RESUMEN
BACKGROUND: Many programs which aim to reduce tobacco consumption in young people are carried out in the school environment, addressing a "captive audience" and monitoring the actions over a period of several years. The approaches identified as promising involve putting in place a tobacco prevention program throughout the entire school years incorporated in the school program. Several studies showed that early initiation to psychoactive substances is a strong predictor of addiction. Considering the above points, an intervention trial on tobacco prevention covering the four years of secondary school (±11-15 years old) was implemented in the Essonne area, in France. METHOD: This study was based on a cluster randomized trial comparing three groups: two intervention groups and a control group. The present paper describes the school children (1st year in six secondary schools) included in the trial. It studies the national representativity of this population, the comparability between the control and intervention groups and the items link to tobacco initiation. RESULTS: When considering tobacco behavior in 2014, the included population was representative of the school children in 1st year of secondary school in France with 11.5% of tobacco initiation and 2.5% of regular smokers. The groups were comparable except for four items (family and friends smoking, only child, sensitive urban areas). With this knowledge on factors linked to smoking behaviors this population can be included in the trial analysis. CONCLUSION: The study of the included population will help to perform the trial analysis and authorize the transferability of the trial results if positive.
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Promoción de la Salud/métodos , Servicios de Salud Escolar , Instituciones Académicas , Prevención del Hábito de Fumar , Estudiantes , Escritura , Rendimiento Académico/estadística & datos numéricos , Estudios de Casos y Controles , Niño , Femenino , Francia/epidemiología , Promoción de la Salud/organización & administración , Humanos , Masculino , Evaluación de Programas y Proyectos de Salud , Servicios de Salud Escolar/organización & administración , Servicios de Salud Escolar/normas , Instituciones Académicas/estadística & datos numéricos , Prevención del Hábito de Fumar/métodos , Prevención del Hábito de Fumar/organización & administración , Estudiantes/psicología , Estudiantes/estadística & datos numéricos , Encuestas y Cuestionarios , Escritura/normasRESUMEN
BACKGROUND: Based on international and national recommendations, organized breast cancer screening in France raises questions of medical ethics built around the key concepts of individual autonomy and public health policy. Because of the evolving knowledge, professionals and institutions involved in the program must review the ethical values associated with this medical practice. METHODS: The ethical aspects of organized breast cancer screening were studied. In response to newly acquired knowledge highlighted by a review of texts governing this practice in France, proposals for changes resulting from reflections of a working group coordinated by the National Cancer Institute are presented. RESULTS: Ethical issues raised by screening must find expression in the general principles of the program's organization: acceptability of screening, efficiency, adverse effects, equity of access, free care , but also at different stages of the procedure: information delivery, first and second invitations, refusal of further diagnostic investigation CONCLUSION: A better match between breast cancer screening and recently developed knowledge requires optimal information delivery to women targeted by the program as well as a stronger role for the referring healthcare professional.
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Neoplasias de la Mama/diagnóstico , Detección Precoz del Cáncer/ética , Femenino , Francia , Humanos , Difusión de la InformaciónRESUMEN
Today in France, low attendance to cervical screening by Papanicolaou cytology (Pap-smear) is a major contributor to the 3,000 new cervical cancer cases and 1,000 deaths that occur from this disease every year. Nonattenders are mostly from lower socioeconomic groups and testing of self-obtained samples for high-risk Human Papilloma virus (HPV) types has been proposed as a method to increase screening participation in these groups. In 2011, we conducted a randomized study of women aged 35-69 from very low-income populations around Marseille who had not responded to an initial invitation for a free Pap-smear. After randomization, one group received a second invitation for a free Pap-smear and the other group was offered a free self-sampling kit for HPV testing. Participation rates were significantly different between the two groups with only 2.0% of women attending for a Pap-smear while 18.3% of women returned a self-sample for HPV testing (p ≤ 0.001). The detection rate of high-grade lesions (≥CIN2) was 0.2 in the Pap-smear group and 1.25 in the self-sampling group (p = 0.01). Offering self-sampling increased participation rates while the use of HPV testing increased the detection of cervical lesions (≥CIN2) in comparison to the group of women receiving a second invitation for a Pap-smear. However, low compliance to follow-up in the self-sampling group reduces the effectiveness of this screening approach in nonattenders women and must be carefully managed.
