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1.
Cancer ; 126(2): 390-399, 2020 01 15.
Artículo en Inglés | MEDLINE | ID: mdl-31639221

RESUMEN

BACKGROUND: The extent of breast cancer outcome disparity can be measured by comparing Surveillance, Epidemiology, and End Results (SEER) breast cancer-specific survival (BCSS) by region and with institutional cohort (IC) rates. METHODS: Patients who were diagnosed with a first primary, de novo, stage IV breast cancer at ages 25 to 84 years from 1990 to 2011 were studied. The change in 5-year BCSS over time from 1990 to 2011 was compared using the SEER 9 registries (SEER 9) without the Seattle-Puget Sound (S-PS) region (n = 12,121), the S-PS region alone (n = 1931), and the S-PS region IC (n = 261). The IC BCSS endpoint was breast cancer death confirmed from chart and/or death certificate and cause-specific survival for SEER registries. BCSS was estimated using the Kaplan-Meier method. Hazard ratios (HzR) were calculated using Cox proportional-hazards models. RESULTS: For SEER 9 without the S-PS region, 5-year BCSS improved 7% (from 19% to 26%) over time, it improved 14% for the S-PS region (21% to 35%), and it improved 27% for the S-PS IC (29% to 56%). In the IC Cox proportional-hazards model, recent diagnosis year, chemotherapy, surgery, and age <70 years were associated with better survival. For SEER 9, additional significant factors were white race and positive hormone receptor status and S-PS region was associated with better survival (HzR, 0.87; 95% CI, 0.84-0.90). In an adjusted model, hazard of BC death decreased in the most recent time period (2005-2011) by 28% in SEER 9 without S-PS, 43% in the S-PS region and 45% in the IC (HzR, 0.72 [95% CI, 0.67-0.76], 0.57 [95% CI, 0.49-0.66], and 0.55 [95% CI, 0.39-0.78], respectively). CONCLUSIONS: Over 2 decades, the survival of patients with metastatic breast cancer improved nationally, but with regional survival disparity and differential improvement. To achieve equitable outcomes, access and treatment approaches will need to be identified and adopted.


Asunto(s)
Neoplasias de la Mama/mortalidad , Disparidades en Atención de Salud/estadística & datos numéricos , Programa de VERF/estadística & datos numéricos , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/patología , Neoplasias de la Mama/terapia , Certificado de Defunción , Femenino , Geografía , Humanos , Estimación de Kaplan-Meier , Persona de Mediana Edad , Estadificación de Neoplasias , Pronóstico , Modelos de Riesgos Proporcionales , Tasa de Supervivencia , Estados Unidos/epidemiología
2.
BMC Health Serv Res ; 20(1): 928, 2020 Oct 08.
Artículo en Inglés | MEDLINE | ID: mdl-33032599

RESUMEN

BACKGROUND: Evidence-based healthcare (EBHC) principles are essential knowledge for patient and consumer ("consumer") engagement as research and research implementation stakeholders. The aim of this study was to assess whether participation in a free, self-paced online course affects confidence in explaining EBHC topics. The course comprises six modules and evaluations which together take about 6 h to complete. METHODS: Consumers United for Evidence-based Healthcare (CUE) designed, tested and implemented a free, online course for consumers, Understanding Evidence-based Healthcare: A Foundation for Action ("Understanding EBHC"). The course is offered through the Johns Hopkins Bloomberg School of Public Health. Participants rated their confidence in explaining EBHC topics on a scale of 1 (lowest) to 5 (highest), using an online evaluation provided before accessing the course ("Before") and after ("After") completing all six course modules. We analyzed data from those who registered for the course from May 31, 2007 to December 31, 2018 (n = 15,606), and among those persons, the 11,522 who completed the "Before" evaluation and 4899 who completed the "After" evaluation. Our primary outcome was the overall mean of within-person change ("overall mean change") in self-reported confidence levels on EBHC-related topics between "Before" and "After" evaluations among course completers. Our secondary outcomes were the mean within-person change for each of the 11 topics (mean change by topic). RESULTS: From May 31, 2007 to December 31, 2018, 15,606 individuals registered for the course: 11,522 completed the "Before" evaluation, and 4899 of these completed the "After" evaluation (i.e., completed the course). The overall mean change in self-reported confidence levels (ranging from 1 to 5) from the "Before" to "After" evaluation was 1.27 (95% CI, 1.24-1.30). The mean change by topic ranged from 1.00 (95% CI, 0.96-1.03) to 1.90 (95% CI, 1.87-1.94). CONCLUSION: Those who seek to involve consumer stakeholders can offer Understanding EBHC as a step toward meaningful consumer engagement. Future research should focus on long-term impact assessment of online course such as ours to understand whether confidence is retained post-course and applied appropriately.


