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International audience; Background: Long-term psychosocial outcomes and health-related quality of life (HRQOL) in adults with pediatric onset of frequently relapsing or steroid-dependent idiopathic nephrotic syndrome (FRNS or SDNS) remain to be determined.Methods: In this prospective cohort study, 59 adults with pediatric onset of FRNS/SDNS and persistent active glomerular disease in adulthood completed the GEDEPAC-2 questionnaire exploring 11 well-being domains. Data were compared to the French general population (FGP) with standardized incidence ratio ([SIR]; adjusted for period, age, gender). Regression models were performed to identify predictive factors of psychosocial well-being.Results: In 82% of cases, the questionnaire was completed while the participants (n = 59; 47 men; median age = 32 years; median number of relapses = 13) were in complete remission (under specific therapy in 76% of cases). Participants had higher educational degree than in the FGP (SIR = 6.3; p < 0.01) and more frequently a managerial occupation (SIR = 3.1; p < 0.01). Social integration was acceptable with regard to marital status and experience of sexual intercourse, but experiences of discrimination were far more frequent (SIR = 12.5; p < 0.01). The SF-12 mental component summary (MCS) score was altered (Z-score = - 0.6; p < 0.01) and mean multidimensional fatigue inventory (MFI-20) global fatigue score appeared high (12). Transfer from pediatric to adult healthcare was followed by a period of discontinued care for 33% of participants. Multivariate analysis revealed a close relationship between MFI-20, physical health, and MCS.Conclusions: This study shows that pediatric onset FRNS and SDNS may have a long-term negative impact on mental HRQOL and highlights the impact of fatigue, which is often not adequately considered in routine care.

Introduction A patient education program has been developed in the field of cancer for supporting cancer patients undergoing oral anticancer therapies. Its implementation was tested in 3 different settings. The objectives of this study were to 1) identify barriers and facilitators for implementing the patient education program, 2) identify practices encouraging or hindering implementation and 3) produce recommendations for its dissemination. Methods Twenty semi-structured interviews were conducted with caregivers from all three establishments. Results The main factors associated with successful implementation were as follows: prescribers' representations on patient education, considered of low value; on oral anticancer therapies, considered too dangerous to be handled by the patient him/herself, the indefinite legitimacy of certain professions in charge of patient education programs; patients' engagement in their care pathway and provision of caregivers. Conclusion Recommendations include developing patient education culture within the environment of the medical doctors' curriculum, to consider contextual, pre-existing cooperative units for implementing patient education, to systematically send patients to patient education programs without practicing triage. Successful implementation of patient education critically depends on the prescribing physicians' perceived value of patient education. Patient education should become mandatory, integrated as part of the cancer care pathway. Physicians lack the necessary time and/or means to assess patients' capacity for engagement, without adequate strategies for their support. Therefore, physicians should systematically refer all patients to patient education, where nurses can tailor their coaching of cancer patients. Trial registration The study protocol was approved by the IRB SUD EST I (N° EudraCT: 2016-A00113-48). All participants were given written and verbal information about the study and gave informed consent to participate.

OBJECTIVE To characterize the phenotypic expression of children with conductance regulator-related metabolic syndrome (CRMS)/cystic fibrosis screen positive inconclusive diagnosis (CFSPID) designation after positive newborn screening, reassign labeling if applicable and better define these children's prognosis. METHODS A multicenter cohort with CRMS/CFSPID designation was matched with cystic fibrosis (CF)-diagnosed cohort. Cohorts were prospectively compared on baseline characteristics, cumulative data and when they reached 6 to 7 years at endpoint assessment. RESULTS Compared to infants with CF (n = 63), the CRMS/CFSPID cohort (n = 63) had initially lower immunoreactive trypsinogen (IRT) and sweat chloride (SC) values, delayed visits, less symptoms, and better nutritional status; during follow-up, they had fewer hospitalizations, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus identification, CF comorbidities, and treatment burden. At endpoint assessment, they presented a milder pulmonary phenotype on Brody computed tomography scores (0.0[0.0; 2.0] vs 13[2.0; 31.0]; P

The number of averted deaths due to therapeutic advances in oncology and hematology is substantial and increasing. Survival of critically ill cancer patients has also improved during the last 2 decades. However, these data stem predominantly from unadjusted analyses. The aim of this study was to assess the impact of ICU admission year on short-term survival of critically ill cancer patients, with special attention on those with neutropenia. Systematic review and meta-analysis of individual data according to the guidelines of meta-analysis of observational studies in epidemiology. Pubmed and Cochrane databases. Adult studies published in English between May 2005 and May 2015. Overall, 7354 patients were included among whom 1666 presented with neutropenia at ICU admission. Median ICU admission year was 2007 (IQR 2004–2010; range 1994–2012) and median number of admissions per year was 693 (IQR 450–1007). Overall mortality was 47.7%. ICU admission year was associated with a progressive decrease in hospital mortality (OR per year 0.94; 95% CI 0.93–0.95). After adjustment for confounders, year of ICU admission was independently associated with hospital mortality (OR for hospital mortality per year: 0.96; 95% CI 0.95–0.97). The association was also seen in patients with neutropenia but not in allogeneic stem cell transplant recipients. After adjustment for patient characteristics, severity of illness and clustering, hospital mortality decreased steadily over time in critically ill oncology and hematology patients except for allogeneic stem cell transplant recipients.

The use of oral cancer drugs (OAD) has increased over the last two decades. The objective of this study was to measure the impact of a nurse-led telephone follow-up in the therapeutic management of patients treated with an OAD regarding toxicity, medication adherence and quality of life. A randomized, multicenter, controlled trial was conducted. All consecutive over 18-year-old patients, treated in medical oncology, radiotherapy, or hematology departments, receiving OAD for any cancer were invited to participate to the study. A total of 183 patients treated for solid or hematological cancers with an OAD were randomly assigned to receive a nurse-led telephone follow-up or standard care for 24 weeks. Data were collected between 2015 and 2018. Nurse telephone follow-up did not improve the global score toxicity in the intervention group. However, telephone calls directed by trained nurses induced a significant decrease in number of patients with grade 3 adverse events throughout the follow-up [OR 0.45 (IC a 95%) (0.23, 0.9)](P = 0.03). There was no significant difference in quality of life and medication adherence between groups at any follow-up time point. In this first French real-life study, the advice provided by qualified nurses via phone calls improved the management of grade 3 toxicities but failed to demonstrate an improvement of all grades of toxicities. More prospective studies are needed to confirm the impact of telephone calls on the toxicities related to OAD. Clinical trial registration is NCT02459483. Protection committee SUD-ESTI registration is 2015-A00527-42 on 13 April 2015. National Agency for the Safety of Medicines and Health Products registration is 150619-B on the 27 may 2015.

Background The last 20 years have seen many attempts to improve transition to adult healthcare for adolescents with chronic disease, but there is currently no established consensus on generic practices. Our goal was to identify relevant and pragmatic guidelines for transition practice for each step of this process (before, during and after transfer), applicable to a wide range of chronic illnesses and health services, via a participatory approach involving all the key stakeholders. Methods We conducted interviews and a literature review to elaborate a questionnaire for use in an online 2-round Delphi survey. The survey panel included 36 French health and social professionals from different care settings, and young adults and parents with an experience of healthcare transition related to all types of chronic disease. Results The survey consensus identified 19 items on feasibility and relevance criteria, which form the guidelines. It is composed of five practices to be adopted during preparation in paediatrics, seven practices in the active phase of transition and seven in adult care. Two guidelines achieved complete consensus: having a longer consultation for the first appointment with the adult doctor, and keeping the same adult doctor throughout follow-up. A further 36 items met the criterion of relevance, but were deemed unfeasible. Conclusions Taking into account all stakeholder views and the real-world applicability of care practices enabled us to elaborate consensual guidelines whose implementation requires no additional health service resources.

