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Automated closed-loop (CL) insulin therapy has come of age. This major technological advance is expected to significantly improve the quality of care for adults, adolescents and children with type 1 diabetes. To improve access to this innovation for both patients and healthcare professionals (HCPs), and to promote adherence to its requirements in terms of safety, regulations, ethics and practice, the French Diabetes Society (SFD) brought together a French Working Group of experts to discuss the current practical consensus. The result is the present statement describing the indications for CL therapy with emphasis on the idea that treatment expectations must be clearly defined in advance. Specifications for expert care centres in charge of initiating the treatment were also proposed. Great importance was also attached to the crucial place of high-quality training for patients and healthcare professionals. Long-term follow-up should collect not only metabolic and clinical results, but also indicators related to psychosocial and human factors. Overall, this national consensus statement aims to promote the introduction of marketed CL devices into standard clinical practice., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Background: A surveillance program was performed in colorectal cancer (CRC) patients after surgery, to diagnose asymptomatic recurrence., Aims: To assess whether 18-FDG positron emission tomography/CT (PET/CT) improved the detection of recurrence during a 3-year follow-up., Methods: A multicentre, two-arm randomised prospective trial comparing different 36-month follow-up strategies. Complete colonoscopy was performed at baseline and after 3 years and clinical exams with imaging every 3 months. The conventional arm (A) received carcinoembryonic antigen, liver echography, and alternated between lung radiography and computed tomography (CT) scans. The experimental arm (B) received PET/CT., Results: A total of 365 patients with colon (79.4%) or rectal cancer (20.6%), stages II (48.2%) or III (50.8%), were enroled in this study. At 36 months, intention-to-treat analysis revealed recurrence in 31 (17.2%) patients in arm A and 47 (25.4%) in arm B (p = 0.063). At 3 years, 7 of 31 relapses (22.5%) in arm A were surgically treated with curative intent, compared to 17 of 47 (36.2%) in arm B (p = 0.25). The rates of recurrence and new cancers were higher in arm B than arm A (p = 0.038)., Conclusions: PET/CT follow-up every 6 months did not increase the rate of recurrence at 3 years or the rate of surgically treated recurrence compared with conventional follow-up., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Medical oncology bad news consultation is a particularly stressful situation for both the patient and the physician. High-fidelity simulation is a learning option that has never been evaluated in France in this field., Materials and Methods: This is a feedback from simulated announcement consultations carried out from January 2018 to May 2019. Residents from the medical oncology and radiotherapy departments performed high-fidelity simulations at the announcement consultation with an announcement nurse, a psychologist, a certified coach and an oncologist. A competency assessment was completed in pre-test, immediate post-test and after 5 months., Results: Fourteen of the 16 eligible interns participated. The pre-test competency assessment showed that interns over 5 semesters reported being more comfortable at the consultation (P=0.04) and thought they were clearly explaining the disease (P=0.03). However, all residents, regardless of the semester, felt stressed before a consultation. The evolution of parameters skills after the simulation was positive for all criteria, particularly for adaptation to patient reactions, use of appropriate vocabulary and reduction of stress (P<0.05). This evolution was independent of the gender, curriculum, semester, or previous completion of a medical oncology internship. More than 80% of the students were ready to repeat this type of training., Conclusion: This training demonstrates the value of simulation training for medical oncology advertising consultation., (Copyright © 2020 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

The use of transition readiness questionnaires is strongly recommended in adolescents with chronic conditions. The aim of our study was to validate "Good2Go," the first French-language transition readiness questionnaire. We analyzed the data from 2 multicentric studies (Canada and France) involving adolescents with chronic conditions (type 1 diabetes, inflammatory bowel disease, cystic fibrosis, epilepsy, juvenile idiopathic arthritis). Content and construct validity were examined using factorial and Rasch analysis (structural validity), Spearman's correlation, and Mann-Whitney test (external validity). Cronbach's α and intra-class correlation coefficients explored reliability. Cognitive interviews assessed wording comprehension and item appropriateness. Good2Go was completed by 321 participants (boys = 51%; mean age = 16.4 years (standard deviation = 1.5; min = 14.0; max = 18.0); Canada = 51.1%). Factor analysis identified 3 domains: "health self-advocacy," "knowledge about chronic conditions," and "self-management skills." The 3-domain structure showed a satisfying Rasch fit, internal consistency, and test-retest reliability. Good2Go domain scores were significantly higher in participants over 17 years of age, indicating satisfactory external validity.Conclusion: Good2Go is a valid 20-item questionnaire to assess transition readiness in adolescents with chronic conditions and may be useful in routine care to propose individually tailored preparation for their transfer to adult healthcare. Further research is now needed to analyze correlation between domain scores and success of transition.What is Known:• In adolescents with chronic conditions, the use of transition readiness questionnaires is recommended to propose individually tailored preparation for their transfer to adult healthcare.• However, no French-language questionnaire has been so far validated.What is New:• Based on a complete validation methodology, this study highlights that the French-language 20-items Good2Go questionnaire has good psychometric properties.• It explores all transition key points though 3 scored domains: "health self-advocacy", "knowledge about chronic disease" and "self-management skills".

