[Show abstract][Hide abstract] ABSTRACT: Background
While much research is devoted to identifying novel biomarkers, addressing the prognostic value of routinely measured clinical parameters is of great interest. We studied early blood pressure (BP) and body weight (BW) trajectories in incident haemodialysis patients and their association with all-cause mortality.
In a cohort of 357 incident patients, we obtained all records of BP and BW during the first 90 days on dialysis (over 12 800 observations) and analysed trajectories using penalized B-splines and mixed linear regression models. Baseline comorbidities and all-cause mortality (median follow-up: 2.2 years) were obtained from the French Renal Epidemiology and Information Network (REIN) registry, and the association with mortality was assessed by Cox models adjusting for baseline comorbidities.
During the initial 90 days on dialysis, there were non-linear decreases in BP and BW, with milder slopes after 15 days [systolic BP (SBP)] or 30 days [diastolic BP (DBP) and BW]. SBP or DBP levels at dialysis initiation and changes in BW occurring in the first month or during the following 2 months were significantly associated with survival. In multivariate models adjusting for baseline comorbidities and prescriptions, higher SBP value and BW slopes were independently associated with a lower risk of mortality. Hazard ratios of mortality and 95% confidence intervals were 0.92 (0.85–0.99) for a 10 mmHg higher SBP and 0.76 (0.66–0.88) for a 1 kg/month higher BW change on Days 30–90.
BW loss in the first weeks on dialysis is a strong and independent predictor of mortality. Low BP is also associated with mortality and is probably the consequence of underlying cardiovascular diseases. These early markers appear to be valuable prognostic factors.
[Show abstract][Hide abstract] ABSTRACT: Background:
Health inequalities have increased over the last 30 years. Our goal was to investigate the relationship between low individual socioeconomic status and poor breast cancer prognosis. Our hypothesis was: low socioeconomic status patients have a higher risk of being diagnosed with late stage breast cancer than high socioeconomic status ones due to delayed diagnosis. METHODS: We conducted a matched case-control study on 619 women with breast cancer, living in the Hérault, a French administrative area. Both Cases and Controls were recruited among invasive cases diagnosed in 2011 and 2012 and treated in Hérault care centers. Cases were defined as patients with advanced stages. Controls were composed of early stage patients. Individual socioeconomic status was assessed using a validated individual score adapted to the French population and health care system. RESULTS: We observed that low socioeconomic status patients have a 2-fold risk of having late stage breast cancer regardless of cancer characteristics and detection mode (screening vs. clinical signs). CONCLUSION: One reason explaining those results could be that low socioeconomic status patients have less regular follow-up which can lead to later and poorer diagnosis. Follow-up is improved for women with a better awareness of breast cancer. Health policy makers could reduce health inequalities by reducing the delay in breast cancer diagnosis for low socioeconomic status women.
No preview · Article · Jan 2016 · The European Journal of Public Health
[Show abstract][Hide abstract] ABSTRACT: Purpose:
The objective of this randomised phase II study was to evaluate the impact in terms of response and toxicities of induction or consolidation chemotherapy respectively before or after concurrent chemoradiotherapy in unresectable stage III non-small-cell lung cancer.
Patients and methods:
In the induction arm, patients received induction chemotherapy with cisplatin (80 mg/m(2)) and paclitaxel (200 mg/m(2)) on days 1 and 29 followed by a concurrent chemoradiotherapy (66 Gy in 33 fractions, cisplatin 80 mg/m(2) days 1, 29 and 57, vinorelbine 15 mg/m(2) days 1, 8, 29, 36, 57 and 64). In consolidation arm, the same concurrent chemoradiotherapy began on day 1 followed by two cycles of cisplatin and paclitaxel.
One hundred twenty seven patients were randomised. The intent to treat response rates in induction and consolidation arms were 58% and 56% respectively. Median survival was 19.6 months in induction arm and 16.3 months in consolidation arm and 4-year survival rates were 21% and 30% respectively. Haematologic and non-haematologic toxicities were similar in both arms, except grade 3/4 oesophagitis, more frequent in consolidation arm than in induction arm (17% versus 10%).
Cisplatin-based chemotherapy as induction or consolidation with concurrent chemoradiotherapy can be administrated safely. Response rates were similar in both arms with a trend in favour for consolidation arm for long-term survival.
Full-text · Article · Jan 2016 · European journal of cancer (Oxford, England: 1990)
[Show abstract][Hide abstract] ABSTRACT: Estimations of survival rates are diverse and the choice of the appropriate method depends on the context. Given the increasing interest in multiple imputation methods, we explored the interest of a multiple imputation approach in the estimation of cause-specific survival, when a subset of causes of death was observed.