The Doppler-based resistive index (RI) and semi-quantitative evaluation of renal perfusion using color Doppler (SQP) have shown promising results for predicting persistent acute kidney injury (AKI) in preliminary studies. This study aimed at evaluating the performance of RI and SQP to predict short-term renal prognosis in critically ill patients.Prospective multicenter cohort study including unselected critically ill patients. Renal Doppler was performed at admission to the intensive care unit. The diagnostic performance of RI and SQP to predict persistent AKI at day 3 was evaluated.Overall, 371 patients were included, of whom 351 could be assessed for short-term renal recovery. Two thirds of the included patients had AKI (n = 233; 66.3%), of whom 136 had persistent AKI (58.4%). Doppler-based RI was higher and SQP lower in AKI patients and according to AKI recovery. Overall performance in predicting persistent AKI was however poor with area under ROC curve of respectively 0.58 (95% CI 0.52-0.64) and 0.59 (95% CI 0.54-0.65) for RI and SQP. Optimal cutoff was respectively 0.71 and 2 for RI and SQP. At optimal cutoff, sensitivity and specificity were 50% (95% CI 41-58%) and 68% (62-74%) for RI and 39% (32-45%) and 75% (66-82%) for SQP.Although statistically associated with AKI occurrence, RI and SQP perform poorly in predicting persistent AKI at day 3. Further studies are needed to adequately describe factors influencing Doppler-based assessment of renal perfusion and to delineate whether these indicators may be useful at the bedside. CLINICALTRIAL.GOV: NCT02355314.

Max-Adrien Garcia,1 Julie Kalecinski,1 Mathieu Oriol,1,2 Armand Bonne,1 Mohamed Lofti,1 Sophie Espenel,3 Fabien Tinquaut,1 Pierre Fournel,4 Olivier Collard,4 Cécile Vassal,4 Romain Rivoirard,4 Véronique Regnier,1,5 Franck Chauvin,1,2,5 Aurélie Bourmaud1,5 1Hygee Center, Lucien Neuwirth Cancer Institut, INSERM – CIC-EC, CIC 1408, Saint Priest en Jarez, France; 2Jean Monnet University, Saint Etienne, France; 3Radiotherapy Department, Lucien Neuwirth Cancer Institut, Saint Priest en Jarez, France; 4Medical Oncology Department, Lucien Neuwirth Cancer Institut, Saint Priest en Jarez, France; 5Quality Safety Performance in Health (HESPER) EA7425, Lyon 1 University, Lyon, France Introduction: The announcement of cancer coupled with initiation of its treatment impacts patients’ psychological and physical states as well as their lifestyles. The objective of this study was to identify and confirm the needs of patients starting off on anticancer chemotherapy treatment. Methods: This study was based on a qualitative–quantitative mixed method. In 2009, a qualitative study was conducted at the Lucien Neuwirth Cancer Institut for cancer patients undergoing intravenous chemotherapy for the first time. Exploratory and semi-directed interviews were carried out by a sociologist. In 2014, a questionnaire was hetero-administered to 100 patients starting off on chemotherapy. Results: Forty patients were interviewed in 2009. Ninety-seven patients answered the questionnaire in 2014. Food was a theme that was identified by a majority of patients in 2009 (13/40) and confirmed in 2014: 63% needed help in identifying favorable food and 67% in identifying those that had to be avoided. The other needs identified were those linked to better understanding of the treatment, of how it may affect the couple, its side effects, hygiene and beauty, and knowledge about other treatments. These needs were confirmed in 2014. New needs were elicited in 2014: activities and leisure (33%), psychological needs (32.6%), and family relations (29.9%). Conclusion: This study enabled us to identify, confirm, and enrich our knowledge of the needs of cancer patients starting off on intravenous chemotherapy. These results led to the modification of an existing patient education program for these patients, in order to fulfill their needs in an updated and tailored manner. Keywords: assessment of needs, patients’ needs, cancer, patient education, mixed qualitative–quantitative method, psychosocial needs

The need to accurately identify cancer outpatients at high risk of thrombotic complications is still unmet. In a prospective, multicenter cohort study (ONCOlogie et Chambres ImPlantables [ONCOCIP]), consecutive adult patients with a solid tumor and implanted port underwent 12-month follow-up. Our primary objective was to identify risk factors for (1) catheter-related thrombosis, defined as ipsilateral symptomatic upper-limb deep-vein thrombosis with or without pulmonary embolism, and (2) venous thromboembolism other than catheter-related, defined as any symptomatic superficial- or deep-vein thrombosis (other than catheter-related) or pulmonary embolism, and incidental pulmonary embolism. All events were objectively confirmed and centrally adjudicated. Rate assessments integrated competing risk of death. Overall, 3032 patients were included (median age: 63 years; women: 58%). The most frequent cancer locations were breast (33.7%), lung (18.5%), and colorectal (15.6%), cancer being metastatic in 43.2% of patients. Most patients (97.1%) received chemotherapy. By 12 months, 48 (1.6%) patients had been lost to follow-up and 656 (24.6%) had died; 3.8% (n = 111) of patients had experienced catheter-related thrombosis, and 9.6% (n = 276) venous thromboembolism other than catheter-related. By multivariate analysis, use of cephalic vein for catheter insertion predicted catheter-related thrombosis, whereas ongoing antiplatelet therapy was protective; risk factors for venous thromboembolism other than catheter-related were advanced age, previous venous thromboembolism, cancer site, and low hemoglobin level or increased leukocyte count before chemotherapy. In conclusion, this large prospective cohort study showed a high rate of venous thromboembolism in patients with a solid tumor and implanted port. Risk factors for catheter-related thrombosis differed from those for venous thromboembolism not catheter-related. This trial was registered at www.clinicaltrials.gov as #NCT02025894.

Objective To describe the current state of knowledge concerning the quality of reporting in phase II clinical trials in oncology and to describe the various methods published allowing this quality evaluation. Methods databases including MEDLINE and COCHRANE were searched. Reviews and meta-analyses analyzing the quality of the reporting of phase II trials in oncology were included. Descriptive analysis of the results was performed. Results Thirteen publications were retained. Only 2 publications adopted a systematic approach of evaluation of the quality of reporting by overall scores. The Key Methodological Score (KMS), proposed by Grellety et al., gathering 3 items, seemed adapted for such an evaluation. A score of 3/3 was found in 16.1% of the 156 phase II trials analysed by this score. The other reviews used a qualitative analysis to evaluate the reporting, via an analysis of a single criterion, generally the statistical plan of the study. This item was considered as having been correctly reported in less than 50% of the analysed articles. Conclusion The quality of reporting in phase II trials in oncology is a field that has been investigated very little (13 publications). When it is studied, the estimated level of quality is not satisfactory, whatever the method employed. The use of an overall score of evaluation is a path which should be pursued, in order to get reliable results. It also seems necessary to propose strong recommendations, which would create a consensus for the methodology and the reporting of these studies.