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Tamizaje Masivo , Prueba de Papanicolaou , Neoplasias del Cuello Uterino/epidemiología , Adulto , Femenino , Francia , Humanos , Papillomaviridae/aislamiento & purificación , Papillomaviridae/patogenicidad , Infecciones por Papillomavirus/diagnóstico , Infecciones por Papillomavirus/epidemiología , Pobreza , Embarazo , Autocuidado , Manejo de Especímenes , Neoplasias del Cuello Uterino/diagnóstico , Neoplasias del Cuello Uterino/patología , Neoplasias del Cuello Uterino/virologíaRESUMEN
BACKGROUND: The possibility that life events, personality or depression can be considered risk factors for cancer has been of great interest among the lay public and doctors. METHODS: A critical review of different publications of meta-analyses, case-control studies and cohort studies investigating a possible relation between the onset of cancer and life events, personality disorders or depression is presented. Many studies have methodological limitations with possible bias, which may explain controversial results. We selected 32 studies from which conclusions can be drawn with the least amount of bias. RESULTS: Eighteen out of 32 publications whose methodology permits unbiased interpretation show no link between psychological factors and the risk of cancer. Six publications show a significant link only in one or several subgroups and four surveys, three of which were published by the same author, show an inverse relation in gynecological cancers. As for life events and breast cancer, the results are slightly in favor of a positive relation in four studies; four others showed no relation and one argues in favor of an inverse risk, which means a protective effect for this cancer. For life events and other cancers, studies show no relation, with the possible exception of cancers in women where endogenous estrogens can play a role (colon and endometrial cancers), where there is an inverse relation. No studies showed a significant relation between personality features and the risk of cancer. The studies of a possible relation between depression and cancer are controversial and no conclusion can be drawn. CONCLUSION: It cannot be confidently concluded that life events, personality features or depression play a role in the onset of cancer.
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Depresión/complicaciones , Acontecimientos que Cambian la Vida , Neoplasias/epidemiología , Trastornos de la Personalidad/complicaciones , Estrés Psicológico/complicaciones , Anciano , Consumo de Bebidas Alcohólicas/efectos adversos , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/psicología , Estudios de Casos y Controles , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Neoplasias/psicología , Riesgo , Factores de Riesgo , Fumar/efectos adversos , Encuestas y Cuestionarios , Factores de TiempoRESUMEN
BACKGROUND: To reduce tobacco smoking is, in Tunisia, a public health priority. The tobacco cessation consultation is one of the interventions to fight against the tobacco epidemic; it is a new activity developed in the Salah-Azeiz Tunis cancer centre. The objective of this work is to evaluate the impact of the consultation on the smokers after one year of activities and to analyse the prognostic factors of tobacco cessation in order to improve the efficacy of such an activity in the future, in Tunisia. METHODS: The cessation methods were based on cognitive and behavioral therapies associated with nicotine patch, delivered free of charge. During one year (July 2003 to June 2004), 340 smokers were attended. Data on their smoking status and psychological characteristics were collected using a standardized questionnaire. RESULTS: The patients were mostly men (79%), these smokers did not present important anxiety-depressive troubles, 68% thought that they were able to quit easily. The majority (57%) smoked more than 20 cigarettes a day and was nicotine-dependent (Fagenström >7). Half of this population had already intended to stop, they declared to smoke mostly because of stress. The global cessation rate after a median follow-up of 32 weeks is 27%. The cessation rate lasting six months for 83 patients followed regularly was 23%. The good prognostic factors of cessation, after multivariate analysis, were (when taking out from the model the regular follow-up), to be confidant on the possibility to stop (OR=0.87 [0.78-0.97]). On the contrary, a high score (>7) for Fagerström test (OR=1.9 [1.1-3.4), the use of smoking to fight against stress (OR=1.08 [1.0-1.2) and a smoking environment at home (OR=4.5 [1.1-18.9]) were prognostic of a failure in quitting smoking. CONCLUSION: These results show that the cessation rate, which is still too low as compared with the literature, could be increased by a better follow-up of smokers associated with an information campaign on the existing possibilities to quit smoking in Tunisia.
