[Profile of first year secondary school children involved in the anti-smoking prevention trial "PEPITES"]. / Les collégiens de 6e participant à l'essai de prévention du tabagisme en milieu scolaire en Essonne : « PEPITES ¼.

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.

[Breast cancer screening program in France: for optimization of the information]. / Dépistage organisé du cancer du sein en France : pour une optimisation de l'information.

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.

HPV self-sampling or the Pap-smear: a randomized study among cervical screening nonattenders from lower socioeconomic groups in France.

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.

[Should psychological events be considered cancer risk factors?]. / Existe-t-il un lien entre un événement psychique et le risque de survenue d'un cancer ?

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.

[The tobacco cessation consultation of the Salah-Azeiz Tunis cancer center: one year results]. / La consultation d'aide au sevrage tabagique de l'institut de cancérologie Salah-Azeiz de Tunis : résultats à un an.

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.

Comparison of risk patterns in carcinoma and melanoma of the skin in men: a multi-centre case-case-control study.

We directly compared risk factors between 214 histologically confirmed melanomas (CMM), 215 basal-cell carcinomas (BCC) and 139 squamous-cell carcinomas (SCC) in a multiple case-case-control study with 349 controls from patients without dermatological disease admitted to the same hospitals. Subjects with fair hair had a significant risk increase for all types of tumours at a comparable level (OR(adj) for blonde hair: CMM 2.3; SCC 2.4; BCC 2.3). The effect of pale eyes was significant and similar for CMM and BCC (OR(adj) 2.6). Intermittent sun exposure measured in hours spent at beach during holidays was significant for both CMM (OR(adj) 2.6 for more than 7000 lifelong hours) and BCC (OR(adj) 2.1 for more than 7000 lifelong hours), while SCC exhibited a significant risk increase for chronic exposure to sunlight measured in hours of outdoor work (OR(adj) 2.2 for more than 6000 lifelong hours). In the case-case comparison using a multinomial logistic regression model, we found a statistically significant risk difference for pale eyes, and number of naevi in the CMM group, compared to other skin cancers. For intermittent sun exposure, there was a significant risk difference of BCC when compared to the risk of SCC. Factors influencing risk of SCC are different, with chronic exposure to sun playing a major role in causing this type of carcinoma.

[Prevention of skin cancer programs: analysis of the impact of randomized trials]. / Programmes de prévention des cancers cutanés. Analyse de l'impact des études randomisées.

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.

[Sun exposure and sun protection behavior and attitudes among the French population]. / Connaissances, attitudes et comportements des adultes vis-à-vis du soleil en France.

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.

Development of an integrated method of skin phenotype measurement using the melanins.

Different types of melanin pigments have recently been identified and recognized as critical determinants of the photosensitivity of individuals. Eumelanin, the black to brown melanin pigments, are believed to protect against ultraviolet-induced cell damage, while phaeomelanin, the reddish brown variant, is thought to be photosensitizing. The relative, qualitative and absolute amount of melanin production under stimulation of solar radiation is likely to be genetically determined. The hypothesis of this study is that determination of these values can help in identifying those people who are less protected. However, these techniques must be evaluated at a population level and against traditional epidemiological measures. We assessed the amount and type of melanin in 195 subjects in four centres across Europe, relating the results to epidemiological measures such as skin characteristics, history of sunburns and number of naevi. The most important finding was that eumelanin and phaeomelanin have very different distributions in the population, being associated with other phenotype characteristics with different patterns. The relationship between phaeomelanin and eumelanin is linearly inverse in the range from black to dark blonde hair colour, while it is weakly directly proportional in the range from dark blonde to light blonde, with people with red hair showing a peculiar pattern. Phaeomelanin rather than eumelanin seemed to be independent of other skin characteristics. The results show the feasibility of a further study with an appropriate case-control design and accurate determination of melanin.

[Standards, Options and Recommendations for the management of stage I or II primary bronchial cancers treated exclusively with radiotherapy]. / Standards, Options et Recommandations pour la prise en charge des patients atteints d'un cancer bronchique primitif de stade I ou II traités par irradiation exclusive.

