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Purpose@#This single-arm phase II trial investigate the efficacy and safety of S-1 plus oxaliplatin (SOX) in patients with metastatic breast cancer. @*Materials and Methods@#Patients with metastatic breast cancer previously treated with anthracyclines and taxanes were enrolled. Patients received S-1 (40-60 mg depending on patient’s body surface area, twice a day, day 1-14) and oxaliplatin (130 mg/m2, day 1) in 3 weeks cycle until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumor 1.1. Secondary endpoints included time-to-progression (TTP), duration-of-response (DoR), overall survival (OS), and adverse events. @*Results@#A total of 87 patients were enrolled from 11 institutions in Korea. Hormone receptor was positive in 54 (62.1%) patients and six (6.9%) had human epidermal growth factor receptor 2–positive disease. Forty-eight patients (85.1%) had visceral metastasis and 74 (55.2%) had more than three sites of metastases. The ORR of SOX regimen was 38.5% (95% confidence interval [CI], 26.9 to 50.0) with a median TTP of 6.0 months (95% CI, 5.1 to 6.9). Median DoR and OS were 10.3 months (95% CI, 5.5 to 15.1) and 19.4 (95% CI, not estimated) months, respectively. Grade 3 or 4 neutropenia was reported in 28 patients (32.1%) and thrombocytopenia was observed in 23 patients (26.6%). @*Conclusion@#This phase II study showed that SOX regimen is a reasonable option in metastatic breast cancer previously treated with anthracyclines and taxanes.
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Purpose@#In hormone receptor-positive, human epidermal growth factor receptor 2–negative metastatic breast cancer (HR+ HER2–MBC), the mainstay treatment options include cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) and everolimus (EVE) in combination with endocrine treatment. This study aims to compare the outcomes of the following treatment sequences: CDK4/6i followed by EVE and EVE followed by CDK4/6i. @*Materials and Methods@#Data from HR+ HER2– MBC patients treated between January 2014 and November 2020 with both CDK4/6i and EVE were retrospectively analyzed. @*Results@#Among the 88 patients included in the study, 51 received CDK4/6i before EVE (C→E group), and 37 received EVE before CDK4/6i (E→C group) with endocrine treatment. More patients in the E→C group had endocrine resistance (13.7% vs. 40.5%), experienced palliative chemotherapy (7.8% vs. 40.5%), and were heavily treated (treated as ≥ 3rd line, 5.9% vs. 40.5%). Median overall survival was 46.8 months in the C→E group and 38.9 months in the E→C group (p=0.151). Median composite progression-free survival (PFS), defined as the time from the start of the preceding regimen to disease progression on the following regimen or death, was 24.8 months in the C→E group vs. 21.8 months in the E→C group (p=0.681). Median PFS2/PFS1 ratio did not differ significantly between groups (0.5 in the C→E group, 0.6 in the E→C group; p=0.775). Ten patients (11.4%) discontinued EVE, and two patients (2.3%) discontinued CDK4/6i during treatment. @*Conclusion@#Although the CDK4/6i-based regimen should be considered as an earlier line of treatment, CDK4/6i- and EVE-based treatments can be valid options in circumstances where the other treatment had been already given.
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Purpose@#For liposarcoma (LPS), clinical course and proper treatment strategies have not been well-established. Recently, immune-checkpoint inhibitors have shown potential efficacy in LPS. We aimed to describe the clinical course of LPS and evaluate the clinical impact of programmed death-ligand 1 (PD-L1). @*Materials and Methods@#We reviewed all consecutive patients (n=332) who underwent curative-intent surgery for localized LPS at Asan Medical Center between 1989 and 2017. PD-L1 testing was performed in well-differentiated and dedifferentiated LPS. @*Results@#The median age was 56 years with males comprising 60.8%. Abdomen-pelvis (47.6%) and well-differentiated (37.7%) were the most frequent primary site and histologic subtype, respectively. During a median follow-up of 81.2 months, recurrence was observed in 135 (40.7%), and 86.7% (117/135) were loco-regional. Well-differentiated subtype (hazard ratio [HR], 0.38), abdomen-pelvis origin (HR, 2.43), tumor size larger than 5 cm (HR, 1.83), positive resection margin (HR, 2.58), and postoperative radiotherapy (HR, 0.36) were significantly related with recurrence-free survival as well as visceral involvement (HR, 1.84) and multifocality (HR, 3.79) in abdomen-pelvis LPS. PD-L1 was positive in 31.5% (23/73) and 51.3% (39/76) of well-differentiated and dedifferentiated LPS, respectively, but had no impact on survival outcomes. @*Conclusion@#Clinical course of LPS was heterogeneous according to histology and anatomic location. Clear resection margin was important to lower recurrence and postoperative radiotherapy might have additional benefit. A decent portion of well-differentiated and dedifferentiated LPS were positive for PD-L1, but its prognostic role was unclear. Further research is needed to determine clinical implications of PD-L1, especially for advanced-stage LPS with unmet needs for effective systemic treatment.
