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Hematological malignancies (HMs) have heterogeneous serological responses after vaccination due to disease or treatment. The aim of this real-world study was to analyze it after Pfizer-BioNT162b2 mRNA vaccination in 216 patients followed up for 1 year. The first 43 patients had an initial follow-up by a telemedicine (TM) system with no major events reported. The anti-spike IgG antibodies were checked 3–4 weeks post-first vaccination and every 3–4 months, by two standard bioassays and a rapid serological test (RST). Vaccine boosts were given when the level was

Hematological malignancies patients (HM) have heterogeneous serological response after vaccination. Real-world data. 216 patients with HM and 12 non-malignant hemopathies received BNT162b2 COVID-19 and monitored for >1 year. The first 43 patients had initial follow-up by telemedicine system (TM). Anti-Spike IgG antibodies were monitored 3-4 weeks post-1st vaccination and every 3-4 months, by 2 standard bioassays and a rapid serological test (RST). Vaccine boosts were given when the level was Follow-up and results. Tolerance using TM was good. 15 results were discordant between 2 standard bioassays. Good agreement was observed between standard and RST on 97 samples. After 2 doses, 68% were seroconverted (median 59 BAU/mL) with a median of 162 BAU/mL in untreated patients and 9 BAU/mL in treated patients (P), particularly for patients receiving rituximab. Patients with low levels of gammaglobulin levels ( (p=0.019). Median levels were 228 BAU/mL post-2nd dose if seroconverted post-1st and 2, if seronconverted only post-2nd. 68% of post-2nd negative patients were post-3rd positive. 16 pts received TC, 6 with non-severe symptomatic COVID-19 within 15-40 days. Conclusion: Personalized serological monitoring must be applicated particularly for HM patients.

In France, cervical cancer screening based on cervical smear has a participation rate of around 60%. New screening strategies are encouraged to increase the participation of under-screened women, including vaginal self-sampling with high-risk human papillomavirus (HR-HPV) testing. This study was based on the distribution of an anonymous self-administered questionnaire to assess the acceptability of vaginal self-sampling with HR-HPV testing by women aged 25 to 65 years in two French Departments of the South of France, Aude, and Hérault, showing low participation in cervical cancer screening. Factors influencing this acceptability were also analyzed. From May to July 2017, 349 completed questionnaires were collected. Women declared high acceptability for vaginal self-sampling (81%) preferably at home (82.6%). Acceptability was statistically higher in the Department of Herault (

International audience; Current day robots often rely - for visual perception - on the coupling of two cameras: one for color and one for depth. While for custom RGB-D cameras, the manufacturer takes care of aligning the two images, this is not done when two commercial cameras are coupled (e.g., on the Pepper robot) without having been calibrated beforehand. In this article, we present a simple open library for reconstructing the 3D position of RGB pixels without knowing the parameters of the two cameras. The library requires a simple preliminary calibration step based on pixel-to-pixel matching, and then automatically reconstructs 3D colored point clouds from a given set of pixels in the RGB image. The source code is available at the following link https://github.com/jordan-nowak/OpenHSML.

According to clinical guidelines, the occurrence of very early-onset breast cancer (VEO-BC) (diagnosed ≤ age 30 years) or VEO ovarian cancer (VEO-OC) (diagnosed ≤ age 40 years) in families with BRCA1 or BRCA2 mutation (BRCAm) prompts advancing the age of risk-reducing strategies in relatives. This study aimed to assess the relation between the occurrence of VEO-BC or VEO-OC in families with BRCAm and age at BC or OC diagnosis in relatives. We conducted a retrospective multicenter study of 448 consecutive families with BRCAm from 2003 to 2018. Mean age and 5-year–span distribution of age at BC or OC in relatives were compared in families with or without VEO-BC or VEO-OC. Conditional probability calculation and Cochran–Mantel–Haenszel chi-square tests were used to investigate early-onset cancer occurrence in relatives of VEO-BC and VEO-OC cases. Overall, 15% (19/245) of families with BRCA1m and 9% (19/203) with BRCA2m featured at least one case of VEO-BC; 8% (37/245) and 2% (2/203) featured at least one case of VEO-OC, respectively. The cumulative prevalence of VEO-BC was 5.1% (95% CI 3.6–6.6) and 2.5% (95% CI 1.4–3.6) for families with BRCA1m and BRCA2m, respectively. The distribution of age and mean age at BC diagnosis in relatives did not differ by occurrence of VEO-BC for families with BRCA1m or BRCA2m. Conditional probability calculations did not show an increase of early-onset BC in VEO-BC families with BRCA1m or BRCA2m. Conversely, the probability of VEO-BC was not increased in families with early-onset BC. VEO-BC or VEO-OC occurrence may not be related to young age at BC or OC onset in relatives in families with BRCAm. This finding—together with a relatively high VEO-BC risk for women with BRCAm—advocates for MRI breast screening from age 25 regardless of family history.

In France, more than 10 million women at ”average” risk of breast cancer (BC), are included in the organized BC screening. Existing predictive models of BC risk are not adapted to the French population. Thus, we set up a new score in the French Hérault region and looked for a graded level of risk in women at "average" risk. We recruited a retrospective cohort of women, aged 50 to 60, who underwent the organized BC screening, and included 2241 non-cancer women and 527 who developed a BC during a 12-year follow-up period (2006-2018). The risk factors identified were high breast density (ACR BI-RADS grading)(B vs A: HR 1.41, 95%CI [1.05; 1.9], p=0.023; C vs A: HR=1.65 [1.2; 2.27], p=0.02 ; D vs A: HR=2.11 [1.25;3.58],p=0.006), a history of maternal breast cancer (HR=1.61 [1.24; 2.09], p < 0.001), and socioeconomic difficulties (HR 1.23 [1.09; 1.55], p=0.003). While early menopause (HR=0.36 [0.13; 0.99], p=0.003) and an age at menarche after 12 years (HR=0.77 [0.63; 0.95], p=0.047) were protective factors. We identified 3 groups at risk: lower, average, and higher, respectively. A low threshold was characterized at 1.9% of risk and a high threshold at 4.5%. Mean risks in the 3 groups of risk were 1.37%, 2.68%, and 5.84%, respectively. Thus, 12% of women presented a level of risk different from the average risk group, corresponding to 600,000 women involved in the French organized BC screening, enabling to propose a new strategy for performing an organized and personalized national BC screening.

PURPOSE Sentinel node (SN) biopsy is accurate in operable oral and oropharyngeal cT1-T2N0 cancer (OC), but, to our knowledge, the oncologic equivalence of SN biopsy and neck lymph node dissection (ND; standard treatment) has never been evaluated. METHODS In this phase III multicenter trial, 307 patients with OC were randomly assigned to (1) the ND arm or (2) the SN arm (experimental arm: biopsy alone if negative, or followed by ND if positive, during primary tumor surgery). The primary outcome was neck node recurrence-free survival (RFS) at 2 years. Secondary outcomes were 5-year neck node RFS, 2- and 5-year disease-specific survival (DSS), and overall survival (OS). Other outcomes were hospital stay length, neck and shoulder morbidity, and number of physiotherapy prescriptions during the 2 years after surgery. RESULTS Data on 279 patients (139 ND and 140 SN) could be analyzed. Neck node RFS was 89.6% (95% CI, 0.83% to 0.94%) at 2 years in the ND arm and 90.7% (95% CI, 0.84% to 0.95%) in the SN arm, confirming the equivalence with P < .01. The 5-year RFS and the 2- and 5-year DSS and OS were not significantly different between arms. The median hospital stay length was 8 days in the ND arm and 7 days in the SN arm ( P < .01). The functional outcomes were significantly worse in the ND arm until 6 months after surgery. CONCLUSION This study demonstrated the oncologic equivalence of the SN and ND approaches, with lower morbidity in the SN arm during the first 6 months after surgery, thus establishing SN as the standard of care in OC.