Reducing inequalities in the field of cancer involves studying the knowledge and mental representations of cancer among children. A qualitative study was conducted on 191 children aged 9 to 12 using the “write and draw” technique to get spontaneous mental representations of “healthy things”, “unhealthy things” and “cancer”. We grouped the voluntary schools according to two deprivation levels. In response to the request to “write or draw anything you think keeps you healthy”, the main responses categories were physical activity, healthy food and basic needs. Smoking, drinking alcohol, sedentary lifestyles/lack of sport were identified as “unhealthy”. The first theme associated with “cancer” is the “cancer site” implying children have a segmented perception of cancer. Deprived children have radically different views about the key items representing cancer: they are more likely to believe the illness is systematically deadly. They are less likely to believe it is a treatable illness. They are less likely to associate cancer with risky behaviors, particularly alcohol consumption. Conclusion: Social inequalities affect representations of cancer and health literacy from early childhood. Prevention programs taking into account these representations need to be introduced at school. What is Known: • Social inequalities for cancer mortality are observed in all European countries and are particularly pronounced in France. • Reducing these inequalities in prevention programs implies studying the knowledge and mental representations of cancer among children. What is New: • This study identified representations of cancer in young children according to social level. • At age 9, children living in deprived areas are less able to produce content in discussions about cancer and have narrower mental representations and a more fatalistic view.

In-line filtration is increasingly used in critically-ill infants but its benefits, by preventing micro-particle infusion in very preterm neonates, remain to be demonstrated. We conducted a randomized controlled trial among very preterm infants allocated to receive either in-line filtration of all the intra-venous lines or standard care without filters. The primary outcome was differences greater than 20% in the median changes in pro-inflammatory cytokine serum concentrations measured at day 3 and day 8 (+/−1) using a Luminex multianalytic profiling technique. Major neonatal complications were analyzed as secondary predefined outcomes. We randomized 146 infants, assigned to filter (n = 73) or control (n = 73) group. Difference over 20% in pro-inflammatory cytokine concentration between day 3 and day 8 was not found statistically different between the two groups, both in intent-to-treat (with imputation) and per protocol (without imputation) analyses. The incidences of most of neonatal complications were found to be similar. Hence, this trial did not evidence a beneficial effect of in-line filtration in very preterm infants on the inflammatory response syndrome and neonatal morbidities. These data should be interpreted according to local standards in infusion preparation and central line management.

Background Although the benefits of physiotherapy is well supported in the literature, the impact of having direct access to physiotherapy is not well established. Update of the current available evidence is warranted. The aim of this systematic review was to update the current evidence regarding the impact of direct access physiotherapy compared to usual care for patients with musculoskeletal disorders. Methods Systematic searches were conducted in 5 bibliographic databases up until May 2018. Two independent raters reviewed studies and used the Quality Assessment Tool for Quantitative Studies to conduct the methodological quality assessment and a data extraction regarding patient outcomes, adverse events, health care utilization and processes, patient satisfaction and health care costs. Results Sixteen studies of weak to moderate quality were included. Five studies found no significant differences in pain reduction between usual family physician led care and direct access physiotherapy. However, three studies reported better clinical outcomes in patients with direct access in terms of function and quality of life. Five studies did not observe any adverse events with direct access physiotherapy. Three studies showed shorter waiting time and four studies reported fewer number of physiotherapy visits with direct access. Three studies showed that patients with direct access were less likely to have medication and imaging tests prescribed compared to usual care. Five studies reported higher levels of satisfaction for direct access. In terms of health care costs, four studies demonstrated that costs were lower with direct access and one study reported similar costs between both types of care. Conclusions Emerging evidence, although of weak to moderate quality, suggest that direct access physiotherapy provides equal or better outcomes than family physician led care models for musculoskeletal disorders patients. More methodologically strong studies are needed. Key messages This review supports the efficacy, safety and cost-effectiveness of direct access PT, while increasing access to care with a more efficient use of resources. There is a need for more methodologically strong studies to evaluate the efficiency of direct access models of care of physiotherapy for patients with MSKD.

To update and appraise the available evidence with respect to the impact of direct access physiotherapy compared to primary care physician-led usual medical care for patients with musculoskeletal disorders in terms of efficacy, health care utilization and processes, health care costs, patient satisfaction, and compliance.Systematic searches were conducted in five bibliographic databases up to June 2019. Studies presenting quantitative data of any research related to direct access physiotherapy for patients with musculoskeletal disorders were included. Two independent raters reviewed the studies, conducted the methodological quality assessment and a data extraction regarding patient outcomes, adverse events, health care utilization and processes, patient satisfaction, and health care costs.Eighteen studies of weak to moderate quality were included. Five studies found no significant differences in pain reduction between usual primary care physician-led medical care and direct access physiotherapy. Four studies reported better clinical outcomes in patients with direct access in terms of function and quality of life. In terms of health care costs, four studies demonstrated that costs were lower with direct access and one study reported similar costs between both types of care.Emerging evidence of weak to moderate quality suggest that direct access physiotherapy could provide better outcomes in terms of disability, quality of life, and healthcare costs compared to primary physician-led medical care for patients with musculoskeletal disorders but not for pain outcomes. These conclusions could be modified when higher quality trials are published.Direct access physiotherapy for patients with musculoskeletal disorders appears as a promising model to improve efficiency of care and reduce health care costs, but more methodologically sound studies are required to formally conclude.#CRD42018095604IMPLICATIONS FOR REHABILITATIONEmerging evidence of weak to moderate quality indicates that direct access physiotherapy could provide better outcomes in terms of disability, quality of life and healthcare costs compared to primary physician led usual medical care for musculoskeletal disorders patients.Direct access physiotherapy may lead to increased access to care and a more efficient use of health care resources.Direct access physiotherapy does not appear to improve pain outcomes compared to primary care physician-led usual medical care.

// Marie Bouteloup 1,* , Sophie Perinel 1,* , Aurelie Bourmaud 2 , Elie Azoulay 3,4 , Djamel Mokart 5 and Michael Darmon 1,6,7 1 Medical-Surgical ICU, Hopital Nord, Universite Jean Monnet, Saint-Etienne, France 2 Department of Public Health, Hygee Centre, Lucien Neuwirth Cancer Institut, Saint Priest en Jarez, France 3 Medical ICU, Saint-Louis University Hospital, AP-HP, Paris, France 4 Faculte de Medecine, Universite Paris-Diderot, Sorbonne-Paris-Cite, Paris, France 5 Anesthesiology and Intensive Care Unit, Institut Paoli Calmette, Marseille Cedex 9, France 6 Thrombosis Research Group, EA 3065, Saint-Etienne University Hospital and Saint-Etienne Medical School, Saint-Etienne, France 7 pour le Groupe de Recherche en Reanimation Respiratoire du patient d’Onco-Hematologie (GRRR-OH) * These authors have contributed equally to this work Correspondence to: Michael DARMON, email: // Keywords : prognosis; outcomes; hematologic; neoplasms; intensive care units Received : April 28, 2016 Accepted : September 14, 2016 Published : September 21, 2016 Abstract PURPOSE: Whether neutropenia has an impact on the mortality of critically ill cancer patients remains controversial, yet it is widely used as an admission criterion and prognostic factor. METHODS: Systematic review and meta-analysis. Studies on adult cancer patients and intensive care units were searched on PubMed and Cochrane databases (2005-2015). Summary estimates of mortality risk differences were calculated using the random-effects model. RESULTS: Among the 1,528 citations identified, 38 studies reporting on 6,054 patients (2,097 neutropenic patients) were included. Median mortality across the studies was 54% [45-64], with unadjusted mortality in neutropenic and non-neutropenic critically ill patients of 60% [ 53 - 74 ] and 47% [ 41 - 68 ], respectively. Overall, neutropenia was associated with a 10% increased mortality risk (6%-14%; I² = 50%). The admission period was not associated with how neutropenia affected mortality. Mortality significantly dropped throughout the study decade [-11% (-13.5 to -8.4)]. This mortality drop was observed in non-neutropenic patients [-12.1% (-15.2 to -9.0)] but not in neutropenic patients [-3.8% (-8.1 to +5.6)]. Sensitivity analyses disclosed no differences in underlying malignancy, mechanical ventilation use, or Granulocyte-colony stimulating factor use. Seven studies allowed the adjustment of severity results (1,350 patients). Although pooled risk difference estimates were similar to non-adjusted results, there was no significant impact of neutropenia on mortality (risk difference of mortality, 9%; 95% CI, −15 to +33) CONCLUSION: Although the unadjusted mortality of neutropenic patients was 11% higher, this effect disappeared when adjusted for severity. Therefore, when cancer patients become critically ill, neutropenia cannot be considered as a decision-making criterion.