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Consejo , Hospitales Universitarios , Oncología Médica/educación , Cese del Hábito de Fumar/métodos , Prevención del Hábito de Fumar , Adulto , Colinérgicos/uso terapéutico , Femenino , Estudios de Seguimiento , Educación en Salud/métodos , Humanos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Nicotina/uso terapéutico , Psicoterapia de Grupo , Estudios Retrospectivos , Fumar/epidemiología , Encuestas y Cuestionarios , Túnez/epidemiologíaRESUMEN
Angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) are the cornerstone treatment in chronic kidney disease patients. Despite facilitating a reduction in blood pressure and albuminuria, there are insufficient data in kidney transplant recipients (KTRs). They are often administered for hypertension and polycythemia treatment. The aim of this study was to investigate the frequency and route of administration of ACEIs and ARBs and their early clinical effects in the KTR population. In a cross-sectional, retrospective study we analyzed 874 medical records of all KTRs treated in our unit in 2014. A total of 391 KTRs (44.7%) using ARBs or ACEIs were qualified for the study. The primary reasons for renin-angiotensin-aldosterone system antagonist administration were hypertension (59.1%), polycythemia (19.2%), and proteinuria (18.2%). Among the studied KTRs, 86.7% of patients were treated with ACEIs and 12.2% were treated with ARBs. The majority of patients treated with ACEIs and ARBs received these agents in a dose range below 25% and between 25% and 49% of their maximal dose, respectively. Both the mean serum creatinine level and estimated glomerular filtration rate (chronic kidney disease epidemiology collaboration) remained fairly stable and urine protein excretion (g/24 hours) was significantly reduced after 3 months of ACEI and ARB therapy. The serum potassium level increased significantly, while hemoglobin concentration dropped significantly. In KTRs, renin-angiotensin-aldosterone system antagonists were applied mainly due to hypertension, proteinuria, and polycythemia. ACEIs and ARBs were effective in the reduction of proteinuria and hemoglobin, but graft function was stable and the increase of serum potassium was not of clinical significance.
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Antagonistas de Receptores de Angiotensina/administración & dosificación , Inhibidores de la Enzima Convertidora de Angiotensina/administración & dosificación , Trasplante de Riñón , Estudios Transversales , Femenino , Humanos , Hipertensión/tratamiento farmacológico , Masculino , Persona de Mediana Edad , Policitemia/tratamiento farmacológico , Proteinuria/tratamiento farmacológico , Sistema Renina-Angiotensina/efectos de los fármacos , Estudios RetrospectivosRESUMEN
BACKGROUND: Hypertension is a very common complication in renal transplant recipients (RTRs). It has been identified as a potent cardiovascular risk factor associated with impaired patient and graft survival. METHODS: A longitudinal retrospective analysis was performed to evaluate adherence to recommended blood pressure (BP) targets and to estimate the tendency in the management of hypertension from 2001 to 2015. A total of 96 RTRs (55 male, 41 female; overall mean age (2001), 41.66 ± 11.08 years; mean serum creatinine level, 1.45 ± 0.3 mg/dL; 41.2 ± 34.9 months after kidney transplantation) with diagnoses of hypertension and monitored continuously in the unit from 2001 to 2015 were included in the study. RESULTS: The average diastolic BP decreased (P < .01) and the average systolic BP did not change in this period. The target values of BP (ie, <140/90 mm Hg) were accomplished by 45.8% (2001) and 53.1% (2015) of patients. When the target BP was corrected by age (<150/90 mm Hg for people >65 years old) the adherence improved to 57.29% in 2015. The average number of antihypertensive agents used per patient increased significantly (P < .001): 2.03 ± 1.0 (2001) versus 2.69 ± 1.26 (2015). The most commonly used antihypertensive agents were beta-blockers: 69% and 74% in 2001 and 2015, respectively. There was a significant increase in the percentage of RTRs treated with the use of alpha-blockers (P < .01), angiotensin-converting enzyme inhibitors (P < .001), and angiotensin II receptor blockers (P < .05). CONCLUSIONS: The study showed modest improvement of the hypertension control rate from 2001 to 2015 in RTRs. Greater efforts are needed to implement the guidelines, which would further improve patient and graft outcomes.
