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BACKGROUND: The safety and feasibility of using 1-month dual antiplatelet therapy (DAPT) followed by P2Y12inhibitor monotherapy for patients after percutaneous coronary intervention (PCI) with thin-strut biodegradable polymer drug-eluting stents (BP-DES) in daily clinical practice remain uncertain. METHODSâANDâRESULTS: The REIWA region-wide registry is a prospective study conducted in 1 PCI center and 9 local hospitals in northern Japan. A total of 1,202 patients who successfully underwent final PCI using BP-DES (Synergy: n=400; Ultimaster: n=401; Orsiro: n=401), were enrolled in the registry, and received 1-month DAPT followed by P2Y12inhibitor (prasugrel 3.75 mg/day or clopidogrel 75 mg/day) monotherapy. The primary endpoint was a composite of cardiovascular and bleeding events at 12 months, including cardiovascular death, myocardial infarction (MI), definite stent thrombosis (ST), ischemic or hemorrhagic stroke, and Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding. Based on the results of a previous study, we set the performance goal at 5.0%. Over the 1-year follow-up, the primary endpoint occurred in 3.08% of patients, which was lower than the predefined performance goal (Pnon-inferiority<0.0001). Notably, definite ST occurred in only 1 patient (0.08%) within 1 year (at 258 days). No differences were observed in the primary endpoint between stent types. CONCLUSIONS: The REIWA region-wide registry suggests that 1-month DAPT followed by P2Y12inhibitor monotherapy is safe and feasible for Japanese patients with BP-DES.
Assuntos
Implantes Absorvíveis , Clopidogrel , Stents Farmacológicos , Terapia Antiplaquetária Dupla , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária , Antagonistas do Receptor Purinérgico P2Y , Sistema de Registros , Humanos , Masculino , Idoso , Feminino , Intervenção Coronária Percutânea/efeitos adversos , Pessoa de Meia-Idade , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Inibidores da Agregação Plaquetária/uso terapêutico , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/administração & dosagem , Clopidogrel/uso terapêutico , Clopidogrel/efeitos adversos , Clopidogrel/administração & dosagem , Estudos Prospectivos , Japão , Terapia Antiplaquetária Dupla/métodos , Hemorragia/induzido quimicamente , Cloridrato de Prasugrel/administração & dosagem , Cloridrato de Prasugrel/uso terapêutico , Cloridrato de Prasugrel/efeitos adversos , Polímeros , Resultado do TratamentoRESUMO
Obinutuzumab frequently triggers an infusion reaction(IR). In the GALLIUM study, despite the use of corticosteroids, antipyretic analgesics, and antihistamines to prevent IR, IR occurred at a high frequency of 68.2% for all Grades and 12.4% for Grades 3 or higher. The dose of methylprednisolone was increased from 80 mg administered in the GALLIUM study to 125 mg, and the development of IR was investigated in 30 patients with follicular lymphoma who received the initial dose of obinutuzumab. The incidence of IR was 43.3% for all Grades and 0% for Grades 3 or higher, and no serious IR was observed. It also had no effect on infectious diseases. Increased doses of corticosteroids were well tolerated and suggested as an effective method for reducing the frequency of IR.
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Gálio , Linfoma Folicular , Humanos , Anticorpos Monoclonais Humanizados , Corticosteroides/uso terapêutico , Linfoma Folicular/tratamento farmacológico , Linfoma Folicular/induzido quimicamente , Linfoma Folicular/patologia , Pré-Medicação , Gálio/uso terapêuticoRESUMO
The region behind the coronary calcium could not be visualized by intravascular ultrasound (IVUS) because of acoustic shadow. However, some pathological studies have shown that IVUS delineated the vessel border behind thin coronary calcium sheets. This study aimed to reveal whether recent IVUS can visualize the region behind thin coronary calcium sheets. Using 534 cross-sectional optical frequency domain images (OFDI), including severe calcified coronary lesions, calcium sheet thickness was measured by every 1°. Accordingly, the visibility of the vessel border behind the coronary calcium sheet was evaluated using 60-MHz IVUS images, which were longitudinally linked with OFDI ones. After carefully coordinating with the axial position, the association between the IVUS-derived permeability of the coronary calcium sheet and calcium thickness was evaluated. The maximum and mean calcium thickness by OFDI was 0.88 ± 0.39 and 0.62 ± 0.30 mm, respectively. By 60-MHz IVUS, 12.1% of the coronary calcium sheets had permeable segments. Comparing between OFDI and IVUS images, 48.6% of the coronary calcium sheets with maximum thickness ≤ 0.3 mm were sometimes permeable by 60-MHz IVUS, whereas most > 0.5 mm thick calcium sheets were impermeable. In the receiver operating characteristic curve analysis, the best cutoff values for the maximum and mean thickness of permeable calcium were 0.48 and 0.31 mm, respectively. Thus, 60-MHz IVUS can occasionally visualize the region behind a thin coronary calcium sheet. When using 60-MHz IVUS, this finding may be a predictive marker of calcium sheet with a thickness of < 0.5 mm.
