Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 107
Filtrar
Más filtros

Banco de datos
Tipo del documento
Intervalo de año de publicación
1.
Oncologist ; 29(10): 842-849, 2024 Oct 03.
Artículo en Inglés | MEDLINE | ID: mdl-38906704

RESUMEN

INTRODUCTION: Early discontinuation of endocrine therapy (ET) is higher among patients with early breast cancer (EBC) compared to patients with metastatic hormone receptor-positive (HR+) breast cancer (MBC). In our clinical experience the reasons for this may include a significant burden of ET side effects impacting quality of life (QOL) in patients with EBC. We hypothesized that QOL is lower in patients with HR + EBC compared to patients with HR + MBC on ET. METHODS: We conducted a cross-sectional observational study to assess QOL utilizing FACT-ES & EORTC QLQ C30 tools among patients with EBC and MBC receiving ET across 5 Irish hospitals. RESULTS: A total of 417 patients were enrolled-EBC (79% n = 331) and MBC 21% (n = 86). Using the FACT-ES, we found no difference in overall QOL by stage (139.2 vs 141, P  = .33). Patients with HR + MBC had a lower symptom burden from ET compared to HR + EBC (61.4 vs 54, P < .01). In adjusted multivariate linear regression models, there was no difference in QOL for patients with EBC and MBC receiving ET. CONCLUSIONS: There was no significant difference in overall QOL for patients with EBC and MBC. However, patients with EBC experienced more endocrine symptoms. In adjusted multivariate linear regression models, the stage did not predict QOL. Our results suggest that endocrine symptoms are significant contributors to impaired QOL for patients with EBC but the role of other determinants of QOL (eg, stage) is less clear. Future work could include the development of stage-specific QOL tools and utilization of electronic patient-reported outcomes (ePROs) to identify and manage emergent toxicities.


Asunto(s)
Neoplasias de la Mama , Calidad de Vida , Receptor ErbB-2 , Humanos , Femenino , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/psicología , Neoplasias de la Mama/patología , Persona de Mediana Edad , Estudios Transversales , Receptor ErbB-2/metabolismo , Anciano , Antineoplásicos Hormonales/uso terapéutico , Antineoplásicos Hormonales/efectos adversos , Adulto , Receptores de Estrógenos/metabolismo , Metástasis de la Neoplasia , Estadificación de Neoplasias , Receptores de Progesterona/metabolismo
2.
Support Care Cancer ; 32(10): 693, 2024 Sep 28.
Artículo en Inglés | MEDLINE | ID: mdl-39340564

RESUMEN

Dental disease remains the most common non-communicable disease worldwide. It predisposes patients to significant morbidities following bone modifying agents or radiation therapy to the head and neck. Preventative dental regimes effectively reduce the risk of both medication-related osteonecrosis of the jaw (MRONJ) and osteoradionecrosis (ORN) in these patients. Co-ordination of routine dental care as a component of mainstream oncology treatment optimises long term outcomes for oncology patients. This case series offers insights into patient, institutional and social difficulties that challenge the dental-oncology interface. These obstacles and subsequent resolutions experienced whilst establishing a dental-oncology service in a cancer centre highlight the importance of effective multidisciplinary lead care for oncology patients. It reinforces the need for structured, supported dental pathways for these oncology patients.


Asunto(s)
Osteorradionecrosis , Humanos , Masculino , Femenino , Osteorradionecrosis/etiología , Osteorradionecrosis/terapia , Osteorradionecrosis/prevención & control , Persona de Mediana Edad , Anciano , Instituciones Oncológicas/organización & administración , Neoplasias de Cabeza y Cuello/terapia , Neoplasias de Cabeza y Cuello/radioterapia , Neoplasias/terapia , Neoplasias/complicaciones
3.
Omega (Westport) ; : 302228231196620, 2023 Sep 05.
Artículo en Inglés | MEDLINE | ID: mdl-37670454

RESUMEN

The COVID-19 pandemic compounded isolation for patients through social distancing measures and staff shortages. We were concerned about the impact of COVID-19 on the quality of care provided at end-of-life in 2021 in a national cancer centre, and instigated the first ever review of the care of the dying. Quality of care was assessed retrospectively using a validated instrument developed by the United Kingdom's National Quality Board. Sixty-six patient deaths occurred in our cancer centre in 2021. The 'risk of dying' was documented in 65.2% of records. Palliative care services were involved in 77%, and pastoral care in 10.6%. What was important to the patient was documented in 24.2%. The 'quality-of-death' score was satisfactory for most but poor in 21.2%. Our study prompted change, including appointment of an end-of-life coordinator, development of a checklist to ensure comprehensive communication, expansion of the end-of-life committee to include junior doctors, and regular audit.