Introduction The aim of this study was to assess the cost-effectiveness of low molecular weight heparin versus aspirin as primary thromboprophylaxis throughout chemotherapy for newly diagnosed multiple myeloma patients treated with protocols including thalidomide from the perspective of French health care providers. Methods We used a modeling approach combining data from the only randomized trial evaluating the efficacy of the two treatments and secondary sources for costs, and utility values. We performed a decision-tree analysis and our base case was a hypothetical cohort of 10,000 patients. A bootstrap resampling technique was used. The incremental cost-effectiveness ratio was calculated using estimated quality-adjusted life years as the efficacy outcome. Incremental costs and effectiveness were estimated for each strategy and the incremental cost-effectiveness ratio was calculated. One-way sensitivity analyses were performed. Results The number of quality-adjusted life years was estimated to be 0.300 with aspirin and 0.299 with heparin. The estimated gain with aspirin was therefore approximately one day. Over 6 months, the mean total cost was € 1518 (SD = 601) per patient in the heparin arm and € 273 (SD = 1019) in the aspirin arm. This resulted in an incremental cost of € 1245 per patient treated with heparin. The incremental cost-effectiveness ratio for the aspirin versus heparin strategy was calculated to be – 687,398 € (95% CI, − 13,457,369 to − 225,385). Conclusions Aspirin rather than heparin thromboprophylaxis, during the first six months of chemotherapy for myeloma, is associated with significant cost savings per patient and also with an unexpected slight increase in quality of life.

PURPOSE/OBJECTIVES To develop and test the feasibility of a tailored therapeutic educational program, with the aim of improving adherence to oral endocrine adjuvant chemotherapy in women with breast cancer. . DESIGN A qualitative study to identify educational needs and a feasibility study assessing the efficacy of the program. . SETTING A comprehensive cancer center, the Lucien Neuwirth Cancer Institute in Saint-Priest-en-Jarez, France. . SAMPLE Two consecutive samples (N = 11, N = 6) of women taking adjuvant oral endocrine chemotherapy for breast cancer. . METHODS A mixed qualitative and quantitative method was used. The participants' representations of disease and treatment were explored through one-on-one interviews and then translated into educational needs, which were used to develop a tailored therapeutic education program. The pilot study evaluated the reach and efficacy using before-and-after comparisons. . MAIN RESEARCH VARIABLES Educational objectives, knowledge, trust in the treatment, and anxiety. . FINDINGS Five educational objectives (acquiring knowledge, improving communication skills, managing anxiety, managing side effects, and improving adherence) were identified through 11 interviews. A three-session program was developed. Eight of the 23 patients invited to participate in a pilot study accepted, and six completed the intervention. Knowledge improved from 38.9 of 100 preintervention to 69.4 of 100 postintervention (p = 0.045). Trust in treatment showed a trend to improvement from 5.5 of 10 to 8 of 10 (p = 0.14), but anxiety did not change significantly; anxiety went from 6 to 7 (p = 0.88). . CONCLUSIONS Results from the feasibility study showed promising efficacy for the educational objectives and provided information about how the program could be improved. . IMPLICATIONS FOR NURSING Tailored educational programs conducted by trained nurses may help patients to adhere to and live with the effects of endocrine therapy.

Controversies regarding the benefits of breast cancer screening programs have led to the promotion of new strategies taking into account individual preferences, such as decision aid. The aim of this study was to assess the impact of a decision aid leaflet on the participation of women invited to participate in a national breast cancer screening program. This Randomized, multicentre, controlled trial. Women aged 50 to 74 years, were randomly assigned to receive either a decision aid or the usual invitation letter. Primary outcome was the participation rate 12 months after the invitation. 16 000 women were randomized and 15 844 included in the modified intention-to-treat analysis. The participation rate in the intervention group was 40.25% (3174/7885 women) compared with 42.13% (3353/7959) in the control group (p = 0.02). Previous attendance for screening (RR = 6.24; [95%IC: 5.75-6.77]; p < 0.0001) and medium household income (RR = 1.05; [95%IC: 1.01-1.09]; p = 0.0074) were independently associated with attendance for screening. This large-scale study demonstrates that the decision aid reduced the participation rate. The decision aid activate the decision making process of women toward non-attendance to screening. These results show the importance of promoting informed patient choices, especially when those choices cannot be anticipated.

Background The study objective was to assess the influence of neutropenia on outcome of critically ill cancer patients by meta-analysis of individual data. Secondary objectives were to assess the influence of neutropenia on outcome of critically ill patients in prespecified subgroups (according to underlying tumor, period of admission, need for mechanical ventilation and use of granulocyte colony stimulating factor (G-CSF)). Methods Data sources were PubMed and the Cochrane database. Study selection included articles focusing on critically ill cancer patients published in English and studies in humans from May 2005 to May 2015. For study selection, the study eligibility was assessed by two investigators. Individual data from selected studies were obtained from corresponding authors. Results Overall, 114 studies were identified and authors of 30 studies (26.3% of selected studies) agreed to participate in this study. Of the 7515 included patients, three were excluded due to a missing major variable (neutropenia or mortality) leading to analysis of 7512 patients, including 1702 neutropenic patients (22.6%). After adjustment for confounders, and taking study effect into account, neutropenia was independently associated with mortality (OR 1.41; 95% CI 1.23–1.62; P = 0.03). When analyzed separately, neither admission period, underlying malignancy nor need for mechanical ventilation modified the prognostic influence of neutropenia on outcome. However, among patients for whom data on G-CSF administration were available (n = 1949; 25.9%), neutropenia was no longer associated with outcome in patients receiving G-CSF (OR 1.03; 95% CI 0.70–1.51; P = 0.90). Conclusion Among 7512 critically ill cancer patients included in this systematic review, neutropenia was independently associated with poor outcome despite a meaningful survival. Neutropenia was no longer significantly associated with outcome in patients treated by G-CSF, which may suggest a beneficial effect of G-CSF in neutropenic critically ill cancer patients. Systematic review registration PROSPERO CRD42015026347. Date of registration: Sept 18 2015 Electronic supplementary material The online version of this article (10.1186/s13054-018-2076-z) contains supplementary material, which is available to authorized users.