Aim: To compare the efficacy of three strategies for real-time continuous glucose monitoring (RT-CGM) over 12 months in children and adolescents with type 1 diabetes., Methods: A French multicenter trial (NCT00949221) with a randomized, controlled, prospective, open, and parallel-group design was conducted. After 3 months of RT-CGM, patients were allocated to one of three groups: return to self-monitoring of blood glucose, continuous CGM (80% of the time), or discontinuous CGM (40% of the time). The primary outcome was hemoglobin A1c (HbA1c) levels from 3 to 12 months. The secondary outcomes were acute metabolic events, hypoglycemia, satisfaction with CGM and cost., Results: We included 151 subjects, aged 2 to 17 years, with a mean HbA1c level of 8.5% (SD0.7; 69 mmol/mol). The longitudinal change in HbA1c levels was similar in all three groups, at 3, 6, 9 and 12 months. The medical secondary endpoints did not differ between groups. The rate of severe hypoglycemia was significantly lower than that for the pretreatment year for the entire study population. Subjects reported consistent use and good tolerance of the device, regardless of age or insulin treatment. The use of full-time RT-CGM for 3 months costs the national medical insurance system €2629 per patient., Conclusion: None of the three long-term RT-CGM strategies evaluated in pediatric type 1 diabetes was superior to the others in terms of HbA1c levels. CGM-use for 3 months decreased rates of severe hypoglycemia. Our results confirm the feasibility of long-term RT-CGM-use and the need to improve educational support for patients and caregivers., (© 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Androgen deprivation therapy (ADT) plus docetaxel is the standard of care in fit men with metastatic castration-naive prostate cancer (mCNPC) following results from GETUG-AFU 15, CHAARTED, and STAMPEDE. No data are available on the efficacy of treatments used for metastatic castration-resistant prostate cancer (mCRPC) in men treated upfront with ADT plus docetaxel for mCNPC., Objective: To investigate the efficacy and tolerance of subsequent treatments in patients treated upfront with chemo-hormonal therapy for mCNPC., Design, Setting, and Participants: Retrospective data from the GETUG-AFU 15 phase 3 trial were collected for treatments received for mCRPC., Outcome Measurements and Statistical Analysis: For the first three lines of salvage treatment for mCRPC we investigated the biochemical progression-free survival, maximum prostate-specific antigen (PSA) decline, overall survival, and tolerance., Results and Limitations: Overall, 245 patients received at least one treatment for mCRPC. For docetaxel used in first-line, a PSA decline ≥50% was observed in 25/66 (38%) and in 4/20 patients (20%) who had received upfront ADT alone and ADT plus docetaxel (p=0.14). The median biochemical progression-free survival was 6.0 mo (95% confidence interval: 3.6-7.7) and 4.1 mo (95% confidence interval: 1.3-4.9), respectively. For docetaxel used in first- or second-line, a PSA decline ≥50% was observed in 36/80 (45%) and in 4/29 patients (14%) who had received upfront ADT alone and ADT plus docetaxel (p=0.07). PSA declines ≥50% were observed with bicalutamide in 12/28 (43%) and 4/23 patients (17%) who had received upfront ADT alone and ADT plus docetaxel. Among men treated upfront with ADT plus docetaxel who received abiraterone or enzalutamide for mCRPC, 10/19 patients (53%) achieved a PSA decline ≥50%. Few grade 3-4 events occurred. Study limitations include the observational design and retrospective characteristics of this analysis, without standardized therapeutic salvage protocols, and the limited number of patients in some of the treatment subgroups., Conclusions: Docetaxel rechallenge following progression to mCRPC after upfront ADT plus docetaxel for mCNPC was active only in a limited number of patients. Available data on abiraterone and enzalutamide support maintained efficacy in this setting. The lack of standardized therapeutic protocols for men developing mCRPC limits the comparability between patients., Patient Summary: Rechallenging docetaxel at castration-resistance was active only in a limited number of patients treated upfront with chemo-hormonal therapy for metastatic castration-naive prostate cancer. Anticancer activity was suggested with abiraterone or enzalutamide in this setting., (Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background and Objectives: Nuclear receptors PXR (pregnane X receptor, NR1I2) and CAR (constitutive androstane receptor, NR1I3) are key regulators of irinotecan metabolism, and ligand-dependent modulation of their activity leads to significant drug-drug interactions. Because genetic polymorphisms can also affect the activity of these xenobiotic-sensing receptors, we hypothesized that they could contribute to the interpatient variability of irinotecan pharmacokinetics and to the toxicity of irinotecan-based regimens., Patients and Methods: In a cohort of 109 metastatic colorectal cancer patients treated with irinotecan (180 mg/m(2)) in combination with other drugs, associations were assessed between 21 selected single nucleotide polymorphisms of NR1I2 or NR1I3 and pharmacokinetic parameters or toxicity of irinotecan and its metabolites., Results: After adjustment of the tests by the UGT1A1*28 genotype and correction for multiple testing, the A allele of NR1I2-rs10934498 was associated with a decreased exposition and an increased degradation of SN-38, the active metabolite (p = 0.009 and p = 0.017, respectively). The risk of hematological toxicity was associated with NR1I2-rs10934498 and NR1I2-rs2472677 (p = 0.009 and p = 0.003, respectively)., Conclusion: Our results reveal for the first time the involvement of NR1I2 in the pharmacogenetics of irinotecan and suggest that it may help to predict the toxicity of low-dose irinotecan.