4.
Nature ; 536(7617): 419-24, 2016 08 25.
Artículo en Inglés | MEDLINE | ID: mdl-27459054

RESUMEN

We report genome-wide ancient DNA from 44 ancient Near Easterners ranging in time between ~12,000 and 1,400 bc, from Natufian hunter-gatherers to Bronze Age farmers. We show that the earliest populations of the Near East derived around half their ancestry from a 'Basal Eurasian' lineage that had little if any Neanderthal admixture and that separated from other non-African lineages before their separation from each other. The first farmers of the southern Levant (Israel and Jordan) and Zagros Mountains (Iran) were strongly genetically differentiated, and each descended from local hunter-gatherers. By the time of the Bronze Age, these two populations and Anatolian-related farmers had mixed with each other and with the hunter-gatherers of Europe to greatly reduce genetic differentiation. The impact of the Near Eastern farmers extended beyond the Near East: farmers related to those of Anatolia spread westward into Europe; farmers related to those of the Levant spread southward into East Africa; farmers related to those of Iran spread northward into the Eurasian steppe; and people related to both the early farmers of Iran and to the pastoralists of the Eurasian steppe spread eastward into South Asia.


Asunto(s)
Agricultura/historia , Genómica , Migración Humana/historia , Filogenia , Grupos Raciales/genética , África Oriental , Animales , Armenia , Asia , ADN/análisis , Europa (Continente) , Historia Antigua , Humanos , Hibridación Genética/genética , Irán , Israel , Jordania , Hombre de Neandertal/genética , Filogeografía , Turquía
5.
Proc Natl Acad Sci U S A ; 116(38): 19064-19070, 2019 09 17.
Artículo en Inglés | MEDLINE | ID: mdl-31481615

RESUMEN

Britain and Ireland are known to show population genetic structure; however, large swathes of Scotland, in particular, have yet to be described. Delineating the structure and ancestry of these populations will allow variant discovery efforts to focus efficiently on areas not represented in existing cohorts. Thus, we assembled genotype data for 2,554 individuals from across the entire archipelago with geographically restricted ancestry, and performed population structure analyses and comparisons to ancient DNA. Extensive geographic structuring is revealed, from broad scales such as a NE to SW divide in mainland Scotland, through to the finest scale observed to date: across 3 km in the Northern Isles. Many genetic boundaries are consistent with Dark Age kingdoms of Gaels, Picts, Britons, and Norse. Populations in the Hebrides, the Highlands, Argyll, Donegal, and the Isle of Man show characteristics of isolation. We document a pole of Norwegian ancestry in the north of the archipelago (reaching 23 to 28% in Shetland) which complements previously described poles of Germanic ancestry in the east, and "Celtic" to the west. This modern genetic structure suggests a northwestern British or Irish source population for the ancient Gaels that contributed to the founding of Iceland. As rarer variants, often with larger effect sizes, become the focus of complex trait genetics, more diverse rural cohorts may be required to optimize discoveries in British and Irish populations and their considerable global diaspora.


Asunto(s)
ADN Antiguo/análisis , Etnicidad/genética , Variación Genética , Genética de Población , Genoma Humano , Humanos , Irlanda , Islas , Escocia
6.
Oncologist ; 26(4): e603-e607, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33252154