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Doença da Artéria Coronariana , Humanos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/patologia , Cálcio , Estudos Transversais , Ultrassonografia de Intervenção/métodos , Valor Preditivo dos Testes , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/patologia , Tomografia de Coerência Óptica/métodos , Angiografia CoronáriaRESUMO
A 77-year-old woman who had undergone laparoscopic pylorus-preserving gastrectomy for gastric cancer showed dilatation of the main pancreatic duct in the distal pancreas on ultrasonography during postoperative surveillance. Detailed examination revealed that she had a main-duct type intraductal papillary mucinous neoplasm with high-risk stigmata. As invasive malignancy was not suggested, laparoscopic splenic vessel-preserving distal pancreatectomy was performed to preserve the remnant stomach. Although adhesions around the gastroduodenostomy and splenic artery were severe, the magnified laparoscopic view facilitated the identification of appropriate dissection layers, resulting in limited blood loss. The distal pancreas was successfully resected without sacrificing blood flow to the remnant stomach. The postoperative course was uneventful. The pathological diagnosis was low-grade intraductal papillary mucinous neoplasm. Laparoscopic splenic vessel-preserving distal pancreatectomy for benign or low-grade malignant disease of the distal pancreas can be useful for preserving the remnant stomach in patients with a history of gastrectomy.
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Laparoscopia , Neoplasias Pancreáticas , Idoso , Feminino , Gastrectomia , Humanos , Laparoscopia/métodos , Pancreatectomia/métodos , Neoplasias Pancreáticas/diagnóstico por imagem , Neoplasias Pancreáticas/cirurgia , Piloro/cirurgia , Artéria Esplênica/patologiaRESUMO
BACKGROUND: The detection of circulating tumor DNA (ctDNA) in colorectal cancer (CRC) by liquid biopsy may have prognostic information. In this perioperative study, we evaluate if there is a relationship between mutant allele frequency (MAF) of Kirsten rat sarcoma viral oncogene homolog (KRAS) and tumor recurrence and how that could be useful in the early detection of recurrence. METHODS: Among 304 cases of colorectal cancer surgery, ctDNA was sampled from the perioperative blood of 84 patients with CRC with KRAS mutation (exon 4 p.A146T, exon 4 p.A146V, exon 2 p.G12A, exon 2 p.G12C, exon 2 p.G12D, exon 2 p.G12S, exon 2 p.G12V, exon 2 p.G13D, exon 3 p.Q61H) and analyzed using the digital polymerase chain reaction system. The median observation period was 26 months. RESULTS: Although the relationship between the perioperative MAF of KRAS and recurrence was not proved, tumor diameter, tumor depth, and stage were correlated with the preoperative MAF of KRAS (p = 0.034, p = 0.002, p = 0.008). However, tumor diameter, tumor depth, and stage did not correlate with MAF of KRAS at postoperative day 30. CONCLUSIONS: In this study, pathological tumor size, tumor depth, and stage were correlated with preoperative MAF of KRAS, but it was unreliable to predict recurrence by detection of ctDNA with KRAS mutation in the perioperative period of colorectal surgery.
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DNA Tumoral Circulante , Neoplasias Colorretais , DNA Tumoral Circulante/genética , Neoplasias Colorretais/genética , Neoplasias Colorretais/patologia , Neoplasias Colorretais/cirurgia , Humanos , Biópsia Líquida , Mutação , Proteínas Proto-Oncogênicas p21(ras)/genéticaRESUMO
While optical frequency domain imaging (OFDI) can delineate calcium modification and fracture, the capability of high-definition intravascular ultrasound (HD-IVUS) for detecting these remains unclear. This study evaluated diagnostic accuracy of HD-IVUS for assessing calcium modification and fracture as compared to OFDI. HD-IVUS and OFDI were used during orbital or rotational atherectomy procedures conducted for 21 heavily calcified coronary lesions in 19 patients. With OFDI assessment used as the gold standard, diagnostic accuracies of HD-IVUS for calcium modification and fracture were compared every 1 mm to the matched pre-stenting images (n = 1129). Calcium modification, as assessed by OFDI, was defined as polished and concave-shaped calcium. For HD-IVUS, calcium modification was defined as the presence of reverberation with concave-shaped calcium. In both assessments, the definition of calcium fracture was defined as a slit or complete break in the calcium plate. Calcified plaque was found in 86.4% of analyzed OFDI images. Calcium modification and fracture were detected in 20.6% and 11.0% of detected calcified plaques. Sensitivity, specificity, positive and negative predictive values of HD-IVUS detection for calcium modification and fracture were 54.4%, 97.8%, 86.7%, 89.1% and 86.0%, 94.5%, 58.2%, 96.8%, respectively. Discordance cases between both assessments demonstrated that heterogeneous calcium visualized by OFDI, separated calcium, and guide wire artifact can be misdiagnosed. Diagnostic accuracies of HD-IVUS for assessing calcium modification and fracture were acceptable as compared to OFDI. Such findings can be of utility during imaging guided interventional procedures with atherectomy.