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This single-institute, retrospective cohort study enrolled patients with human epidermal growth factor receptor 2-positive metastatic breast cancer treated with trastuzumab deruxtecan between August 2017 and January 2021 from four previous studies. Of 31 patients, 4 (12.9%) had interstitial lung disease (ILD). The dominant pattern observed on computed tomography was organizing pneumonia (100%), comprising subpleural consolidations in the lung periphery. However, no dominant distribution was observed in radiological lesions of the lungs. Of all the tested patients, lower lobe predominance was noted in 2 (50.0%) patients, upper lobe predominance in 1 (25.0%) patient, and diffused lobe distribution in 1 (25.0%) patient. All events were confined to the Common Terminology Criteria for Adverse Events grade 1 or 2 (100%). None of the patients died. Despite the small number of cases investigated, the incidence of trastuzumab deruxtecan-induced ILD in the Korean population was comparable to that previously reported.
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Purpose@#The tumor-infiltrating lymphocytes (TILs) expression in breast cancer is a positive prognostic marker for certain breast cancer subtypes. We evaluated the efficacy of dual antihuman epidermal growth factor receptor 2 (HER2) blockade in HER2-positive breast cancer and hypothesized that high TILs tumors are associated with better outcomes. @*Methods@#A total of 176 patients who were treated with neoadjuvant docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP) between December 2015 and December 2018 were reviewed. They were grouped based on a cut-off value of the stromal TILs grade (≤ 20% TILs, > 20% TILs). @*Results@#In total, 107 patients (60.8%) achieved pathological complete response (pCR).Hormone receptor (HR)-negativity (p = 0.001) and a high TILs grade (p = 0.022) were independent predictors of pCR. Among the HR-negative patients, high TILs tumors were significantly associated with pCR (p = 0.035). @*Conclusion@#HR status and the TILs grade are significantly correlated with pCR in dual anti-HER2 neoadjuvant therapy. The evaluation of the TILs at baseline may be beneficial for predicting pCR in HER2-positive breast cancer.
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Purpose@#The tumor-infiltrating lymphocytes (TILs) expression in breast cancer is a positive prognostic marker for certain breast cancer subtypes. We evaluated the efficacy of dual antihuman epidermal growth factor receptor 2 (HER2) blockade in HER2-positive breast cancer and hypothesized that high TILs tumors are associated with better outcomes. @*Methods@#A total of 176 patients who were treated with neoadjuvant docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP) between December 2015 and December 2018 were reviewed. They were grouped based on a cut-off value of the stromal TILs grade (≤ 20% TILs, > 20% TILs). @*Results@#In total, 107 patients (60.8%) achieved pathological complete response (pCR).Hormone receptor (HR)-negativity (p = 0.001) and a high TILs grade (p = 0.022) were independent predictors of pCR. Among the HR-negative patients, high TILs tumors were significantly associated with pCR (p = 0.035). @*Conclusion@#HR status and the TILs grade are significantly correlated with pCR in dual anti-HER2 neoadjuvant therapy. The evaluation of the TILs at baseline may be beneficial for predicting pCR in HER2-positive breast cancer.