The aim of the study was to evaluate, after the first year of a national information campaign, the effect on the frequency and severity of diabetic ketoacidosis (DKA) at diagnosis of type 1 diabetes (T1D) in children and adolescents in France. The following data were collected during a 2-year period in people younger than 15 years of age at diagnosis of T1D, in 146 pediatric centers: age, sex, duration of symptoms, patient's previous care, clinical and biological signs, and family history of T1D. DKA was defined as pH<7.30 or bicarbonate<15mmol/L, severe DKA as pH<7.10 or bicarbonate <5mmol/L. During the 2nd year, an information campaign targeting health professionals and families was launched with the objective of reducing the time to diagnosis. Data were compared between the year before the campaign (year 0) and the first year of the campaign (year 1). The number of new cases of T1D was 1299 for year 0 and 1247 for year 1. Between year 0 and year 1, the rate of DKA decreased from 43.9% to 40.5% (P=0.08), exclusively due to the decrease of severe DKA from 14.8 to 11.4% (P=0.01). In the 0- to 5-year-old and 5- to 10-year-old age groups, the relative decrease in the rate of DKA was 13% and 15%, and 23% and 41% for severe DKA, respectively. In patients referred to the hospital by a pediatrician or who came at the family's initiative, the decrease was 34% and 7%, and 39% and 32% for severe DKA, respectively. No change was observed in the 10- to 15-year-old group or in those children who were referred by a general practitioner. In multivariate analyses, a higher DKA rate was associated with the young age of the child (<5 years), being hospitalized at the parents' initiative rather than being referred by a doctor, and the absence of a family history of T1D. A higher rate of severe DKA was associated with these last two factors but not with the child's age. The frequency of DKA at diagnosis of type 1 diabetes remains high in children and adolescents, but the first year of an information campaign decreased it. The results have also helped better define the strategy and targets of the continuing prevention campaign, to more efficiently reduce the morbidity and mortality of T1D at diagnosis in children and adolescents in France., (Copyright © 2014 Elsevier Masson SAS. All rights reserved.)

Objectives: This study aimed to evaluate the frequency of diabetic ketoacidosis (DKA) and its associated factors at the diagnosis of type 1 diabetes (T1D) in French children and adolescents prior to launching a public-health campaign of information to prevent DKA., Patients and Methods: Over a 1-year period, 1299 youngsters (aged < 15 years) were diagnosed with T1D at 146 paediatric centres in all regions of France. Age, gender, duration of symptoms, patient's pathway to diagnosis, clinical and biological signs, and family history of T1D were collected for each newly diagnosed patient. DKA was defined as pH < 7.30 or bicarbonate < 15 mmol/L, and severe DKA as pH < 7.10 or bicarbonate < 5 mmol/L., Results: At the time of diagnosis, 26% of the children were aged 0-5 years, 34% were 5-10 years and 40% were 10-15 years. The overall prevalence of DKA was 43.9% (0-5 years: 54.2%; 5-10 years: 43.4%; and 10-15 years: 37.1%) and 14.8% for severe DKA (0-5 years: 16.6%; 5-10 years: 14.4%; and 10-15 years: 13.9%; < 2 years: 25.3%). Severe DKA was more frequent when the child was hospitalized at the family's behest (26.6%) than when referred by a general practitioner (7.6%) or paediatrician (5.1%; 30.6%, 53.7% and 9.2%, respectively, by patients' age group). The frequency of DKA decreased to 20.1% (severe DKA: 4.4%) in families with a history of T1D. Multivariate analysis showed that age, pathway to diagnosis, duration of polyuria/polydipsia (< 1 week) and family history of T1D were associated with the presence of DKA, while pathway to diagnosis and family history of T1D were associated with severe DKA., Conclusion: DKA at the time of T1D diagnosis in children and adolescents is frequent and often severe. Patients' age, pathway to hospitalization and family history of diabetes were the main factors associated with DKA. These data suggest that a public-health campaign to prevent DKA at diagnosis can help reduce the frequency of DKA and also provide baseline data for evaluating the efficacy of such a campaign., (Copyright © 2014. Published by Elsevier Masson SAS.)