// Guillaume Moriceau 1,2 , Aurelie Bourmaud 2,3 , Fabien Tinquaut 2 , Mathieu Oriol 2 , Jean-Philippe Jacquin 1 , Pierre Fournel 1 , Nicolas Magne 4 and Franck Chauvin 2,3,5 1 Medical Oncology Lucien Neuwirth Cancer Institute, Saint Priest en Jarez, France 2 Department of Public Health, Hygee Centre, Lucien Neuwirth Cancer Institute, Saint Priest en Jarez, France 3 Therapeutic Targeting in Oncology, EMR3738, Claude Bernard University, Lyon, France 4 Radiation Oncology Lucien Neuwirth Cancer Institute, Saint Priest en Jarez, France 5 Clinical Investigation Center and Clinical Epidemiology, Jean Monnet University, Saint-Etienne, France Correspondence to: Aurelie Bourmaud, email: // Keywords : cancer, access to care, socio-economic inequalities, european deprivation Index, population based Received : July 17, 2015 Accepted : September 30, 2015 Published : November 02, 2015 Abstract Context: The European Deprivation Index (EDI), is a new ecological estimate for Socio-Economic Status (SES). This study postulates that Time-To-Treatment could be used as a cancer quality-of -care surrogate in order to identify the association between cancer patient’s SES and quality of care in a French comprehensive cancer center. Methods: retrospective mono-centered cohort study. All consecutive incoming adult patients diagnosed for breast cancer(BC), prostate cancer(PC), colorectal cancer (CRC), lung cancer(LC) or sarcoma(S) were included between January 2013 and December 2013. The association of EDI and Time-To-Diagnosis(TTD), as well as Time-To-Treatment(TTT) was analyzed using a cox regression, and a strata analysis per tumor site was performed. Results: 969 patients were included. Primitive tumor site was 505 BC(52%), 169 PC(17%), 145 LC(15%), 116 CRC(12%), and 34 S(4%). Median TTD was 1.41 months (Q1-Q3 0.5 to 3.5 months). Median TTT was 0.9 months (0.4 - 1.4). In a multivariate analysis, we identified the tumor site as a predictive factor to influence TTD, shorter for BC (0.75months, [0.30- 1.9]) than PC (4.69 months [1.6-29.7]), HR 0.27 95%CI= [0.22-0.34], p < 0.001. TTT was also shorter for BC (0.75months [0.4-1.1]) than PC (2.02 [0.9-3.2]), HR 0.32 95%CI= [0.27-0.39], p < 0.001. EDI quintiles were not found associated with either TTT or TTD. Conclusions: Deprivation estimated by the EDI does not appear to be related to an extension of the Time-to-Diagnosis or Time-to-Treatment in our real-life population. Further research should be done to identify other frailty-sensitive factors that could be responsible for delays in care.

Objective To assess the prognostic impact of clinical presentation in children with polyarteritis nodosa (PAN). Methods Children diagnosed between 1986 and 2006 in a tertiary care pediatric rheumatology center were classified as “cutaneous PAN” (group 1), “cutaneous PAN with significant extra-cutaneous features” (group 2) or “visceral childhood PAN” (group 3). Outcome measures: (1) clinical remission off-therapy at last follow-up, (2) requirement and length of glucocorticoid therapy, (3) presence of disease-related sequelae. Results Twenty-nine children were included. Sixteen met the Ankara criteria for PAN. Nine patients were qualified as group 1, 11 as group 2, and 9 as group 3. At last follow-up, 15 children were in clinical remission off-therapy: 4 from group 1 (44%), 4 from group 2 (36%) and 7 from group 3 (78%). Glucocorticoid therapy was required for 8 (89%), 7 (64%) and 7 (78%) patients from groups 1, 2 and 3, respectively. Seven children did not require any glucocorticoid therapy. Time-dependent probability of achieving glucocorticoid-free clinical remission was similar between the three groups. Three patients (one from each group) had digital ischemia leading to amputation. There were no significant between-group differences in outcome based on the three outcome measures addressed. Conclusion Outcome was not strikingly predictable from initial presentation in children with PAN. The organ distribution-based distinction between cutaneous and visceral PAN had little prognostic power in this series.

Background: Invasive fungal infections (IFIs) remain one of the worrying complications in patients with acute myeloid leukemia (AML) due to their incidence and high level of attributable mortality. In light of these risks, antifungal prophylaxis has always been debated. We conducted a single-center retrospective study of two prophylactic antifungal agents (fluconazole/posaconazole) in 91 consecutive patients receiving induction chemotherapy for AML between 2005 and 2009, in order to evaluate the impact on the incidence of IFI and on the mycological flora of the patients. Methods: In total, 39 patients received prophylactic fluconazole versus 52 who received posaconazole. The baseline characteristics of the two groups were comparable. Results: Overall, 17 patients developed an IFI, with no difference in frequency between the two groups. Utilization of empirical or pre-emptive therapy was similar irrespective of the type of prophylaxis used. Mycological examination of stools revealed an increase in non- albicans Candida colonization in the fluconazole group during hospitalization and the appearance of Saccharomyces cerevisiae colonization in patients receiving posaconazole. Conclusion: The present study does not distinguish between fluconazole and posaconazole as a primary effective prevention against fungal infections. More prospective studies and meta-analyses are warranted.

The aim of this study was to assess the outcome and the prognosis factors of uterine and ovarian carcinosarcomas.From January 1993 to January 2010, data from 68 consecutively treated patients with uterine (n=59) and ovarian (n=9) carcinosarcomas were retrospectively analyzed in a single French comprehensive cancer center.The median follow-up was 24.2 months (interquartile range [IQR]: 13.5 to 54.6). The median age was 69 years (IQR: 63 to 77). Patients were classified as FIGO stage I (n=28; 41%) and FIGO stage II to IV (n=40; 59%), respectively. There were 33 (49%) and 29 (43%) homologous and heterologous type, respectively. The median disease-free survival and overall survival were 21.9 months (IQR: 7.9 to 22.3) and 27.1 months (IQR: 14.5 to 72), respectively. No statistical differences of survival were reported concerning the initial location of the carcinosarcoma (uterine vs. ovarian). Radiation therapy (hazards ratio [HR]=0.3; 95% confidence interval [CI], 0.16-0.67) and FIGO stage I (HR=0.4; 95% CI, 0.17-0.9) were associated with an increased disease-free survival. Homologous type (HR=3; 95% CI, 1.4-6.3) and FIGO stage II to IV (HR=2.64; 95% CI, 1.3-5.4) were associated with a decreased overall survival. There was no survival improvement for the 12% of patients receiving a multimodal adjuvant therapy.Uterine and ovary carcinosarcomas present a worse prognosis. On the basis of the present study data, although it should be prospectively confirmed, a sequential or multimodal adjuvant therapy should be proposed to patients with early-stage uterine and ovary carcinosarcomas.

Objective: Several studies have demonstrated that daily physical activity (PA) prevents the development of breast cancer. Our objective was to examine the relationship between PA and clinical and biological tumor characteristics in breast cancer patients in order to determine the impact of energy expenditure (EE) on tumor prognosis. Methods: We pooled data from two prospective studies, including a total of 121 breast cancer patients. The measure of PA was done using the self-completion Population Physical Activity Questionnaire, which was answered by each patient. Results: Ten patients harbored triple negative (TN) tumors. The mean body mass index (BMI) in the general population and in patients with TN tumors was 24.3 and 25.6, respectively. The mean daily EE (DEE) was 10,266 kJ × 24 h-1 in the general population and 11,212 kJ × 24 h-1 in patients with TN tumors. In the whole population, there was an inverse statistical correlation between BMI and DEE, rest, low PA, and high PA (p = 0.0002, p = 0.003, p < 0001, and p = 0.03, respectively). There was a positive correlation between negative estrogen receptor status and intensive PA (p = 0.041) and DEE (p = 0.007). For TN tumors, there was no significant correlation between BMI and categories of EE. Conclusions: Lifestyle (weight regulation, PA) should be adapted and personalized according to biological, clinical, and epidemiological characteristics of the tumors.