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PURPOSE: We investigated whether irinotecan plus capecitabine improved progression-free survival (PFS) compared with capecitabine alone in patients with human epidermal growth factor 2 (HER2) negative and anthracycline and taxane pretreated metastatic breast cancer (MBC). MATERIALS AND METHODS: A total of 221 patients were randomly assigned to irinotecan (80 mg/m2, days 1 and 8) and capecitabine (1,000 mg/m2 twice a day, days 1-14) or capecitabine alone (1,250 mg/m2 twice a day, days 1-14) every 3 weeks. The primary endpoint was PFS. RESULTS: There was no significant difference in PFS between the combination and monotherapy arm (median, 6.4 months vs. 4.7 months; hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.63 to 1.11; p=0.84). In patients with triple-negative breast cancer (TNBC, n=90), the combination significantly improved PFS (median, 4.7 months vs. 2.5 months; HR, 0.58; 95% CI, 0.37 to 0.91; p=0.02). Objective response rate was numerically higher in the combination arm, though it failed to reach statistical significance (44.4% vs. 33.3%, p=0.30). Overall survival did not differ between arms (median, 20.4 months vs. 24.0 months; p=0.63). While grade 3 or 4 neutropenia was more common in the combination arm (39.6% vs. 9.0%), hand-foot syndrome was more often observed in capecitabine arm. Quality of life measurements in global health status was similar. However, patients in the combination arm showed significantly worse symptom scales especially in nausea/vomiting and diarrhea. CONCLUSION: Irinotecan plus capecitabine did not prove clinically superior to single-agent capecitabine in anthracycline- and taxane-pretreated HER2 negative MBC patients. Toxicity profiles of the two groups differed but were manageable. The role of added irinotecan in patients with TNBC remains to be elucidated.
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Humanos , Brazo , Neoplasias de la Mama , Mama , Capecitabina , Diarrea , Supervivencia sin Enfermedad , Factor de Crecimiento Epidérmico , Salud Global , Síndrome Mano-Pie , Neutropenia , Calidad de Vida , Neoplasias de la Mama Triple Negativas , Pesos y MedidasRESUMEN
PURPOSE: The prognosis of human epidermal growth factor receptor 2 (HER2)-positive breast cancer has markedly improved since the introduction of trastuzumab. We aimed to evaluate the association between stromal tumor-infiltrating lymphocyte (sTIL) or FcrR polymorphisms and survival among patients with metastatic HER2-positive breast cancer who were treated with trastuzumab. METHODS: A total of 56 women with recurrent or metastatic HER2-positive breast cancer who received the trastuzumab-taxane combination as first-line treatment were included in this retrospective analysis. The single-step multiplex allele-specific real-time polymerase chain reaction technique was employed for FcrR3A genotyping. sTILs were identified via immunohistochemical analysis of surgical (n=34, 60.7%) or biopsy specimens of metastatic lesions (n=22, 39.3%). RESULTS: We classified patients based on the sTIL level (≤10% [n=44] or >10% [n=12]); high sTIL counts were more commonly observed in patients with hormone receptor-negative tumors than in those with hormone receptor-positive tumors (34.8% vs. 12.1%, p=0.02). There was a significant association between high sTIL levels and longer progression-free survival in comparison to low sTIL levels (median, 28.4 months vs. 16.8 months; p=0.03). With regard to the FcrR3A-158 genotype, patients were classified into the Phenylalanine/Phenylalanine group (23 patients, 41.1%), Phenylalanine/Valine group (23 patients, 41,1%), or Valine/Valine group (10 patients, 17.9%); these classifications were not associated with clinical outcomes. CONCLUSION: High sTIL expression may be associated with better efficacy of trastuzumab-containing therapy in patients with metastatic HER2-positive breast cancer. However, this finding warrants further evaluation in the larger population.