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Antagonistas Adrenérgicos beta/uso terapéutico , Antihipertensivos/uso terapéutico , Hipertensión/tratamiento farmacológico , Trasplante de Riñón/efectos adversos , Complicaciones Posoperatorias/tratamiento farmacológico , Adulto , Anciano , Antagonistas de Receptores de Angiotensina/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Presión Sanguínea/fisiología , Determinación de la Presión Sanguínea , Creatinina/sangre , Femenino , Supervivencia de Injerto , Humanos , Hipertensión/etiología , Hipertensión/fisiopatología , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/fisiopatología , Estudios RetrospectivosRESUMEN
Central diabetes insipidus (DI) is extremely rare during the neonatal period. Most cases of central DI are secondary to a known aetiology. Substitutive treatment with desmopressin is effective with nasal or oral preparation, but doses are variable and must be tailored individually. We report on a case in a very low birth weight infant with an idiopathic central DI during the first month of life. He was successfully treated with oral desmopressin. The treatment was maintained after discharge with low doses desmospressin.
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Fármacos Antidiuréticos/uso terapéutico , Desamino Arginina Vasopresina/uso terapéutico , Diabetes Insípida Neurogénica/tratamiento farmacológico , Recién Nacido de muy Bajo Peso , Humanos , Recién Nacido , Recien Nacido Prematuro , MasculinoRESUMEN
INTRODUCTION: Exposure to ultraviolet sun rays is an important risk factor for the development of skin cancer. Confronted with the increase in the incidence of severe forms (melanoma), primary prevention plays a major part, together with the development of campaigns promoting individual and collective protection against ultraviolet rays. OBJECTIVE: The aim of this trial was to identify the factors of success or failure of skin cancer prevention programs and to analyze their impact. METHOD: Articles published in the literature from 1982 to 2002 were selected from the Medline databank using the following key words: "skin cancer, melanoma, evaluation, prevention and education, review, program, campaign and randomized controlled trial". For the final analysis, only the randomized trials with control group were retained. RESULTS: All the prevention programs increased short, median or long term knowledge. Conversely, the trials were sometimes contradicting with regard to the change in attitude. No methodologically correct trial clearly reported any change in behavior, the majority of them only collected intent behavior. CONCLUSION: Despite the methodological weaknesses of most of the trials published, this review of the literature underlined certain points. The most efficient programs appear to be those targeting children, the training sessions of which are long and/or repeated, with active individual participation. Programs based on the deleterious consequences of sun exposure on physical appearance appeared to produce better results in terms of any change in attitude and intent behavior.
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Ensayos Clínicos Controlados Aleatorios como Asunto , Neoplasias Cutáneas/prevención & control , Rayos Ultravioleta/efectos adversos , Actitud Frente a la Salud , Niño , Conductas Relacionadas con la Salud , Promoción de la Salud , Humanos , Medicina Preventiva , Proyectos de Investigación , Resultado del TratamientoRESUMEN
INTRODUCTION: The number of new skin cancers has constantly increased in France over the past two decades. The role of sun exposure can partly explain this phenomenon and justifies the development of information and prevention campaigns to change peoples' attitude towards sun bathing. To be effective, we need to know how much information and what attitudes the population currently has with regard to the sun. Although several studies in France have targeted children, little data is available regarding adults. This trial was aimed at pinpointing the knowledge, attitude and behavior of adults regarding sun exposure. MATERIAL AND METHODS: Data were collected during a randomized multicenter study on the prevention and early diagnosis of cutaneous tumors, conducted in 26 Health Centers from 1998 to 2000. Standardized questionnaires were handed to those consulting to assess their knowledge, attitudes and behavior towards sun bathing. The population was composed of 41 143 adults aged over 30, consulting one of the 26 Health Check-up units. Analysis of the data was made using SAS v 6.12 and STATA 7.0 software. Logistic regression identified the explicative factors of knowledge and behavior. All the statistical analyses were considered significant above a threshold of alpha<5%. RESULTS: A total of 33 021 persons filled-in the self-questionnaire. Forty-nine percent were women and 51% were men, with a mean age of 50 years. Geographically, 25% lived in the North-East, 16% in the North-West, 25 p.cent in the South-East