Purpose to present our experience in the management of pathological nipple discharge using the procedure D.DL.DB: "ductoscopy" (D) coupled to "duct lavage" (DL) plus "duct brushing" (DB) for etiologic diagnosis. Also to compare the diagnosis obtained with D.DL.DB to the final histology. Material and method Eighty-five patients with organic unilateral nipple discharge were enrolled in two Breast Units. 82 of 85 patients were investigated successfully with D.DL.DB. Results:: The final histological results were: papilloma 46.3%, duct ectasia 36.5%, breast cancer 8.5%, precancer lesions 4.9%, and mixed benign lesions 3.8%. Pyramidectomy and radical ductectomy were performed in 76 and 6 cases respectively. In 80% of the cases, DLDB cytology results were identical to the final histology. (Kappa=0;69 CI=[0.56 -0.82]. The sensitivity of D.DL.DB versus pathology, for cancer or precancer lesions was 81.8% (CI=0.59 -1) and the specificity was 97.1% (CI=0.93 -1). Using Koch scale, the concordance between the two methods D.DL.DB and surgery was high and the sensitivity was in the upper range regarding the literature (58% to 90%). Conclusion Our experience confirms the high value of D.DL.DB in the management of organic nipple discharge.

BACKGROUND: There is currently a lack of evidence for the relative effectiveness of partial resection (PR) and total resection (TR) before managing abdominal aortic graft infection (AGI). Most authorities agree that TR is mandatory for intracavitary AGI in patients with favorable conditions but there is an increasing number of patients with severe comorbidities for whom this approach is not suitable, resulting in a prohibitive mortality rate. The purpose of this study was to determine the most appropriate indication for TR or PR. METHODS: A meta-analysis was conducted on the rates of early/late mortality, amputations and reinfection. A meta-regression was performed with 8 variables: patient age, male prevalence, presence of virulent or nonvirulent organisms, urgency, omentoplasty and follow-up. RESULTS: Twenty-one studies and 1.052 patients were included. For TR and PR the rates of early mortality and reinfection were 16.8% and 10.5%, 11% and 27% respectively. For TR urgency and male gender were associated with increased rate of early mortality and male gender, PDF and virulent organisms were associated with increased risk of reinfection. For PR no statistical correlation was analyzable except for PDF with increased risk of reinfection. CONCLUSIONS: Early mortality rates are higher for TR and reinfection rates are higher for PR. For TR early mortality increases in urgent cases and it is suggested that alternative option must be discussed, reinfection decreases in the presence of nonvirulent organisms and TR seems optimal. For TR and PR reinfection increases in presence of PDF and alternative technique may be more appropriate.

Pts with HM and particularly those under therapy or with secondary immune deficiency have been reported to have a low or delayed specific immune response. In addition, pts receiving rituximab for either HM or auto-immune disease presented a low specific antibody response. Daratumumab, an anti-CD38 moAb was demonstrated to lower normal plasma cells and to reduce polyclonal IgA, M and E in pts with multiple myeloma (MM). It is fundamental to evaluate the early post-vaccination tolerance and the level of seroconversion for such pts. Patients' population. 194 pts having HM and followed at the Institute (IC), received at least 2 doses of BNTCV (BioNTech Pfizer, Paris, France) by IM route with 3 weeks between the 2 doses. Currently, analysis was performed on 147 pts, including 63 pts with non-Hodgkin lymphoma (NHL), 18 with B-chronic lymphocytic leukemia (CLL), 34 with MM, 14 with monoclonal gammopathy of undetermined significance (MGUS) and 18 with myeloproliferative disorder (MPD). Mean age was 69 years-old (range 27-92). Follow-up of early tolerance in pts using a telemedicine application. 43 pts vaccinated at the IC received Thess®, a telemedicine system connecting the patient to the IC, developed by La Valeriane Inc. (Montpellier, France, www.thess-corp.fr) 24/24h, 7days. Local pain (38°C) for at least 2 days, headache, or general pain. The satisfaction survey of monitoring system was good. In addition, adherence to vaccination was excellent with only one refusal out of the 194 pts. AcAS follow-up IgG AcAS and IgG+M AcAS were analyzed in the serum 3 to 4 weeks after the 1st dose and 4-8 weeks after the 2 nd dose and every 2 months, respectively by SARS-CoV-2 IgG II Quant ® Assay with a threshold of positivity at 50 AU/mL (Abbott, Rungis, France) and Elecsys ® Anti-SARS-CoV-2 S (Roche Diagnostics, Meylan, France) with a threshold of positivity at 0.8 U/mL. 270 samples were analyzed in duplicate with the 2 assays, by 2 independent labs. Data were reported and statistically analyzed by the clinical research team. 17 results were discordant including 12 with Abbott IgG test undetectable and Roche IgG+M detectable, and 5 with Abbott test detectable and Roche undetectable. After the first dose of BNTCV, 72/147 (49%) pts were seroconverted, including 7/18 (39%) with CLL, 27/63 (43%) with NHL, 10/14 (71%) with MGUS, 17/34 (50%) with MM and 11/18 (61%) with SMD. The median levels of the AcAS response for pts were 0 (range 0-40 000 AU/mL) for the AdviseDX test as compared to 12 normal subjects (mean 257 AU/mL, range 226-283), and 0 U/mL (range 0-2500) for the Elecsys test. 49/75 (65%) of untreated pts were seroconverted after the 1 st dose as compared to 26/72 (36%) of treated patients (p After the second dose of BNTCV, 50 pts have currently been tested, with only 25 additional pts seroconverted. The median levels of the AcAS response for pts were 310 AU/mL (range 62-11760) for the AdviseDX test as compared to 12 normal subjects (mean 6725 AU/mL, range 3002-9787), and 1250 U/mL (range 0.87-2500) for the Elecsys test. The 25 patients who were not seroconverted after the 2nd dose received a 3rd dose of BNTCV, including 8 with MM, 9 with NHL, 5 with CLL, 1 with MGUS (with polyneuropathy under daratumumab) and 2 with SMD. Currently, 9 pts were tested after the 3 rd dose. AcAS levels were respectively 268 AU/mL for 1 MM treated by daratumumab, 103 and 313 AU/mL for 2 MM under carfilzomib, 1622 AU/mL for 1 untreated SMD, 29100 AU/mL for 1 untreated MGUS, 537 AU/mL for 1 CLL and 2 negative NHL. In conclusion, there is a need to follow AcAS for pts having HM including SMD after BNTCV aiming to adapt vaccine strategy including a 3 rd dose and eventual recall. As some pts are always negative after a 3 rd dose, vaccination strategy could be discussed by using different combinations of vaccine or the addition of immune adjuvant in a more personalized medicine. In addition, the usage of telemedicine connecting system may help to follow the early tolerance and to improve the pts' adherence. Disclosures Rossi: NPO Petrovax Pharm: Consultancy; LEO Pharma: Consultancy; EUSA Pharma: Consultancy; E-SANA Inc: Other: Co-founder of E-SANA Inc .