RESUMEN

INTRODUCTION: "Transgender" and "gender diverse" are umbrella terms encompassing those whose gender identities or expressions differ from those typically associated with the sex they were assigned at birth. There is scant global information on cancer incidence, outcome, and mortality for this cohort. This group may present with advanced cancer, have mistrust in health care services and report anxiety and depression at higher frequencies, a finding often seen in marginalized groups because of minority stress. MATERIALS AND METHODS: Medical oncologists were contacted by secure email to identify patients who self-identify as transgender and gender diverse in three Irish hospitals. Five patients were identified. A retrospective chart review was conducted and a pseudonymized patient survey was distributed. RESULTS: All patients included in our chart review (n = 5) were diagnosed with advanced disease on initial diagnosis. Two patients identified as men, two as women, and one as a transwoman. Two of five patients' health record charts reflected a name or gender change. Three patients had gender transitioning treatment postponed. Assessing comorbidities, it was seen that four patients required psychiatry input. Predominant issues noted in our patient survey by the two respondents (n = 2) were "mis-gendering," lack of a gender-neutral hospital environment, lack of inclusion in cancer groups, and barriers in changing name and/or sex on hospital records. CONCLUSION: Components of care requiring revision include patient accessible pathways to change names and gender on health records, earlier access to psychological support and targeted screening and support groups. Resources for hospital staff to improve awareness of correct terminology and to provide gender neutral facilities are worthwhile. IMPLICATIONS FOR PRACTICE: The implications for practice on an international level include patient-friendly pathways for changing hospital name and gender so that patients may feel comfortable using wristbands. The need for international screening guidelines for transgender patients and national transgender cancer support groups is highlighted. On a day-to-day level for providers, the correct use of pronouns makes a big difference to patients. Asking about preferred pronoun on first visit and noting on patient's file is worthwhile. It is important for providers to know that increased psychological support should be offered early on first clinic visit and engaged with as necessary when patient has a history of anxiety or depression. Providers should discuss openly that some gender transitioning treatment will be postponed because of cancer care and refer to both the physical and psychological sequelae of this. Asking transgender patients which room or bathroom they would prefer when rooms are gendered is essential.


Asunto(s)
Neoplasias , Personas Transgénero , Femenino , Identidad de Género , Humanos , Recién Nacido , Irlanda/epidemiología , Masculino , Neoplasias/epidemiología , Neoplasias/terapia , Investigación Cualitativa , Estudios Retrospectivos
7.
Breast Cancer Res Treat ; 189(1): 269-283, 2021 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-34125341

RESUMEN

PURPOSE: Pregnancy-associated breast cancer (PABC) is defined as breast cancer diagnosed during the gestational period (gp-PABC) or in the first postpartum year (pp-PABC). Despite its infrequent occurrence, the incidence of PABC appears to be rising due to the increasing propensity for women to delay childbirth. We have established the first retrospective registry study of PABC in Ireland to examine specific clinicopathological characteristics, treatments, and maternal and foetal outcomes. METHODS: This was a national, multi-site, retrospective observational study, including PABC patients treated in 12 oncology institutions from August 2001 to January 2020. Data extracted included information on patient demographics, tumour biology, staging, treatments, and maternal/foetal outcomes. Survival data for an age-matched breast cancer population over a similar time period was obtained from the National Cancer Registry of Ireland (NCRI). Standard biostatistical methods were used for analyses. RESULTS: We identified 155 patients-71 (46%) were gp-PABC and 84 (54%) were pp-PABC. The median age was 36 years. Forty-four patients (28%) presented with Stage III disease and 25 (16%) had metastatic disease at diagnosis. High rates of triple-negative (25%) and HER2+ (30%) breast cancer were observed. We observed an inferior 5-year overall survival (OS) rate in our PABC cohort compared to an age-matched breast cancer population in both Stage I-III (77.6% vs 90.9%) and Stage IV disease (18% vs 38.3%). There was a low rate (3%) of foetal complications. CONCLUSION: PABC patients may have poorer survival outcomes. Further prospective data are needed to optimise management of these patients.


Asunto(s)
Neoplasias de la Mama , Complicaciones Neoplásicas del Embarazo , Adulto , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/terapia , Femenino , Humanos , Irlanda/epidemiología , Periodo Posparto , Embarazo , Complicaciones Neoplásicas del Embarazo/epidemiología , Complicaciones Neoplásicas del Embarazo/terapia , Estudios Retrospectivos
8.
Rep Pract Oncol Radiother ; 26(3): 416-422, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34277095