and 34% in the South-West. Thirty percent claimed that they tanned without burning and 2% of the population studied had often suffered from sun burn, generally when they were adult. The risks related to sun burn were known, because 92% knew that the sun increased the risk of skin aging and 89% knew that it increased the risk of skin cancer. Regarding sun screens, knowledge was not so good; 42% thought that all products were the same and 53% that they allowed one to sun bathe longer. This knowledge was better in those with fair skins, in those who had a history of sun burn, in women and in those who lived in the northern areas of France. Conversely, knowledge decreased with age and was limited in those aged over 60. Regarding behavior, those with fair skin and who reddened under the sun without tanning, protected themselves more. The women declared they protected themselves more than the men, but they used less sun protective measures (clothing, hats...), other than sun screens, than men. Subjects aged over 60 protected themselves more than younger subjects. Lastly, a personal cutaneous history increased protective behavior, and those from northern France protected themselves more than those from the South. DISCUSSION: This analysis of 33 021 adults aged over 30 shows the good global knowledge of the consequences of sun bathing, but also the lack of knowledge on the interest of using external sun protection and the role of physical means of protection. Attitudes varied depending on gender, age and phototype and also depending on the area where they lived. Despite good knowledge, the most frequent behavior of adults aged over 30 is still not appropriate with differences depending on age, gender and area, which must prompt more appropriate targeting of prevention campaigns according to the populations concerned.
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Conocimientos, Actitudes y Práctica en Salud , Neoplasias Cutáneas/prevención & control , Luz Solar/efectos adversos , Adulto , Actitud Frente a la Salud , Femenino , Francia , Encuestas Epidemiológicas , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Neoplasias Cutáneas/etiología , Pigmentación de la PielRESUMEN
Recent developments on engineered multifunctional nanomaterials have opened new perspectives in oncology. But assessment of both quality and safety in nanomedicine requires new methods for their biological characterization. This paper proposes a new model-based approach for the pre-characterization of multifunctional nanomaterials pharmacokinetics in small scale in vivo studies. Two multifunctional nanoparticules, with and without active targeting, designed for photodynamic therapy guided by magnetic resonance imaging are used to exemplify the presented method. It allows to the experimenter to rapidly test and select the most relevant PK model structure planned to be used in the subsequent explanatory studies. We also show that the model parameters estimated from the in vivo responses provide relevant preliminary information about the tumor uptake, the elimination rate and the residual storage. For some parameters, the accuracy of the estimates is accurate enough to compare and draw significant pre-conclusions. A third advantage of this approach is the possibility to optimally refine the in vivo protocol for the subsequent explanatory and confirmatory studies complying with the 3Rs (reduction, refinement, replacement) ethical recommendations. More precisely, we show that the identified model may be used to select the appropriate duration of the MR imaging sessions planned for the subsequent studies. The proposed methodology integrates MRI image processing, continuous-time system identification algorithms and statistical analysis. Except, the choice of the model parameters to be compared and interpreted, most of the processing procedure may be automated to speed up the PK characterization process at an early stage of experimentation.
RESUMEN
Two case-control studies have examined the relationship between black or blond tobacco smoking and the occurrence of pharynx or larynx cancer. The first study was carried out in several European countries. Tobacco smoking was found to be associated with higher risks for supraglottic and epilarynx cancer localisations than for pharynx, glottic and subglottic localisation. In all localisations, risk was twice as high again in users of black tobacco after adjusting for alcohol and for lifetime average daily dose of tobacco. The other study was carried out in Uruguay. After taking into account age, age at start of smoking, duration of smoking, years since stopping smoking and filter use, risks were found to be higher in black tobacco smokers than in blond tobacco smokers. All known studies which have been performed in countries where blond tobacco is generally smoked showed lower risks even when adjusted for alcohol. Use of black tobacco appears to be associated with higher risks of cancer of the pharynx and larynx than blond tobacco use.
