Paul Strauss Comprehensive Cancer Center

Sainte-Foy-lès-Lyon, France

Paul Strauss Comprehensive Cancer Center

Sainte-Foy-lès-Lyon, France
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Nabholtz J.M.,University of Auvergne | Nabholtz J.M.,Clinical and Translational Research Division | Abrial C.,University of Auvergne | Abrial C.,Clinical and Translational Research Division | And 36 more authors.
Annals of Oncology | Year: 2014

Background: Triple negative breast cancer (TNBC) is a heterogeneous group of tumors for some of which the Epithelial Growth Factor Receptor (EGFR) pathway may play an important role. We investigated the efficacy and toxicity of an anti-EGFR antibody (panitumumab) combined with a standard neoadjuvant anthracycline-taxane based chemotherapy in patients with operable, stage II-III, TNBC. Methods: Treatment in this multicentric neoadjuvant pilot study consisted of panitumumab (9 mg/kg) for 8 cycles q.3 weeks combined with 4 cycles of 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC100: 500/100/500 mg/m2) q.3 weeks followed by 4 cycles of docetaxel (T: 100 mg/m2) q.3 weeks. Following therapy, all patients underwent surgical resection. Pathological complete response (pCR) in evaluable patients was the main endpoint while clinical response, toxicity and ancillary studies were secondary endpoints. Paraffinembedded and frozen tumor samples were systematically collected with the aim to identify predictive biomarkers of efficacy and resistance in order to select biologically defined subpopulations for potential further clinical development of the anti-EGFR antibody. Results: Sixty patients were enrolled with 47 assessable for pathologic response. The pathological complete response (pCR) rates were 46.8% [95% CI: 32.5-61.1] and 55.3% [95% CI: 41.1-69.5] according respectively to Chevallier and Sataloff classifications. The complete clinical response rate (cCR) was 37.5%. Conservative surgery was performed in 87% of cases. Toxicity was manageable. The association of high EGFR and low cytokeratin 8/18 expression in tumor cells on one hand and high density of CD8+ tumor-infiltrating lymphocytes on the other hand were significantly predictive of pCR. Conclusions: Panitumumab in combination with FEC100 followed by docetaxel appears efficacious, with acceptable toxicity, as neoadjuvant therapy of operable TNBC. Several biomarkers could help define large subsets of patients with high probability of pCR, suggesting a potential interest to further develop this combination in biologically defined subgroups of patients with TNBC. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

Dabakuyo T.S.,Biostatistics and Epidemiology Unit | Dabakuyo T.S.,University of Sfax | Dabakuyo T.S.,Quality of Life and Cancer Clinical Research Platform | Guillemin F.,French Institute of Health and Medical Research | And 18 more authors.
Quality of Life Research | Year: 2013

Purpose: To characterize response shift effects in patients with breast cancer (BC). Methods: The QLQ-C30, BR23, and EurQOL-EQ-5D were assessed at baseline and at the end of the first hospitalization. We used the then-test approach to characterize changes in internal standards by calculating the mean difference between the then-test (retrospective measure) and pre-test baseline QoL assessments. The Ideal Scale Approach was also used to assess changes in standards by comparing health and QoL expectancies between baseline and the end of the first hospitalization. Successive Comparison Approach was used to assess changes in values through the longitudinal assessment of the relative importance of EuroQOL dimensions. Results: The results of this study showed that recalibration RS effects occurred early after the first hospitalization for 6/15 dimensions of QLQ-C30 (emotional, cognitive, fatigue, insomnia, appetite loss, diarrhea) and 2/8 of BR-23 (future perspective, systemic therapy side effects). Moreover, health and QoL expectancies changed between the baseline and the end of the first hospitalization, and changes in values were seen for the self-care and usual activities dimensions of the EuroQOL-EQ-5D. Conclusions: The occurrence of RS early after the first hospitalization suggests that it needs to be taken into account to interpret QoL changes in BC. © 2012 Springer Science+Business Media B.V.