RESUMEN

BACKROUND: The purpose of this study is to assess the impact of trimodal therapy [surgery, chemotherapy and external beam radiotherapy (EBRT)] in patients with anaplastic thyroid cancer (ATC) treated with curative intent. MATERIALS AND METHODS: Retrospective review of patients with ATC treated at a tertiary referral centre between January 2009 and June 2020. Data were collected regarding demographics, histology, staging, treatment and outcomes. RESULTS: Seven patients (4 female) were identified. Median age was 58 years (range 52-83 years). All patients received EBRT with concurrent doxorubicin. Six patients received surgery followed by chemoradiotherapy (CRT), and one underwent neoadjuvant CRT followed by surgery. Median radiological tumour size was 50mm (range 40-90 mm). Six patients had gross extrathyroidal extension and three had N1b disease. Prescribed radiotherapy schedules were 46.4 Gy in 29 bidaily fractions (n = 2, treated 2010), 60 Gy in 30 daily fractions (n = 2), 66 Gy in 30 fractions (n = 2) and 70 Gy in 35 fractions (n = 1; patient received neoadjuvant CRT). CRT was discontinued early for two patients due to toxicities. At median follow up of 5.8 months, 42.9% (3/7) patients were alive and disease-free. Only one patient developed a local failure. Three patients died from distant metastases without locoregional recurrence. CONCLUSIONS: Despite poor prognosis of ATC, selected patients with operable tumours may achieve high locoregional control rates with trimodal therapy, with possibility of long-term survival in select cases.

10.
Exp Mol Pathol ; 114: 104404, 2020 06.
Artículo en Inglés | MEDLINE | ID: mdl-32067942

RESUMEN

BACKGROUND: de novo metastatic breast cancer (dnMBC) is responsible for 6-10% of breast cancer presentations with increasing incidence and has remained resistant to detection by mammography screening. Recent publications hypothesized that in addition to poor screening uptake, the presentation of dnMBC may be due to its unfavourable biology which remains unknown at the molecular level. Here we investigated the tumour biology of dnMBC in the form of clinicopathology, genomic alterations and differential gene expression to create a comparative landscape of de novo versus relapsed metastatic breast cancer (rMBC). Additionally, to address the current screening limitations, we conducted a preliminary biomarker investigation for early dnMBC detection. METHODS: In this retrospective case-control study, gene expression and clinical data were accessed from the Cancer Genome Atlas (TCGA) for primary tumours of treatment-naïve patients with dnMBC (n = 17), rMBC (n = 49), and normal tissue (n = 113). The clinical and histological data were assessed categorically using Fisher's Exact-Test for significance (p < .05), or continuously using the Mann-Whitney Test (p < .05) where appropriate. The differential gene expression analysis was performed using EdgeR's negative binomial distribution model with a false discovery rate (FDR) <0.05. The resulting gene list was analysed manually for roles in metastasis as well as ontologically using STRING-DB with FDR <0.05. RESULTS: dnMBCs showed improved median survival vs rMBC (36 vs. 12 months). dnMBCs were more likely to be hormone receptor positive, less likely to be triple negative with lower histological lymphocytic infiltrate. In terms of genome alterations, dnMBCs had 4-fold increased PTEN mutations and poor survival with ABL2 and GATA3 alterations. Expression-wise, dnMBCs down-regulated TNFa, IL-17 signalling, and chemotaxis, while up-regulating steroid biosynthesis, cell migration, and cell adhesion. Biomarker analysis detected pre-existing and novel breast cancer biomarkers. CONCLUSION: The comparative tumour landscape revealed significant clinical, pathological and molecular differences between dnMBC and rMBC, indicating that dnMBC may be a separate biological entity to rMBC at the primary level with differing paths to metastasis. Additionally, we provided a list of potential serum biomarkers that may be useful in detecting dnMBC in its pre-metastatic window if such a window exists.