Purpose: Whether an anticoagulant prophylaxis is needed for patients with cancer with a central venous catheter is a highly controversial subject. We designed a study to compare different prophylactic strategies over 3 months of treatment., Methods: We performed a phase III prospective, open-label randomized trial. After the insertion of a central venous access device, consecutive patients with planned chemotherapy for cancer were randomized to no anticoagulant prophylaxis, low molecular weight heparin [low molecular weight heparin (LMWH); with isocoagulation doses], or warfarin 1 mg/day. Treatments were given over the first 3 months. Doppler ultrasound and venographies were performed on days 1 and 90, respectively, or sooner in case of clinical presumption of thrombosis., Results: A total of 420 patients were randomized, and 407 were evaluable. Forty-two catheter-related deep vein thrombosis (DVT) occurred (10.3 %), 20 in those with no anticoagulation, 8 in those receiving warfarin, and 14 in those receiving LMWH. Nine additional non-related catheter deep vein thrombosis (CDVT) occurred. Anticoagulation significantly reduced the incidence of catheter-related DVT (p = 0.035) and catheter non-related DVT (p = 0.007), with no difference between warfarin and LMWH. Safety was good (3.4 % of attributable events) but compliance with randomized prophylaxis was lower than expected., Conclusions: Prophylaxis showed a benefit regarding catheter-related and non-catheter-related DVT with no increase in serious side effects.

Background: Since 2005, 12 months of adjuvant trastuzumab has been the standard treatment for patients with HER2-positive early-stage breast cancer. However, the optimum duration of treatment has been debated. We did a non-inferiority trial of a shorter exposure of 6 months versus the standard 12 months of trastuzumab for patients with early breast cancer., Methods: We did an open-label, randomised, phase 3 trial in 156 centres in France. Patients with HER2-positive early breast cancer who had received at least four cycles of chemotherapy, had breast-axillary surgery, and had received up to 6 months of trastuzumab (administered by intravenous infusions over 30-90 min every 3 weeks; initial loading dose 8 mg/kg; 6 mg/kg thereafter) before randomisation were eligible. Patients were randomly assigned via central randomisation procedure with web-based software to continue trastuzumab for another 6 months (12 months total duration; control group) or to discontinue trastuzumab at 6 months (6 months total duration; experimental group). Randomisation was stratified by concomitant or sequential administration of trastuzumab with chemotherapy, oestrogen-receptor status, and centre using a minimisation algorithm. The primary endpoint was disease-free survival, with a prespecified non-inferiority margin of 1·15. Analyses were done in the intention-to-treat population. This study is registered at ClinicalTrials.gov, number NCT00381901., Findings: 1691 patients were randomly assigned to receive 12 months of trastuzumab and 1693 to receive 6 months of trastuzumab; 1690 patients in each group were included in the intention-to-treat analyses. After a median follow-up of 42·5 months (IQR 30·1-51·6), 175 disease-free survival events were noted in the 12-month group and 219 in the 6-month group. 2-year disease-free survival was 93·8% (95% CI 92·6-94·9) in the 12-month group and 91·1% (89·7-92·4) in the 6-month group (hazard ratio 1·28, 95% CI 1·05-1·56; p=0·29). 119 (93%) of the 128 cardiac events (clinical or based on assessment of left ventricular ejection fraction) occurred while patients were receiving trastuzumab. Significantly more patients in the 12-month group experienced a cardiac event than did those in the 6-month group (96 [5·7%] of 1690 patients vs 32 [1·9%] of 1690 patients, p<0·0001)., Interpretation: After 3·5 years follow-up, we failed to show that 6 months of treatment with trastuzumab was non-inferior to 12 months of trastuzumab. Despite the higher rates of cardiac events, 12 months of adjuvant trastuzmab should remain the standard of care., Funding: French National Cancer Institute., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

The Ceduc, a multi-pathology therapeutic education centre. Patient therapeutic education has undergone rapid development in France. In 2005, at the Robert-Debré hospital in Paris, the professionals involved in education activities grouped together to create a multipathology centre, the Ceduc. This centre benefits from experiences and resources of the various actors who take care of sick children and their families.