Quantin C.,Center Hospitalier University | Quantin C.,Teaching Hospital of Dijon | Quantin C.,University of Burgundy | Benzenine E.,Teaching Hospital of Dijon | And 6 more authors.
American Journal of Epidemiology | Year: 2013

Vaccine safety studies are increasingly conducted by using administrative health databases and self-controlled case series designs that are based on cases only. Often, several criteria are available to define the cases, which may yield different positive predictive values, as well as different sensitivities, and therefore different numbers of selected cases. The question then arises as to which is the best case definition. This article proposes new methodology to guide this choice based on the bias of the relative incidence and the power of the test. We apply this methodology in a validation study of 4 nested algorithms for identifying febrile convulsions from the administrative databases of 10 French hospitals. We used a sample of 695 children aged 1 month to 3 years who were hospitalized in 2008-2009 with at least 1 diagnosis code of febrile convulsions. The positive predictive values of the algorithms ranged from 81% to 98%, and their sensitivities were estimated to be 47%-99% in data from 1 large hospital. When applying our proposed methods, the algorithm we selected used a restricted diagnosis code and position on the discharge abstract. These criteria, which resulted in the selection of 502 cases with a positive predictive value of 95%, provided the best compromise between high power and low relative bias. © 2013 The Author.

Hanf M.,French Institute of Health and Medical Research | Hanf M.,University Paris - Sud | Quantin C.,Teaching Hospital of Dijon | Quantin C.,University of Burgundy | And 9 more authors.
Vaccine | Year: 2013

In the French national health insurance information system (SNIIR-AM), routine records of health claimed reimbursements are linked to hospital admissions for the whole French population. The main focus of this work is the usability of this system for vaccine safety assessment programme. Self-controlled case series analyses were performed using an exhaustive SNIIR-AM extraction of French children aged less than 3 years, to investigate the relationship between MMR immunization and children hospitalizations for febrile convulsions, a well-documented rare adverse event, over 2009-2010. The results suggest a significant increase of febrile convulsions during the 6-11 days period following any MMR immunization (IRR = 1.49, 95% CI = 1.22, 1.83; p= 0.0001) and no increase 15-35 days post any MMR immunization (IRR = 1.03, 95% CI = 0.89, 1.18; p= 0.72). These results are in accordance with other results obtained from large epidemiologic studies, which suggest the usability of the SNIIR-AM as a relevant database to study the occurrence of adverse events associated with immunization. For future use, results associated with risk of convulsion during the day of vaccination should nevertheless be considered with particular caution. © 2013 Elsevier Ltd.

Jegu J.,University of Strasbourg | Binder-Foucard F.,University of Strasbourg | Borel C.,Paul Strauss Comprehensive Cancer Center | Velten M.,University of Strasbourg | Velten M.,Paul Strauss Comprehensive Cancer Center
Oral Oncology | Year: 2013

Objectives: Patients with a head and neck squamous cell carcinoma (HNSCC) carry a high risk of second primary cancer (SPC). In recent years, a rise in incidence of human papillomavirus (HPV)-associated HNSCC has been recorded. Moreover, tobacco and alcohol consumption levels have changed and major advances have been made in radiation treatment approaches. This raises the question of a modification to the risk of SPC, taking into account variations of patient characteristics related to the HPV-cancer epidemic. Materials and methods: All patients with a first HNSCC diagnosed between 1975 and 2006 in the French Bas-Rhin region were followed up for 10 years. Multivariate Poisson regression models were used to model standardized incidence rates and excess absolute risks (EARs) over years of diagnosis, taking into account confounders such as sex, age, subsite of first HNSCC and follow-up. Results: Among these 6258 patients, 1326 presented with a SPC. High EAR values were observed for SPC of lung, head and neck, and esophagus sites (EAR of 172.8, 159.3 and 72.5 excess cancers per 10,000 person-years, respectively). Multivariate analysis showed that the excess risk of SPC of head and neck (P <.001) and esophagus (P =.029) sites decreased, with 53% lower EARs values in 2000-2006 compared to 1975-1979. In contrast, the excess risk of SPC of the lung did not change significantly (P =.174). Conclusions: Efforts made by public health policy-makers and oncology care providers should be sustained to develop effective smoking cessation interventions, as the excess risk of lung SPC remains high and unchanged. © 2012 Elsevier Ltd. All rights reserved.