Asunto(s)
Información de Salud al Consumidor , Educación a Distancia/organización & administración , Práctica Clínica Basada en la Evidencia/educación , Adulto , Curriculum , Evaluación Educacional , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven
3.
Breast Cancer Res Treat ; 167(2): 579-590, 2018 01.
Artículo en Inglés | MEDLINE | ID: mdl-29039120

RESUMEN

BACKGROUND: Differences in de novo (dnMBC) and recurrent metastatic breast cancer (rMBC) presentation and survival over time have not been adequately described. METHODS: A retrospective cohort study, 1990-2010, with follow up through 2015 of dnMBC patients (stage IV at diagnosis) and rMBC patients with subsequent distant metastatic recurrence (stage I-III initial diagnosis) [dnMBC = 247, rMBC = 911)]. Analysis included Chi squared tests of categorical variables, Kaplan-Meier survival estimates, and Cox proportional adjusted hazard ratios (HzR) and 95% confidence intervals (CI). Disease specific survival (DSS) was time from diagnosis or distant recurrence to BC death. RESULTS: Over time, 1990-1998, 1999-2004, and 2005-2010, dnMBC incidence was constant (3%) and rMBC incidence decreased [18% to 7% (p < 0.001)] with no change in dnMBC hormone receptor (HR) or her2-neu (HER2) status but a decrease in rMBC HER2-positive cases and increase in triple negative breast cancer (HR-negative/HER2-negative) (p = 0.049). Five-year dnMBC DSS was 44% vs. 21% for rMBC (p < 0.001). Five-year dnMBC DSS improved over time [28% to 55% (p = 0.008)] and rMBC worsened [23% to 13%, p = 0.065)]. Worse DSS was associated with HR-negative status (HzR = 1.63; 1.41, 1.89), rMBC (HzR = 1.88; 1.58, 2.23), older age (70 +) (HzR = 1.88; 1.58, 2.24), > 1 distant metastases (HzR 1.39; 1.20, 1.62), and visceral dominant disease (HzR 1.22; 1.05, 1.43). After 1998, HER2-positive disease was associated with better DSS (HzR = 0.72, 95% CI 0.56, 0.93). CONCLUSIONS: Factors associated with the widening survival gap and non-equivalence between dnMBC and rMBC and decreased rMBC incidence warrant further study.


Asunto(s)
Neoplasias de la Mama/epidemiología , Recurrencia Local de Neoplasia/epidemiología , Pronóstico , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/genética , Neoplasias de la Mama/patología , Femenino , Humanos , Estimación de Kaplan-Meier , Persona de Mediana Edad , Metástasis de la Neoplasia , Recurrencia Local de Neoplasia/tratamiento farmacológico , Recurrencia Local de Neoplasia/patología , Estadificación de Neoplasias , Receptor ErbB-2/genética , Receptores de Estrógenos/genética , Receptores de Progesterona/genética , Trastuzumab/uso terapéutico
4.
Nat Rev Cancer ; 7(4): 309-15, 2007 04.
Artículo en Inglés | MEDLINE | ID: mdl-17384585

RESUMEN

Each year, over 200,000 people are diagnosed with breast cancer in the United States. Although the use of biomarkers has the potential to guide preventive interventions and improve survival and quality of life, there have been few successes and many disappointments. In November 2005, the National Breast Cancer Coalition Fund convened a conference aimed at developing a patient-centred, strategic approach to breast cancer biomarker research. The consumers, clinicians, researchers, industry representatives and US regulators who served on the consensus panel developed a set of principles and recommendations to guide the field and ensure that biomarker research results in clinically important applications.