6501 Background: Although sentinel node (SN) biopsy is known to be accurate in operable oral and oropharyngeal cT1-T2N0 squamous cell carcinomas (OC), the oncological equivalence of a treatment based on SN compared to that based on neck dissection (ND) has to be evaluated. Methods: A prospective multicenter randomized medico economic study included patients with OC operated of primary tumor and systematic neck dissection in ND-arm (standard treatment) versus patients operated of primary tumor and SN biopsy only if negative or ND if SN biopsy positive (SN-arm, experimental treatment). Primary endpoint was neck-relapse-free survival at 2 years and 5 years. Hypothesis of equivalence was tested with a delta of 10%. Functional outcomes were assessed by comparing the length of the hospital stay, the number of physiotherapy prescriptions and dysfunctions in neck and shoulder scales during the 2 post-operative years. Results: Out of 307 included patients in 10 hospital centers, 279 evaluable cases showed a neck-relapse-free survival at 2 years and 5 years respectively of 89,6% (95%CI: 0.827; 0.938) and 89,6 %, (95%CI: 0.827; 0.938) in the ND-arm (14 neck relapses out of 139 patients) and of 90,7% (95%CI: 0.842; 0.946) and 89,4% (95%CI: 0.823; 0.938) in the SN-arm (13 neck relapses out of 140 patients). The survival difference between the two arms was less than the 10% expected interval, confirming the equivalence with p = 0.008. The median length of hospital stay was 7 days (ext. 3-30) in SN-arm and 8 days (ext. 2-94) in ND-arm (Wilcoxon’s test, p = 0.001). The other functional outcomes were statistically worse in the ND-arm at the 2nd, 4th and 6th postoperative months. There was no more difference at 12 months and later. Conclusions: This study demonstrated the oncological equivalence of the SN approach compared to the ND approach in a multicenter study with a lower morbidity and care consumption in the SN approach during the 6 first post-operative months. Treatment based on sentinel node biopsy is established as a standard of care in OC. Clinical trial information: NCT02855723 .

Early diagnosis of axial spondyloarthritis (axSpA) remains a challenge due to the lack of specificity of clinical symptoms and variable prevalence of axial imaging findings permitting a definite diagnosis. Power Doppler ultrasonography (PDUS) of the entheses has demonstrated to be a potential useful tool for the classification and diagnostic management of early SpA independently of the phenotype.Objectives To assess the classification value (sensitivity and specificity) of PDUS-defined enthesitis for identifying patients fulfilling Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA (ASAS+) in patients with recent inflammatory back pain (IBP) (the DESIR (DEvenir des Spondylarthropathies Indifférenciées Récentes) cohort).Methods Baseline PDUS was performed at eight entheseal sites, and PDUS enthesitis was defined by the presence of vascularisation at entheseal insertion.Results 402 patients from the DESIR cohort underwent a PDUS evaluation. PDUS enthesitis was detected in 58 (14.4%) patients of whom 40 (14.2%) belonged to the ASAS+ patients and 18 (17%) to the ASAS- patients. The sensitivity of PDUS enthesitis was 13.9% and the specificity was 83.5%, with a positive predictive value of 69% and 26.8% of negative predictive value for meeting ASAS criteria for axSpA. Of the 18 ASAS- patients with positive PDUS, 59% fulfilled Amor’s criteria, 88% European Spondyloarthropathy Study Group criteria and 59% both.ConclusionsIn a cohort of patients with recent IBP, the prevalence of PDUS enthesitis was low (14.4%); however, its specificity for classifying patients as axSpA according to ASAS criteria was high (83.5%). PDUS enthesitis might be of additional value for classifying as patients with axSpA IBP who do not fulfil ASAS criteria.

Objective: To confirm the advantage of in situ reconstruction (ISR) over extra-anatomic reconstruction (EAR) for aortic graft infection and determine the most appropriate conduit including autogenous veins, cryopreserved allografts, and synthetic prosthesis (standard, rifampicin of silver polyesters). Methods: A meta-analysis was conducted with rate of mortality, graft occlusion, amputation, and reinfection. A meta-regression was performed with 4 factors: patients’ age, presence of prosthetic-duodenal fistula (PDF), virulent organisms, or nonvirulent organisms. Results: In situ reconstruction over EAR seems to favor all events. For the 5 conduits used for ISR, according to operative mortality, age of the patients looks to have a positive correlation only for silver polyester and no conduit present any advantage in the presence of PDF. Reinfection seems to be not significantly different for the 5 conduits, and only autogenous veins appear to have a positive correlation with infecting organisms. Conclusion: In situ reconstruction may be considered as first-line treatment. Our results suggest that silver polyesters appear to be most appropriate for older patients, and in order to limit reinfection, autogenous veins are probably the most suitable conduit.

Asthma is the leading chronic disease of the child; control and treatment remain inadequate. Our objective was to assess whether the use of the Childhood Asthma Control Test (C -ACT) in primary care had an impact on adapting therapy.The study was quantitative prospective and compared 2 groups of general practioners. All had the same reminders about childhood asthma management. The C-ACT was detailed to one group only. Doctors in the control group had to work as usual without C-ACT. Doctors included asthmatic children aged 6 to 11 years who were consulting for their asthma or any other reason. The primary endpoint was the adaptation of asthma treatment according to the Global Initative for Asthma (GINA). Evaluations of the control group were compared with the after consultation self-administered online C-ACT.From April to October 2014, 61 physicians included 179 patients in two comparable groups. Although not significant statistically, doctors using C-ACT found 45% of uncontrolled asthma (vs. 31%). When the reason for consultation was not related to asthma, the figure was 25% (vs. 15%). Doctors using the C-ACT made twice less therapeutic adaptations not recommended by the GINA: 8% vs. 16%. 25% of evaluations of doctors in the control group were discordant with the internet C-ACT. After correction with the internet C-ACT of these imprecise initial assessments, the figure was 25%: 3 times more than in the C-ACT group (P=0.014).The use in primary care of C-ACT should allow a better assessment of asthma control and adaptation of treatment in children.