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Femenino , Humanos , Biopsia , Neoplasias de la Mama , Mama , Clasificación , Supervivencia sin Enfermedad , Genotipo , Linfocitos Infiltrantes de Tumor , Pronóstico , Reacción en Cadena en Tiempo Real de la Polimerasa , Receptores ErbB , Receptor ErbB-2 , Estudios Retrospectivos , TrastuzumabRESUMEN
PURPOSE: The purpose of this study is to investigate the prognostic value of lymph node (LN) ratio (LNR) in patients with breast cancer after neoadjuvant chemotherapy. MATERIALS AND METHODS: This retrospective analysis is based on the data of 814 patientswith stage II/III breast cancer treated with four cycles of doxorubicin/cyclophosphamide followed by four cycles of docetaxel before surgery. We evaluated the clinical significance of LNR (3 categories: low 0-0.20 vs. intermediate 0.21-0.65 vs. high 0.66-1.00) using a Cox proportional regression model. RESULTS: A total of 799 patients underwent breast surgery. Pathologic complete response (pCR, ypT0/isN0) was achieved in 129 patients (16.1%) (hormone receptor [HR] +/human epidermal growth factor receptor 2 [HER2] –, 34/373 [9.1%]; HER2+, 45/210 [21.4%]; triple negative breast cancer, 50/216 [23.1%]). The mean numbers of involved LN and retrieved LN were 2.70 (range, 0 to 42) and 13.98 (range, 1 to 64), respectively. The mean LNR was 0.17 (low, 574 [71.8%]; intermediate, 170 [21.3%]; high, 55 [6.9%]). In univariate analysis, LNR showed significant association with a worse relapse-free survival (3-year relapse-free survival rate 84.8% in low vs. 66.2% in intermediate vs. 54.3% in high; p < 0.001, log-rank test). In multivariate analysis, LNR did not show significant association with recurrence after adjusting for other clinical factors (age, histologic grade, subtype, ypT stage, ypN stage, lymphatic or vascular invasion, and pCR). In subgroup analysis, the LNR system had good prognostic value in HR+/HER2–subtype. CONCLUSION: LNR is not superior to ypN stage in predicting clinical outcome of breast cancer after neoadjuvant chemotherapy. However, the prognostic value of the LNR system in HR+/HER2–patients is notable and worthy of further investigation.
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Humanos , Neoplasias de la Mama , Mama , Estudios de Cohortes , Quimioterapia , Escisión del Ganglio Linfático , Ganglios Linfáticos , Análisis Multivariante , Terapia Neoadyuvante , Pronóstico , Receptores ErbB , Recurrencia , Estudios Retrospectivos , Tasa de Supervivencia , Neoplasias de la Mama Triple NegativasRESUMEN
PURPOSE: This study analyzed the role of plasma biomarkers for TSU-68 in a previous phase II trial comparing TSU-68 plus docetaxel and docetaxel alone in patients with metastatic breast cancer. MATERIALS AND METHODS: A total of 77 patients were eligible for this study (38 in the TSU-68 plus docetaxel arm and 39 in the docetaxel alone arm). Blood samples were collected prior to the start of each cycle, and vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF)-AA, -AB, -BB, fibroblast growth factor, M30, C-reactive protein (CRP), and interleukin 6 (IL-6) levels were measured using enzyme linked immunosorbent assay. The primary endpoint was progression-free survival (PFS). RESULTS: In patients with baseline PDGF-AA ≥ median, median PFS was significantly worse in the TSU-68 plus docetaxel group than in the docetaxel alone group (5.4 months vs. 13.7 months, p=0.049), while a trend toward a PFS benefit was observed in those with baseline PDGF-AA < median (9.7 months vs. 4.0 months, p=0.18; p for interaction=0.03). In the TSU-68 plus docetaxel group, PFS showed significant association with fold changes in CRP (p=0.001), IL-6 (p < .001), PDGF-BB (p=0.02), and VEGF (p=0.047) following the first treatment cycle. CONCLUSION: Baseline PDGF-AA levels and dynamics of VEGF, PDGF-BB, CRP, and IL-6 levels were predictive for the efficacy of TSU-68.
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Humanos , Brazo , Biomarcadores , Neoplasias de la Mama , Mama , Proteína C-Reactiva , Supervivencia sin Enfermedad , Ensayo de Inmunoadsorción Enzimática , Factores de Crecimiento de Fibroblastos , Interleucina-6 , Farmacología , Plasma , Factor de Crecimiento Derivado de Plaquetas , Factor A de Crecimiento Endotelial VascularRESUMEN
A perfusion deficit of the aortic branch vessels in a patient with a type B aortic dissection is a challenging complication, as it leads to hemodynamic instability and doubles the mortality rate; however, the optimal management strategy in these cases remains controversial. Although surgical repair is still performed as the standard, endovascular approaches have been used recently as alternatives because of the high rate of perioperative complications. Herein, we report a patient with a type B aortic dissection and compromised renal and iliac arteries who was successfully treated by thoracic endovascular repair and insertion of a percutaneous stent. In addition, we adopted the chimney technique to preserve blood flow to the left subclavian artery due to the short proximal landing zone.