Asunto(s)
Biomarcadores de Tumor , Biomarcadores , Neoplasias de la Mama/diagnóstico , Biomarcadores/análisis , Biomarcadores de Tumor/análisis , Neoplasias de la Mama/terapia , Diseño de Fármacos , Femenino , Directrices para la Planificación en Salud , Humanos , Pronóstico , Sistema de Registros , Investigación/educación , Investigación/legislación & jurisprudencia , Medición de Riesgo
5.
Cancer ; 120(17): 2657-64, 2014 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-24930388

RESUMEN

BACKGROUND: The importance of human epidermal growth factor receptor 2 (HER2) as a prognostic and predictive marker in invasive breast cancer is well established. Accurate assessment of HER2 status is essential to determine optimal treatment options. METHODS: Breast cancer tumor tissue samples from the VIRGO observational cohort tissue substudy that were locally HER2-negative were retested centrally with both US Food and Drug Administration (FDA)-approved immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) assays, using FDA-approved assay cutoffs; results were compared. RESULTS: Of the 552 unique patient samples centrally retested with local HER2-negative results recorded, tumor samples from 22 (4.0%) patients were determined to be HER2-positive (95% confidence interval [CI] = 2.5%-5.7%). Of these, 18 had been tested locally by only one testing methodology; 15 of 18 were HER2-positive after the central retesting, based on the testing methodology not performed locally. Compared with the 530 patients with centrally confirmed HER2-negative tumors, the 22 patients with centrally determined HER2-positive tumors were younger (median age 56.5 versus 60.0 years) and more likely to have ER/PR-negative tumors (27.3% versus 22.3%). These patients also had shorter median progression-free survival (6.4 months [95% CI = 3.8-15.9 months] versus 9.1 months [95% CI = 8.3-10.3 months]) and overall survival (25.9 months [95% CI = 13.8-not estimable] versus 27.9 months [95% CI = 25.0-32.9 months]). CONCLUSIONS: This study highlights the limitations of employing just one HER2 testing methodology in current clinical practice. It identifies a cohort of patients who did not receive potentially efficacious therapy because their tumor HER2-positivity was not determined by the test initially used. Because of inherent limitations in testing methodologies, it is inadvisable to rely on a single test to rule out potential benefit from HER2-targeted therapy.


Asunto(s)
Biomarcadores de Tumor/metabolismo , Neoplasias de la Mama/metabolismo , Receptor ErbB-2/metabolismo , Biomarcadores de Tumor/genética , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/genética , Reacciones Falso Negativas , Femenino , Humanos , Inmunohistoquímica , Hibridación Fluorescente in Situ , Persona de Mediana Edad , Estudios Prospectivos , Receptor ErbB-2/genética , Sensibilidad y Especificidad
6.
Breast Cancer Res Treat ; 145(3): 725-34, 2014 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-24706168

RESUMEN

Improvements in screening and adjuvant therapy for breast cancer are associated with decreased recurrence, which may have the effect of increasing the proportion of patients presenting with first-line de novo versus recurrent metastatic breast cancer (MBC). Here, we describe and compare patients with de novo versus recurrent human epidermal growth factor 2 (HER2)-positive MBC. registHER was a prospective observational cohort study (late 2003-early 2006) of 1,023 patients with HER2-positive MBC. Baseline characteristics, treatment patterns, and clinical outcomes were examined in patients with newly diagnosed de novo (n = 327) compared with recurrent HER2-positive MBC after prior treatment for early-stage disease (n = 674). Patients with de novo HER2-positive MBC were less likely to have lung metastases, more likely to have lymph node, bone, and/or liver metastases and >4 sites of metastases and more likely to receive combined or concurrent chemotherapy and hormonal therapy with or without trastuzumab than those with recurrent HER2-positive MBC. Median follow-up was 29 months. Median progression-free survival was 12.1 versus 9.3 months [hazard ratio = 0.716 (95 % confidence interval (CI) 0.617-0.831)], and overall survival was 41.7 versus 32.8 months [hazard ratio = 0.766 (95 % CI 0.633-0.928)] for patients with de novo versus recurrent HER2-positive MBC, respectively. Patients with recurrent HER2-positive MBC had similar outcomes regardless of whether they received prior adjuvant therapy, excluding hormonal therapy. Despite presenting with more advanced-stage disease and higher tumor burdens, patients with de novo HER2-positive MBC have more favorable clinical outcomes than those with recurrent HER2-positive MBC. These differences may be due to effects of prior drug exposure and could have implications for designing and interpreting clinical trials.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Recurrencia Local de Neoplasia/patología , Receptor ErbB-2/metabolismo , Anticuerpos Monoclonales Humanizados/uso terapéutico , Antineoplásicos/uso terapéutico , Neoplasias Óseas/tratamiento farmacológico , Neoplasias Óseas/secundario , Neoplasias de la Mama/mortalidad , Estudios de Cohortes , Supervivencia sin Enfermedad , Femenino , Humanos , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Hepáticas/secundario , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias Pulmonares/secundario , Metástasis Linfática , Estudios Prospectivos , Trastuzumab , Resultado del Tratamiento , Carga Tumoral
7.
Am J Pathol ; 183(4): 1084-1095, 2013 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-23895915