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Neoplasias Laríngeas/etiología , Nicotiana , Neoplasias Faríngeas/etiología , Plantas Tóxicas , Fumar/efectos adversos , Consumo de Bebidas Alcohólicas/efectos adversos , Estudios de Casos y Controles , Femenino , Humanos , Masculino , Factores de RiesgoRESUMEN
Between February 1978 and January 1984, 222 eligible patients were randomised in a multicentre trial of preoperative intra-arterial chemotherapy in the treatment of oral cavity and oropharynx carcinoma. Patients were randomised between either surgery or preoperative chemotherapy. This latter group received vincristine and bleomycin for 12 days. Patients were stratified according to the primary site: floor of the mouth (FM) versus posterior oral cavity or oropharynx (POC) and institution. The FM group received postoperative radiotherapy depending upon quality of the margins and lymph-node pathological involvement, when it was systematically applied in the POC group. Tumour regression after chemotherapy either complete (CR) or partial (PR greater than 50%) was observed in 48% in the FM group and 41% in the POC group, and lymph-node regression (CR + PR) was respectively 15% and 23%. Some discrepancies appeared between clinical regression and pathological response, and the number of cases without histological response was clearly higher than the number of cases without clinical response. The overall survival showed a statistically significant difference (P = 0.048) between FM and POC groups. In the FM group, median survival in the chemotherapy arm was estimated at 7 years compared with 3 years in the surgery arm. In the POC group, median survival was estimated at 3 years in both treatment arms. Chemotherapy lowered the uncontrolled disease and local recurrence in the FM group. These differences do not exist in the POC group, which may be due to the systematically postoperative radiotherapy.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma de Células Pequeñas/tratamiento farmacológico , Neoplasias de la Boca/tratamiento farmacológico , Neoplasias Orofaríngeas/tratamiento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Bleomicina/administración & dosificación , Bleomicina/efectos adversos , Carcinoma de Células Pequeñas/mortalidad , Carcinoma de Células Pequeñas/patología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Boca/patología , Neoplasias de la Boca/mortalidad , Neoplasias de la Boca/patología , Neoplasias Orofaríngeas/mortalidad , Neoplasias Orofaríngeas/patología , Orofaringe/patología , Vincristina/administración & dosificación , Vincristina/efectos adversosRESUMEN
In France, as in other European countries the incidence and mortality rates of carcinoma of the cervix uteri indicate a clear decrease in invasive cancers. Opportunistic screening has spread and, presently, approximately 60% of the female population undergo a regular cytological test. This rate increases up to 80% in the younger age groups and decreases to 20% after the age of 60 years. In 1990, intervention procedures were defined at a consensus conference; the major recommendations were to screen all women exclusively by cervical smears, for ages 25-65 years over a 3-year period. Guidelines on the quality control of cervical smear taking and reading were published by the national agency of evaluation of health intervention (ANAES). Since 1990, four population-based, organised pilot programmes, have been implemented in Isère. Doubs, Bas-Rhin and Martinique. These programmes evaluate the participation rate (from approximately 20-80% depending upon the age and the geographical area), the rate of abnormal tests (0.2-3%), according to the laboratories, the cancer detection rate (0.04%-0.15%) and some other quality indicators. Recently (November 1998) a law was passed stipulating that the screening test will be free of charge when performed in agreement with the national recommendations. A specific organisation for cytological quality control will be implemented. An effort to better identify and to include the screening process the women in the population who are not yet participating has to be made.
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Tamizaje Masivo/organización & administración , Neoplasias del Cuello Uterino/prevención & control , Adulto , Distribución por Edad , Anciano , Femenino , Francia/epidemiología , Humanos , Tamizaje Masivo/normas , Persona de Mediana Edad , Garantía de la Calidad de Atención de Salud/organización & administración , Derivación y Consulta , Sistema de Registros , Neoplasias del Cuello Uterino/epidemiología , Frotis Vaginal/métodosRESUMEN
Recently, it was found that, among post menopausal breast cancer patients receiving no adjuvant therapy, the highest oestrogen receptor (ER) levels (ER++) as opposed to the intermediate ER levels (ER+) indicated a poorer prognosis in terms of recurrence-free survival (Thorpe et al. Eur J Cancer 1993, 29A, 971-977). In the present study, we confirm, in a series of 218 node negative, postmenopausal patients in whom ER was determined using a one-dose saturating method, that ER+ tumours have a more negative effect on disease-free survival (DFS) than ER+ tumours (P = 0.02). In another series of 87 ER positive, postmenopausal patients, we found a significant correlation (P = 0.04) between the ER level and ER+R ratio (ER protein/ER-specific mRNA): the higher the ER level, the more numerous the high ER+R ratio cases (ER+R > 1.5), reflecting an imbalance between the ER protein level and ER-specific mRNA. From these results, we hypothesise that high ER levels related to a high ER+R ratio suggest the presence of a modified ER gene product.