Objective: To determine the most appropriate indication for total resection (TR) or partial resection(PR) of infected aortic grafts.Methods: A meta-analysis was conducted on the rates of early/late mortality, amputations and reinfection. A meta-regression was performed with 8 variables: patient age, male prevalence, presence of prosthetic duodenal fistula (PDF), presence of virulent or nonvirulent organisms, urgency, omentoplasty and follow-up.Results: For TR and PR, the rates of early mortality and reinfection were 16.8% and 10.5%, 11% and 27% respectively.For TR, the rates of early mortality and reinfection for in situ reconstruction with allografts and veins were 23% and 10.7%, 10.5% and 2.8% respectively.For TR, urgency, male gender and omentoplasty all had a negative correlation with early mortality. Omentoplasty had a positive correlation with late mortality. Male gender, PDF and virulent organisms had a negative correlation with reinfection, whereas nonvirulent organisms had a positive correlation. Presence of PDF and follow-up had a negative correlation with amputation, whereas male gender had a positive correlation. For PR, no statistical correlation was analyzable except a negative correlation between PDF and reinfection.Conclusion: For TR, operative mortality increases in males, and in emergencies, so total removal of the infected aortic graft seems not advisable, and alternative interventions should be considered. With regard to the risk of reinfection, TR appears recommendable in the presence of nonvirulent infectious organisms, but there is increased risk in the presence of virulent organisms and PDF, and so other optimal options may be discussed.For PR results were not analyzable except for a negative correlation in the presence of PDF.

International audience; OBJECTIVES:To evaluate the outcomes of hypospadias surgery according to age and to determine if some complications are age-related.PATIENTS AND METHODS:This retrospective study was based on 722 boys with hypospadias undergoing primary repair. A total of 501 boys underwent urethroplasty and were included in the study. Complications requiring an additional procedure (stenosis, fistula, dehiscence, relapse of curvature, urethrocele) were included in the analysis, as well as healing problems, infections, haematomas and detrusor-sphincter dyssynergy. Logistic regression analysis was performed.RESULTS:Hypospadias was anterior in 63.1%, mid-penile in 20.5%, posterior in 8.4% and scrotal in 7.9% of the boys. The median (range) age was 4 (1-16) years. The overall rates of re-intervention and complications were 22.8% and 36.2%, respectively. Age >2 years was a significant predictor of complications (P = 0.002, odds ratio 1.98 [95% confidence interval 1.26-3.13]). Some periods of time appeared to be associated with a specific complication: dyssynergy was more common between the ages of 24 and 36 months (12.5 vs 3.6%; P = 0.01) and healing problems were more common in boys aged >13 years (1.5 vs 28.5%; P = 0.06).CONCLUSION:Delayed surgery may be detrimental for patients. Factors related to age may influence the rate of complications. After the age of 2 years, urethral surgery may interfere with the normal toilet-training process. During puberty, endogenous testosterone may alter healing. Even if no specific data exist for severe hypospadias, it may be prudent to continue to advocate early surgery in patients with disorders of sex development.

Medical-administrative databases are an important source of big data to assess the epidemiology of diseases and interventions, compare drugs, and investigate rare adverse events. We describe the French national health insurance system databases and the Epidemiology and Safety (EPISAFE) collaboration program in ophthalmology and illustrate the paper with recent studies that used the databases to investigate cataract surgery. The Système national d'information inter-régime de l'assurance maladie (SNIIR-AM) is one of the largest databases of medical and administrative data for a general population, covering nearly 65 million people. The SNIIR-AM database links data for all outpatient-reimbursed health expenditures, hospitalization in all 1,546 French private or public healthcare facilities, and date of death. The use of this database provides information at the scale of the entire country, allowing measurement of the impact of changes in practices and new guidelines. Between 2009 and 2012, a total of 2,717,203 eyes in 1,817,865 patients underwent cataract surgery in France, and the incidence of cataract surgery increased from 9.86 to 11.08/1,000 person-years. The 4-year cumulative risk of retinal detachment was 0.99%, and patients

High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) is a standard therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are chemosensitive. The combination of carmustine, etoposide, cytarabine, and melphalan (BEAM) is commonly used as a conditioning regimen. The addition of yttrium-90 ((90) Y)-ibritumomab tiuxetan (Zevalin(®)) to BEAM (Z-BEAM) is increasingly being used to improve outcomes and overcome refractory disease. We conducted a literature review and meta-analysis in order to evaluate the clinical effects of Z-BEAM followed by ASCT in patients with DLBCL. A literature search was conducted for randomized controlled trials and observational studies of Z-BEAM as a conditioning regimen for ASCT in adult patients with DLBCL. Extracted data included baseline patient demographics, overall response (ORR), complete response (CR), overall survival (OS), progression-free survival (PFS), nonrelapse mortality (NRM), median time to ANC and platelet engraftment, and rate of myelodysplastic syndrome. Mixed-effects models were used to determine estimates. Ten studies (N = 328) were included in the meta-analysis. The 2-year OS and PFS were 84.5% (n = 328) and 67.2% (n = 285), respectively. Outcomes were superior in patients with nontransformed lymphoma. Posttransplant, ORR and CR rates were 72.6% and 68.5%, respectively. The NRM rate was 6.3% and the incidence rate of myelodysplastic syndrome was 2.5%. Two-year OS was significantly associated with pretransplant ORR (P = 0.008, τ(2) = 0). There was no significant association between PFS and pretransplant response. Z-BEAM is safe and effective as a conditioning regimen in relapsed/refractory DLBCL.

In oncology, overall survival (OS) is the optimal endpoint for measuring the clinical benefit. However, and contrary to progression-free survival (PFS) which represents a potential surrogate endpoint of OS in clinical trials, OS often requires a long follow-up where the effect of the studied treatment may be diluted by subsequent therapies. In the literature, the relationship between PFS and OS was investigated more analytically than theoretically. We propose a new statistical modelling for OS based on the two survival times: PFS and post-progression survival (PPS) which we assumed to be linked using a conditional exponential distribution. This model allows us to test the existence of an association between PFS and PPS to better understand the process of improvement or decrement of OS. We found a closed form of the correlation coefficient between PFS and both PPS and OS. We expressed them as simple formulas in function of model parameters. One of the model parameters proved to be a correlation indicator between these survival times. We also defined the likelihood of the model in order to use the maximum likelihood estimator to estimate the model parameters from Phase III randomized clinical trial data, involving patients with locally advanced non-small cell lung cancer. The results showed a significant link between PFS and PPS and a strong association between improvements in PFS and OS.

The management of pT1a-bN0M0 breast cancer remains an area of controversy. Data from 714 patients classified as having pT1a-bN0M0 breast cancer and treated, from 1999 to 2004 in the Languedoc-Roussillon France, were analyzed. The human epidermal growth factor receptor 2 (HER2) status analyses were centralized. The objective of this study was to describe the prognosis of pT1a-bN0M0 breast cancer according to HER2 distribution and hormonal status. The median follow-up was 6.4 years. Ten-year overall survival was 94%. HER2 overexpression was observed in 6.1% of the patients. The 10-year prognosis of patients with HER2-positive tumors was worse than that of those with HER2-negative (disease-free survival 73% vs. 89%, P