Gonzalez M.,University of Strasbourg | Jegu J.,University of Strasbourg | Kopferschmitt M.-C.,University of Strasbourg | Donnay C.,University of Strasbourg | And 8 more authors.
Clinical and Experimental Allergy | Year: 2014

Introduction: An increased incidence of asthma has been reported among healthcare workers. The role of quaternary ammonium compounds (QACs), commonly used in cleaning/disinfection products, has not been clearly defined. The aim of this study was to analyse associations between asthma and occupational exposure to disinfectants, especially QACs. Methods: The study was performed on a stratified random sample of the various healthcare departments of 7 healthcare settings. The study included: questionnaire, physical examination and specific IgE assays. Occupational exposure assessment was performed by means of a work questionnaire, workplace studies and a review of products ingredients. Data were analysed by logistic regression. Results: Response rate was 77%; 543 workers (89% female) participated; 37.1% were registered nurses (RNs), 16.4% auxiliary nurses (ANs), 17.3% cleaners; 32.8% were atopic. 335 participants were exposed to QACs. Nursing professionals reported a significantly higher risk of reported physician-diagnosed asthma and, for RNs, of nasal symptoms at work than administrative staff working in healthcare sector. This risk was particularly marked during disinfection tasks and when exposure to QACs. Exposure to QACs increased significantly the risk of reported physician-diagnosed asthma and nasal symptoms at work (adjusted OR = 7.5 and 3.2, respectively). No significant association was found with other exposures such as latex glove use, chlorinated products/bleach or glutaraldehyde. Conclusion: RNs and ANs presented a higher risk of reported asthma than administrative staff. The highest risk was associated with tasks involving dilution of disinfection products by manual mixing, suggesting possible exposure to repeated peaks of concentrated products known to be strong respiratory irritants. Workplace interventions should be conducted to more clearly determine QAC exposure and improve disinfection procedures. © 2013 John Wiley & Sons Ltd.

Boudas R.,University of Strasbourg | Jegu J.,University of Strasbourg | Grollemund B.,University of Strasbourg | Quentel E.,University of Strasbourg | And 4 more authors.
Health and Quality of Life Outcomes | Year: 2013

Background: The IOFS (Impact On Family Scale) questionnaire is a useful instrument to assess the impact of chronic childhood conditions on general family quality of life. As this instrument was not validated in French, we proposed to translate, adapt and validate the IOFS questionnaire for clinical and research use in French-speaking populations.Findings: The sample studied comprised French-speaking parents with a child presenting a cleft lip or cleft lip and palate, aged 6 to 12 years and treated in the University Hospital of Strasbourg, France. The 15-item version of the IOFS was translated into French and then sent to the parents by post. The structure of the measure was studied using Exploratory Factor Analysis (EFA), internal consistency was assessed using Cronbach's alpha coefficient and test-retest reliability was studied by calculating the Intraclass Correlation Coefficient (ICC).A total of 209 parents answered the questionnaire. Its acceptability was good, with 67.9% of mothers and 59.9% of fathers answering the questionnaire. EFA identified one main factor that explained 77% of the variance. Internal consistency was good, with a Cronbach's alpha of 0.93. Finally, the ICC values were 0.77 (95% confidence interval 0.66-0.85) and 0.87 (95% confidence interval 0.80-0.92) for inter- and intra-observer reliability respectively.Conclusions: The French version of the IOFS questionnaire exhibited very good psychometric properties. For practitioners, this instrument will facilitate the assessment of the impact of chronic childhood conditions on quality of life among French-speaking families. © 2013 Boudas et al.; licensee BioMed Central Ltd.

Le Borgne G.,University of Franche Comte | Mercier M.,University of Franche Comte | Mercier M.,University Hospital Jean Minjoz | Woronoff A.-S.,University Hospital Jean Minjoz | And 7 more authors.
Gynecologic Oncology | Year: 2013