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Humanos , Aorta , Enfermedades de la Aorta , Hemodinámica , Arteria Ilíaca , Mortalidad , Perfusión , Stents , Arteria SubclaviaRESUMEN
p21-activated kinases (PAKs) are key regulators of actin dynamics, cell proliferation and cell survival. Deregulation of PAK activity contributes to the pathogenesis of various human diseases, including cancer and neurological disorders. Using an ELISA-based screening protocol, we identified naphtho(hydro)quinone-based small molecules that allosterically inhibit PAK activity. These molecules interfere with the interactions between the p21-binding domain (PBD) of PAK1 and Rho GTPases by binding to the PBD. Importantly, they inhibit the activity of full-length PAKs and are selective for PAK1 and PAK3 in vitro and in living cells. These compounds may potentially be useful for determining the details of the PAK signaling pathway and may also be used as lead molecules in the development of more selective and potent PAK inhibitors.
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Humanos , Actinas , Proliferación Celular , Supervivencia Celular , Técnicas In Vitro , Tamizaje Masivo , Enfermedades del Sistema Nervioso , Quinasas p21 Activadas , Fosfotransferasas , Proteínas de Unión al GTP rhoRESUMEN
p21-activated kinases (PAKs) are key regulators of actin dynamics, cell proliferation and cell survival. Deregulation of PAK activity contributes to the pathogenesis of various human diseases, including cancer and neurological disorders. Using an ELISA-based screening protocol, we identified naphtho(hydro)quinone-based small molecules that allosterically inhibit PAK activity. These molecules interfere with the interactions between the p21-binding domain (PBD) of PAK1 and Rho GTPases by binding to the PBD. Importantly, they inhibit the activity of full-length PAKs and are selective for PAK1 and PAK3 in vitro and in living cells. These compounds may potentially be useful for determining the details of the PAK signaling pathway and may also be used as lead molecules in the development of more selective and potent PAK inhibitors.
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Humanos , Actinas , Proliferación Celular , Supervivencia Celular , Técnicas In Vitro , Tamizaje Masivo , Enfermedades del Sistema Nervioso , Quinasas p21 Activadas , Fosfotransferasas , Proteínas de Unión al GTP rhoRESUMEN
PURPOSE: The purpose of this study was to evaluate the push-out bond strength of glass-fiber post cemented with different adhesive systems and surface treatments. MATERIALS AND METHODS: 160 tooth samples made from 48 human maxillary single-rooted teeth with similar root length were divided into 4 groups according to the adhesive system (no adhesive, Adper Single Bond 2, Clearfil SE Bond, Clearfil S3). Each group had 4 subgroups according to the post surface treatment methods (no treatment, sandblast, silane, sandblast and silane). Posts (Parapost Fiber White) were cemented with Rely X Unicem. The teeth were sectioned perpendicular to their long axis into 1-mm thick sections. The push-out tests was performed at a speed of 0.5 mm/min. The results were evaluated by 2-way ANOVA, 1-way ANOVA and multiple comparison procedures (Tukey test) (α=0.05). RESULTS: Tukey test showed that the adhesive system significantly influenced the push-out strength. The Clearfil SE Bond group showed the highest value. Post surface treatments showed no significant effect. CONCLUSION: Bond strength of glass-fiber post cemented with self-adhesive resin cement using Clearfil SE Bond showed significantly higher values compared to other adhesive systems.