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Biomarcadores de Tumor/análisis , Neoplasias de la Mama/química , Posmenopausia , Receptores de Estrógenos/análisis , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/genética , Supervivencia sin Enfermedad , Femenino , Humanos , Persona de Mediana Edad , Pronóstico , ARN Mensajero/genética , ARN Neoplásico/genética , Receptores de Estrógenos/genéticaRESUMEN
From July 1987 to July 1990, 374 patients were randomized in a multicenter trial coordinated by the Gustave-Roussy Institute. Patients were treated either by radiotherapy alone (RT) or by combined etanidazole with radiotherapy (ETA). The same radiotherapy protocol was used in both arms. Major deviations from the protocol occurred in 16% of the patients. Etanidazole was given at a dose of 2 g/m2, 3 times per week, for a total of 30-34 g/m2. Seventeen percent of the patients received less than 14 injections (4% refused, 12% presented a toxicity, 1% died before beginning). The rate of neuropathy was 28% in the ETA arm and 3% in the RT arm. Acute radiotherapy reactions occurred in similar proportions in both arms. The 3-month rates of complete regression are presently 75.3% in the RT alone group and 77.6% in the ETA group; this difference is not significant. No definitive results are presently available and we must wait for the two-year survival results. In addition, if a meta-analysis could be performed with the parallel RTOG study, the results would be more valid.
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Carcinoma de Células Escamosas/radioterapia , Neoplasias de Cabeza y Cuello/radioterapia , Nitroimidazoles/uso terapéutico , Fármacos Sensibilizantes a Radiaciones/uso terapéutico , Carcinoma de Células Escamosas/tratamiento farmacológico , Terapia Combinada , Etanidazol , Femenino , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Humanos , Masculino , Nitroimidazoles/efectos adversos , Fármacos Sensibilizantes a Radiaciones/efectos adversosRESUMEN
PURPOSE: The aim of the study was to evaluate the efficacy and toxicity of Etanidazole, a hypoxic cell sensitizer, combined with radiotherapy in the treatment of head and neck squamous cell carcinoma. METHODS AND MATERIALS: A total of 374 patients from 27 European centers were included in this trial between 1987 and 1990. Treatment was either conventional radiotherapy alone (between 66 Gy in 33 fractions and 74 Gy in 37 fractions, 5 fractions per week), or the same radiotherapy dose plus Etanidazole 2 g/m2, three times weekly for 17 doses. A minimization procedure, balancing for center, site, and T stage (T1-T3 vs. T4) was used for randomization. RESULTS: Among the 187 patients in the Etanidazole group, 82% received at least 14 doses of the drug. Compliance to the radiotherapy protocol was 92% in the Etanidazole group and 88% in the control group; the main cause of deviation was acute toxicity, which was observed at an equal rate in the two treatment groups. Fifty-two cases of Grade 1 to 3 peripheral neuropathy were observed in the Etanidazole group vs. 5 cases, all of Grade 1, in the control group (p < 0.001). The 2-year actuarial loco-regional control rates were 53% in the Etanidazole group and 53% in the control group (p = 0.93), and the overall 2-year survival rates were 54% in each group (p = 0.99). CONCLUSION: Adding Etanidazole to conventional radiotherapy did not afford any benefit for patients with head and neck carcinoma. This study failed to confirm the hypothesis of a benefit for patients with N0-N1 disease, which had been suggested by the results of a previous study (10).