RESUMEN

Despite important progress in adjuvant and neoadjuvant therapies, metastatic disease often develops in breast cancer patients and remains the leading cause of their deaths. For patients with established metastatic disease, therapy is palliative, with few breaks and with mounting adverse effects. Many have hypothesized that a personalized or precision approach (the terms are used interchangeably) to cancer therapy, in which treatment is based on the individual characteristics of each patient, will provide better outcomes. Here, we discuss the molecular basis of breast cancer metastasis and the challenges in personalization of treatment. The instability of metastatic tumors remains a leading obstacle to personalization, because information from a patient's primary tumor may not accurately reflect the metastasis, and one metastasis may vary from another. Furthermore, the variable presence of tumor subpopulations, such as stem cells and dormant cells, may increase the complexity of the targeted treatments needed. Although molecular signatures and circulating biomarkers have been identified in breast cancer, there is lack of validated predictive molecular markers to optimize treatment choices for either prevention or treatment of metastatic disease. Finally, to maximize the information that can be obtained, increased attention to clinical trial design in the metastasis preventive setting is needed.


Asunto(s)
Neoplasias de la Mama/patología , Metástasis de la Neoplasia/prevención & control , Metástasis de la Neoplasia/terapia , Medicina de Precisión , Ensayos Clínicos como Asunto , Femenino , Humanos , Terapia Molecular Dirigida , Células Neoplásicas Circulantes/patología
8.
Oncologist ; 18(5): 501-10, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-23652380

RESUMEN

BACKGROUND: Limited data are available describing the natural history of patients with HER2-positive and hormone receptor (HR)-positive metastatic breast cancer (MBC). We examined first-line treatment patterns and clinical outcomes in patients with HER2-positive, HR-positive MBC in a real-world setting. METHODS: registHER is a prospective, observational cohort of 1,023 patients with HER2-positive MBC diagnosed within 6 months of enrollment and followed until death, disenrollment, or June 2009 (median follow-up time: 27 months). Demographics, first-line treatment patterns, and clinical outcomes were examined for 530 HER2-positive, HR-positive patients. Progression-free survival (PFS) and overall survival (OS) times were examined. Multivariate analyses adjusted for baseline demographic and prognostic factors. RESULTS: HER2-positive, HR-positive patients receiving first-line trastuzumab plus hormonal therapy had significantly longer PFS times than patients who received hormonal therapy only (13.8 vs. 4.8 months; adjusted hazard ratio [HR]: 0.37, 95% confidence interval [CI]: 0.22-0.60); a nonsignificant reduction in OS time was observed (adjusted HR: 0.55, 95% CI: 0.27-1.14). Compared with patients who received first-line trastuzumab plus chemotherapy, patients who received first-line trastuzumab plus chemotherapy and hormonal therapy had longer median PFS times (20.4 months vs. 9.5 months; adjusted HR: 0.53, 95% CI: 0.42-0.68); a statistically significant reduction in risk of death was observed (adjusted HR: 0.50, 95% CI: 0.36-0.70). Sequential use of chemotherapy and hormonal therapy was associated with improved OS times when compared with concurrent use (adjusted PFS HR: 0.81, 95% CI: 0.54-1.21; adjusted OS HR: 0.48, 95% CI: 0.26-0.89). CONCLUSIONS: These real-world data in patients with HER2-positive/HR-positive MBC provide evidence that, with or without chemotherapy, dual targeting of HRs and HER2 receptors is associated with significantly prolonged PFS and OS times.