Introduction Use of sorafenib remains debated in elderly patients treated for advanced hepatocellular carcinoma (HCC). Methods This was a bicentric retrospective study including all patients ≥75 years and treated with sorafenib for advanced HCC between January 2010 and March 2014. Results Of the 51 patients included (median age: 78 years, range: 75–92; performance status (PS) 0–1: 98%; cirrhosis: 88.2%; Child–Pugh A: 95.6%) all experienced at least one adverse event (AE). About 2/3 of them (66.7%) had grade 3–4 toxicities, including fatigue (43.1%), hand foot skin syndrome (11.8%), anorexia (9.8%) or diarrhea (9.8%). After adjustment for arterial hypertension, heart failure, other(s) cardiovascular history(ies), and sorafenib dose at baseline, only patients ≥80 years were associated with severe AE (OR: 13.3; p = 0.009). Discontinuation for toxicity was reported in 31 (60.8%) patients, mainly within the 3rd months, especially in those who had PS ≥1 at baseline (OR: 10.4; p = 0.01), or other cardiovascular histories (OR: 30.9; p = 0.016). In this setting, overall survival was significantly reduced (HR: 4.5; p Conclusion Tolerance of Sorafenib seems to be low in elderly, especially for patients aged ≥80 years or with PS ≥1. Starting with reduced dose of sorafenib does not seem to impact results. Some of these patients may truly benefit from the treatment in terms of survival.

Aims: To provide burden estimates of mental disorders in France and compare the results with findings from other countries and EU in general. Method: Stepwise top down approach, consisting of analyses of existing data sets, national surveys and ad hoc surveys. Mental disorder was defined by diagnoses in the chapter ‘Mental and behavioural disorders’ from the International Classification of Diseases, tenth revision (ICD-10), excluding, dementia and mental retardation. Disease burden was measured by total health care costs, social care costs, lost output and loss of well being, 2007 data was used consistently. Results: The total cost of mental health care was estimated at €13.4 billion, or 8% of total healthcare expenditures. Total cost of health and social services was estimated at €6.3 billion, including €1.3 billion for informal care. Total cost of lost production amounted to €24.4 billion, €20.0 billion for lost output and €4.4 billion for workers' compensation. Mental disorders resulted in a total loss of 2.2 million QALY and a total cost of lost well being of €65.08 billion. The total costs of mental disorders were estimated at €109 billion, 20% of which are actual money spent and 80% the social value of disease consequences. Conclusion: In France with a population of 65 million, an estimated 12 million inhabitants currently suffer from one or more mental disorders. The true size and burden of mental disorders in France was significantly underestimated by policy makers in the past.

Background The mass colorectal cancer screening program was implemented in 2008 in France, targeting 16 million French people aged between 50 and 74. The current adhesion is insufficient and the participation rate is even lower among the underserved population, increasing health inequalities within our health care system. Patient Navigation programs have proved their efficiency to promote the access to cancer screening and diagnosis. Methods/Design The purpose of the study is to assess the implementation of a patient navigation intervention that has been described in another cultural environment and another health care system. The main objective of the program is to increase the colorectal cancer screening participation rate among the deprived population through the intervention of a navigator to promote the Fecal Occult Blood Test (FOBT) and complementary exams. We performed a multisite cluster randomized controlled trial, with three groups (one experimental group and two control groups) for 18 months. Discussion The study attempts to give a better understanding of the adhesion barriers to colorectal cancer screening among underserved populations. If this project is cost-effective, it could create a dynamic based on peer approaches that could be developed for other cancer screening programs and other chronic diseases. Trial registration NCT02369757

Background Quality of reporting for Randomized Clinical Trials (RCTs) in oncology was analyzed in several systematic reviews, but, in this setting, there is paucity of data for the outcomes definitions and consistency of reporting for statistical tests in RCTs and Observational Studies (OBS). The objective of this review was to describe those two reporting aspects, for OBS and RCTs in oncology. Methods From a list of 19 medical journals, three were retained for analysis, after a random selection: British Medical Journal (BMJ), Annals of Oncology (AoO) and British Journal of Cancer (BJC). All original articles published between March 2009 and March 2014 were screened. Only studies whose main outcome was accompanied by a corresponding statistical test were included in the analysis. Studies based on censored data were excluded. Primary outcome was to assess quality of reporting for description of primary outcome measure in RCTs and of variables of interest in OBS. A logistic regression was performed to identify covariates of studies potentially associated with concordance of tests between Methods and Results parts. Results 826 studies were included in the review, and 698 were OBS. Variables were described in Methods section for all OBS studies and primary endpoint was clearly detailed in Methods section for 109 RCTs (85.2%). 295 OBS (42.2%) and 43 RCTs (33.6%) had perfect agreement for reported statistical test between Methods and Results parts. In multivariable analysis, variable "number of included patients in study" was associated with test consistency: aOR (adjusted Odds Ratio) for third group compared to first group was equal to: aOR Grp3 = 0.52 [0.31–0.89] (P value = 0.009). Conclusion Variables in OBS and primary endpoint in RCTs are reported and described with a high frequency. However, statistical tests consistency between methods and Results sections of OBS is not always noted. Therefore, we encourage authors and peer reviewers to verify consistency of statistical tests in oncology studies.

The peritoneal carcinomatosis of ovarian cancer led to the development of optimal cytoreduction surgery completed by hyperthermic intraperitoneal chemotherapy (HIPEC). The main goal of this study is to evaluate the feasibility, tolerance and efficacy of this technique in patients with ovarian cancer. A retrospective monocentric study has evaluated 43 patients with HIPEC procedures from 1995 to 2009. After a complete cytoreduction surgery, a HIPEC procedure with cisplatin is performed. Data on complications and survival parameters were collected. Prognostic factors were also analyzed. Post-surgery complications included one death due to a septic shock (2.3%) and six patients have presented major complications (13.9%). The median of overall survival and progression free survival were 53.6 and 39 months, respectively. Patients with a primary complete surgical cytoreduction of the peritoneal carcinomatosis presented overall survival length of 131 months versus 84 months without initial complete resection (P

Introduction: For a long time patients with cancer receiving chemotherapy were ’captive’, and were considered as passive during the administration of their treatment. The development of oral treatments over the last decade has considerably changed this situation. However, very little is known about the behaviour of the patients and the physicians in this new setting. Our team carried out a social anthropological survey on patients who were autonomous in the management of their oral chemotherapy, before developing a therapeutic patient educational programme. Objectives: The objective of the survey was to identify the mental representations and behaviour of patients and prescribing oncologists. Methods: The survey included 42 patients receiving oral chemotherapy and 10 oncologists from two cancer centres in the Rhone-Alpes region in France between January and March 2007. Different qualitative study methods were used: repeated focus groups and individual face-to-face or telephone interviews. Results and discussion: The results of this survey were used to develop the objectives for a therapeutic educational programme. The way patients managed their oral chemotherapy was found to be linked to their beliefs about the treatment efficacy and toxicity. The structure and contents of the educational sessions were adapted to take into consideration the identified representation.

The present review gives an overview of systematic reviews published in peer reviewed Journals analysing quality of reporting in oncology studies. PUBMED and Cochrane library were searched to identify systematic reviews assessing quality of reporting for randomized controlled trials (RCTs) and observational studies (OBS). Recommendations and primary endpoints used to assess the quality of reporting were described. Intrinsic quality of reporting was analyzed using an Overall Quality Score for literature Reviews (OQSR). Main evaluation themes were overall quality of reporting (20/58) and reporting of Health-Related Quality Of Life (HRQOL) in RCTs (7/58). Reporting recommendations used were not detailed in 56.9% of reviews. Insufficient reporting for the methodological description (randomization, blinding details, and allocation concealment) and the rationale for using specific measure of HRQOL were highlighted. OQSR was significantly higher for reviews published between 2010 and 2014 (after the PRISMA Publication), as compared to those published between 1996-2009 (median OQSR 10 (10-11) versus median OQSR 9 (6-10) respectively, p=0.0053). Intrinsic quality of reporting is satisfactory and has been improved in the last years.