By using European Randomized Study of Screening for Prostate Cancer (ERSPC), 20 multiply imputed datasets were created and analyzed with a Multivariate Imputation by Chained Equation (MICE) algorithm. Then, cause-specific survival was estimated on each dataset with two methods: Kaplan-Meier and competing risks. The two pooled cause-specific survival and confidence intervals were obtained using Rubin's rules after complementary log-log transformation. Net survival was estimated using Pohar-Perme's estimator and was compared to pooled cause-specific survival. Finally, a sensitivity analysis was performed to test the robustness of our constructed multiple imputation model.
Cause-specific survival performed better than net survival, since this latter exceeded 100 % for almost the first 2 years of follow-up and after 9 years whereas the cause-specific survival decreased slowly and than stabilized at around 94 % at 9 years. Sensibility study results were satisfactory.
On our basis of prostate cancer data, the results obtained by cause-specific survival after multiple imputation appeared to be better and more realistic than those obtained using net survival.
Full-text · Article · Dec 2015 · BMC Medical Research Methodology
[Show abstract][Hide abstract] ABSTRACT: Background:
Ovarian cancer is the fourth most common cancer among women in France, and mainly affects the elderly. The primary objective of this study was to compare treatment of ovarian cancer according to age.
All patients with invasive cancer (n = 1151) diagnosed between 1997 and 2011 in the Herault Department of southern France were included. Demographic data (age, area of residence), cancer characteristics (stage, histology, grade) and treatment modality (type, period and location of treatment) were analysed. Univariate and multivariate logistic regression was used to compare treatment by age.
Ovarian cancer was less treated in elderly compared to younger patients, regardless of the type of treatment. This difference was more pronounced for chemotherapy, and was maximal for surgery followed by chemotherapy (odds ratio (OR) for surgery for patients aged >70 vs those aged <70 years = 0.47 [0.24-0.91], OR for chemotherapy, age >70 vs <70 = 0.30 [0.16-0.55] and OR for surgery plus chemotherapy, age >70 vs <70 = 0.14 [0.08-0.28]). This effect of age was independent of other variables, including stage and grade. The probability of receiving standard treatment, in accordance with recommendations, was reduced by 50 % in elderly patients compared to their younger counterparts. Overall and net survival of elderly patients with standard treatment was similar to those of younger patients treated outside standard treatment.
Elderly women with ovarian cancer were therapeutically disadvantaged compared to younger women. Further studies including co morbidities are necessary to refine these results and to improve therapeutic management of elderly patients with ovarian cancer.
[Show abstract][Hide abstract] ABSTRACT: Desir est une étude de cohorte prospective, longitudinale, multicentrique, française de patients souffrant de rachialgie inflammatoire évocatrice de spondyloarthrite, avec un suivi de 10 ans. Le but est d’évaluer les performances des différents systèmes de critères de classification de la spondyloarthrite axiale, et de décrire la fréquence et les caractéristiques des signes cliniques de spondyloarthrite axiale.
[Show abstract][Hide abstract] ABSTRACT: Receiver operating characteristic (ROC) research has been limited to binary choice. Recently, the method was generalized based on the Lehmann assumption also known as the proportional hazards specification. This model accommodates a variety of research questions such as covariate adjustments. By applying this method to three-class ROC analysis, simple analytical forms of ROC surface and volume under the surface were derived without and with covariates. Furthermore, the model parameters and the corresponding asymptotic variances were evaluated. Simulation studies were performed to assess the validity of our proposed method in finite samples and extension work for dimension higher than three-class is considered.
No preview · Article · Feb 2015 · Journal of Statistical Computation and Simulation
[Show abstract][Hide abstract] ABSTRACT: This paper presents a semiparametric method for estimating receiver operating characteristic surface under density ratio model. The construction of the proposed method is based on the adjacent-category logit model and the empirical likelihood approach. A bootstrap approach for the VUS estimator inference is presented. In a simulation study, the proposed estimator is compared with the existing parametric and nonparametric estimators in terms of bias, standard error and mean square error. Finally, a real data example and some discussions on the proposed method are provided.
No preview · Article · Dec 2014 · Communication in Statistics- Simulation and Computation
[Show abstract][Hide abstract] ABSTRACT: Background:
Allergic rhinitis (AR) is a highly prevalent disease that affects the quality of life, especially in the “severe chronic upper airway disease” (SCUAD) group of patients who still have severe symptoms after adequate treatment. This study investigated
the prevalence of uncontrolled AR and SCUAD consulting in the Allergy Department of Tongji Hospital, Wuhan, China.