Asunto(s)
Neoplasias de la Mama/epidemiología , Proteínas de Neoplasias/genética , Recurrencia Local de Neoplasia/epidemiología , Pronóstico , Adulto , Anciano , Biomarcadores de Tumor/genética , Neoplasias de la Mama/genética , Neoplasias de la Mama/patología , Supervivencia sin Enfermedad , Detección Precoz del Cáncer , Femenino , Regulación Neoplásica de la Expresión Génica/genética , Humanos , Persona de Mediana Edad , Metástasis de la Neoplasia , Recurrencia Local de Neoplasia/genética , Recurrencia Local de Neoplasia/patología , Estadificación de Neoplasias , Recurrencia
11.
Breast J ; 26(7): 1372-1374, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32212186

RESUMEN

We report the first case of extreme hypercalcemia (Ca 2+ >6.0 mmol/L) as the initial presentation of de novo metastatic breast cancer. Following treatment and stabilization of the patient, imaging revealed a large breast mass and widespread osseous metastases. Whole body bone scintigraphy demonstrated significant extra osseous uptake of radiotracer in the lungs, liver, and kidneys-a rare phenomenon secondary to profound hypercalcemia. Biopsy revealed estrogen receptor (ER) positive breast carcinoma, for which the patient was treated.


Asunto(s)
Neoplasias Óseas , Neoplasias de la Mama , Hipercalcemia , Neoplasias Óseas/complicaciones , Neoplasias Óseas/diagnóstico por imagen , Mama , Neoplasias de la Mama/complicaciones , Neoplasias de la Mama/diagnóstico por imagen , Femenino , Humanos , Hipercalcemia/diagnóstico por imagen , Hipercalcemia/etiología , Cintigrafía
12.
Health Promot Int ; 35(2): 267-278, 2020 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-31220245

RESUMEN

Consumer trust in the modern food system is essential given its complexity. Contexts vary across countries with regard to food incidents, regulation and systems. It is therefore of interest to compare how key actors in different countries might approach (re)building consumer trust in the food system; and particularly relevant to understanding how food systems in different regions might learn from one another. The purpose of this paper is to explore differences between strategies for (re)building trust in food systems, as identified in two separate empirical studies, one conducted in Australia, New Zealand and the UK (Study 1) and another on the Island of Ireland (Study 2). Interviews were conducted with media, food industry and food regulatory actors across the two studies (n = 105 Study 1; n = 50 Study 2). Data were coded into strategy statements, strategies describing actions to (re)build consumer trust. Strategy statements were compared between Studies 1 and 2 and similarities and differences were noted. The strategy statements identified in Study 1 to (re)build consumer trust in the food system were shown to be applicable in Study 2, however, there were notable differences in the contextual factors that shaped the means by which strategies were implemented. As such, the transfer of such approaches across regions is not an appropriate means to addressing breaches in consumer trust. Notwithstanding, our data suggest that there is still capacity to learn between countries when considering strategies for (re)building trust in the food system but caution must be exercised in the transfer of approaches.


Asunto(s)
Comportamiento del Consumidor , Comparación Transcultural , Industria de Alimentos , Alimentos/normas , Confianza , Australia , Inocuidad de los Alimentos , Abastecimiento de Alimentos , Humanos , Irlanda , Nueva Zelanda
14.
BMC Cancer ; 19(1): 1177, 2019 12 03.
Artículo en Inglés | MEDLINE | ID: mdl-31795977

RESUMEN

Following publication of the original article [1], the authors reported an omission in the affiliations.

15.
Appetite ; 135: 146-158, 2019 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-30482412

RESUMEN

This study investigates the factors affecting consumers' motivation to engage with food product labelling in the new product context. Using yogurt as a case food, due to its positive association with health, enjoyment and convenience, this study uses eye-tracking experiments, a retrospective think-aloud protocol and semi-structured interviews, to bring to light the conscious and subconscious mechanisms associated with label usage, in order to explore the cognitive processes underlying usage of labels for new product offerings and situate these within the participant's personal context. Key information usage and decision-making strategies and the factors which give rise to these are identified. Findings suggest that consumer involvement is being shaped by the perceived importance of negative consequences (i.e. risk importance) and is further reflected in the label usage strategies identified, which align to the negotiability and specificity of health-related goals. Integration of eye-tracking, retrospective think-aloud and interview data reveal that although labelling cues promoted non-volitional attention through design features, in the absence of 'personal motivational relevance', information attended to was discounted from the evaluation process, confirming the importance of needs-based information provision.