Aims: Various types of musculoskeletal disorders (MSDs) have comorbid mental disorders, which may in turn have a negative influence on disease course and role impairment, but the contribution of social factors to this type of comorbidity is a much under-researched area. This study investigates whether there is a socially patterned association of MSDs with different dimensions of mental malaise., Methods: The sample included 3,368 economically active participants aged 18-64 years, randomly selected from the Lorraine region in north-eastern France. Information was provided through a post-mailed questionnaire on fatigue, sadness/depression (Duke questionnaire) and cognitive disability during the last eight days., Results: MSDs were significantly more prevalent in manual workers, clerks and other occupations than in upper and intermediate professionals, and similar occupational disparities were found for cognitive disability, fatigue and sadness/ depression. Stratifying the sample, we found the occupational disparities in cognitive disability to be much stronger among participants suffering from MSDs than among participants not suffering from MSDs, and the occupational disparities in fatigue and sadness/depression to be limited to the subsample of subjects suffering from MSDs., Conclusions: The findings demonstrate that the association of MSDs with mental malaise is much stronger in the lower occupational groups than in the higher groups. Given that psychological factors are implicated in disease prognosis and in the development of disabilities, awareness of the social dimension of the association and treatment of the comorbid mental disorders could open a promising avenue for reducing social inequalities in disability related to MSDs.

The education of children with chronic diseases and of their parents is a treatment procedure that must be integrated into the management of the child's disease: it is essential for his or her physical and psychological health and quality of life. This continuous process is part of long-term follow-up and of the child's development; it is not a procedure that can be carried out once and for all. The program must include initial, follow-up, and advanced education. Treatment education for parents occurs simultaneously with the child's medical management and has the same requirements as that of the child (which means that the time spent in this education requires financial support). The role of the pediatrics departments serving these children is essential, and they must work with other participants, whose roles are not identical to they perform in education for adult patients. Pediatric patient education requires an interdisciplinary pediatric team with specific skills and appropriate liaison with those involved in other aspects of the child's life (e.g., daycare and school). The child's psychological development is central to the design and implementation of pediatric patient education programs. Knowledge of child development is critical in providing these services for children and adolescents; training in this field is required in addition to that necessary for adult patient education. Epidemiologic findings of the increased incidence of several chronic diseases in children must be considered in decisions about the resources allocated to coping with them. The particularities and requirements of adolescence and its interactions with chronic disease must also be considered in specific patient education programs for adolescents, and in the training and skills of healthcare professionals.

The distribution of human leukocyte antigen (HLA)-DRB1-DQA1-DQB1 haplotypes was analyzed separately in two distinct French ethnic groups with type I diabetes (T1D), i.e. French North African migrants (n= 64, mean age at diagnosis = 8.25 years) and ancient French natives (n= 60, mean age at diagnosis = 7.42 years). HLA associations were determined by calculating odds ratios (ORs) between patients and two ethnic-matched control populations. Results show highly similar ORs for the conservative DRB1*0301-DQA1*0501-DQB1*0201 haplotype of susceptibility (OR: 3.22 and 3.93 in migrants and natives, respectively) and the DRB1*1501-DQA1*0102-DQB1*0602 haplotype of resistance (OR: 0.05 and 0.03, respectively). In contrast, among the more variable DRB1*04-DQB1*0302 haplotypes of susceptibility, the DRB1*0402 (OR: 3.10 and 32.84) and 0405 (OR: 5.90 and 16.25, respectively) were associated with T1D in migrants and natives, whereas an increase of DRB1*0401, a rare allele in migrants, was significant in natives only. Also, among the DRB1*11-DQA1*0505-DQB1*0301 haplotypes of resistance, the OR observed for DRB1*1104-DQA1*0505-DQB1*0301, common in migrants, was lower (OR: 0.08) than for DRB1*1101-DQA1*0505-DQB1*0301 (OR: 0.32), common in natives. How DRB1*11 subtypes might affect differently the risk conferred by DQA1*0505-DQB1*0301 will be discussed.

We report pathological characteristics of screen detected breast cancers versus breast cancers diagnosed outside the official breast screening program. The breast cancer screening program was organised in the county of Haute-Vienne and a pathological record was established in the Association de dépistage des cancers du sein (ADCS 87). Three hundred and thirty three cases were recorded in 50 to 74 years-old women who had been screened (74 were interval cancers), six hundred and eighty seven in 50 to 74 years-old women without screening and three hundred and fifteen in women under 50. No difference in ductal carcinoma in situ or histological type was noted but tumor size and lymph node involvement presented significantly more favorable prognosis in screen detected breast cancers. This study confirms the potential benefit of screening in breast cancer.