In this prospective cohort study, all patients consulting for AR were prospectively assessed using visual analog scale (VAS) and Allergic Rhinitis
Control Test (ARCT) and put on standardized treatment based on the Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines. After 15 days, they were reevaluated by a telephone interview using a numerical scale (NS) and ARCT. A score of ARCT of
No preview · Article · Oct 2014 · American journal of rhinology & allergy
[Show abstract][Hide abstract] ABSTRACT: Objective:
RA is a chronic disease with frequent psychological co-morbidities, of which depression and anxiety are two common manifestations. We aimed to identify predictive factors of psychological distress in a large prospective cohort of very early RA patients.
ESPOIR (Etude et Suivi des Polyarthrites Indifférenciées Récentes) is a multicentre, longitudinal and prospective cohort study of patients with early arthritis (<6 months disease duration). The study sample comprised 641 patients with very early RA according to the 2010 ACR/European League Against Rheumatism RA criteria from the ESPOIR cohort. Psychological distress was assessed over 3 years by the five-item Mental Health Inventory questionnaire at various time points (baseline, 6, 12, 18, 24 and 36 months). Logistic regression with a generalized estimating equation model was used to analyse the association of disease variables and risk of psychological distress.
At baseline, 46.9% of RA patients were screened as positive for psychological distress. Over 3 years, psychological distress decreased significantly, with a prevalence of 25.8% at 36 months. The HAQ Disability Index (HAQ-DI) score was the most important factor predicting psychological distress over 3 years [odds ratio 2.10 (95% CI 1.41, 3.14)-3.59 (2.29, 5.63)]. Baseline biological and radiological variables and treatment regimens were not associated with distress.
Psychological distress in very early RA is frequent and the HAQ-DI score is a predictor of depression and anxiety in these patients. A psychological evaluation in patients with early RA is important for further individual psychiatric diagnosis and management.
[Show abstract][Hide abstract] ABSTRACT: Aim: The use of a CGA is recommended to detect a patient's vulnerability but its integration in treatment decision making has never been prospectively evaluated. Our main objective was to test if the use of CGA in the allocation of treatment could improve the management of advanced NSCLC in first line. Methods: Randomized, multicentric, prospective phase III study in patients ≥70 y, PS 0-2 with stage IV NSCLC. Arm A standard algorithm of chemotherapy allocation: carboplatin based doublet in PS ≤ 1 and age ≤75y, docetaxel in PS =2 or age >75y. Arm B treatment allocation based on CGA: carboplatin based doublet for fit patients, mono-therapy for vulnerable patients and BSC for frail patients. Four cycles were given every three weeks. Main endpoint: time to failure free survival (TFFS) Secondary endpoints: overall Response Rate (ORR), overall survival (OS), toxicity, QoL and life expectancy adjusted on QoL. QoL was assessed during treatment by EQ-5D health questionnaire at baseline, weeks 6, 12, 20, 28, and 36. A mixed-effects model was used, to compare the utility score and therefore the QOL between arms A and B. Results: 493 patients were randomized from 01/2010 to 01/2013 by 45 centers. Respectively in arms A and B, 34.4% and 47% of patients received a carboplatin-based doublet, 65.6% and 31.4% received docetaxel and in arm B 21.5% received BSC. Median TFFS was 3.2 m, 95%CI:[2.9; 4.1] for standard arm and 3.1 m, 95%CI:[2.7; 4.4] for experimental arm, p = 0.71. Compliance with QoL was 87% at baseline and respectively 66%, 65%, 54%, 60% and 57% at week 6, 12, 20, 28 and 36. The utility score at each evaluation is superior in the experimental arm than in the standard arm, but this difference is significant only at week 36 (p = 0.02). Using a linear mixed generalized model, the utility score tends to decrease over time and is not significantly different between the two arms (p = 0.85). Life expectancy adjusted on QoL was 130.1 days in standard arm and 133.3 days in experimental arm, p = 0.51. Conclusions: ESOGIA did not show a superiority of a CGA-based treatment allocation. In the experimental arm, more patients received a carboplatin-based doublet and 21% of frail patients received an exclusive BSC management. Despite a trend in favor of CGA arm, there is no significant difference in terms of QoL score and life expectancy adjusted on QoL. Further sudies are needed for GA in NSCLC elderly patients. Disclosure: C. Chouaid: advisory board LILLY; H. Lena: advisory board Lilly. All other authors have declared no conflicts of interest.