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Humanos , Adhesivos , Cementos de Resina , DienteRESUMEN
Thoracic endovascular aortic repair (TEVAR) shows limitations in cases in which the aortic pathology involves the aortic arch. The study aims were to test a fenestrated aortic arch stent graft (FASG) with a preloaded catheter for the supraaortic arch vessels and to perform a preclinical study in swine to evaluate the safety and efficacy of this device. Six FASGs with 1 preloaded catheter and 5 FASGs with 2 preloaded catheters were advanced through the iliac artery in 11 swines. The presence of endoleaks and the patency and deformity of the grafts were examined with computed tomography (CT) at 4 weeks postoperatively. A postmortem examination was performed at 8 weeks. The mean procedure time for the one and two FASG groups was 30.2 (27.9-34.5) min and 43.1 (39.2-53.7) min. The mean time for the selection of the carotid artery was 4.8 (4.2-5.5) min and 6.2 (4.6-9.4) min. Major adverse event was observed in one of 11 pigs. One pig died at 4 weeks likely because of the effects of the high dose of ketamine, while the remaining 10 pigs survived 8-week. For both the one and two FASG groups, no endoleaks, no disconnection, no occlusion of the stent grafts were observed in the CT findings and the postmortem gross findings. The procedure with the FASG could be performed safely in a relatively short procedure time and involved an easy technique. The FASG is found to be safe and convenient in this preclinical study with swine.
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Animales , Aorta Torácica/cirugía , Catéteres , Procedimientos Endovasculares/efectos adversos , Stents , Porcinos , Tomografía Computarizada por Rayos XRESUMEN
PURPOSE: Given the promising activity of capecitabine and vinorelbine in metastatic breast cancer, this randomized phase II trial evaluated the efficacy and safety of this combination as neoadjuvant chemotherapy in breast cancer. MATERIALS AND METHODS: Patients with operable breast cancer (n=75) were randomly assigned to receive either four cycles of adriamycin 60 mg/m2 plus cyclophosphamide 600 mg/m2 every 3 weeks followed by four cycles of docetaxel 75 mg/m2 every 3 weeks (AC-D) or four cycles of capecitabine 2,000 mg/m2 (day 1-14) plus vinorelbine 25 mg/m2 (days 1 and 8) every 3 weeks followed by four cycles of docetaxel 75 mg/m2 (CV-D). The primary endpoint was pathologic complete response (pCR) in the primary breast (ypT0/is). RESULTS: Most patients (84%) had locally advanced (n=41) or inflammatory breast cancer (n=22). pCR rates in the primary breast were 15% (95% confidence interval [CI], 7% to 30%) and 11% (95% CI, 4% to 26%) in the AC-D and CV-D groups, respectively. The overall response rates and 5-year progression-free survival rates in the AC-D and CV-D groups were 62% and 64%, and 51.3% (95% CI, 34.6% to 68.0%) and 30.2% (95% CI, 13.3% to 47.1%), respectively. Although both regimens were well tolerated, CV-D showed less frequent grade 3-4 neutropenia and vomiting than AC-D, whereas manageable diarrhea and hand-foot syndrome were more common in the CV-D group. CONCLUSION: CV-D is a feasible and active non-anthracycline-based neoadjuvant chemotherapy regimen for breast cancer.
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Humanos , Antraciclinas , Mama , Neoplasias de la Mama , Ciclofosfamida , Diarrea , Supervivencia sin Enfermedad , Doxorrubicina , Quimioterapia , Síndrome Mano-Pie , Neoplasias Inflamatorias de la Mama , Terapia Neoadyuvante , Neutropenia , Reacción en Cadena de la Polimerasa , VómitosRESUMEN
A large aortic aneurysm invading the aortic arch can be catastrophic if rupture occurs. In the past, the standard treatment was an open thoracotomy followed by total aortic arch replacement. However, open surgery is difficult in patients at high operative risk. Consequently, thoracic endovascular aortic repair (TEVAR) is preferred in high-risk patients. In patients with a short proximal landing whose aortic aneurysm invades the aortic arch, TEVAR is not available because of innominate, left carotid, and left subclavian artery occlusion. We report two cases in which aortic aneurysms invaded the aortic arch, and who were treated with TEVAR after a supra-aortic artery bypass operation.
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Humanos , Aneurisma , Aorta , Aorta Torácica , Aneurisma de la Aorta , Arterias , Procedimientos Endovasculares , Rotura , Stents , Arteria Subclavia , ToracotomíaRESUMEN
A large aortic aneurysm invading the aortic arch can be catastrophic if rupture occurs. In the past, the standard treatment was an open thoracotomy followed by total aortic arch replacement. However, open surgery is difficult in patients at high operative risk. Consequently, thoracic endovascular aortic repair (TEVAR) is preferred in high-risk patients. In patients with a short proximal landing whose aortic aneurysm invades the aortic arch, TEVAR is not available because of innominate, left carotid, and left subclavian artery occlusion. We report two cases in which aortic aneurysms invaded the aortic arch, and who were treated with TEVAR after a supra-aortic artery bypass operation.