Increasing awareness of the heterogeneity of diabetes mellitus (DM) at presentation is changing our approach to this disease. We used the American Diabetes Association (ADA) criteria to determine the distribution of DM patterns in a large pediatric cohort, with the aim of documenting the emergence of type 2 diabetes mellitus. Charts of diabetic children aged 1 to 16 years and admitted to our center between 1993 and 1998 were reviewed for data needed to classify the type of diabetes mellitus. They were compared with the charts of diabetic children admitted to our center in 2001. During the first period, 370 children were admitted for diabetes, and type 2 diabetes was diagnosed in 8 cases. In 2001, 90 children were admitted for diabetes, of whom 5 were diagnosed with type 2 diabetes. The incidence of type 2 diabetes in France remains relatively low. Even though our data seem to indicate a slight increase, they are far below the figures reported by American pediatricians. However, cases in France are marked by major obesity. With the increase in childhood obesity in France, the incidence of type 2 diabetes may eventually rise to North American levels.

Purpose: This outpatient multicenter trial tested the hypothesis that subcutaneous administration of an interleukin-2 (IL-2)/interferon alfa (IFN alpha) combination produces a response rate greater than 20% in patients with renal cell carcinoma (RCC)., Patients and Methods: Patients with metastatic RCC received a 12-week induction treatment with subcutaneous IL-2 (5 days/wk, 9 and 18 million U/d)/IFN alpha (3 days/wk, 6 million U/d). After evaluation, patients with objective response or stable disease were randomly assigned to maintenance treatment or short consolidation treatment., Results: Lack of benefit was shown at the 12th sequential analysis, and the trial was closed. At the end of the induction period, 26 (21%) of 122 patients had objective responses (including six complete responses). Thirty-three patients (27%) developed severe toxicity requiring dose reductions, delayed treatment, or treatment termination. Survival rates at one, two, and four years were 63%, 38%, and 17%, respectively. Three-year survival was 20% in patients with two poor prognosis factors and 37% in patients with one or no poor prognosis factors (P =.016). Three-year survival was significantly better (P < 10-3) in patients with erythrocyte sedimentation rate less than 35 mm (43%) compared with those with 1-hour sedimentation rate greater than 35 mm (19%)., Conclusion: This study confirms the importance of prognostic factors when initiating cytokine immunotherapy in patients with metastatic RCC and underlines the prognostic value of erythrocyte sedimentation rate before treatment initiation. Nonetheless, this subcutaneous IL-2/IFN alpha combination does not improve response rate or survival compared with subcutaneous IL-2 alone, although a definitive conclusion cannot be drawn in the absence of a randomized study comparing the two treatments.

Background: A multicentric cohort of 142 children with insulin-dependent diabetes has been longitudinally studied to evaluate if their diabetes knowledge was modified by time and to assess the factors associated to this change., Methods: A knowledge scale, previously translated and validated in French (TDK), was independently completed by the children and their parents at inclusion (T0) and 4 years later (T4)., Results: Mean age of the children was 10.2 years at T0. Mean knowledge score of the parents did not differ between T0 and T4 but mean score of the children was significantly higher at T4 than at T0 (22.2 +/- 5.7 vs 26.9 +/- 3.8, p<0.001). Age-adjusted knowledge score of children at T4 was significantly correlated to compliance to treatment (r=0.23, p<0.01). The factors associated with knowledge score of the children at T4 were: age at T4 (r=0.49, p<0.001), knowledge score of children at T0 (r=0.59, p<0.001), school results of the children (r=0.18, p=0.04), educational level of the mother (r=0.21, p=0.01), family income (r=0.19, p=0.03), knowledge score of parents at T0 (r=0.16, p=0.09), number of diabetes summer camp periods (r=0.19, p=0.03). Multivariate analysis showed that these 7 factors accounted for 59% of the variance in predicting knowledge score of the children at T4 (p<0.001). After adjustment, age at T4, knowledge score of the children at T0 and educational level of the mother stayed significantly associated with the knowledge score at T4., Conclusion: These results emphasise the importance of diabetes education programs specifically developed for children with the aim of improving diabetes knowledge at adolescence.

Objective: The aim of this study was to evaluate changes in the mode of discovery of breast cancer in the last 15 years. We compared two periods separated by a 10-year interval, during which a mass mammographic screening programme was established in our department., Materials and Method: We made a retrospective comparison of the records of female patients with breast cancer diagnosed in our hospital over the period 1986-1989 (first period) and 1997-1999 (second period). The mass screening programme for breast cancer began in 1995., Results: We collected 372 patients in the first period and 341 in the second. We found a significant change in the mode of the discovery of breast cancer between the two periods: 80.2% versus 51.9%, respectively, of the cases of breast cancer were discovered by breast self-examination, 10.2% versus 13.7% were discovered by a physician, and 4.8% versus 29.1% were discovered by routine mammography as part of an individual or mass screening programme. The mean size of the tumours decreased significantly (2.6 cm versus 2.3 cm: p = 0.019), and the number of tumours with initial metastases or lymph node involvement decreased, almost attaining the level of significance (p = 0.06). It is difficult to compare the survival and disease-free survival curves because of the short follow-up in the second period (median follow-up = 10 months). However, a marked difference appears to be developing (p < 0.0001): patients diagnosed by mammography are showing better survival and disease-free survival compared with the others., Discussion: We observed that more widespread use of mammography screening for breast cancer led to smaller tumours being discovered during the second period, with less lymph node involvement and less initial metastasis. Breast cancer screening is one of the most intensively evaluated health care practices with eight completed randomized trials yet its net benefit has remained controversial. It has been shown that, at least for patients aged 50 to 70, properly organized mass screening for breast cancer led to a reduction in mortality rate. However, individual breast self-exam, physician and mammographic screening can interfere with assessment of mass screening programmes in terms of individual benefit. In addition, introducing a mass screening programme may induce opportunistic screening in non-invited age groups and influence health behaviour in the target and non target populations. A retrospective study was performed to evaluate the mode of discovery, the diagnostic presentation, and prognostic factors in breast cancer in a French department before and after initiation of a mass-screening programme (MSP).