CONTEXT: The 'Standards, Options and Recommendations' (SOR) project, started in 1993, is a collaboration between the Federation of the French Cancer Centres (FNCLCC), the 20 French cancer centres and specialists from French public universities, general hospitals and private clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines according to the definitions of the Standards, Options and Recommendations project for the management of stage I and II non small cell lung carcinoma treated by radiotherapy alone. METHODS: Data were identified by searching Medline and personal reference lists of members of the expert groups. Once the guidelines were defined, the document was submitted for review to independent reviewers, and to the medical committees of the 20 French cancer centres. RESULTS: The main recommendations for the management of stage I and II non small cell lung carcinoma treated by radiotherapy alone are: 1) The curative external irradiation with a continual course is an alternative to surgery only in the case of medically inoperable tumors or because the patient refuses surgery; 2) The external irradiation of the primary tumor only without the mediastinum could be proposed in peripheral stage IA. In proximal stage IA and IB, external irradiation should be carried out only as part of prospective randomised controlled trials comparing a localised irradiation of the primary tumor with a large irradiation of the mediastinum and the primary tumor. The treated volume must include the macroscopic tumoral volume with or without the microscopic tumoral volume and with a security margin from 1.5 to 2 cm; 3) There is a benefit to delivering a total dose in the primary tumor higher than 60 Gy in so far as the proposed irradiation, taking into account the respiratory function, does not increase the likelihood of severe adverse events due to radiation; and 4) The change in fractionation, the radiochemotherapy combination, the endobronchial brachytherapy with high dose rate alone or with external irradiation could be proposed only as part of prospective controlled trials for tumors classified as stage IB or II.

Reproducibility of histopathologic diagnosis and classification of non-melanocytic skin cancer: a panel exercise in the framework of the multicenter southern European study HELIOS.

AIMS AND BACKGROUND: The reproducibility of histologic diagnoses, and in particular of the distinction between basal and squamous cell forms, has been evaluated in the framework of a multicenter case-control study (in Italy, France, Spain and Switzerland) aimed to assess the causes of non-melanocytic skin cancers. METHODS: A panel composed of 10 pathologists from the collaborating centers was appointed. A total of 1,774 slides of routine diagnoses were blindly reviewed by a second panelist; discordant diagnoses underwent a third examination. Controversial and interesting cases were discussed during general sessions. RESULTS: The results showed a high degree of concordance (99.5%), with a Cohen's kappa of 0.85 (95% CI, 0.77-0.94) in the assessment of malignancy of lesions. The concordance in the distinction between large morphologic groups, basal cell carcinoma and squamous cell carcinoma was also high (Cohen's kappa = 0.85; 95% CI, 0.82-0.89). The assessment of histologic subtypes, degree of invasion and differentiation showed a lower degree of concordance, presumably as a consequence of a weaker consistency in the relevant classifications. CONCLUSIONS: The reproducibility study has therefore validated the epidemiologic study and in particular allowed to correct some misclassifications that could have lessened the analysis of the case-control study. In general, because of its characteristics (number of pathologists and variety of their origins, the large number of cases examined, blind examination of histologic slides), the conclusions of the study may show a certain degree of generalization, at least with regard to the countries represented. Routine histologic diagnoses of cutaneous carcinoma showed a high degree of reliability with reference to the assessment of malignancy and the distinction between basal and squamous cell carcinoma morphotypes.

[Standards, options and recommendations for the management of locally advanced non small cell lung carcinoma]. / Standards, otions et recommandationspour la prise en charge thérapeutique des patients atteints d'un cancer bronchopulmonaire primitif non à petites cellules localement avancé.

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of the French Cancer Centres (FNCLCC), the 20 French Cancer Centres and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines according to the definitions of the Standards, Options and Recommendations project for the management of locally advanced non small cell lung carcinoma. METHODS: Data were identified by searching Medline and the personal reference lists of members of the expert groups. Once the guidelines were defined, the document was submitted for review to independent reviewers and to the medical committees of the 20 French Cancer Centres. RESULTS: The main recommendations are: 1) The management of the locally advanced non small cell lung carcinoma has two main goals: firstly to obtain local control of the disease (or to at least delay local progression in order to improve the survival or relapse free survival), and secondly to prevent the development of metastases. 2) There is a consensus that locally advanced non small cell lung carcinoma should be irradiated. External beam radiotherapy should be of optimal quality and delivered at a minimal dose of 60 Gy by standard fractionation. For patients with a poor life expectancy, this can be delivered as a split-course or hypofractionated scheme. 3) Treatment for patients with a performance status of 0-1 should consist of short duration induction chemotherapy (with a least two drugs one of which must be cisplatin), combined sequentially with conventional radiotherapy. 4) Surgery is contraindicated in extensive N3 disease. Combined radio-chemotherapy (adjuvant or neoadjuvant) is not indicated outside clinical trials. Surgery is justified in stage N2 disease as good local control can be achieved. T4-N0 disease should be treated surgically with curative intent.