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OBJECTIVE: This study aimed to investigate transitions of recurrence hazard and peak recurrence time in patients with nonmetastatic CRC using the hazard function. SUMMARY OF BACKGROUND DATA: A postoperative surveillance period of 5 years is consistent across major guidelines for patients with nonmetastatic CRC, but surveillance intervals differ. Estimates of instantaneous conditional recurrence rate can help set appropriate intervals. METHODS: The study population consisted of 4330 patients with stage I to III CRC who underwent curative resection at the National Cancer Center Hospital between January 2000 and December 2013. Hazard rates of recurrence were calculated using the hazard function. RESULTS: Recurrence rates in patients with stage I, II, and III CRC were 4% (50/1432), 11% (136/1231), and 25% (424/1667), respectively. The hazard curve for stage I was relatively flat and hazard rates were consistently low (<0.0015) for 5 years after surgery. The hazard curve for stage II had a peak hazard rate of 0.0046 at 13.7 months, after which the curve had a long hem to the right. The hazard curve for stage III had an earlier and higher peak than that of stage II (0.0105 at 11.6 months), with a long hem to the right. CONCLUSIONS: Changes in recurrence hazard for CRC patients varied considerably by stage. Our findings suggest that short-interval surveillance might be unnecessary for stage I patients for the first 3 years after surgery, whereas short-interval surveillance for the first 3 years should be considered for stage III patients.
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Neoplasias Colorretais , Recidiva Local de Neoplasia , Neoplasias Colorretais/patologia , Neoplasias Colorretais/cirurgia , Humanos , Recidiva Local de Neoplasia/epidemiologia , Recidiva Local de Neoplasia/patologia , Estadiamento de Neoplasias , Estudos RetrospectivosRESUMO
BACKGROUND: Primary gastric synovial sarcoma is extremely rare, only 44 cases have been reported so far, and there have been no reports of laparoscopic endoscopic cooperative surgery for this condition. CASE PRESENTATION: A 45-year-old male patient presented with gastric pain. Esophagogastroduodenoscopy was performed that led to the identification of an 8-mm submucosal tumor in the anterior wall of the antrum, and a kit-negative gastrointestinal stromal tumor was suspected following biopsy. On endoscopic ultrasonography, the boundary of the tumor, mainly composed of the second layer, was depicted as a slightly unclear low-echo region, and a pointless no echo region was scattered inside. A boring biopsy revealed synovial sarcoma. Positron emission tomography did not reveal fluorodeoxyglucose (18F-FDG) accumulation in the stomach or other organs. Thus, the patient was diagnosed with a primary gastric synovial sarcoma, and laparoscopic endoscopic cooperative surgery was performed. The tumor of the antrum could not be confirmed laparoscopically from the serosa, and under intraoperative endoscopy, it had delle on the mucosal surface, which was removed by a method that does not involve releasing the gastric wall. Immunohistochemistry showed that the spindle cells were positive for EMA, BCL-2 protein, TLE-1, and SS18-SSX fusion-specific antibodies but negative for KIT and DOG-1. The final pathological diagnosis was synovial sarcoma of the stomach. The postoperative course was good, and the patient was discharged from the hospital on the 11th postoperative day. CONCLUSION: Resection with laparoscopic endoscopic cooperative surgery (LECS), which has not been reported before, was effective for small synovial sarcomas that could not be confirmed laparoscopically. With the combination of laparoscopic and endoscopic approaches to neoplasia with a non-exposure technique (CLEAN-NET) procedure, it was possible to excise the tumor with the minimum excision range of the gastric serosa without opening the stomach.