[Show abstract][Hide abstract] ABSTRACT: 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.
[Show abstract][Hide abstract] ABSTRACT: Objective:
To compare the initial clinical, biological, and radiographic findings of early arthritis by positivity for rheumatoid factor (RF) and/or anticyclic citrullinated peptide antibodies (anti-CCP), and to validate a patient profile based on this serologic information.
The ESPOIR cohort comprises patients presenting synovitis of at least 2 joints for 6 weeks to 6 months. Patients underwent testing for IgM rheumatoid factor (IgM-RF) and anti-CCP2 antibodies and were divided into 4 groups: RF- and anti-CCP- (group 1), RF+ and anti-CCP- (group 2), RF- and anti-CCP+ (group 3), RF+ and anti-CCP+ (group 4). We compared the groups in terms of clinical, biological, and radiographic features (baseline scores and 6-month and 12-month progression).
Of the 813 recruited patients, 406 (50%) were in group 1, 91 (11.2%) in group 2, 34 (4.1%) in group 3, and 281 (34.6%) in group 4. Mean baseline erythrocyte sedimentation rate and C-reactive protein were higher for anti-CCP+ groups (groups 3 and 4) than for other groups (p < 0.001), and van der Heijde-modified Sharp score for radiographs was higher for group 4 than for other groups (p < 0.001). Clinical presentation was not consistently associated with serologic profile. Radiographic progression at 1 year was higher for anti-CCP+ groups than other groups (p < 0.001).
The phenotype of patients with early arthritis with or without anti-CCP and/or RF positivity did not correspond to a particular clinical presentation. However, baseline acute-phase reactants and short-term radiographic progression were high in patients with anti-CCP positivity, which may be associated with the inflammatory process and progressive disease in patients with early arthritis.
No preview · Article · Jul 2014 · The Journal of Rheumatology
[Show abstract][Hide abstract] ABSTRACT: Data from the national French Renal Epidemiology and Information Network (REIN) registry were used to compare survival between transplant recipients under age 65 who resumed dialysis after graft failure during 2007-2009 and transplant-naïve incident dialysis patients matched for age, gender, diabetes mellitus, and year of starting dialysis. Among 911 transplant patients who returned to dialysis, 103 had died by 1 January 2011. Multivariate analysis showed that age over 48 years, coronary artery disease, peripheral artery disease, and inability to walk unassisted were significant predictors of death. In the case-control analysis, the observed mortality rates in 778 transplant failure and 778 transplant-naïve dialysis patients were 11.8 and 10.8%, respectively. Kaplan-Meier estimates of survival after transplant failure vs. the transplant-naïve controls were 95.2 vs. 94.1% at 1 year, 90.3 vs. 88.8% at 2 years, and 84.2 vs. 80.2% at 3 years (log rank P=0.197 overall). Dialysis in transplant failure vs. transplant-naïve patients was not associated with significantly increased mortality. At the start of dialysis, the serum creatinine levels and the rate of unplanned dialysis were significantly lower in transplant failure patients compared with transplant-naïve controls. Thus, in patients under 65 years of age in France, survival of dialysis patients after graft loss is similar to that of incident dialysis patients who have not undergone transplantation.Kidney International advance online publication, 19 February 2014; doi:10.1038/ki.2014.6.
No preview · Article · Feb 2014 · Kidney International
[Show abstract][Hide abstract] ABSTRACT: Compared to dialysis, kidney transplantation appears to be the best treatment for chronic kidney failure, even for older aged patients. Nevertheless, the individual benefit of transplanting elderly patients has to be balanced against the corresponding increase in the number of patients awaiting grafts.
We analyzed the excess mortality related to kidney transplant recipients by taking into account the expected mortality of the general population (additive regression model for relative survival). We applied this method to a cohort of patients who received a first deceased-donor kidney transplant between 1998 and 2009 in France (DIVAT, n=3641).
Overall 10-year mortality was 13%. As expected, recipient age was the main risk factor associated with overall mortality. In contrast, recipient age was no longer significantly associated with the excess of mortality related to kidney transplant status by subtracting the expected mortality of the general population. Delayed graft function (DGF), pre-transplantation immunization and past history of diabetes appeared as the main risk factors of this higher mortality rate.
Our results constitute a strong argument in favor of kidney transplantation regardless the patient's age. Preventing DGF may be more effective for decreasing the risk of death specifically attributable to the disease. This article is protected by copyright. All rights reserved.
Full-text · Article · Nov 2013 · Transplant International