Guias de Prática Clínica como Assunto , Radioisótopos de Ítrio/uso terapêutico , Fígado/diagnóstico por imagem , Fígado/patologia , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/patologia , Neoplasias Hepáticas/radioterapia , Microesferas , Modelos Moleculares , Seleção de Pacientes , Tomografia Computadorizada de Emissão de Fóton Único/métodos , Carga TumoralAssuntos
Abscesso/diagnóstico , Falso Aneurisma/diagnóstico , Vasos Coronários/cirurgia , Leucócitos/diagnóstico por imagem , Falha de Prótese , Stents , Tecnécio Tc 99m Exametazima , Abscesso/sangue , Abscesso/complicações , Idoso , Falso Aneurisma/sangue , Falso Aneurisma/complicações , Humanos , Masculino , Tomografia Computadorizada de Emissão de Fóton Único , Tomografia Computadorizada por Raios XRESUMO
Yttrium-90 (Y-90) selective internal radiation therapy (SIRT) is increasingly used to treat inoperable hepatocellular carcinoma. We describe two patients where hepatic falciform ligament Technetium-99m-macroaggregated albumin (Tc-99m-MAA) activity was identified on single photon emission computed tomography with integrated low-dose CT (SPECT/CT) scan during pre-therapy planning, and the steps taken to prevent radiation dermatitis. The first patient underwent prophylactic coil embolization of the patent hepatic falciform artery; the second patient underwent super-selective infusion of Y-90 resin microspheres to avoid the patent hepatic falciform artery. The incidence of falciform ligament Tc-99m-MAA activity detected on SPECT/CT at our institution is 10%. Tc-99m-MAA SPECT/CT scan provides valuable diagnostic information for treatment planning prior to Y-90 SIRT.
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Artérias/efeitos da radiação , Embolização Terapêutica/efeitos adversos , Ligamentos/diagnóstico por imagem , Fígado/anormalidades , Tomografia Computadorizada de Emissão de Fóton Único , Tomografia Computadorizada por Raios X , Artérias/metabolismo , Humanos , Fígado/irrigação sanguínea , Fígado/diagnóstico por imagem , Masculino , Microesferas , Pessoa de Meia-Idade , Doses de Radiação , Agregado de Albumina Marcado com Tecnécio Tc 99m , Radioisótopos de Ítrio/química , Radioisótopos de Ítrio/metabolismo , Radioisótopos de Ítrio/uso terapêuticoRESUMO
OBJECTIVE: 2-deoxy-2-[¹8F]fluoro-D-glucose positron emission tomography/computed tomography ([¹8F] FDG PET/CT) has become an established imaging tool in oncology and is now emerging in the field of infectious disease. The aim of this study is to assess the value of fluorine [¹8F] FDG PET/CT in the investigation of patients with fever of unknown origin (FUO). METHODS: [¹8F] FDG PET/CT scans and clinical data of 12 patients were reviewed. These patients met the revised definition criteria of FUO (febrile illness of greater than 3 weeks duration, temperature greater than 38.3°C and no diagnosis after at least 3 days of in-patient investigation or 2 weeks of outpatient investigation). A retrospective analysis of our local database was performed and evaluated for the diagnostic contribution of [¹8F] FDG PET/CT scans. RESULTS: An infective cause of the FUO was found in four (33.3%) patients, a neoplasm in two (16.7%) patients, non-infectious inflammatory disease or autoimmune in one (8.3%) patient. A definitive causative agent could not be found in five (41.7%) patients despite extensive investigations.In all, five (41.6%) patients had a PET/CT scan that was abnormal and was deemed 'helpful' as part of the investigation that pointed to the final diagnosis. Two (16.7%) patients had abnormal scans, which were deemed 'not-helpful' for the final diagnosis. CONCLUSION: [¹8F] FDG PET/CT can be helpful in some patients with FUO. This study adds value to the limited data published so far on this subject.