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INTRODUCTION AND IMPORTANCE: Intraductal papillary mucinous neoplasm (IPMN) of the pancreas is often found incidentally during examination for other diseases. In addition to the risk of malignant transformation, patients with IPMN are at risk of developing pancreatic cancer. We report a case of pancreatic tail cancer that developed separately from a preexisting IPMN after minimally invasive esophagectomy for cancer of the esophagogastric junction and was resected successfully by laparoscopic distal pancreatectomy. CASE PRESENTATION: A 72-year-old man underwent thoracoscopic and laparoscopic esophagectomy for esophagogastric junction cancer. He had undergone surgery for ascending colon cancer 20 years ago. At that time, IPMN was confirmed in the pancreatic body by a preoperative examination. Computed tomography was regularly performed for postoperative work-up and follow-up of the IPMN, and a solid lesion with cystic components was detected in the pancreatic tail 9 months after the operation. On detailed examination, pancreatic ductal adenocarcinoma concomitant with IPMN, accompanied by a retention cyst, was considered. Laparoscopic distal pancreatectomy was successfully performed after neoadjuvant chemotherapy. Pathological diagnosis of the lesion in the pancreatic tail was of an invasive intraductal papillary mucinous carcinoma (ypT3ypN0yM0 ypStageIIA). CLINICAL DISCUSSION: If an IPMN is detected during preoperative examination for malignancies of other organs, careful follow-up is necessary due to the high risk of pancreatic cancer development. Furthermore, initial operation with minimally invasive surgery may reduce adhesion and facilitate subsequent surgeries. CONCLUSION: We have provided evidence that supports the importance of a careful follow-up of IPMNs, even if they are low risk.
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The detection of circulating cell-free DNA (cfDNA) by liquid biopsy is reported to provide prognostic information in colorectal cancer (CRC). Although the frequency of BRAF V600E mutation in CRC is less than 10%, it is associated with poor responses to conventional chemotherapy. We conducted a prospective study to investigate the relationship between the perioperative mutant allele frequency (MAF) of BRAF V600E and tumor recurrence, and to evaluate the possibility of early detection of recurrence. Among 362 patients who underwent radical resection, cfDNA was extracted from the perioperative blood of 11 CRC patients with BRAF V600E mutation and analyzed using the digital polymerase chain reaction (dPCR) system. The median follow-up time was 22 months, and there were four cases of recurrence. Although there was no correlation between recurrence and the perioperative MAF of BRAF V600E, tumor diameter was correlated with the MAF (p = 0.024), and the MAF increased with time in two patients from whom additional samples were obtained prior to recurrence. In this study, we identified a correlation between the pathological tumor diameter and the MAF, but it was difficult to predict recurrence by measuring cfDNA with BRAF V600E mutation in the perioperative period of radical resection of CRC.
Assuntos
Ácidos Nucleicos Livres/genética , Neoplasias Colorretais/genética , Proteínas Proto-Oncogênicas B-raf/genética , Idoso , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/cirurgia , Feminino , Frequência do Gene/genética , Humanos , Biópsia Líquida , Masculino , Pessoa de Meia-Idade , Mutação/genética , Recidiva Local de Neoplasia/genética , Período Perioperatório , Prognóstico , Estudos ProspectivosRESUMO
An 83-year-old woman underwent laparoscopic distal gastrectomy and Billroth â ¡ reconstruction for gastric cancer. Since histopathological examination revealed that the lesion was Stage â ¢A, she had started taking S-1 as an adjuvant chemotherapy 7 weeks after gastrectomy. Seventeen days later after taking S-1 administration, she felt nauseous and self-interrupted. Nineteen days later, she was urgently hospitalized. Esophagogastroduodenoscopy(EGD)showed anastomotic lumen was open, but reconstructed small intestine mucosal damage was found, and reconstructed small intestine muscle layer was fused to anastomotic region. On 50th day of hospitalization, mucosa was regenerated and endoscopic balloon dilatation (EBD)was performed from 78th day. She was discharged on 151th day of hospitalization after 7 times of EBD. One year later, she does not need EBD and can be taken orally and has no recurrence.