The aim of the study was to determine whether IDDM affects the course of psychological adjustment in youths. The study sample included 164 children with IDDM (mean age=10.2) and their parents compared to 164 healthy controls matched for age, sex and socioeconomic status. Adjustment was measured with the Child Behavior Checklist, a parental rating scale, validated and adapted for the French population. Two-way ANOVAs on CBCL scale scores showed that scores for both internalizing and externalizing problem behaviors and the total CBCL score were significantly raised in diabetic children (p<0.001). Further comparisons on the 8 narrow-band scale scores of the CBCL indicated increased scores for diabetic children on 6 dimensions. A significant Gender x Status (IDDM versus Controls) interaction was found, supportive of higher rates of aggressive behaviors amongst male diabetic children (p<0.01). Controlling for age, no correlation was found between CBCL total, internalizing and externalizing scores and duration of IDDM or HbA1c levels within the diabetic group. Psychological adjustment to chronic illness needs to be considered with respect to both normal developmental demands as well as in the context of the specific challenges posed by the disease.

Aim: The purpose of this study was to evaluate the conditions in which diabetic adolescents are transferred from pediatric to adult health care, and to record the opinions of the physicians about this issue., Methods: A questionnaire-based study was performed among all the pediatricians in the hospital setting and all the diabetologists from the Paris-Ile-de-France area. Questionnaires from 50 pediatricians and 51 diabetologists were completed (response rate: 68%)., Results: 1) Not enough information was transmitted: a quarter of the diabetologists were visiting for the first time without any information on the adolescent, and only half the pediatricians received feedback information from the internists after the first visit. And yet, when considered, it was important to be kept informed after the first visit and the following ones. 2) Medical relationships were poor: more than three out of four pediatricians and diabetologists had none or very few professional meetings, and two thirds of them were not aware of the way the others were working. 3) Eighty percent of pediatricians and diabetologists considered that the transfer of diabetic adolescents had to be organised in order to keep the coherence of medical follow-up, to minimise the psychological effects of the transition, and to avoid a complete break in the patient follow-up. 4) The expectations of the pediatricians were: the validation of their previous follow-up through the feedback information from diabetologists and the continuity of the medical follow-up; those of the diabetologists were: to gain the patient's confidence and to master the patient's previous history, in order to provide a better follow-up. 5) According to the opinion of both pediatricians and diabetologists, the main errors to avoid were, by the paediatricians, to miss the time and the preparation of the transfer and, by the diabetologists, to denigrate the previous pediatric management and to change the insulin regimen immediately., Conclusion: This study demonstrates a lack of communication between physicians of pediatric and adult health care centres. But it also underlines their recognition of the importance of the transition's stakes and their common motivations in order to improve it.

A cross-sectional multicentre study was conducted in 165 French diabetic children aged 7-13 y and their parents. A standardized scale (FACES III) was used to determine if family cohesion and adaptability (i) differed in diabetic children's families, as compared to other families; (ii) were related to an adherence measure; or (iii) were related to metabolic control. More diabetic families than comparison families fell into the categories of disengaged with low levels of cohesion, and rigid with low levels of adaptability. Scores of cohesion and adaptability were significantly and positively correlated with both children's and parents' adherence scores, but not with HbA1c levels. Children whose families were characterized as rigidly disengaged had a significantly greater number of hypoglycaemias and six times as many episodes of ketoacidosis than the other diabetic children. Not only in adolescents, but also in families of diabetic children, family-centred interventions are needed to improve compliance and to prevent acute metabolic complications.