Asunto(s)
Atención , Cognición , Comportamiento del Consumidor , Toma de Decisiones , Etiquetado de Alimentos , Motivación , Adolescente , Adulto , Señales (Psicología) , Recolección de Datos , Femenino , Objetivos , Salud , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Encuestas y Cuestionarios , Yogur , Adulto Joven
16.
J Clin Nurs ; 28(23-24): 4424-4433, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31410895

RESUMEN

AIMS AND OBJECTIVES: To measure cancer-related fatigue (CRF), self-care agency (SCA) and fatigue self-care strategies, and to explore the relationship between CRF and SCA. BACKGROUND: Cancer-related fatigue has been consistently rated as the most elusive, common and severe of symptoms that patients with cancer undergoing chemotherapy experience. Despite its frequency and severity, CRF is poorly managed. A renewed focus on supporting self-care among patients with cancer has been found to reduce symptom burden, empower patients and improve patient satisfaction. Understanding the link between self-care agency (i.e. capability and willingness to self-care) and CRF levels will help practitioners to better support individuals on the cancer journey. DESIGN: A descriptive, correlational survey design was employed. METHODS: Patients (n = 362) undergoing chemotherapy with a primary diagnosis of breast, colorectal, Hodgkin's and non-Hodgkin's lymphoma cancers were recruited from four oncology centres in one city in the South of Ireland. Participants completed the Piper Fatigue Scale-Revised, Appraisal of Self-care Agency Scale and a researcher-developed Fatigue Self-Care Survey. Multivariate logistic regression was used to examine the relationship between CRF and self-care agency using a dichotomous dependent variable score of four as the cut-off between those deemed to be fatigued (≥4) and those not fatigued (<4). As recommended by the EQUATOR Network, the STROBE checklist of items for cross-sectional studies is used to report the study. RESULTS: The incidence of CRF was high with 75% of participants scoring clinically relevant CRF. Higher SCA (OR = 0.96, 95% CI = 0.93-0.99, p = .011) was associated with decreased odds of developing CRF. Having non-Hodgkin's lymphoma (OR = 3.02, 95% CI = 1.29-7.07, p = .011) was associated with increased odds of developing CRF. CONCLUSIONS: Patient's undergoing chemotherapy experience significant fatigue. Higher capability for self-care is associated with lower fatigue. The promotion of SCA and self-care strategies can impact on CRF. RELEVANCE TO CLINICAL PRACTICE: Understanding the link between self-care abilities and fatigue can lead to more individualised and tailored approaches to CRF.


Asunto(s)
Antineoplásicos/efectos adversos , Fatiga/etiología , Neoplasias/tratamiento farmacológico , Autocuidado/psicología , Adulto , Anciano , Estudios Transversales , Fatiga/psicología , Femenino , Humanos , Irlanda , Modelos Logísticos , Masculino , Persona de Mediana Edad , Encuestas y Cuestionarios , Adulto Joven
17.
Lancet Oncol ; 19(1): 127-138, 2018 01.
Artículo en Inglés | MEDLINE | ID: mdl-29158011