Background Young women exposed to a high hereditary breast and ovarian cancer (HBOC) risk are particularly vulnerable. They are ignored by health prevention measures but exposed to a stream of contradictory information (medicine, media, Internet). They may feel concerned about surgical prevention issues at a key moment of their identity construction (self, relationship, sexuality). We designed a special psychoeducational intervention to help these women cope better with these difficulties. Methods/design The BRACAVENIR study consists of a prospective, randomized superiority phase II trial with a wait list control group. Participants are childless young female counselees (aged 18–30 years) seen at the oncogenetics department of the Centre Jean Perrin and belonging to HBOC families either with or without BRCA mutations. They will be invited to attend a weekend group session at a spa resort and to participate in short expert conferences and focus group activities (group sharing, Moreno role game) supervised by a psychotherapist. Two sessions separated by a 6-month delay (wait list) will enable us to evaluate the intervention’s effect by comparing questionnaire scores between the 6-month time points. The main endpoint is an increase of the Herth Hope Index by at least 1 SD. Secondary endpoints are self-esteem, anxiety trait, anxiety state, coping, and quality of life. With a one-sided α = 0.05 and β = 0.20, 12 participants will be needed by group, plus an additional 2 in anticipation of dropouts. Participants will be randomized 1:1 to the first or the second session so that the groups will be comparable. Discussion The intent of this trial is to bridge the gap on a psychosocial level in these young women with HBOC. A particularity of the design is the use of a waiting list, which should allow for avoiding major bias. The intervention consists of a short session that could be proposed to other young counselees if successful. The results may bring complementary information to facilitate the intervention and also influence the contents of the oncogenetic consultation. Trial registration Ethics committee CPP SUD-EST-6: IRB00008526. Registered on 18 March 2016. ClinicalTrials.gov identifier: NCT02705924. Registered on 2 March 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1642-4) contains supplementary material, which is available to authorized users.

International audience; IMPORTANCE:Postoperative endophthalmitis (POE) often results in severe visual impairment. In clinical studies, an intracameral cefuroxime injection at the end of surgery was found to be effective at reducing the incidence of POE. Two important issues are the retinal safety of cefuroxime and its use for patients with perioperative capsular rupture where the risk of POE is dramatically increased.OBJECTIVE:To assess the effectiveness and retinal safety of an intracameral injection of cefuroxime sodium for the prevention of POE and its possible use in cases of a perioperative capsular rupture of the lens.DESIGN, SETTING, AND PARTICIPANTS:Population-based cohort study of patients 40 years of age or older who underwent cataract surgery at 1 of 1546 French health care facilities, public or private, and whose medical records were obtained from the national administrative database. Data analyses were performed between March and November 2015.MAIN OUTCOMES AND MEASURES:The effectiveness and safety of the prophylactic injection of cefuroxime as measured by the incidence of POE and cystoid macular edema.RESULTS:From January 2010 to October 2014, a total of 3 351 401 eyes of 2 434 008 patients 40 years of age or older (58.9% were women, and the mean [SD] age was 73.9 [9.5] years) underwent cataract surgery; 1941 patients (0.08%) developed POE during the 6 weeks after cataract surgery. The incidence of POE after cataract surgery decreased over the course of the study (0.11%, 0.09%, 0.08%, 0.06%, and 0.05% in 2010, 2011, 2012, 2013, and 2014, respectively [P = .001 for trend]) as the use of cefuroxime prophylactic injections increased (11.1%, 14.4%, 32.8%, 64.8%, and 79.1% in 2010, 2011, 2012, 2013, and 2014, respectively [P = .001 for trend]). After multivariate adjustment, the risk of POE was reduced with the use of cefuroxime (odds ratio, 0.61 [95% CI, 0.56-0.68]). The retinal safety of an injection of cefuroxime, which was assessed by multiadjusted odds of retinal cystoid macular edema, was not increased for patients receiving cefuroxime injections (odds ratio, 0.86 [95% CI, 0.71-1.05]). For patients with a perioperative capsular rupture of the lens (the major risk factor for POE), the incidence of POE was lower for those who received an injection of cefuroxime than for those who did not (0.37% vs 0.51%, respectively [P = .001]), whereas an increased risk of cystoid macular edema was not identified for those who received or did not receive an injection of cefuroxime (5.6% vs 7.3%, respectively [P = .12]).CONCLUSIONS AND RELEVANCE:These data suggest that, in routine practice, the intracameral injection of cefuroxime at the conclusion of cataract surgery is associated with a lower risk of POE and is safe for patients with or without a perioperative capsular rupture. While these data might be used to support the consideration of its routine use to prevent POE, in the absence of a randomized clinical trial, they cannot prove a direct cause-and-effect relationship between the injection of cefuroxime and POE.

Objectives Lyme disease may be considered by rheumatologists in patients with recent-onset arthritis, even in the absence of suggestive symptoms. The aim of this study was to determine the diagnostic impact of routine Lyme serology in a French cohort of patients with recent-onset arthritis affecting at least 2 joints. Methods We performed an ancillary study of a French prospective multicentre cohort established to monitor clinical, biological and radiographic data in patients with inflammatory arthritis in at least 2 joints, lasting for 6 weeks to 6 months. Borrelia IgM and IgG antibodies were sought routinely at baseline, using ELISA tests, independently from the physician's strategy for detecting a spirochetal infection. We recorded the proportion of patients with a final diagnosis of Lyme arthritis and evaluated the diagnostic performance of Lyme serology in this particular context. The clinical and biological characteristics of patients according to the Lyme serology results were analysed. Results Of 810 patients, 657 (81.1%) were negative for IgM and IgG antibodies, 91 (11.2%) had only IgM antibodies, 49 (6%) had only IgG antibodies, and 13 (1.6%) had IgG and IgM antibodies. Thus, 7.6% had IgG positivity, consistent with exposure to Borrelia infection. IgG positivity was significantly more prevalent in the North and North-East regions of France (χ2=14.6, p

International audience; BackgroundSkin-sparing mastectomy (SSM) with immediate breast reconstruction (IBR) is increasingly used in invasive breast cancer. However, adjuvant chemotherapy (CT) and radiotherapy (RT) can increase the rate of local complications.ObjectiveThe aim of this study was to assess the morbidity of SSM–IBR after neoadjuvant CT and RT.MethodsA French prospective pilot study of women aged 18–75 years with invasive breast cancer requiring mastectomy after CT and RT. Reconstruction was performed using autologous latissimus dorsi flap with or without prosthesis. The primary endpoint was the skin necrosis rate within 6 months, while secondary endpoints included pathological complete response rate (pCR) and global morbidity.ResultsAmong 94 patients included in this study, 83 were analyzed (mean age 45.2 ± 9.5 years, T1 23.6 %, T2 55.6 %, T3 18.1 %). All but one patient received anthracyclines and taxanes, and all patients received RT (49.3 ± 5.2 Gy) before SSM–IBR. Prostheses were used for IBR in 32 patients (mean volume 256 ± 73 mm3). Five patients had necrosis (≤2 cm2, 2–10 cm2 and >10 cm2, in three, one, and one cases, respectively), and they all recovered without revision surgery. Among 50 patients who underwent upfront mastectomy, 36 % achieved pCR.ConclusionsSSM–IBR performed after CT and RT is safe, with an acceptable local morbidity rate. Long-term data are needed to evaluate recurrence rates.