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Laparoscopia , Neoplasias Gástricas , Idoso de 80 Anos ou mais , Constrição Patológica , Feminino , Gastrectomia/efeitos adversos , Gastroenterostomia , Humanos , Neoplasias Gástricas/tratamento farmacológico , Neoplasias Gástricas/cirurgiaRESUMO
BACKGROUND: In Japan, total mesorectal excision plus lateral lymph node dissection without preoperative therapy is the standard treatment for advanced lower rectal cancer. Although long-term oncologic outcomes with preoperative therapy based on circumferential resection margin status in preoperative MRI has been reported, outcomes without preoperative therapy are unknown. OBJECTIVE: This study evaluated long-term oncologic outcomes of radical surgery without preoperative therapy in advanced lower rectal cancer based on circumferential resection margin status in preoperative MRI, with the aim of defining appropriate patient populations for preoperative therapy. DESIGN: This retrospective analysis compared long-term oncologic outcomes with preoperative MRI in patients with lower rectal cancer. SETTINGS: Patients were identified through a database managed by our institute. PATIENTS: In total, 338 patients with lower rectal cancer who underwent radical surgery between 2000 and 2014 at the National Cancer Center Hospital without preoperative therapy were included. MAIN OUTCOME MEASURES: The main outcome was relapse-free survival. RESULTS: The median follow-up period was 61.7 months (range, 3-153 months). Five-year relapse-free survival rates in MRI-predicted circumferential resection margin negative patients and positive patients were 76.0% and 55.6% (p < 0.001). Univariate and multivariate analyses revealed pN stage (HR, 2.35; 95% CI, 1.470-3.770; p < 0.001), lymphatic invasion (HR, 2.03; 95% CI, 1.302-3.176; p = 0.002), venous invasion (HR, 2.15; 95% CI, 1.184-3.9; p = 0.01), surgical procedure (HR, 1.72; 95% CI, 1.115-2.665; p = 0.01), and MRI-predicted circumferential resection margin (HR, 1.850; 95% CI, 1.206-2.838; p = 0.0051) to be independent risk factors for postoperative recurrence. LIMITATIONS: This study was retrospective in design. CONCLUSIONS: Magnetic resonance imaging-predicted circumferential resection margin was associated with relapse-free survival without preoperative therapy, indicating its potential for use in selecting optimal preoperative therapy. See Video Abstract at http://links.lww.com/DCR/B335. ESTADO DEL MARGEN DE RESECCIÓN CIRCUNFERENCIAL COMO FACTOR PREDICTIVO DE RECURRENCIA EN LA RESONANCIA MAGNÉTICA PREOPERATORIA, PARA EL CÁNCER RECTAL BAJO AVANZADO SIN TERAPIA PREOPERATORIA: En Japón, la escisión mesorrectal total con disección de ganglios linfáticos laterales y sin terapia preoperatoria, es el tratamiento estándar para el cáncer rectal bajo avanzado. Aunque se han reportado resultados oncológicos a largo plazo con terapia preoperatoria, basada en el estado del margen de resección circunferencial en la resonancia magnética preoperatoria, se desconocen los resultados sin terapia preoperatoria.Este estudio evaluó los resultados oncológicos a largo plazo de cirugía radical sin terapia preoperatoria, en cáncer rectal bajo avanzado, basado en el estado del margen de resección circunferencial en la resonancia magnética preoperatoria, con el objetivo de definir poblaciones de pacientes apropiadas para terapia preoperatoria.Este análisis retrospectivo comparó los resultados oncológicos a largo plazo con resonancia magnética preoperatoria, en pacientes con cáncer rectal bajo.Los pacientes fueron identificados a través de una base de datos administrada por nuestro instituto.Se incluyeron un total de 338 pacientes con cáncer rectal bajo, que se sometieron a cirugía radical entre 2000 y 2014 en el Hospital Nacional del Centro de Cáncer, sin terapia preoperatoria.El resultado principal fue la supervivencia libre de recaídas.La mediana del período de seguimiento fue de 61,7 meses (rango, 3-153 meses). Las tasas de supervivencia sin recaídas a cinco años, con margen de resección circunferencial predicho por resonancia magnética, en pacientes negativos y pacientes positivos fueron 76.0% y 55.6% (p <0.001), respectivamente. Los análisis univariados y multivariados revelaron estadio pN (razón de riesgo [HR], 2.35; intervalo de confianza [IC] del 95%, 1.470-3.770; p <0.001), invasión linfática (HR, 2.03; IC del 95%, 1.302-3.176; p = 0.002), invasión venosa (HR, 2.15; IC 95%, 1.184-3.9; p = 0.01), procedimiento quirúrgico (HR, 1.72; IC 95%, 1.115-2.665; p = 0.01) y circunferencial predicho por resonancia magnética en margen de resección (HR, 1.850; IC 95%, 1.206-2.838; p = 0.0051), como factores de riesgo independientes, para la recurrencia postoperatoria.Este estudio fue retrospectivo en diseño.El margen de resección circunferencial predicho de resonancia magnética, se asoció con una supervivencia libre de recaída sin terapia preoperatoria, lo que indica su potencial para uso en la selección de la terapia óptima preoperatoria. Consulte Video Resumen en http://links.lww.com/DCR/B335.