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Humanos , Aneurisma , Aorta , Aorta Torácica , Aneurisma de la Aorta , Arterias , Procedimientos Endovasculares , Rotura , Stents , Arteria Subclavia , ToracotomíaRESUMEN
PURPOSE: The purpose of this study is to assess the efficacy and safety of everolimus in Korean patients with metastatic renal cell carcinoma (mRCC) for whom initial treatment with a vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFr-TKI) has failed. MATERIALS AND METHODS: Eligible patients with mRCC (any histology) who had progressed on or were intolerant of VEGFr-TKI therapy received oral everolimus (10 mg dose once daily). Tumor response was reassessed according to Response Evaluation Criteria in Solid Tumors (RECIST). RESULTS: This study included 100 patientswith a median follow-up duration of 10.2 months, a median progression-free survival (PFS) of 4.2 months (95% confidence interval [CI], 3.4 to 5.0 months), and an overall survival of 10.1 months (95% CI, 6.9 to 13.3 months). The most common grade 3 or greater adverse events (AEs) overall were anemia (13%), pneumonitis (9%), hyperglycemia (8%), and stomatitis (6%). While the incidence of pneumonitis was similar (26 cases, 26%) to the reported incidence in Western patients, the Korean presentations were more severe: 10 patients permanently discontinued everolimus due to pneumonitis, including two deaths on treatment. Statistically significant relationships were established between biologic toxicities, hyperglycemia and anemia, and PFS (hyperglycemia vs. non-hyperglycemia: hazard ratio [HR], 0.61; p=0.055 and anemia vs. non-anemia: HR, 0.51; p=0.021). CONCLUSION: Everolimus was effective in Korean patients with mRCC who had failed initial VEGFr-TKI therapy. While everolimus was well tolerated in general and the AE incidence of this study was similar to those of previous reports, severe pneumonitis was common. Hyperglycemia and anemia showed significant correlation with PFS and thus may be potentially useful as prognostic indicators.
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Humanos , Anemia , Carcinoma de Células Renales , Supervivencia sin Enfermedad , Estudios de Seguimiento , Hiperglucemia , Incidencia , Fosfotransferasas , Neumonía , Estomatitis , Insuficiencia del Tratamiento , Resultado del Tratamiento , Factor A de Crecimiento Endotelial Vascular , EverolimusRESUMEN
PURPOSE: Silk fibroin (SF) is a new degradable barrier membrane for guided bone regeneration (GBR) that can reduce the risk of pathogen transmission and the high costs associated with the use of collagen membranes. This study compared the efficacy of SF membranes on GBR with collagen membranes (Bio-Gide(R)) using a rat calvarial defect model. MATERIALS AND METHODS: Thirty-six male Sprague Dawley rats with two 5 mm-sized circular defects in the calvarial bone were prepared (n=72). The study groups were divided into a control group (no membrane) and two experimental groups (SF membrane and Bio-Gide(R)). Each group of 24 samples was subdivided at 2, 4, and 8 weeks after implantation. New bone formation was evaluated using microcomputerized tomography and histological examination. RESULTS: Bone regeneration was observed in the SF and Bio-Gide(R)-treated groups to a greater extent than in the control group (mean volume of new bone was 5.49 +/- 1.48 mm3 at 8 weeks). There were different patterns of bone regeneration between the SF membrane and the Bio-Gide(R) samples. However, the absolute volume of new bone in the SF membrane-treated group was not significantly different from that in the collagen membrane-treated group at 8 weeks (8.75 +/- 0.80 vs. 8.47 +/- 0.75 mm3, respectively, P=.592). CONCLUSION: SF membranes successfully enhanced comparable volumes of bone regeneration in calvarial bone defects compared with collagen membranes. Considering the lower cost and lesser risk of infectious transmission from animal tissue, SF membranes are a viable alternative to collagen membranes for GBR.