Objectives To assess long-term quality of life (QOL) in cervical cancer survivors (CCSs), 5, 10, and 15 years after diagnosis. Methods In a cross-sectional population-based study, CCSs diagnosed in 1990, 1995, or 2000 were randomly selected from 3 tumor registries in France. Healthy controls were randomly selected from electoral rolls, stratifying on age group and residence area. Five QOL questionnaires (SF-36, EORTC QLQ-C30, the cervical cancer-specific module (EORTC QLQ-CX24), the MFI fatigue questionnaire, the STAI for anxiety) and a life condition questionnaire were used. Analysis of variance was used to compare QOL scores of survivors by period of diagnosis (5, 10, and 15 years) with those of controls and according to treatment modality, adjusted for socio-demographic data. Results A total of 173 localized CCSs (42% treated with surgery alone and 58% with a combination of treatments) and 594 controls participated in the study. Compared with controls, CCSs expressed globally similar good QOL, except for impaired psychoemotional domains in 15-year survivors (p < 0.01). Worsening of some symptoms was observed over time, 15-year survivors in particular reported significantly more lymphedema than 5-year (p = 0.0009) and 10-year CCSs (p = 0.002). Compared with CCSs treated by surgery alone, QOL of CCSs who received radiotherapy was significantly more affected in terms of cervical cancer specific problems, such as sexual dysfunction (p = 0.002), voiding and abdominal symptoms (p = 0.01), and lymphedema (p = 0.01). Conclusions Even after 15 years, QOL of CCSs is impacted in psychological domains, compared with healthy controls. Among CCSs, women treated by adjuvant radiotherapy expressed more physical sequelae. © 2012 Elsevier Inc.

Klein D.,University of Strasbourg | Mercier M.,University of Franche Comte | Mercier M.,University Hospital Jean Minjoz | Abeilard E.,Francois Baclesse Comprehensive Cancer Center | And 10 more authors.
Breast Cancer Research and Treatment | Year: 2011

Population-based studies on quality of life (QOL) of long-term breast cancer survivors are quite recent and insufficient attention has been paid to the effect of time since diagnosis. We compared long-term QOL of population-based breast cancer survivors 5, 10, and 15 years after diagnosis with that of healthy controls. Breast cancer survivors were randomly selected from three population-based cancer registries (Bas-Rhin, Calvados and Doubs, France) along with healthy controls, stratified for age and place of residence, randomly selected from electoral rolls. Participants completed five self-administered questionnaires: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Short Form-36 (SF-36), Spielberger State-Trait Anxiety Inventory (STAI), Multidimensional Fatigue Inventory (MFI) and a life conditions questionnaire. An analysis of variance was used to compare QOL scores of breast cancer survivors by period (5, 10, or 15 years) of diagnosis with those of controls, adjusted for sociodemographic data and comorbidities. Six hundred and fifty-two cases and 1,188 controls participated in the study. For many QOL scales, scores were significantly different between cancer survivors and controls. A clinically significant difference was evidenced for the fatigue scales, the SF36 physical functioning, role-physical, and role-emotional scales, with more favorable results for controls. Differences decreased with time and 15-year cancer survivors were generally not different from controls. Scores were particularly influenced by age and mean household income. More efforts should be made, specifically during the first 5 to 10 years after diagnosis, to help women with breast cancer to overcome their impairment in QOL. © 2011 Springer Science+Business Media, LLC.

Caravati-Jouvenceaux A.,University of Franche Comte | Caravati-Jouvenceaux A.,University Hospital Jean Minjoz | Launoy G.,University of Caen Lower Normandy | Klein D.,University of Strasbourg | And 8 more authors.
Oncologist | Year: 2011

Background. The number of long-term colorectal cancer survivors is increasing. Cancer and its treatment can cause physical and psychological complications, but little is known about how it impacts quality of life (QOL) over the long term-5, 10, and 15 years after diagnosis. Methods. Cancer survivors were randomly selected from three tumor registries in France, diagnosed in 1990 (±1 year), 1995 (±1 year), and 2000 (±1 year). Controls were randomly selected from electoral rolls, stratifying on gender, age group, and residence area. Participants completed two QOL questionnaires, a fatigue questionnaire, an anxiety questionnaire, and a life conditions questionnaire. An analysis of variance was used to compare QOL scores of cancer survivors by period of diagnosis (5, 10, and 15 years) with those of controls, adjusted for sociodemographic data and comorbidities. Results. We included 344 colon cancer and 198 rectal cancer survivors and 1,181 controls. In a global analysis, survivors reported a statistically and clinically significant lower score in social functioning 5 years after diagnosis and higher scores in diarrhea symptoms 5 and 10 years after diagnosis. In subgroup analyses, rectal cancer affected QOL in the physical dimensions at 5 years and in the fatigue dimensions at 5 and 10 years. Conclusion. Survivors of colorectal cancer may experience the effects of cancer and its treatment up to 10 years after diagnosis, particularly for rectal cancer. Clinicians, psychologists, and social workers must pay special attention to rectal cancer survivors to improve overall management. © AlphaMed Press.

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