Background There are only scarce data on the management of patients aged 90 years or older with cancer, and more particularly on the place of radiation therapy (RT). We report the first large study on patients (pts) aged 90 years or older receiving RT. Methods and materials Records from RT departments from five institutions were reviewed to identify pts 90 years of age and older who underwent RT for various malignant tumours treated between 2003 and 2012. Tumours’ characteristics were examined, as well as treatment specificities and treatment intent. Results 308 pts receiving 318 RT courses were identified, mean age was 93.2 years (standard deviation 2.8). Treatment was given with curative and palliative intent in 44% and 56%, respectively. Factors associated with a curative treatment were performance status (PS), place of life, previous surgery and tumour stage. Median total prescribed dose was 36 Gy (4–76 Gy). Hypofractionation and split course were used in 88% and 7.3%, respectively. Most toxicities were mild to moderate. RT could not be completed in 23 pts (7.5%). No long-term toxicity was reported. Median overall survival was 22.9 months (95CI: 15.5–42.7 months). Cancer was the cause of death in 8.7% and 46% of pts treated with curative and palliative intent, respectively. Conclusion This study shows that RT is feasible for patients aged 90 years or more. PS, place of life and tumour stage were factors of the therapeutic decision. There is no reason to withdraw pts with good general health condition from potentially curative RT, provided that careful attention is paid to factors of toxicity and to geriatric vulnerabilities.

Introduction De plus en plus de chimiotherapies sont administrees par voie orale. Les traitements en cancerologie sont, de ce fait, soumis au meme risque de non-adherence que les autres traitements oraux. Ce travail de these avait pour objectif d’etudier : (i) les facteurs de risques de non-adherence ; (ii) de developper un programme d’education du patient (PEP) permettant d’ameliorer l’adherence des patients. Methode (i) Enquete transversale realisee par questionnaire telephonique aupres d’oncologues prescripteurs de chimiotherapies orales, afin d’evaluer le contenu et l’encadrement de leur pratiques de prescription, (ii) etude prospective de cohorte portant sur des patients souffrant de cancers traites par Capecitabine orale. L’objectif etait d’identifier des profils-types de patients en termes d’adherence, grâce a une approche mixte quantitative (analyse en composante multiple) et sociologique, (iii) etude pilote de faisabilite et d’evaluation d’un PEP visant a ameliorer l’adherence de patientes traitees par hormonotherapie adjuvante du cancer du sein. Resultats (i) Au total, 157 oncologues ont repondu a l’enquete : 23 % declarent ne jamais controler l’adherence de leurs patients et 54 % seulement fournissent du materiel educatif a la premiere prescription ; (ii) trois profils de patients ont ete identifies : les patients actifs avec un niveau educatif eleve sont moins adherents que les deux autres ; (iii) le PEP a demontre une efficacite dans l’amelioration des connaissances des patientes et de la confiance dans le traitement. Discussion Identifier les facteurs de risques de non-adherence au traitement permet de construire des strategies d’amelioration de l’adherence ciblees et efficaces, en faisant levier sur ces facteurs.

Introduction Chimerism analysis after allogeneic hematopoietic stem cells transplantation (HSCT) allows documentation and understanding of important clinical events such as engraftment, graft failure, and/or relapse. Few data are available on whether T-cell chimerism might be more informative than global chimerism. In this study, we focused on selective CD3+ T-cell chimerism and its interest to predict events after allogeneic HSCT. Methods This is a single center retrospective study. Only patients with a survival more than 3 months were included. Information concerning donors, recipients, conditioning regimen, graft harvesting and follow-up were collected in our center using prospective forms from Promise database. Evaluation of T-cell chimerism was performed on CD3+ blood cells after immunomagnetic sorting, by PCR-STR (short-tandem repeats) multiplex technique using 15 different markers. Analysis of the tandem repeat polymorphism was performed by sequencer and Genscan software (Applied Biosystem Inc.). Chimerism was evaluated in 2 ways: positive or negative, and % of recipient. An analysis with repeated measures was also performed to determine the utility of a positive measure of chimerism, independently of the date of sample after allograft, to predict a relapse. Results Between January 2006 and December 2011, 148 patients (pts) were admitted in our unit for allogeneic HSCT (32% with myeloablative conditioning and 68% with reduced conditioning). Median age was 54.3 years, 59 male, 89 female. Diagnosis included AML/MDS (n=77), ALL (n=23), Aplastic anemia (n=4), lymphoma and CLL (n=23), myeloma (n= 8) and myeloproliferative disorders (n=13). The donor was matched sibling (n=51), matched unrelated (10/10) (n=74) or mismatched unrelated (9/10)(n=23). Graft source was PBSC (n=97), BM (n=33) or CB (n=18). At transplant, 108 pts (73%) were in complete remission, 19 (13%) presented partial response and 21 (14%) have progressive disease. At time of analysis, median follow-up was 1.75 years. Median overall Survival (OS) was estimated at 2 years. Forty-seven pts (32%) presented relapse. Seventy pts (47%) are still alive. Main causes of death were HSCT related (n=38), relapse or progression (n=33) and other (n=7). Acute GVHD grade II-IV incidence was 32% (13.5% grade III-IV) and 58% for chronic GVHD. At day +30, 56% of pts presented a mixed T-cell chimerism with 36 (24.3%) pts with a chimerism higher than 25% recipient. At day +90, 41% have remained positive. For NRM, aGVHD and age were the only prognostic parameters statistically identified. For PFS, only T-cell chimerism with a positive 25% cut-off at D+30 was identified as a prognostic factor (p=.0017, HR(IC 95%) 2.52(1.39; 4.58). PFS was not reached if T-cell chimerism was inferior to 25% at D+30 versus 1.35 years (figure 1). The results were concordant in a subgroup analysis performed according to the myeloid or lymphoid neoplasia status. Otherwise, cGVHD incidence was higher if T-cell chimerism was less than 25% at D+30 (70% vs. 18%). Finally, the analysis with repeated measures confirmed that positive T-cell chimerism is strongly correlated with relapse (p=.001; HR (CI95%) 90.18(30.11; 270.13)). Conclusion After allogeneic HSCT, mixed T-cell chimerism higher than 25% at day +30 is strongly correlated with poor PFS, independently of source of cells, donors, intensity of conditioning, diagnosis or disease status at transplant. Considering this high-risk population, early intervention should probably be considered. Disclosures: No relevant conflicts of interest to declare.

e13594 Background: Given the expanding use of oral chemotherapies, optimal compliance to treatment is critical to achieve the best clinical outcome in terms of efficacy and safety. The aim of the OCTO clinical study was to measure patient compliance, either electronically or by self-assessment, to capecitabine-based treatment. Methods: A cohort of patients with either locally advanced or metastatic, breast or colorectal, cancer were monitored for 6 cycles, and ambulatory treated with monotherapy of capecitabine (Xeloda). Treatment was prescribed at 1250 mg/m² as a combination of 500 and 150 mg pills, taken twice daily for 14 days every 3-week cycle. Tumor response was evaluated after 3 and 6 cycles using the RECIST criteria. Toxicity was evaluated using the NCI CTC scale. Compliance was assessed in all patients by self-completed questionnaires on disease, treatment and ambulatory management of side effects; and in half of the cohort by electronic medication event monitoring systems (MEMS) recording the opening times of the pill bottle. Results: Forty patients were enrolled between November 2008 and September 2011 and treated by capecitabine for an average of 4.75 cycles (range: 1-6). 63% patients completed 6 cycles, 22% and 15% patients discontinued due to respectively disease progression and adverse events. Best tumor response was evaluable in 35 patients: 23% had partial response, 54% stable disease and 23% progressed. Hand-foot syndrome was the most reported toxicity (77% patients), and to a lesser extent diarrhea (45%), nausea (30%) and vomiting (30%). In the MEMS cohort, 20 patients were included. Patient compliance was excellent with very few missing occasions (23/2272 records). Timing of morning doses was less variable (p=0.03) than timing of evening ones. Thirty-eight questionnaires were returned. Autonomy of ambulatory oral treatment was appreciated by 54% patients, while resulting in anxiety in 6%. Only 39% patients were concerned by the potential impact of non-compliance while 45% declined answering the question. Conclusions: Compliance to oral anticancer chemotherapy was found excellent in this population, with few deviations from prescription.