Introduction Cancer population studies require reliable and complete baseline data, which should theoretically be available by collecting histopathology records. The completeness of such a collection was evaluated using capture–recapture analysis based on three data sources concerning breast and colorectal cancers over an identical period and within the same geographical area. Method The total number of breast and colon cancer cases was estimated using capture–recapture analysis based on the number of cases which were common or not between sources recording screened, diagnosed and treated cancers in the French Alpes Maritimes district. Result The estimated total number of new cases of breast cancer diagnosed among Alpes Maritimes residents women aged 50–75 was 791 (95% CI: 784–797) in 2008. Of these 791 cases, 729 were identified through histopathology records, thus amounting to 92.2% completeness (95% CI: 91.5–93.0%). The total estimated number of new cases of colorectal cancer diagnosed among Alpes Maritimes residents aged 50–75 was 527 (95% CI: 517–536). Of these 527 cases, 481 were identified through histopathology records, thus amounting to 91.3% completeness (95% CI: 89.7–93.0%). Conclusion The estimated completeness of cancer records collected from histopathology laboratories was higher than 90% for new cases of breast and colorectal cancer within the age range concerned by the screening programme. A verified and validated histopathology data collection may be useful for cancer population studies.

Background Over the past decades, an increasing trend in male external genital malformations such as cryptorchidism and hypospadias has led to the suspicion that environmental chemicals are detrimental to male fetal sexual development. Several environmental pollutants, including organochlorine pesticides, polychlorinated biphenyls, bisphenol A, phthalates, dioxins and furans have estrogenic and anti-androgenic activity and are thus considered as endocrine-disrupting chemicals (EDCs). Since male sex differentiation is critically dependent on the normal production and action of androgens during fetal life, EDCs may be able to alter normal male sex differentiation. Objective The objective of this study was to determine the incidence of external genital malformations in a population of full-term newborn males in southern France. We also performed a case-control study to identify the risk factors for male external genital malformations, with a focus on parental occupational exposure to EDCs. Methods Over a 16-month period, 1615 full-term newborn males with a birth weight above 2500 g were registered on a level-1 maternity ward, and the same pediatrician systematically examined 1442 of them (89%) for cryptorchidism, hypospadias and micropenis. For every male newborn with genital malformation, we enrolled nearly two males matched for age, parity and term. All parents of the case and control newborns were interviewed about pregnancy aspects, personal characteristics, lifestyle and their occupational exposure to EDCs using a detailed questionnaire. RESULTS We report 39 cases of genital malformation (2.70%), with 18 cases of cryptorchidism (1.25%), 14 of hypospadias (0.97%), 5 of micropenis (0.35%) and 2 of 46,XY disorders of sexual differentiation (DSD; 0.14%). We observed a significant relationship between newborn cryptorchidism, hypospadias or micropenis and parental occupational exposure to pesticides [odds ratio (OR) = 4.41; 95% confidence interval (95% CI), 1.21-16.00]. Familial clustering for male external genital malformations (OR = 7.25; 95% CI, 0.70-74.30) and medications taken by mothers during pregnancy (OR = 5.87; 95% CI, 0.93-37.00) were associated with the risk of cryptorchidism, hypospadias and micropenis, although the association was not statistically significant. Conclusions Although the causes of male genital malformation are multifactorial, our data support the hypothesis that prenatal contamination by pesticides may be a potential risk factor for newborn male external genital malformation and it should thus be routinely investigated in all undervirilized newborn males.

Feasibility and oncological safety of post-adjuvant skin-sparing mastectomy (SSM) plus immediate breast reconstruction (IBR) cannot be evaluated by randomized trials. However, comparative study could modify guidelines for the oncosurgical treatment of invasive breast cancer. Our study compared the feasibility, oncological safety and esthetic outcome of SSM plus latissimus dorsi (LD) flap IBR after chemotherapy (CT) and radiotherapy (RT) with the standard management for invasive breast cancer: mastectomy as primary treatment, adjuvant CT and RT, and LD flap delayed breast reconstruction (DBR). Twenty-six selected patients with stages IIA-IIIA breast cancer were offered post-neoadjuvant SSM plus IBR with LD flap plus implant (IBR group). Seventy-eight other patients had primary mastectomy, adjuvant CT and RT, and LD-assisted DBR (DBR group). After 4.1 years (range 1-8) of follow-up, feasibility, oncological safety, and esthetic outcome were compared. Sixteen (61%) early complications were reported for the IBR group versus 44 (56%) for the DBR group (P = 0.645). Early implant loss was 0% in IBR versus 12% in DBR. IBR had 8 (30%) late complications versus 17 (21%) for DBR (P = 0.362). Capsular contracture and reconstruction failure rates were similar. Local recurrence was 7.7% (2/26) in IBR and 6.4% (5/78) in DBR (P = 0.823). Cosmetic evaluation by independent physicians and by the patients themselves was identical in the two groups. Our concept provides a basis for offering more women the opportunity to elect for immediate reconstruction, even in the setting of radiation therapy.

To determine retrospectively whether the technique of ulnar nerve transposition (subcutaneous versus submuscular) is associated with clinical sensory and motor recovery in cubital tunnel syndrome, and whether recovery is influenced by prognostic factors such as preoperative McGowan stage, age, and duration of symptoms.Twenty-five patients (average age, 53 years; follow-up, 7 years) with cubital tunnel syndrome had submuscular transposition, and 24 patients (average age, 46 years; follow-up, 3 years) were treated by subcutaneous transposition. There were 11 McGowan stage II and 14 stage III patients in the submuscular group and 14 stage II and 10 stage III patients in the subcutaneous group. Preoperatively, all patients presented with diminished 2-point discrimination. Postoperative sensory and motor recovery was evaluated clinically.There was no significant difference between subjective results in the submuscular and subcutaneous groups: 20 of 25 patients in the submuscular group versus 17 of 24 patients in the subcutaneous group were clearly improved, and 3 of 25 patients in the submuscular group versus 6 of 24 patients in the subcutaneous group partially improved. The logistic multivariate regression analysis indicated that sensory and motor function were both significantly improved following both surgical techniques. Sensory function recovered (2-point discrimination6 mm) in 17 of 25 patients in the submuscular group and in 17 of 24 patients in the subcutaneous group, and motor function recovered (intrinsic strength grade 5) in 19 of 25 patients in the submuscular group and in 19 of 24 patients in the subcutaneous group. Symptoms lasting more than 6 months were associated with a poor prognosis.Sensory and motor recovery for patients with McGowan stages II and III of cubital tunnel syndrome were similar following submuscular and subcutaneous transposition techniques, and patients with symptoms lasting longer than 6 months had a worse prognosis regardless of surgical technique.