Assuntos
Adenocarcinoma/diagnóstico por imagem , Imageamento por Ressonância Magnética , Margens de Excisão , Recidiva Local de Neoplasia/etiologia , Cuidados Pré-Operatórios/métodos , Protectomia , Neoplasias Retais/diagnóstico por imagem , Adenocarcinoma/patologia , Adenocarcinoma/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Tomada de Decisão Clínica/métodos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/diagnóstico , Recidiva Local de Neoplasia/patologia , Estadiamento de Neoplasias , Prognóstico , Neoplasias Retais/patologia , Neoplasias Retais/cirurgia , Estudos Retrospectivos , Fatores de Risco , Análise de SobrevidaRESUMO
In Japan, the standard treatment for advanced low rectal cancer has been total mesorectal excision (TME) + lateral pelvic lymph node dissection (LLND). On the other hand, in the West, preoperative chemoradiotherapy (CRT) + TME has been established as the standard. Japanese surgeons developed nerve-preserving LLND that could reduce complications associated with extended dissection. The Japan Clinical Oncology Group (JCOG)0212 trialinvestigated on the outcomes of so-called prophylactic LLND in patients without evident lateral lymph node metastasis in preoperative diagnostic imaging. Data from the JCOG0212 trial demonstrated scientific validity of the theory and practice of the Japanese approach. Data from the JCOG0212 trial supported the validity and safety of the Japanese approach, that is, TME + LLND for low rectal cancer without routine use of preoperative CRT. For future direction, modern approach for rectal cancer should involve both of the Eastern and Western strategies by combining LLND and CRT.
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Several studies have demonstrated the safety and feasibility of short (3-6 months) and very short duration (< 2 months) dual antiplatelet therapy (DAPT) in patients with a durable-polymer drug-eluting stent (DP-DES). However, the clinical importance of using very short duration DAPT has yet to be established in patients with a biodegradable polymer drug-eluting stent (BP-DES). The aim of this REIWA registry (multicenter and prospective registry; investigation of clinical outcomes of patients treated with short duration dual antiplatelet therapy after implantation of biodresorbable-polymer drug-eluting stent: a multicenter, prospective registry from Iwate medical university affiliated hospitals) is to determine the safety and feasibility of using 1-month DAPT followed by P2Y12 inhibitor monotherapy in patients after BP-DES implantation. This study is an observational, prospective, multicenter registry encompassing the entire local medical region of Iwate Prefecture (northern area of mainland Japan). A total of 1200 patients who underwent successful PCI with a novel thin strut BP-DES (Synergy, Ultimaster or Orsiro) and are considered to be appropriate patients for very short DAPT, are registered and subsequently administered 1-month DAPT followed by P2Y12 inhibitor monotherapy (clopidogrel 75 mg/day or prasugrel 3.75 mg/day). The primary endpoint was a composite of cardiovascular and bleeding events, which included cardiovascular death, spontaneous myocardial infarction, definite stent thrombosis, ischemic or hemorrhagic stroke, or TIMI major or minor bleeding at 12 months. The REIWA registry (UMIN000037321) will demonstrate both the safety and feasibility of using 1-month DAPT in patients with BP-DES. Furthermore, results of this study will also be able to provide supportive evidence for P2Y12 inhibitor monotherapy after 1-month DAPT following BP-DES implantation.
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Clopidogrel/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/administração & dosagem , Cloridrato de Prasugrel/administração & dosagem , Implantes Absorvíveis , Clopidogrel/efeitos adversos , Clopidogrel/uso terapêutico , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/tratamento farmacológico , Esquema de Medicação , Quimioterapia Combinada/efeitos adversos , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/tratamento farmacológico , Isquemia Miocárdica/etiologia , Isquemia Miocárdica/terapia , Estudos Observacionais como Assunto , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/uso terapêutico , Polímeros , Cloridrato de Prasugrel/efeitos adversos , Cloridrato de Prasugrel/uso terapêutico , Estudos Prospectivos , Sistema de Registros , Fatores de Tempo , Resultado do TratamentoRESUMO
Capecitabine is selectively converted from 5'-DFUR to 5-fluorouracil (5-FU) in tumours by thymidine phosphorylase (TP). We investigated the addition of 5-nitrouracil (5-NU), a TP inhibitor, into blood samples for precise measurements of plasma 5-FU concentrations. The plasma concentration of 5-FU was measured after capecitabine administration. Two samples were obtained at 1 or 2 h after capecitabine administration and 5-NU was added to one of each pair. Samples were stored at room temperature or 4 °C and 5-FU concentrations were measured immediately or 1.5 or 3 h later. The mean plasma 5-FU concentration was significantly higher at room temperature than at 4 °C (p < 0.001). The 5-FU concentration was significantly increased in the absence of 5-NU than in the presence of 5-NU (p < 0.001). The 5-FU change in concentration was greater in the absence of 5-NU, and reached 190% of the maximum compared with baseline. A significant interaction was found between temperature and 5-NU conditions (p < 0.001). Differences between the presence or absence of 5-NU were greater at room temperature than under refrigerated conditions. 5-FU plasma concentrations after capecitabine administration varied with time, temperature, and the presence or absence of 5-NU. This indicates that plasma concentrations of 5-FU change dependent on storage conditions after blood collection.