Background Numerous oral anticancer chemotherapies are available. Non-adherence or over-adherence to these chemotherapies can lead to lowered efficacy and increased risk of adverse events. The objective of this study was to identify patients’ adherence profiles using a qualitative–quantitative method. Methods A capecitabine treatment was initiated for 38 patients with advanced breast or colorectal cancer. At inclusion, information on patients’ beliefs was reported using a questionnaire. Later, Information on patients’ relation to treatment was obtained from a sub-group during an interview with a sociologist. Questionnaires were analyzed using Multiple Classification Analysis to cluster patients. Treatment adherence was evaluated by an electronic medication event monitoring systems (MEMS caps) and then correlated with patient clusters. Interviews were analyzed to complete and explain results. Results 38 patients were enrolled between 2008 and 2011 and completed the questionnaire. Twenty had adherence measured with MEMS caps all along treatment. Between 4 and 6 months after inclusion, 16 patients were interviewed. Patient profile B (retired, with a regular life, surrounded by a relative’s attention to drug adherence, with a low educational level) was statistically associated with adequate adherence (p = 0.049). A tendency for lower adherence was observed among more highly educated patients with an irregular, active life (NS). All patients taking capecitabine demonstrated a risk of over-adherence, potentiating side effects. Conclusions These encouraging primary results suggest that further studies should be undertaken and that educational programs tailored to patient profiles should be evaluated to enhance adherence for those who need it and to empower all patients to manage treatment side effects. Electronic supplementary material The online version of this article (doi:10.1186/s13104-015-1231-8) contains supplementary material, which is available to authorized users.

Collaborators : AP-HP / Université de Paris / INSERM COVID-19 research collaboration, AP-HP COVID CDR Initiative, “Entrepôt de Données de Santé” AP-HP Consortium: Pierre-Yves Ancel, Alain Bauchet, Nathanaël Beeker, Vincent Benoit, Mélodie Bernaux, Ali Bellamine, Romain Bey, Aurélie Bourmaud, Stéphane Breant, Anita Burgun, Fabrice Carrat, Charlotte Caucheteux, Julien Champ, Sylvie Cormont, Christel Daniel, Julien Dubiel, Catherine Ducloas, Loic Esteve, Marie Frank, Nicolas Garcelon, Alexandre Gramfort, Nicolas Griffon, Olivier Grisel, Martin Guilbaud, Claire Hassen-Khodja, François Hemery, Martin Hilka, Anne Sophie Jannot, Jerome Lambert, Richard Layese, Judith Leblanc, Léo Lebouter, Guillaume Lemaitre, Damien Leprovost, Ivan Lerner, Kankoe Levi Sallah, Aurélien Maire, Marie-France Mamzer, Patricia Martel, Arthur Mensch, Thomas Moreau, Antoine Neuraz, Nina Orlova, Nicolas Paris, Bastien Rance, Hélène Ravera, Antoine Rozes, Elisa Salamanca, Arnaud Sandrin, Patricia Serre, Xavier Tannier, Jean-Marc Treluyer, Damien Van Gysel, Gaël Varoquaux, Jill Jen Vie, Maxime Wack, Perceval Wajsburt, Demian Wassermann, Eric Zapletal; International audience; Several medications commonly used for a number of medical conditions share a property of functional inhibition of acid sphingomyelinase (ASM), or FIASMA. Preclinical and clinical evidence suggest that the (ASM)/ceramide system may be central to SARS-CoV-2 infection. We examined the potential usefulness of FIASMA use among patients hospitalized for severe COVID-19 in an observational multicenter study conducted at Greater Paris University hospitals. Of 2,846 adult patients hospitalized for severe COVID-19, 277 (9.7%) were taking a FIASMA medication at the time of their hospital admission. The primary endpoint was a composite of intubation and/or death. We compared this endpoint between patients taking vs. not taking a FIASMA medication in time-to-event analyses adjusted for sociodemographic characteristics and medical comorbidities. The primary analysis was a Cox regression model with inverse probability weighting (IPW). Over a mean follow-up of 9.2 days (SD=12.5), the primary endpoint occurred in 104 patients (37.5%) receiving a FIASMA medication, and 1,060 patients (41.4%) who did not. Despite being significantly and substantially associated with older age and greater medical severity, FIASMA medication use was significantly associated with reduced likelihood of intubation or death in both crude (HR=0.71; 95%CI=0.58-0.87; p

BackgroundPrevious studies have demonstrated that socioeconomic factors are associated with COVID-19 incidence. In this study, we analysed a broad range of socioeconomic indicators in relation to hospitalised cases in the Paris area.MethodsWe extracted 303 socioeconomic indicators from French census data for 855 residential units in Paris and assessed their association with COVID-19 hospitalisation risk.FindingsThe indicators most associated with hospitalisation risk were the third decile of population income (OR=9.10, 95% CI 4.98 to 18.39), followed by the primary residence rate (OR=5.87, 95% CI 3.46 to 10.61), rate of active workers in unskilled occupations (OR=5.04, 95% CI 3.03 to 8.85) and rate of women over 15 years old with no diploma (OR=5.04, 95% CI 3.03 to 8.85). Of note, population demographics were considerably less associated with hospitalisation risk. Among these indicators, the rate of women aged between 45 and 59 years (OR=2.17, 95% CI 1.40 to 3.44) exhibited the greatest level of association, whereas population density was not associated. Overall, 86% of COVID-19 hospitalised cases occurred within the 45% most deprived areas.InterpretationStudying a broad range of socioeconomic indicators using census data and hospitalisation data as a readily available and large resource can provide real-time indirect information on populations with a high incidence of COVID-19.

Purpose The role of angiotensin receptor blockers (ARB), angiotensin-converting enzyme inhibitors (ACEi), or other antihypertensive agents in the case of Covid-19 remains controversial. We aimed to investigate the association between antihypertensive agent exposure and in-hospital mortality in patients with Covid-19. Methods We performed a retrospective multicenter cohort study on patients hospitalized between February 1 and May 15, 2020. All patients had been followed up for at least 30 days. Results Of the 8078 hospitalized patients for Covid-19, 3686 (45.6%) had hypertension and were included in the study. In this population, the median age was 75.4 (IQR, 21.5) years and 57.1% were male. Overall in-hospital 30-day mortality was 23.1%. The main antihypertensive pharmacological classes used were calcium channel blockers (CCB) (n=1624, 44.1%), beta-blockers (n=1389, 37.7%), ARB (n=1154, 31.3%), and ACEi (n=998, 27.1%). The risk of mortality was lower in CCB (aOR, 0.83 [0.70–0.99]) and beta-blockers (aOR, 0.80 [0.67–0.95]) users and non-significant in ARB (aOR, 0.88 [0.72–1.06]) and ACEi (aOR, 0.83 [0.68–1.02]) users, compared to non-users. These results remain consistent for patients receiving CCB, beta-blocker, or ARB as monotherapies. Conclusion This large multicenter retrospective of Covid-19 patients with hypertension found a reduced mortality among CCB and beta-blockers users, suggesting a putative protective effect. Our findings did not show any association between the use of renin-angiotensin-aldosterone system inhibitors and the risk of in-hospital death. Although they need to be confirmed in further studies, these results support the continuation of antihypertensive agents in patients with Covid-19, in line with the current guidelines. Supplementary Information The online version contains supplementary material available at 10.1007/s10557-021-07155-5.