Asunto(s)
Anticuerpos Monoclonales Humanizados/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias Hormono-Dependientes/epidemiología , Receptor ErbB-2/genética , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/patología , Supervivencia sin Enfermedad , Femenino , Humanos , Estimación de Kaplan-Meier , Persona de Mediana Edad , Metástasis de la Neoplasia/patología , Metástasis de la Neoplasia/terapia , Neoplasias Hormono-Dependientes/genética , Neoplasias Hormono-Dependientes/patología , Neoplasias Hormono-Dependientes/terapia , Pronóstico , Trastuzumab , Resultado del Tratamiento
9.
Breast Cancer Res Treat ; 141(3): 461-70, 2013 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-24062208

RESUMEN

Data characterizing demographics, treatment patterns, and clinical outcomes in black patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) are limited. registHER is a large, observational cohort study of patients (n = 1,001) with HER2-positive MBC diagnosed ≤6 months of enrollment and followed until death, disenrollment, or June 2009 (median follow-up of 27 months). Demographics, treatment patterns, and clinical outcomes were described for black (n = 126) and white patients (n = 793). Progression-free survival (PFS) following first-line therapy and overall survival (OS) were examined. Multivariate analyses adjusted for baseline and treatment factors. Black patients were more likely than white patients to be obese (body mass index ≥30), to have diabetes, and to have a history of cardiovascular disease; they were also less likely to have estrogen receptor or progesterone receptor positive disease. In patients treated with trastuzumab, the incidence of cardiac safety events (grade ≥3) was higher in black patients (10.9 %) than in white patients (7.9 %). Unadjusted median OS and PFS (months) were significantly lower in black patients than in white patients (OS: black: 27.1, 95 % confidence interval [CI] 21.3-32.1; white: 37.3, 95 % CI 34.6-41.1; PFS: black: 7.0, 95 % CI 5.7-8.2; white: 10.2, 95 % CI 9.3-11.2). The adjusted OS hazard ratio (HR) for black patients compared with white patients was 1.29 (95 % CI 1.00-1.65); adjusted PFS HR was 1.29 (95 % CI 1.05-1.59). This real-world evaluation of a large cohort of patients with HER2-positive MBC shows poorer prognostic factors and independently worse clinical outcomes in black versus white patients. Further research is needed to identify potential biologic differences that could have predictive impact for black patients or that could explain these differences.


Asunto(s)
Negro o Afroamericano , Neoplasias de la Mama Masculina/tratamiento farmacológico , Neoplasias de la Mama/tratamiento farmacológico , Disparidades en Atención de Salud , Receptor ErbB-2/metabolismo , Población Blanca , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales Humanizados/efectos adversos , Anticuerpos Monoclonales Humanizados/uso terapéutico , Antineoplásicos/efectos adversos , Antineoplásicos/uso terapéutico , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/patología , Neoplasias de la Mama Masculina/mortalidad , Neoplasias de la Mama Masculina/patología , Supervivencia sin Enfermedad , Femenino , Insuficiencia Cardíaca/inducido químicamente , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Análisis Multivariante , Metástasis de la Neoplasia , Modelos de Riesgos Proporcionales , Racismo , Trastuzumab , Resultado del Tratamiento , Adulto Joven
10.
Breast Cancer Res Treat ; 135(3): 875-83, 2012 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-22923238

RESUMEN

Limited data exist regarding treatment patterns and outcomes in elderly patients with HER2-positive metastatic breast cancer (MBC). registHER is an observational study of patients (N = 1,001) with HER2-positive MBC diagnosed within 6 months of enrollment and followed until death, disenrollment, or June 2009 (median follow-up 27 months). Outcomes were analyzed by age at MBC diagnosis: younger (<65 years), older (65-74 years), elderly (≥75 years). For progression-free survival (PFS) and overall survival (OS) analyses of first-line trastuzumab versus nontrastuzumab, older and elderly patients were combined. Cox regression analyses were adjusted for baseline characteristics and treatments. Estrogen receptor/progesterone receptor status was similar across age groups. Underlying cardiovascular disease was most common in elderly patients. In patients receiving trastuzumab-based first-line treatment, elderly patients were less likely to receive chemotherapy. In trastuzumab-treated patients, incidence of left ventricular dysfunction (LVD) and congestive heart failure (CHF) (grades ≥ 3) were highest in elderly patients (LVD: elderly 4.8 %, younger 2.8 %, older 1.5 %; CHF: elderly 3.2 %, younger 1.9 %, older 1.5 %). Unadjusted median PFS (months) was significantly higher in patients treated with first-line trastuzumab than those who were not (<65 years: 11.0 vs. 3.4, respectively; ≥65 years: 11.7 vs. 4.8, respectively). In patients <65 years, unadjusted median OS (months) was significantly higher in trastuzumab-treated patients; in patients ≥65 years, median OS was similar (<65 years: 40.4 vs. 25.9; ≥65 years: 31.2 vs. 28.5). In multivariate analyses, first-line trastuzumab use was associated with significant improvement in PFS across age. For OS, significant improvement was observed for patients <65 years and nonsignificant improvement for patients ≥65 years. Elderly patients with HER2-positive MBC had higher rates of underlying cardiovascular disease than their younger counterparts and received less aggressive treatment, including less first-line trastuzumab. These real-world data suggest improved PFS across all age groups and similar trends for OS.


