RESUMEN
BACKGROUND: The efficacy of sentinel lymph node (SLN) surgery requires targeted removal of first-draining nodes; however, frequently more nodes are removed than necessary. [(99m)Tc]tilmanocept (TcTM) is a molecular-targeted radiopharmaceutical specifically designed for SLN mapping. We evaluated technical outcomes of SLN biopsy in breast cancer patients mapped with TcTM + vital blue dye (VBD) versus filtered [(99m)Tc]sulfur colloid (fTcSC) + VBD. METHODS: There were 84 versus 115 patients in the TcTM versus fTcSC cohorts, respectively. Main measures were the number of SLNs removed per patient and factors influencing number of nodes removed. We also evaluated whether the radiotracer injected affected the proportion of positive nodes removed in node-positive patients. RESULTS: Fewer nodes were removed among patients mapped with TcTM compared to fTcSC (mean TcTM: 1.85 vs. fTcSC: 3.24, p < 0.001). Logistic regression analysis adjusted for tumor characteristics showed that injection of fTcSC (p < 0.001) independently predicted removal of greater than 3 nodes. A similar proportion of patients was identified as node-positive, whether mapped with TcTM or with fTcSC (TcTM: 24 % vs. fTcSC: 17 %, p = 0.3); however, TcTM detected a greater proportion of positive nodes among node-positive patients compared with fTcSC (0.73 vs. 0.43, p = 0.001). CONCLUSIONS: Patients undergoing SLN biopsy with TcTM required fewer SLNs to identify the same rate of node-positive patients compared with fTcSC in breast cancer patients with similar risk of axillary metastatic disease. These data suggest that a molecularly targeted mechanism of SLN identification may reduce the total number of nodes necessary for accurate axillary staging.
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Neoplasias de la Mama/diagnóstico por imagen , Carcinoma Ductal de Mama/diagnóstico por imagen , Carcinoma Lobular/diagnóstico por imagen , Dextranos , Ganglios Linfáticos/diagnóstico por imagen , Mananos , Radiofármacos , Pentetato de Tecnecio Tc 99m/análogos & derivados , Azufre Coloidal Tecnecio Tc 99m , Neoplasias de la Mama/patología , Neoplasias de la Mama/cirugía , Carcinoma Ductal de Mama/patología , Carcinoma Ductal de Mama/cirugía , Carcinoma Lobular/patología , Carcinoma Lobular/cirugía , Femenino , Estudios de Seguimiento , Humanos , Ganglios Linfáticos/patología , Ganglios Linfáticos/cirugía , Persona de Mediana Edad , Clasificación del Tumor , Invasividad Neoplásica , Estadificación de Neoplasias , Pronóstico , Cintigrafía , Estudios Retrospectivos , Biopsia del Ganglio Linfático CentinelaRESUMEN
BACKGROUND: Dendritic cells (DC) are localized in close proximity to cancer cells in many well-known tumors, and thus maybe a useful target for tumor margin assessment. MATERIALS AND METHODS: [(99m)Tc]- cyanine 7 (Cy7)-tilmanocept was synthesized and in vitro binding assays to bone marrow-derived DC were performed. Fifteen mice, implanted with either 4T1 mouse mammary or K1735 mouse melanoma tumors, were administered 1.0 nmol of [(99m)Tc]-Cy7-tilmanocept via tail vein injection. After fluorescence imaging 1 or 2 h after injection, the tumor, muscle, and blood were assayed for radioactivity to calculate percent-injected dose. Digital images of the tumors after immunohistochemical staining for DC were analyzed to determine DC density. RESULTS: In vitro binding demonstrated subnanomolar affinity of [(99m)Tc]-Cy7-tilmanocept to DC (KA = 0.31 ± 0.11 nM). After administration of [(99m)Tc]-Cy7-tilmanocept, fluorescence imaging showed a 5.5-fold increase in tumor signal as compared with preinjection images and a 3.3-fold difference in fluorescence activity when comparing the tumor with the surgical bed after tumor excision. Immunohistochemical staining analysis demonstrated that DC density positively correlated with tumor percent of injected dose per gram (r = 0.672, P = 0.03), and higher DC density was observed at the periphery versus center of the tumor (186 ± 54 K versus 64 ± 16 K arbitrary units, P = 0.001). CONCLUSIONS: [(99m)Tc]-Cy7-tilmanocept exhibits in vitro and in vivo tumor-specific binding to DC and maybe useful as a tumor margin targeting agent.