The French Groupe des Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) conducted a multicenter phase II study of carboplatin and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) to evaluate the efficacy and side effects of this combination in pretreated advanced ovarian cancer. Patients with progressive ovarian carcinoma during or after platinum-based chemotherapy received paclitaxel 175 mg/m2 intravenously over 3 hours followed by intravenous carboplatin over 30 minutes every 4 weeks. The dose of carboplatin was calculated using a projected area under the concentration-time curve of 5 mg/mL x min. Of the 50 patients entered, 50 were evaluable for toxicity and 42 for response. There were eight complete and 10 partial responses, for an overall response rate of 43% (95% confidence interval, 28% to 56%). Overall response rates in platinum refractory patients and in those with early (> or = 3 and < 12 months) and late (> or = 12 months) relapse was 28%, 33%, and 71%, respectively. Median response duration, progression-free survival, and overall survivals were 8, 6, and 14 months, respectively. The most frequent and severe toxicity was myelosuppression. Grades 3 and 4 neutropenia occurred in 30% and 23% of cycles, and granulocyte colony-stimulating factor was administered in 6%. Only one case of neutropenic fever was observed. Grades 3 and 4 thrombocytopenia occurred in 3% and 1% of cycles, respectively. Alopecia and moderate nausea or vomiting were frequent. Transitory peripheral neuropathy was present in 45% of patients but was severe in only one patient. One early death was observed due to progressive disease and possibly to therapy. The combination of paclitaxel 175 mg/m2 as a 3-hour infusion and carboplatin dosed to an area under the concentration-time curve of 5 is an effective therapy in patients previously treated with platinum-based chemotherapy and may be administered safely to outpatients who relapse after one or two lines of chemotherapy.

In order to evaluate the educational needs of diabetic children, a study was performed to validate a scale for adherence to treatment (compliance) by diabetic children. The lack of such scales in France, led us to validate an existing American scale. After a classic linguistic translation, back-translation, and a pilot study, 165 diabetic children aged 7 to 13 years filled out a 25 item questionnaire that assessed four areas: glucose testing, diet, hypoglycemia, insulin adjustment. Face validity as measured by response rates was excellent and the reliability as measured by Cronbach's alpha was good (alpha = 0.65) as in the American scale. Concordant validity was studied: the insulin adjustment score was inversely correlated with hypoglycemia (r = -0.23, p < 0.01); age (r = 0.28, p < 0.001), age at diagnosis (r = 0.18, p < 0.05), and diabete knowledge (r = 0.47, p < 0.001) were all correlated with adherence. The French version of the adherence to treatment scale is valid and reliable for the study of adherence to treatment in diabetic children. This scale provides an evaluative tool that will facilitate the performance of an educational diagnosis.

A measure of knowledge level of diabetic patients is useful in evaluating their educational needs as well as the impact of the educational programs specifically designed for them. The lack of such scales in French, led us to translate and validate an existing knowledge scale for diabetic children, the Test of Diabetes Knowledge (TDK) (Johnson et al.). After several translations and back translations, the 33 item scale was submitted to the staff members of a pediatric diabetology unit, to establish its content validity. An assessment the questionnaire was performed in a group of 49 children, aged 7.9 to 12.8 years. The mean duration of diabetes was 4.6 +/- 2.9 years and their scholastic level varied from 1st to 6th grades. Time spent in filling out the questionnaires was 12 to 25 minutes. Few missing values were noted. The reliability of the scale was excellent as shown by Cronbach's alpha coefficient: 0.83 for the overall scale, 0.72 for the general knowledge subscale (20 items) and 0.70 for the problem solving subscale (13 items). The level of correct responses was correlated with age and scholastic level (p < 0.0001), but not with sex, duration of diabetes, or HbA1c levels. This study shows that the French version of the TDK is a valid and reliable tool for measuring the level of knowledge in children and adolescents with diabetes. This scale provides the researcher and clinician with a tool that facilitates the performance of an educational diagnosis and the evaluation of educational programs based on the transmission knowledge.

Valid and reliable scales are necessary to describe the numerous factors associated with health status. Multiple studies have shown the impact of familial factors, i.e. family functioning (FF) on health indicators. As no scale exists in french to assess FF, we performed a study to validate the Family Adaptability and Cohesion Evaluation Scale (FACES III, Olson et al.) in french. This scale has a high level of validity and reliability and has been widely used. After 2 translations and back-translations and a pilot study to establish face validity, the final version was studied in 976 healthy subjects (457 families) who attended a preventive medical center in Nancy, France. Parents and adolescents each filled out two 20 item self-administered questionnaires. There were few missing values (0-3% per item). Construct validity was assessed by principal component factor analysis, which found the same two individualized axes as in the original scale. The reliability of the french version was excellent and comparable to Olson's scale. This study demonstrates the validity and reliability of a french version of FACES III in a french population. It provides researchers and clinicians in France with a validated instrument for assessing, in a quantified way, factors associated with family functioning that influence health status in adults, adolescents and children, particularly those with chronic diseases. This scale is especially useful for developing and evaluating health programs.