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Antineoplásicos/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/mortalidad , Receptor ErbB-2/metabolismo , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales Humanizados/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/patología , Estudios de Cohortes , Supervivencia sin Enfermedad , Femenino , Humanos , Persona de Mediana Edad , Estudios Prospectivos , Trastuzumab , Resultado del Tratamiento
12.
Breast ; 39: 131-138, 2018 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-29679849

RESUMEN

Approximately 0.5 million people worldwide die from metastatic breast cancer (mBC) every year. This manuscript provides an overview on the status of mBC in several regions of the world, highlighting the gaps in care, resources, and support available for patients with mBC. Primary research was conducted in 2015 and 2016, comprising four global qualitative and quantitative surveys of approximately 15,000 individuals in 34 countries. Secondary research was conducted using literature reviews of peer-reviewed publications, patient survey reports, and media or online articles. There have been modest improvements in mBC outcomes over the past decade. Patients are not provided with adequate information about mBC. There is a need for open discussion with patients and caregivers about realistic goals; however, physicians are not trained in communicating with patients about their disease. Maintaining patients' quality of life is a crucial goal; however, this has not improved, and in some cases, may have declined in the past decade. Public awareness and understanding of mBC is limited, with damaging consequences for patients and caregivers. Issues affecting employment remain relevant to patients with mBC and their caregivers. Globally, mBC is associated with a substantial economic burden. Relationships with caregivers are crucial to patients with mBC, and caregiver support needs are often overlooked. A strong and united global effort among healthcare professionals, including clinicians, oncologists, pharmaceutical manufacturers, payers, and policy makers, and with advocates, families, and patients, is necessary to improve the outcome and quality of life for patients with mBC.


Asunto(s)
Neoplasias de la Mama , Salud Global/tendencias , Encuestas Epidemiológicas , Neoplasias de la Mama/economía , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/patología , Neoplasias de la Mama/terapia , Costo de Enfermedad , Femenino , Humanos , Relaciones Interpersonales , Calidad de Vida , Reinserción al Trabajo
13.
Cancer Epidemiol Biomarkers Prev ; 26(6): 809-815, 2017 06.
Artículo en Inglés | MEDLINE | ID: mdl-28522448

RESUMEN

Background: Distant metastatic breast cancer (MBC), including metastases found at diagnosis (de novo) and those occurring later (recurrence), represents the most severe form of the disease, when resource utilization is most intensive. Yet, the number of women living with MBC in the United States is unknown. The objective of this article is to use population-based data to estimate the prevalence of MBC.Methods: We used a back-calculation method to estimate MBC prevalence from U.S. breast cancer mortality and survival from the Surveillance, Epidemiology and End Results (SEER) registries. On the basis of the illness-death process, this method assumes that each observed breast cancer death is the result of MBC, either de novo or a recurrence with metastatic disease.Results: We estimate that by January 1, 2017, there will be 154,794 women living with MBC in the United States, three in four initially diagnosed with stage I-III breast cancer who later progressed to MBC.Median survival and 5-year relative survival for de novo MBC increased over the years, especially in younger women. We estimate a two-fold increase in 5-year relative survival rate from 18% to 36%, for women diagnosed with de novo MBC at age 15-49 between 1992-1994 and 2005-2012, respectively.Conclusions: This study demonstrates an increasing number of women in the United States living with MBC, likely the result of improvements in treatment and aging of the U.S. POPULATION: Impact: The increasing burden of MBC highlights the importance of documenting recurrence to foster more research into the specific needs of this understudied population. Cancer Epidemiol Biomarkers Prev; 26(6); 809-15. ©2017 AACR.