To assess a group of children who consecutively received implants more than 10 years after implantation with regard to speech perception, speech intelligibility, receptive language level, and academic/occupational status.A prospective longitudinal study.Pediatric referral center for cochlear implantation.Eighty-two prelingually deafened children received the Nucleus multichannel cochlear implant.Cochlear implantation with Cochlear Nucleus CI22 implant.The main outcome measures were open-set Phonetically Balanced Kindergarten word test, discrimination of sentences in noise, connective discourse tracking (CDT) using voice and telephone, speech intelligibility rating (SIR), vocabulary knowledge measured using the Peabody Picture Vocabulary Test (Revised), academic performance on French language, foreign language, and mathematics, and academic/occupational status.After 10 years of implant experience, 79 children (96%) reported that they always wear the device; 79% (65 of 82 children) could use the telephone. The mean scores were 72% for the Phonetically Balanced Kindergarten word test, 44% for word recognition in noise, 55.3 words per minute for the CDT, and 33 words per minute for the CDT via telephone. Thirty-three children (40%) developed speech intelligible to the average listener (SIR 5), and 22 (27%) developed speech intelligible to a listener with little experience of deaf person's speech (SIR 4). The measures of vocabulary showed that most (76%) of children who received implants scored below the median value of their normally hearing peers. The age at implantation was the most important factor that may influence the postimplant outcomes. Regarding educational/vocational status, 6 subjects attend universities, 3 already have a professional activity, 14 are currently at high school level, 32 are at junior high school level, 6 additional children are enrolled in a special unit for children with disability, and 3 children are still attending elementary schools. Seventeen are in further noncompulsory education studying a range of subjects at vocational level.This long-term report shows that many profoundly hearing-impaired children using cochlear implants can develop functional levels of speech perception and production, attain age-appropriate oral language, develop competency level in a language other than their primary language, and achieve satisfactory academic performance.

Resume La chirurgie oncoplastique associe un geste d'exerese glandulaire a des procedes de mammoplasties, permettant une reconstruction glandulaire immediate. But du travail. – Cette etude prospective a ete realisee pour comparer la qualite de l'exerese glandulaire entre les zonectomies classiques et les techniques d'oncoplastie. Materiel et methodes. – Quarante-deux patientes ont beneficie d'une chirurgie oncoplastique (groupe oncoplastie) et 57 d'une zonectomie (groupe zonectomie). Nous avons compare les tailles tumorales histologiques, l'epaisseur des marges histologiques les plus proches, et les surfaces de glande resequee dans chacun des groupes. Enfin, la frequence des gestes de chirurgie de rattrapage (reexcision et mastectomie) a ete comparee dans chaque groupe. Resultats. – L'exerese des tumeurs mammaires par techniques d'oncoplastie apporte dans notre etude une plus value oncologique par rapport aux techniques classiques de zonectomie. Elle permet une exerese plus large des lesions mammaires. Le recours a une mastectomie secondaire est significativement diminue par rapport a la zonectomie classique, argument supplementaire en faveur de la chirurgie oncoplastique. Conclusions. – Les techniques de chirurgie oncoplastique permettent d'obtenir une exerese plus large des lesions mammaires que les techniques de zonectomie. La frequence des reexcisions secondaires et des mastectomies est significativement diminuee.

International audience

Intravenous albumin infusion prevents complications after large-volume paracentesis (LVP), particularly paracentesis-induced circulatory dysfunction (PCD), and improves patient survival. However, albumin is expensive. We compared a low-molecular weight dextran (Dextran-40) with albumin in treating LVP in cirrhotic patients with tense ascites. Sixty-nine cirrhotic patients were included and 96 LVPs were performed. Any repeat punctures on the same patient were at least three months apart. Patients were randomized to receive either i.v. Dextran-40 infusion (Group I, n = 48) or i.v. albumin infusion after LVP (Group II, n = 48). Clinical, biochemical, and hormonal evaluations were done before and after LVP. Patients were followed up for the detection of any recurrence of ascites or complications.The two groups were similar in age, sex, and etiology of cirrhosis, and in the volumes of ascites recovered. Significant decreases in mean arterial pressure were observed in both groups 24 and 48 h after LVP. Urine volumes increased significantly at 24 h in both groups (p < 0.05), but remained high only in Group I. Plasma renin activity and aldosterone concentrations increased in both groups 48 h after LVP, but they were more marked in Group I. Complications developed in 17 % of patients treated with Dextran-40 and in 23 % treated with albumin (p > 0.05). Ascites recurrence rates and survival were similar in the two groups. In conclusion, Dextran-40 was thus not as efficacious as albumin for preventing PCD.

There have been many epidemiological studies of chickenpox but only a few of herpes zoster. We report data from an observational study, conducted in France during a 1-year period, of 9038 patients who presented with acute herpes zoster (n = 8103) or postherpetic neuralgia (PHN; n = 935) at the office practices of 4635 general practitioners or dermatologists. The incidence of herpes zoster in France was found to be similar to that in the literature: from 1.4 to 4.8 cases per 1000 population per year. The patient profiles and clinical patterns were delineated, as well as the management decisions made according to the type of treating physician. The impact of herpes zoster on quality of life was evaluated on the basis of the Medical Outcome Study Short Form 36 (MOS SF 36) scale, which is widely used for assessing quality of life in the field of health. This study provides reference data on the substantial deterioration in quality of life associated with herpes zoster and PHN.

BACKGROUND Despite numerous studies, the influence of timing at surgery in relation to the menstrual cycle on the prognosis of breast carcinoma is still controversial. Most studies are retrospective, and the reliability of the menstrual history data is limited by the lack of hormonal assessment at the time of surgery. The authors prospectively studied the influence of the menstrual cycle phase as determined by circulating hormones at the time of surgery on the outcome of breast carcinoma. METHODS A population of 360 premenopausal women with nonmetastatic breast carcinoma operated on from 1992 to 1995 was analyzed. Serum estradiol, progesterone, follicle-stimulating hormone (FSH), and luteinizing hormone (LH) levels were assayed the day of surgery to define the menstrual cycle phase (follicular, n = 186; ovulatory, n = 24; luteal, n = 150). The mean follow-up was 48 months. RESULTS There were no relations between the menstrual phase at surgery and tumor size, cathepsin D level, Scarff–Bloom–Richardson grade, Pg receptor (PgR), and the number of positive lymph nodes. The mean estrogen receptor level was higher during the follicular phase than in the ovulatory and luteal phases (P < 0.02). Univariate analysis of recurrence free survival (RFS) and overall survival (OS) showed no relations with the menstrual phase or the level of estradiol and progesterone at the time of surgery. High LH or FSH levels (above the medians) were associated with shorter RFS (P = 0.02 and P = 0.04, respectively) or OS (P ≤ 0.01 and P = 0.01, respectively). In multivariate analysis, lymph node status, PgR status and LH level were the most significant parameters for predicting OS. There appeared to be no survival differences between menstrual cycle groups after stratification by lymph node status. CONCLUSIONS This prospective study showed a lack of prognostic value of timing at surgery in relation to the menstrual period or to estrogen and progesterone levels in premenopausal breast carcinoma. Conversely, high gonadotropin levels could predict OS independently of other prognostic factors. Cancer 2001;91:1854–61. © 2001 American Cancer Society.

Objective To determine whether early placental drainage plus cord traction reduces the incidences of manual removal and blood loss, and to determine the risk factors associated with blood loss after delivery. Design Prospective randomised study. Setting University teaching hospital, Montpellier, France. Methods A randomised study compared 239 women who had placental cord drainage plus cord traction with 238 women with expectant delivery. The need for manual removal of the placenta and the drop in haemoglobin after delivery were assessed. The duration of the third stage of labour and the time between birth and the beginning of perineal suturing were measured. Statistical analysis used the paired t test for continuous variables, the Kruskal-Wallis test for nonparametric data and χ2 test for categoric variables. Stepwise logistic regression analyses were performed with a drop in haemoglobin as the outcome variable. Results No significant difference was found in the two groups with regard to the incidence of manual removal of retained complete or incomplete placenta or postpartum haemorrhage. The median values of the duration of the third stage of labour, birth-to-perineal suture time and drop in haemoglobin were significantly lower in the cord drainage group than in the control group. After controlling for confounding variables, parity proved to be the only significant predictor of drop in haemoglobin. Conclusion Cord drainage decreases the duration of the third stage of labour and reduces blood loss but not the incidence of manual removal of the placenta.