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Antimetabólitos Antineoplásicos/sangue , Capecitabina/sangue , Neoplasias Colorretais/tratamento farmacológico , Fluoruracila/sangue , Timidina Fosforilase/antagonistas & inibidores , Uracila/análogos & derivados , Adulto , Antimetabólitos Antineoplásicos/farmacocinética , Antimetabólitos Antineoplásicos/farmacologia , Biotransformação , Capecitabina/farmacocinética , Capecitabina/farmacologia , Neoplasias Colorretais/enzimologia , Neoplasias Colorretais/genética , Neoplasias Colorretais/patologia , Feminino , Humanos , Fígado/metabolismo , Masculino , Temperatura , Timidina Fosforilase/metabolismo , Fatores de Tempo , Uracila/farmacologiaRESUMO
BACKGROUND: Preoperative and early postoperative serum carcinoembryonic antigen (CEA) levels are known prognostic factors in rectal cancer. Recently, a large-scale study on colon cancer revealed that "preoperatively elevated and postoperatively normalized CEA levels" is not an indicator of poor prognosis. However, whether this hold true in rectal cancer patients is unknown. This study aimed to investigate the prognostic significance of preoperatively elevated and postoperatively normalized CEA levels in rectal cancer patients undergoing curative resection. METHODS: Subjects were consecutive stage I-III rectal cancer patients who underwent curative resection without preoperative treatment at National Cancer Center Hospital between 2000 and 2015. Overall survival (OS) and the hazard function of recurrence or death were analyzed according to the CEA levels, as follows: normal preoperative CEA (normal group), preoperatively elevated but postoperatively normalized CEA (normalized group), and preoperatively and postoperatively elevated CEA (elevated group). RESULTS: The normalized group (n =235) had worse OS (HR 1.49, 95% CI 1.08-2.04; P = .0142) compared to the normal group (n = 1208), and better OS compared to the elevated group (n = 47) (HR 0.53, 95% CI 0.31-0.91; P = .0208). The elevated group had the highest and earliest peak in hazard function, followed by the normalized group and the normal group, with median times to recurrence of 8.8, 15.5, and 18.5 months, respectively (P = .0223). CONCLUSIONS: Prognosis after resection of rectal cancer was worse in patients with preoperatively elevated and postoperatively normalized CEA compared to those with normal preoperative CEA. Patients with elevated preoperative CEA might require intensive follow-up even if levels normalize after resection, especially in earlier periods, for early detection of recurrence.
Assuntos
Adenocarcinoma/secundário , Biomarcadores Tumorais/sangue , Antígeno Carcinoembrionário/sangue , Procedimentos Cirúrgicos do Sistema Digestório/mortalidade , Recidiva Local de Neoplasia/patologia , Neoplasias Retais/patologia , Adenocarcinoma/sangue , Adenocarcinoma/cirurgia , Idoso , Feminino , Seguimentos , Humanos , Metástase Linfática , Masculino , Pessoa de Meia-Idade , Invasividade Neoplásica , Recidiva Local de Neoplasia/sangue , Recidiva Local de Neoplasia/cirurgia , Estadiamento de Neoplasias , Período Pós-Operatório , Cuidados Pré-Operatórios , Neoplasias Retais/sangue , Neoplasias Retais/cirurgia , Estudos Retrospectivos , Taxa de SobrevidaRESUMO
PURPOSE: To describe a multi-center preliminary experience of treating prosthetic above knee femoropopliteal (AKFP) bypass occlusion by placing a Viabahn stent graft inside the occluded prosthetic bypass graft. MATERIALS AND METHODS: Retrospective analysis of consecutive 14 patients (mean age 73.2 ± 10.2, 78.6% male) receiving Viabahn stent graft inside the occluded prosthetic bypass graft for the treatment of prosthetic AKFP bypass occlusion in the collaborating hospitals from November 2016 to June 2019 was performed. RESULTS: Technical success was achieved in all patients. Mean lesion length was 34.0 ± 3.5 cm, concomitant thrombectomy or thrombus aspiration was performed in 11 patients (78.6%), and average of 1.57 ± 0.65 Viabahn stent grafts were used. Mean ankle-brachial index improved from 0.24 ± 0.23 to 0.98 ± 0.14 after the treatment. All patients had preoperative ischemic symptoms with 9 patients (64.3%) having Rutherford class > 4 symptoms; however, all preoperative symptoms resolved after the treatment. During the mean follow-up of 450.9 ± 234.7 days, there were two target lesion revascularizations, leading to a primary patency rate of 92.9% and a secondary patency of 100.0% at 1 year. CONCLUSION: Placing a Viabahn stent graft inside the occluded prosthetic bypass graft for the treatment of prosthetic AKFP bypass occlusion appears to be effective from our preliminary experience. Even though sample size is limited in our study, it may be considered as a potential treatment option before surgical reintervention.