RESUMEN

BACKGROUND: In animal models of breast cancer, resistance to continuous use of letrozole can be reversed by withdrawal and reintroduction of letrozole. We therefore hypothesised that extended intermittent use of adjuvant letrozole would improve breast cancer outcome compared with continuous use of letrozole in postmenopausal women. METHODS: We did the multicentre, open-label, randomised, parallel, phase 3 SOLE trial in 240 centres (academic, primary, secondary, and tertiary care centres) in 22 countries. We enrolled postmenopausal women of any age with hormone receptor-positive, lymph node-positive, and operable breast cancer for which they had undergone local treatment (surgery with or without radiotherapy) and had completed 4-6 years of adjuvant endocrine therapy. They had to be clinically free of breast cancer at enrolment and without evidence of recurrent disease at any time before randomisation. We randomly assigned women (1:1) to treatment groups of either continuous use of letrozole (2·5 mg/day orally for 5 years) or intermittent use of letrozole (2·5 mg/day orally for 9 months followed by a 3-month break in years 1-4 and then 2·5 mg/day during all 12 months of year 5). Randomisation was done by principal investigators or designee at respective centres through the internet-based system of the International Breast Cancer Study Group, was stratified by type of previous endocrine therapy (aromatase inhibitors only vs selective oestrogen receptor modulators only vs both therapies), and used permuted block sizes of four and institutional balancing. No one was masked to treatment assignment. The primary endpoint was disease-free survival, analysed by the intention-to-treat principle using a stratified log-rank test. All patients in the intention-to-treat population who initiated protocol treatment during their period of trial participation were included in the safety analyses. This study is registered with ClinicalTrials.gov, number NCT00553410, and EudraCT, number 2007-001370-88; and long-term follow-up of patients is ongoing. FINDINGS: Between Dec 5, 2007, and Oct 8, 2012, 4884 women were enrolled and randomised after exclusion of patients at a non-adherent centre, found to have inadequate documentation of informed consent, immediately withdrew consent, or randomly assigned to intervention groups in error. 4851 women comprised the intention-to-treat population that compared extended intermittent letrozole use (n=2425) with continuous letrozole use (n=2426). After a median follow-up of 60 months (IQR 53-72), disease-free survival was 85·8% (95% CI 84·2-87·2) in the intermittent letrozole group compared with 87·5% (86·0-88·8) in the continuous letrozole group (hazard ratio 1·08, 95% CI 0·93-1·26; p=0·31). Adverse events were reported as expected and were similar between the two groups. The most common grade 3-5 adverse events were hypertension (584 [24%] of 2417 in the intermittent letrozole group vs 517 [21%] of 2411 in the continuous letrozole group) and arthralgia (136 [6%] vs 151 [6%]). 54 patients (24 [1%] in the intermittent letrozole group and 30 [1%] in the continuous letrozole group) had grade 3-5 CNS cerebrovascular ischaemia, 16 (nine [<1%] vs seven [<1%]) had grade 3-5 CNS haemorrhage, and 40 (19 [1%] vs 21 [1%]) had grade 3-5 cardiac ischaemia. In total, 23 (<1%) of 4851 patients died while on trial treatment (13 [<1%] of 2417 patients in the intermittent letrozole group vs ten [<1%] of 2411 in the continuous letrozole group). INTERPRETATION: In postmenopausal women with hormone receptor-positive breast cancer, extended use of intermittent letrozole did not improve disease-free survival compared with continuous use of letrozole. An alternative schedule of extended adjuvant endocrine therapy with letrozole, including intermittent administration, might be feasible and the results of the SOLE trial support the safety of temporary treatment breaks in selected patients who might require them. FUNDING: Novartis and the International Breast Cancer Study Group.


Asunto(s)
Antineoplásicos/administración & dosificación , Inhibidores de la Aromatasa/administración & dosificación , Neoplasias de la Mama/tratamiento farmacológico , Nitrilos/administración & dosificación , Posmenopausia , Triazoles/administración & dosificación , Anciano , Antineoplásicos/efectos adversos , Inhibidores de la Aromatasa/efectos adversos , Biomarcadores de Tumor/análisis , Neoplasias de la Mama/química , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/patología , Quimioterapia Adyuvante , Supervivencia sin Enfermedad , Esquema de Medicación , Femenino , Humanos , Letrozol , Persona de Mediana Edad , Nitrilos/efectos adversos , Receptor ErbB-2/análisis , Receptores de Estrógenos/análisis , Receptores de Progesterona/análisis , Factores de Tiempo , Resultado del Tratamiento , Triazoles/efectos adversos
18.
Cancer ; 124(15): 3118-3126, 2018 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-29905927