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Benzotiazoles , Carbocianinas , Células Dendríticas/patología , Dextranos , Neoplasias Mamarias Experimentales/patología , Mananos , Melanoma Experimental/patología , Pentetato de Tecnecio Tc 99m/análogos & derivados , Animales , Benzotiazoles/química , Antígeno CD11c/análisis , Antígeno CD11c/química , Carbocianinas/química , Línea Celular , Línea Celular Tumoral , Células Dendríticas/química , Dextranos/química , Femenino , Neoplasias Mamarias Experimentales/química , Mananos/química , Melanoma Experimental/química , Ratones , Ratones Endogámicos BALB C , Ratones Endogámicos C3H , Microscopía Fluorescente , Pentetato de Tecnecio Tc 99m/química , Rayos UltravioletaRESUMEN
INTRODUCTION: Previous smaller studies have reported a wide range, 15% to 45%, of secondary palate surgery. The goal of this study was to report the true incidence of secondary surgery derived from a large statewide database as well as study the timing and risk factors for secondary surgery. METHODS: Retrospective longitudinal analysis was performed of the 1995 to 2010 California Office of Statewide Health Planning and Development patient discharge database, which allows patients to be followed up over time. Patients were included in the study if they had an isolated palate diagnosis in addition to a primary repair code and excluded if they ever carried a cleft lip diagnosis or repair code. RESULTS: A total of 2616 isolated cleft palate patients were identified with a median follow-up of 8.0 years. At 16 years, the overall rate of second surgery was 13.6% with complete cleft palate patients having a higher rate of second surgery (15.92%) than the incomplete cleft palate patients (12.36%). The risk of second surgery over time showed a bimodal distribution; the first peak was seen in the first postoperative year and the second peak was seen 3 to 5 years postoperative. On multivariate regression, the only independent risk factor of a secondary surgery was uninsured status (HR, 4.55 [1.64-12.64]), whereas incomplete cleft palate (HR, 0.68 [0.46-0.98]) and Hispanic ethnicity (HR, 0.68 [0.50-0.94]) were found to be protective for secondary surgery with the rest of the covariates not showing significant association. CONCLUSIONS: The incidence rate of secondary surgery (13.6%) at 16 years was less than reported in the literature. Patients who had a complete cleft palate repaired showed a higher incidence rate compared with those who had an incomplete cleft repaired, likely correlating with the complexity and invasiveness of the primary surgery. The first risk peak at which secondary surgeries were performed reflects the short-term complications that needed to be addressed within the first postoperative year. The second peak reflects the longer-term complications diagnosed at the age at which children reach speech milestones.
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Fisura del Paladar/cirugía , Procedimientos de Cirugía Plástica/estadística & datos numéricos , Adolescente , California , Niño , Preescolar , Femenino , Estudios de Seguimiento , Humanos , Lactante , Recién Nacido , Estimación de Kaplan-Meier , Masculino , Análisis Multivariante , Modelos de Riesgos Proporcionales , Reoperación/estadística & datos numéricos , Estudios Retrospectivos , Factores de Tiempo , Adulto JovenRESUMEN
Breast reconstruction after mastectomy positively affects psychosocial well-being; however, the influence of reconstruction on cancer outcomes is unknown. The objective of our study was to compare survival in reconstructed versus nonreconstructed patients after mastectomy. All consecutive female patients diagnosed with invasive breast cancer and treated with mastectomy between 2002 and 2011 were identified from our single-institution database. All cancer operations were performed by two surgeons. Survival was calculated using the Kaplan-Meier method and compared using the log-rank test. To identify the effect of reconstruction on survival, a multivariate Cox regression analysis was performed. Of 474 patients treated, 340 (71.7%) underwent breast reconstruction. At a mean follow-up 3.3 years, reconstructed patients had a longer 5-year survival (91 vs 74%, P < 0.001). After controlling for age, race, payer source, cancer stage, triple negative status, and receipt of radiation or chemotherapy, reconstructed patients maintained a survival advantage over nonreconstructed patients (hazard ratio, 0.47; 95% confidence interval, 0.25 to 0.88; P = 0.02). Patients with breast cancer who undergo reconstruction have longer survival than nonreconstructed patients. The explanation for this finding may be related to improved psychosocial qualities of life versus possible antitumorigenic effects of implants.
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Neoplasias de la Mama/cirugía , Carcinoma Ductal de Mama/cirugía , Carcinoma Lobular/cirugía , Mamoplastia , Mastectomía , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/mortalidad , Carcinoma Ductal de Mama/mortalidad , Carcinoma Lobular/mortalidad , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Sistema de Registros , Estudios Retrospectivos , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
Sentinel lymph node (SLN) mapping is common, however question remains as to what the ideal imaging agent is and how such an agent might provide reliable and stable localization of SLNs. (99m)Tc-labeled nanocolloid human serum albumin (Nanocoll) is the most commonly used radio-labeled colloid in Europe and remains the standard of care (SOC). It is used in conjunction with vital blue dyes (VBDs) which relies on simple lymphatic drainage for localization. Although the exact mechanism of Nanocoll SLN localization is unknown, there is general agreement that Nanocoll exhibits the optimal size distribution and radiolabeling properties of the commercially available radiolabel colloids. [(99m)Tc]Tilmanocept is a novel radiopharmaceutical designed to address these deficiencies. Our aim was to compare [(99m)Tc]Tilmanocept to Nanocoll for SLN mapping in breast cancer. Data from the Phase III clinical trials of [(99m)Tc]Tilmanocept's concordance with VBD was compared to a meta-analysis of a review of the literature to identify a (99m)Tc albumin colloid SOC. The primary endpoints were SLN localization rate and degree of localization. Six studies were used for a meta-analysis to identify the colloid-based SOC. Five studies (6,134 patients) were used to calculate the SOC localization rate of 95.91 % (CI 0.9428-0.9754) and three studies (1,380 patients) were used for the SOC SLN degree of localization of 1.6683 (CI 1.5136-1.8230). The lower bound of the confidence interval was used for comparison to Tilmanocept. Tilmanocept data included 148 patients, and pooled analysis revealed a 99.99 % (CI 0.9977-1.0000) localization rate and degree of localization of 2.16 (CI 1.964-2.3600). Tilmanocept was superior to the Nanocoll SOC for both endpoints (P < 0.0001).