Asunto(s)
Carcinoma de Células Escamosas/radioterapia , Etanidazol/uso terapéutico , Neoplasias de Cabeza y Cuello/radioterapia , Fármacos Sensibilizantes a Radiaciones/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Supervivencia sin Enfermedad , Esquema de Medicación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dosificación Radioterapéutica , Análisis de Regresión , Insuficiencia del TratamientoRESUMEN
A group of 6 European cancer centers, coordinated by the Institut Gustave-Roussy, began a phase II trial of the radiosensitizing drug, etanidazole, in November 1986. The trial was designed to study the toxicity of the drug and the feasibility of a phase III trial on the combination of etanidazole with radiotherapy for treating head and neck squamous cell carcinomas. Thirty-one patients were included in the phase II trial between November 1986 and June 1987; 25 completed the whole course of treatment. Most of the neuropathies occurred during the two weeks following radiotherapy, but had no major effect on radiotherapy itself. The area under the curve (AUC) was measured in 22 patients; there was no correlation between total AUC and the incidence of neuropathy, although there was a trend towards more neuropathies at high total AUC. The toxicity of Eta did not appear excessive. A phase III trial was therefore begun in July 1987. Twenty-nine centers in 5 European countries (France, Italy, Germany, Austria and the UK) took part. A total of 330 patients had been enrolled by the end of November 1989. This report presents the results available to date. 15% of the patients treated with Eta plus radiotherapy have received less than 15 Eta injections, mainly because of skin rashes (5%), peripheral neuropathies (3%) or patient refusal (3%). The overall frequency of neuropathies was 27%, but most were grade I and occur mainly after treatment. There were similar percentages of radiotherapy-related toxicities, mainly acute reactions in irradiated normal tissues, in both Eta and control arms.(ABSTRACT TRUNCATED AT 250 WORDS)
Asunto(s)
Carcinoma de Células Escamosas/radioterapia , Neoplasias de Cabeza y Cuello/radioterapia , Nitroimidazoles/efectos adversos , Fármacos Sensibilizantes a Radiaciones/efectos adversos , Adulto , Anciano , Anciano de 80 o más Años , Terapia Combinada , Evaluación de Medicamentos , Etanidazol , Europa (Continente) , Humanos , Masculino , Persona de Mediana EdadRESUMEN
Thyroid morphological and functional tests were carried out on 396 patients who were recalled because their thyroid gland had been exposed during hemangioma irradiation in childhood 11-43 years before (median, 22 years). The irradiations have been classified into two categories based on their duration: short duration, from a few seconds to a few minutes (90S and X rays), and long duration, from 30 min to several hours (336Ra, 192Ir, and 32P). The risk of a thyroid nodule increased significantly with the total dose received by the thyroid; it was linked to the dose delivered in the short duration (excess relative risk per Gy = 10), but not to that delivered in the long duration. The risk of a simple diffuse goiter, which also increased with the dose received by the thyroid, did not depend on the duration of the irradiation. In conclusion, this study emphasizes the role of the dose rate in the risk of thyroid nodule, the detection of which does not appear to be improved by plasma thyroid marker determination.
Asunto(s)
Hemangioma/radioterapia , Neoplasias Cutáneas/radioterapia , Glándula Tiroides/efectos de la radiación , Nódulo Tiroideo/etiología , Niño , Francia/epidemiología , Hemangioma/epidemiología , Humanos , Estudios Retrospectivos , Riesgo , Neoplasias Cutáneas/epidemiología , Nódulo Tiroideo/epidemiología , Factores de TiempoRESUMEN
The prospective study conducted by the Organisation internationale d'Etudes Statistiques pour les maladies de l'Oesophage (OESO) (International Organization for Statistical Studies of Esophageal Diseases) created in 1979 concerns 790 patients operated on for a tumor of the esophagus or the mouth of the esophagus. Among the preoperative investigations, endoscopic examinations were associated with a high error rate (20%). Respiratory function tests cannot constitute a formal contraindication to surgery. The value of extended surgical excision is confirmed by the results, although the need for extensive lymphatic resection has not been clearly demonstrated. The incidence of fistula has decreased, but it still remains an important element of operative deaths. However, the complications of esophagectomy are essentially pulmonary and the problem of preoperative identification of high-risk patients has not yet been resolved. The influence of various modalities of postoperative ventilation techniques were evaluated. The overall mortality rate was 14.7%, and a much broader definition of this term is required. Because of a number of contradictions in prognostic factors, the OESO group is currently testing a new clinical and histologic classification.