RESUMEN

BACKGROUND: Regorafenib, a multikinase inhibitor that inhibits angiogenesis, growth, and proliferation, prolongs survival as monotherapy in patients with refractory colorectal cancer. This international, double-blind, placebo-controlled, multicenter trial assessed the efficacy of regorafenib with folinic acid, fluorouracil, and irinotecan (FOLFIRI) as a second-line treatment for metastatic colorectal cancer. METHODS: Patients with metastatic colorectal cancer who progressed on first-line oxaliplatin and fluoropyrimidine enrolled at 45 sites in the United States and Ireland. Patients, stratified by prior bevacizumab use, were randomized 2:1 to regorafenib or placebo. The treatment consisted of FOLFIRI on days 1 and 2 and days 15 and 16 with 160 mg of regorafenib or placebo on days 4 to 10 and days 18 to 24 of every 28-day cycle. Crossover was not allowed. The primary endpoint was progression-free survival (PFS). Under the assumption of a 75% event rate, 180 patients were required for 135 events to achieve 90% power to detect a hazard ratio (HR) of 0.65 with a 1-sided α value of .1. RESULTS: One hundred eighty-one patients were randomized (120 to regorafenib-FOLFIRI and 61 to placebo-FOLFIRI) with a median age of 62 years. Among these, 117 (65%) received prior bevacizumab or aflibercept. PFS was longer with regorafenib-FOLFIRI than placebo-FOLFIRI (median, 6.1 vs 5.3 months; HR, 0.73; 95% confidence interval [CI], 0.53-1.01; log-rank P = .056). The median overall survival was not longer (HR, 1.01; 95% CI, 0.71-1.44). The response rate was higher with regorafenib-FOLFIRI (34%; 95% CI, 25%-44%) than placebo-FOLFIRI (21%; 95% CI, 11%-33%; P = .07). Grade 3/4 adverse events with a >5% absolute increase from regorafenib included diarrhea, neutropenia, febrile neutropenia, hypophosphatemia, and hypertension. CONCLUSIONS: The addition of regorafenib to FOLFIRI as second-line therapy for metastatic colorectal cancer only modestly prolonged PFS over FOLFIRI alone. Cancer 2018. © 2018 American Cancer Society.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Camptotecina/análogos & derivados , Neoplasias Colorrectales/tratamiento farmacológico , Compuestos de Fenilurea/administración & dosificación , Piridinas/administración & dosificación , Adulto , Anciano , Camptotecina/administración & dosificación , Neoplasias Colorrectales/patología , Método Doble Ciego , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/patología , Femenino , Fluorouracilo/administración & dosificación , Humanos , Irinotecán/administración & dosificación , Estimación de Kaplan-Meier , Leucovorina/administración & dosificación , Masculino , Persona de Mediana Edad , Supervivencia sin Progresión
20.
Breast Cancer Res Treat ; 161(2): 289-297, 2017 01.
Artículo en Inglés | MEDLINE | ID: mdl-27878392

RESUMEN

PURPOSE: Electrochemotherapy (ECT) is the application of electric pulses to tumour tissue to render the cell membranes permeable to usually impermeant hydrophilic anti-cancer drugs, thereby enhancing cytotoxic effects. We sought to ascertain whether ECT can be an effective palliative treatment for cutaneous metastases of breast cancer. METHODS: This work reports data from the European Standard Operating Procedures for Electrochemotherapy trial (EudraCT Number: 2004-002183-18). In combination with systemic and/or intratumoural bleomycin, optimised electric pulses were delivered to locally recurrent or metastatic cutaneous breast cancer lesions. Follow-up continued until December 2014. RESULTS: Between February 2004 and December 2014, twenty-four patients were treated. All patients had received prior multimodal therapy. In total, the patient cohort had, or developed, 242 lesions. Two hundred and 36 lesions were treated, with 34 lost to follow-up. An objective response was seen in 161 of 202 lesions (79.7%), with a complete response observed in 130 (64.3%). Thirty-nine lesions (19.3%) did not respond, while 2 (1%) progressed following ECT. 17 (73.9%) patients received two or fewer treatments. A minimum of a partial response was seen in at least 50% of treated lesions in 18 of the 24 (75%) patients. Smaller lesions were more likely to have an objective response (Chi-square test for trend, p < 0.001). CONCLUSIONS: Electrochemotherapy is an effective treatment for cutaneous breast cancer lesions that have proven refractory to standard therapies. As smaller lesions were found to be more responsive, we suggest that ECT should be considered as an early treatment modality, within multimodal treatment strategies.


Asunto(s)
Antineoplásicos/uso terapéutico , Neoplasias de la Mama/patología , Neoplasias Cutáneas/tratamiento farmacológico , Neoplasias Cutáneas/secundario , Adulto , Anciano , Anciano de 80 o más Años , Antineoplásicos/administración & dosificación , Antineoplásicos/efectos adversos , Bleomicina/administración & dosificación , Bleomicina/efectos adversos , Bleomicina/uso terapéutico , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/terapia , Terapia Combinada , Femenino , Humanos , Persona de Mediana Edad , Neoplasias Cutáneas/diagnóstico , Neoplasias Cutáneas/mortalidad , Resultado del Tratamiento , Carga Tumoral
SELECCIÓN DE REFERENCIAS
DETALLE DE LA BÚSQUEDA