Asunto(s)
Neoplasias de la Mama/epidemiología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Persona de Mediana Edad , Metástasis de la Neoplasia , Estados Unidos , Adulto Joven
14.
Cancer J ; 21(5): 357-64, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26389758

RESUMEN

PURPOSE: The antibody-drug conjugate trastuzumab emtansine (T-DM1) has improved outcomes in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC), as demonstrated in phase III studies. Few data approximating its use in routine clinical practice are available. METHODS: The T-DM1 Patient Access Study was an expanded-access, multicenter study of T-DM1 in US patients with pretreated HER2-positive locally advanced breast cancer or MBC. The primary endpoint was safety. The secondary endpoint was investigator-assessed objective response rate among patients with measurable disease at baseline. Data are presented for the first 215 enrolled patients. RESULTS: The median number of prior systemic MBC agents was 8 (range, 3-23). At baseline, median left ventricular ejection fraction was 60%, and 52.6% of patients had nonclinically significant cardiovascular disease. Median T-DM1 treatment duration was 5.0 months (range, 0-29 months; median follow-up, 5.9 months), with 18.6% having received more than 18 cycles. The most common any-grade adverse events were fatigue (50.7%) and nausea (38.1%). Adverse events of grade 3 or greater were reported in 46.5%, most commonly thrombocytopenia and platelet count decrease (10.2%). Bleeding of grade 3 or greater was reported in 4 patients (1.9%). Cardiac dysfunction (primarily asymptomatic left ventricular ejection fraction decreases) was reported in 14 patients (6.5%). Among those with measurable disease at baseline (n = 172), objective response rate was 25.6% (95% confidence interval, 19.2%-32.8%). DISCUSSION: The safety profile of T-DM1 in this real-world setting of heterogeneous, HER2-positive, pretreated, locally advanced breast cancer or MBC was comparable with that reported in phases II and III studies of similar patient populations. T-DM1 was efficacious with no new safety signals.


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Antineoplásicos/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/metabolismo , Maitansina/análogos & derivados , Receptor ErbB-2/metabolismo , Ado-Trastuzumab Emtansina , Adulto , Anciano , Anticuerpos Monoclonales Humanizados/administración & dosificación , Anticuerpos Monoclonales Humanizados/efectos adversos , Antineoplásicos/administración & dosificación , Antineoplásicos/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Biomarcadores de Tumor , Neoplasias de la Mama/patología , Neoplasias de la Mama Masculina/tratamiento farmacológico , Neoplasias de la Mama Masculina/patología , Comorbilidad , Femenino , Humanos , Masculino , Maitansina/administración & dosificación , Maitansina/efectos adversos , Maitansina/uso terapéutico , Persona de Mediana Edad , Terapia Molecular Dirigida , Metástasis de la Neoplasia , Recurrencia Local de Neoplasia , Estadificación de Neoplasias , Receptor ErbB-2/antagonistas & inhibidores , Retratamiento , Trastuzumab , Resultado del Tratamiento
15.
Breast ; 23(6): 763-9, 2014 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-25193423

RESUMEN

Limited data exist on the association of symptom burden, daily activity impairment, and work productivity (WP) in patients with advanced breast cancer. This cross-sectional analysis evaluated baseline patient-reported outcomes (PROs) in patients with locally recurrent or metastatic breast cancer (MBC) receiving first-line hormonal therapy or chemotherapy and/or targeted therapy in the VIRGO observational study. The primary PRO study endpoint, symptom severity and interference score, was measured using the MD Anderson Symptom Inventory (MDASI). Secondary endpoints included Activity Level Scale (ALS), health-related quality of life (HRQOL), and Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) scores. Overall, 152 patients (chemotherapy cohort, 104; hormonal therapy cohort, 48) answered questionnaires. Fatigue, decreased sexual interest, disturbed sleep, emotional distress, and drowsiness were the most common severe symptoms, and were of moderate-to-severe intensity in 38.8%-52.0% of patients. Mean percent daily activity impairment was 30% for study patients, and WP impairment ranged from 20% to 40% across indices in employed patients (n, 58). Significant positive correlations existed for MDASI severity and interference scores with activity impairment and WP indices (Pearson correlation coefficients [R] = 0.47-0.82; p < 0.0001). ALS and overall HRQOL correlated negatively with these indices (R = -0.41 to -0.60; p ≤ 0.001). After adjustment for potential confounders, MDASI symptom interference and ALS were significant predictors of activity and WP impairment. Our results indicate patients receiving treatment for MBC are symptomatic with significant daily activity and/or WP impairment. Symptom severity and interference, functional status, and overall HRQOL were moderately correlated with perceived work-related ability.