[Socio-ethic of cancer chemoprevention]. / Chimioprévention des cancers et socio-ethique

Cancer chemoprevention envisions a reduction in the incidence of the disease through direct action using various chemical products. Chemoprevention trials involve healthy subjects, as a consequence careful ethical consideration must be given to such interventions. The classical contract between the patient and his doctor is altered in this situation and the numerous consequences of extrapolation of results to the general population must be considered. In particular a calculation of the risk-benefit ratio must take into account not only the physical but also the mental and social well being of people whose lives will be medicalised as a result of such intervention. The primacy of collective benefit over individual interest mandates that chemoprevention be based on scientific and well conducted trials. When results are extrapolated to the whole population an evaluation process has also to be permanently performed. The target population must be well informed and the participation based on voluntary consent.

Quality assurance for screening mammography data collection systems in 22 countries.

OBJECTIVES: To document the mammography data that are gathered by the organized screening programs participating in the International Breast Cancer Screening Network (IBSN), the nature of their procedures for data quality assurance, and the measures used to assess program performance and impact. METHODS: A detailed questionnaire covering multiple aspects of quality assurance in screening mammography was mailed to IBSN representatives in 23 countries. RESULTS: Countries collect a wealth of screening mammography data, much of it computerized. Most countries have designated staff for data quality assurance. All provide staff training, and most have documentation requirements for data collection. Nearly all have one or more procedures to maintain data confidentiality. Countries are heterogeneous in collecting and assessing data to monitor screening program performance and impact. CONCLUSIONS: Demonstrating that population-based screening mammography reduces breast cancer mortality requires collection of high-quality data on key aspects of the multi-step screening process. Assuring the quality of data collection systems for screening mammography programs is an important and evolving area for IBSN countries.

Cervical cancer screening in France.

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.

[Role of human behavior and the environment in the prevention of cancer]. / Part des comportements humains, et de l'environnement dans la prévention des cancers.

Cancer is one of the main health issues for the French population. The importance of this burden can be measured through mortality and morbidity rates. Because of the still limited success of therapy, prevention should be the main concern. In theory prevention could avoid 50-80% of new cases. Efficiency of prevention depends, on the one hand, on the identification of risk factors and on estimation of their attributable rate and, on the other hand, on the possibility of controlling the exposure to these factors. Because the greatest risk is due to behavioural factors (smoking, alcohol consumption, diet, etc.), suppression of exposure to these factors depends mainly on individual will. But these individual decisions can be supported by an active preventive policy based on health education and on research in the fields of communication and behavioural determinants.

Randomized trial of neoadjuvant chemotherapy in oropharyngeal carcinoma. French Groupe d'Etude des Tumeurs de la Tête et du Cou (GETTEC).

The objective of the study was to evaluate the effect of neoadjuvant chemotherapy on the survival of patients with oropharyngeal cancer. Patients with a squamous cell carcinoma of the oropharynx for whom curative radiotherapy or surgery was considered feasible were entered in a multicentric randomized trial comparing neoadjuvant chemotherapy followed by loco-regional treatment to the same loco-regional treatment without chemotherapy. The loco-regional treatment consisted either of surgery plus plus radiotherapy or of radiotherapy alone. Three cycles of chemotherapy consisting of Cisplatin (100 mg/m2) on day 1 followed by a 24-hour i.v. infusion of fluorouracil (1000 mg/m2/day) for 5 days were delivered every 21 days. 2-3 weeks after the end of chemotherapy, local treatment was performed. The trial was conducted by the Groupe d'Etude des Tumeurs de la Tête Et du Cou (GETTEC). A total of 318 patients were enrolled in the study between 1986 and 1992. Overall survival was significantly better (P = 0.03) in the neoadjuvant chemotherapy group than in the control group, with a median survival of 5.1 years versus 3.3 years in the no chemotherapy group. The effect of neoadjuvant chemotherapy on event-free survival was smaller and of borderline significance (P = 0.11). Stratification of the results on the type of local treatment, surgery plus radiotherapy or radiotherapy alone, did not reveal any heterogeneity in the effect of chemotherapy.