Assuntos
Implante de Prótese Vascular/métodos , Artéria Femoral/cirurgia , Oclusão de Enxerto Vascular/cirurgia , Artéria Poplítea/cirurgia , Stents , Idoso , Idoso de 80 Anos ou mais , Índice Tornozelo-Braço , Feminino , Artéria Femoral/diagnóstico por imagem , Oclusão de Enxerto Vascular/diagnóstico por imagem , Humanos , Joelho , Masculino , Pessoa de Meia-Idade , Artéria Poplítea/diagnóstico por imagem , Desenho de Prótese , Estudos Retrospectivos , Resultado do Tratamento , Ultrassonografia de Intervenção/métodos , Grau de Desobstrução VascularRESUMO
BACKGROUND: Assessment of preoperative general condition to predict postoperative outcomes is important, particularly in older patients who typically suffer from various comorbidities and exhibit impaired functional status. In addition to various indices such as Charlson Comorbidity Index (CCI), National Institute on Aging and National Cancer Institute Comorbidity Index (NIA/NCI), Adult Comorbidity Evaluation-27 (ACE-27), and American Society of Anesthesiologists Physical Status classification (ASA-PS), controlling nutritional status (CONUT) score is recently gaining attention as a tool to evaluate the general condition of patients from a nutritional perspective. However, the utility of these indices in older patients with colorectal cancer has not been compared. METHODS: The study population comprised 830 patients with Stage I - IV colorectal cancer aged 75 years or older who underwent surgery at the National Cancer Center Hospital from January 2000 to December 2014. Associations of each index with overall survival (OS) (long-term outcome) and postoperative complications (short-term outcome) were examined. RESULTS: For the three indices with the highest Akaike information criterion values (i.e., CONUT score, CCI and ACE-27), but not the remaining indices (NIA/NCI and ASA-PS), OS significantly worsened as general condition scores decreased, after adjusting for known prognostic factors. In contrast, for postoperative complications, only CONUT score was identified as a predictive factor (≥4 versus 0-3; odds ratio: 1.90; 95% CI: 1.13-3.13; P = 0.016). CONCLUSION: For older patients with colorectal cancer, only CONUT score was a predictive factor of both long-term and short-term outcomes after surgery, suggesting that CONUT score is a useful preoperative risk assessment index.
Assuntos
Neoplasias Colorretais/diagnóstico , Estado Nutricional , Idoso , Idoso de 80 Anos ou mais , Neoplasias Colorretais/epidemiologia , Neoplasias Colorretais/mortalidade , Feminino , Humanos , Japão/epidemiologia , Masculino , Estadiamento de Neoplasias , Cuidados Pré-Operatórios , Prognóstico , Estudos Retrospectivos , Medição de Risco , Inquéritos e Questionários , Análise de SobrevidaRESUMO
This phase 2 study evaluated the safety and efficacy of perioperative chemotherapy with S-1 plus oxaliplatin (SOX) for stage III colorectal cancer (CRC). Patients with stage III CRC received surgery after neoadjuvant chemotherapy (NAC; SOX 4 cycles) and adjuvant chemotherapy (AC; SOX 4 cycles). The primary endpoints were response rate and safety. We enrolled 30 patients. Their median age was 62 years (range: 43-87 years); 53% were women. They received a median of 4 cycles (range: 1-4) of NAC and a median 4 cycles (range: 0-4) of AC. Five patients interrupted NAC treatment because of toxicity (grade 3 diarrhoea [n = 1], grade 3 ileus [n = 1], and grade 3-4 thrombocytopenia [n = 3]). Patients' responses were complete responses: n = 2 (6.6%), partial responses: n = 21 (70%), stable disease: n = 6 (20.0%), and progressive disease: n = 1 (3.3%; response rate: 73.3%). Curative resection was performed in 29 patients. No patients showed anastomotic leakage. Five-year overall survival and disease-free survival were 83.3% and 76.7%, respectively (median follow-up time: 48 months). NAC using SOX regimen is safe and effective, and may lead to reduced local recurrence and distant metastasis. Long-term outcomes are awaited to evaluate further the efficacy of this strategy (UMIN000006790).