Asunto(s)
Actividades Cotidianas , Neoplasias de la Mama/complicaciones , Fatiga/etiología , Recurrencia Local de Neoplasia/complicaciones , Trastornos del Sueño-Vigilia/etiología , Estrés Psicológico/etiología , Trabajo , Adulto , Anciano , Anciano de 80 o más Años , Antineoplásicos/uso terapéutico , Antineoplásicos Hormonales/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/patología , Estudios de Cohortes , Costo de Enfermedad , Estudios Transversales , Femenino , Humanos , Persona de Mediana Edad , Metástasis de la Neoplasia , Recurrencia Local de Neoplasia/tratamiento farmacológico , Recurrencia Local de Neoplasia/patología , Evaluación del Resultado de la Atención al Paciente , Estudios Prospectivos , Índice de Severidad de la Enfermedad
17.
Clin Cancer Res ; 17(14): 4834-43, 2011 Jul 15.
Artículo en Inglés | MEDLINE | ID: mdl-21768129

RESUMEN

PURPOSE: registHER is a prospective, observational study of 1,023 newly diagnosed HER2-positive metastatic breast cancer (MBC) patients. EXPERIMENTAL DESIGN: Baseline characteristics of patients with and without central nervous system (CNS) metastases were compared; incidence, time to development, treatment, and survival after CNS metastases were assessed. Associations between treatment after CNS metastases and survival were evaluated. RESULTS: Of the 1,012 patients who had confirmed HER2-positive tumors, 377 (37.3%) had CNS metastases. Compared with patients with no CNS metastases, those with CNS metastases were younger and more likely to have hormone receptor-negative disease and higher disease burden. Median time to CNS progression among patients without CNS disease at initial MBC diagnosis (n = 302) was 13.3 months. Treatment with trastuzumab, chemotherapy, or surgery after CNS diagnosis was each associated with a statistically significant improvement in median overall survival (OS) following diagnosis of CNS disease (unadjusted analysis: trastuzumab vs. no trastuzumab, 17.5 vs. 3.8 months; chemotherapy vs. no chemotherapy, 16.4 vs. 3.7 months; and surgery vs. no surgery, 20.3 vs. 11.3 months). Although treatment with radiotherapy seemed to prolong median OS (13.9 vs. 8.4 months), the difference was not significant (P = 0.134). Results of multivariable proportional hazards analyses confirmed the independent significant effects of trastuzumab and chemotherapy (HR = 0.33, P < 0.001; HR = 0.64, P = 0.002, respectively). The effects of surgery and radiotherapy did not reach statistical significance (P = 0.062 and P = 0.898, respectively). CONCLUSIONS: For patients with HER2-positive MBC evaluated in registHER, the use of trastuzumab, chemotherapy, and surgery following CNS metastases were each associated with longer survival.


Asunto(s)
Neoplasias de la Mama/patología , Neoplasias del Sistema Nervioso Central/secundario , Receptor ErbB-2/metabolismo , Adulto , Anciano , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/terapia , Neoplasias del Sistema Nervioso Central/epidemiología , Neoplasias del Sistema Nervioso Central/mortalidad , Neoplasias del Sistema Nervioso Central/terapia , Progresión de la Enfermedad , Femenino , Humanos , Incidencia , Estimación de Kaplan-Meier , Persona de Mediana Edad , Terapia Molecular Dirigida , Estadificación de Neoplasias , Receptor ErbB-2/antagonistas & inhibidores , Receptor ErbB-2/genética , Sistema de Registros , Factores de Tiempo
20.
Semin Oncol Nurs ; 26(3): 195-202, 2010 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-20656143

RESUMEN

OBJECTIVE: To present findings from two large surveys that explored the needs for information, emotional support, provision of services, perceptions, and attitudes of women with metastatic breast cancer (MBC). DATA SOURCES: Published articles and surveys. CONCLUSION: Results from an online needs assessment of 618 women with MBC and a global survey of 1,342 women with MBC living in 13 countries interviewed following referral by their physicians revealed that the most urgent needs are for good, accurate, in-depth information about their disease, standard and emerging treatments, and ways of coping with side effects and symptoms. IMPLICATIONS FOR NURSING PRACTICE: Much research has focused on coping with early breast cancer, but little has been studied about the needs and experiences of women living with MBC. Nurses can learn from what patients have told us about what they want, to better respond to these needs.


Asunto(s)
Neoplasias de la Mama , Enfermería Oncológica/métodos , Educación del Paciente como Asunto/métodos , Apoyo Social , Neoplasias de la Mama/enfermería , Neoplasias de la Mama/psicología , Neoplasias de la Mama/secundario , Femenino , Humanos , Evaluación de Necesidades
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