We propose a class [I,S] of loss functions for modeling the imprecise preferences of the decision maker in Bayesian Decision Theory. This class is built upon two extreme loss functions I and S which reflect the limited information about the loss function. We give an approximation of the set of Bayes actions for every loss function in [I,S] and every prior in a mixture class; if the decision space is a subset of ℝ, we obtain the exact set.

Purpose: Our purpose was to determine the impact of endometrial inflammation on fertility. Methods: The study population included 49 women: 5 women bearing an intrauterine device, 33 sterile patients, and 11 fertile women. Endometrial biopsies were performed between day 17 and day 21 of the cycle. Immunostaining was performed with an ABC kit. Monoclonal antibodies were CD68 for macrophages, CD3 for T lymphocytes, and B-E8 for interleukin (IL)-6; IL-1α and IL-1β were stained with polyclonal antibodies. A double immunofluorescence staining was performed to identify endometrial cells. Macrophage and lymphocyte rates were defined as the percentage of stained cells by field. Double staining was compared among macrophages, T lymphocytes, and anti-IL antibodies in each group. Results: The macrophage rate was high for women bearing an intrauterine device, intermediate for sterile patients, and low for fertile women (P = 0.03). There was a lack of double staining between activated T lymphocytes and anti–IL-6 antibody in tubal sterility and endometriosis. Endometrial macrophages were stained with anti-IL antibodies for all groups. Conclusions: Endometrial macrophages seem to be an interesting parameter for evaluating endometrial inflammation. In tubal infertility and endometriosis, the lack of expression of IL-6 in T lymphocytes could participate in impaired embryo implantation.

Objective: To compare the variability of transrectal ultrasonographic (TRUS) interpretation for the decision of performing biopsies and the lesions to biopsy. Methods: We extracted at random from our videotape database 16 records of patients who had undergone biopsies, added 2 normal glands and duplicated 2 of these 18 records. Based on the records, 5 well-trained physicians had to describe the images on the tape, and to decide whether or not to biopsy the prostate. A K test was computed between each couple of readers, and for the whole group. The K test denotes the agreement between examiners. A value of K

The association between diabetes and cardiovascular diseases is well established, as still the main cause of death among these patients. We followed a cohort of 703 high risk type 2 diabetic patients during a median follow up of 5,8 years and thought to determine predictive factors associated with mortality and cardiovascular mortality.MethodsSurvival analysis was made. For univariate analysis, we used Kaplan Meyer methods. Covariables with p-value < 0.15 at log-rank test were introduced in COX multivariate analysis. Significant variables were selectioned for final model selection through STEPWISE, BACKWARD, FORWARD methods.ResultsAmong these patients, 58% were male, mean age of 62,06 years, with a mean length of diabetes of 13,80 years and a HbA1c of 8,35%. 29% had positive microalbuminuria or proteinuria, 14% had a creatinin clearance inferior to 60ml/min. 12% had obliterating arteriopathy of the lower limbs definied by pulse abolition. Mean LDL was 1,10g/l, 54% of these patients were under statin treatment. 60% were classified as having hypertension, and 43% were currents somokers. During follow up, 67 patients died (9,5%) with mainly cardiovascular death (57 patients). In multivariate analysis, obliterating arteriopathy of the lower limbs, insulin treatment, antiagregant treatment, triglyceride level above 1,5g/l were associated with global mortality. Regarding predictive factors associated with cardiovascular mortality, we found that obliterating arteriopathy of the lower limbs, creatinin clearance under 60ml/min and high systolic blood pressure were associated. Obliterating arteriopathy of the lower limbs was the strongest predictor of mortality (RR=2,68; IC95%:1,58-4,52) and of cardiovascular mortality (RR=2,79; IC95%:1,68-4,64).ConclusionPresence of obliterating arteriopathy of the lower limbs diagnosed by clinical examination was the strongest factor associated with global and cardiovascular mortality in high risk type 2 diabetic patients.

The aim of this work was to investigate the effect of four H2 receptor antagonist, cimetidine, ranitidine, famotidine, nizatidine, and of two proton pump inhibitors, omeprazole and lansoprazole, on the mitotic response of human hepatocytes in primary culture. After plating at subconfluent density, cells were exposed to 0.2 to 20 mumol/L of these drugs for 48 hours, either in the absence or in the presence of epidermal growth factor (EGF). The rate of DNA synthesis was evaluated by [3H]-thymidine incorporation into genomic DNA. Both the basal rate of DNA synthesis and the extent of stimulation by EGF exhibited a wide interindividual variability, and were not correlated with the viability of freshly prepared cells. In contrast, the effects of anti-ulcer drugs on the rate of DNA synthesis were clearly reproducible from one culture to another. H2 receptor antagonists had no significant effect (P > .2) over the entire range of concentration tested, whereas omeprazole and lansoprazole significantly inhibited the rate of DNA synthesis by 60% to 90% at 30 mumol/L (P = .016). This effect was concentration dependent between 2 and 20 mumol/L. Neither of the drugs tested was cytotoxic under the conditions used in this work, as assessed by measurements of the do nov protein synthesis. We conclude that, in contrast to H2 receptor antagonists, omeprazole and lansoprazole are able to interfere with the replicative synthesis of DNA in human hepatocytes in culture, at suprapharmacological concentrations. Whether or not this effect is clinically significant remains to be established.

OBJECTIVE To assess the efficacy and safety of topical human recombinant basic fibroblast growth factor (bFGF) on the healing of diabetic neurotrophic foot ulcers. RESEARCH DESIGN AND METHODS Seventeen diabetic patients suffering from chronic neuropathic ulcer of the plantar surface of the foot entered a pilot, randomized, double-blind study comparing local application of bFGF with placebo. Main inclusion criteria were a typical neuropathic ulcer of Wagner grade I-III, more than 0.5 cm in the largest diameter, with an abnormally high vibration perception threshold in the absence of significant peripheral vascular disease or wound infection. bFGF or placebo was applied daily during the 6 weeks as inpatients then twice a week for 12 weeks. Evolution of ulcer size was assessed through weekly clinical examination and computerized photographs. RESULTS In the bFGF group, three of nine ulcers healed compared with five of eight in the placebo group (NS). The weekly reduction in ulcer perimeter and area was identical in both groups, as was the rate of linear advance from entry to the 6th week of treatment (bFGF: 0.053 ± 0.048 mm vs. placebo: 0.116 ± 1.129 mm): the same result was obtained at the 11th week. Moreover, percent healed area at the end of the study did not differ significantly. No side effects were observed during bFGF application. CONCLUSIONS Topical application of bFGF has no advantage over placebo for healing chronic neuropathic diabetic ulcer of the foot. Because diabetes causes significant wound-healing defects, we hypothesized that using a single growth factor might be insufficient to accelerate wound closure of diabetic ulcers.