Center clerc

Dijon, France

Center clerc

Dijon, France
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PubMed | EORTC Headquarters, Institute Bergonie, Dana-Farber Cancer Institute, University of Groningen and 6 more.
Type: Clinical Trial, Phase II | Journal: European journal of cancer (Oxford, England : 1990) | Year: 2015

To evaluate whether trabectedin as first-line chemotherapy for advanced/metastatic soft tissue sarcoma prolongs progression-free survival (PFS), compared to doxorubicin and, in the phase IIb part here, to select the most appropriate trabectedin treatment schedule (3-hour or 24-hour infusion) in terms of safety, convenience and efficacy.In this randomised multicentre prospective dose-selection phase IIb superiority trial, 133 patients were randomised between doxorubicin (n=43), trabectedin (3-hour infusion, T3h) (n=47) and trabectedin (24-hour infusion, T24h) (n=43). PFS was defined as time from random assignment until objective progression by response evaluation criteria in solid tumours (RECIST 1.1), a global deterioration of the health status requiring discontinuation of the treatment, or death from any cause.The study was terminated due to lack of superiority in both trabectedin treatment arms as compared to the doxorubicin control arm. Median PFS was 2.8months in the T3h arm, 3.1months in the T24h arm and 5.5months in the doxorubicin arm. No significant improvements in PFS were observed in the trabectedin arms as compared to the doxorubicin arm (T24h versus doxorubicin: hazard ratio (HR) 1.13, 95% confidence interval (CI) 0.67-1.90, P=.675; T3h versus doxorubicin: HR 1.50, 95% CI 0.91-2.48, P=.944). Only one toxic death occurred in the T3h arm, but treatment had to be stopped due to toxicity in 7 (15.2%) (T3h), 8 (19.5%) (T24h) and 1 (2.5%) doxorubicin patients.Doxorubicin continues to be the standard treatment in eligible patients with advanced/metastatic soft-tissue sarcoma (STS). Trabectedin 1.5mg/m(2)/24-hour infusion is the overall proven approach to delivering this agent in the second-line setting for patients with advanced or metastatic STS.


Bourhis J.,Institute Gustave Roussy | Sire C.,Center Hospitalier Of Lorient | Graff P.,Center Alexis Vautrin | Gregoire V.,Catholic University of Leuven | And 24 more authors.
The Lancet Oncology | Year: 2012

Background: Concomitant chemoradiotherapy and accelerated radiotherapy independently improve outcomes for patients with locally advanced head and neck squamous-cell carcinoma (HNSCC). We aimed to assess the efficacy and safety of a combination of these approaches. Methods: In our open-label phase 3 randomised trial, we enrolled patients with locally advanced, stage III and IV (non-metastatic) HNSCC and an Eastern Cooperative Oncology Group performance status of 0-2. We randomly allocated patients centrally with a computer program (with centre, T stage, N stage, and localisation as minimisation factors) in a 1:1:1 ratio to receive conventional chemoradiotherapy (70 Gy in 7 weeks plus three cycles of 4 days' concomitant carboplatin-fluorouracil), accelerated radiotherapy-chemotherapy (70 Gy in 6 weeks plus two cycles of 5 days' concomitant carboplatin-fluorouracil), or very accelerated radiotherapy alone (64·8 Gy [1·8 Gy twice daily] in 3·5 weeks). The primary endpoint, progression-free survival (PFS), was assessed in all enrolled patients. This trial is completed. The trial is registered with ClinicalTrials.gov, number NCT00828386. Findings: Between Feb 29, 2000, and May 9, 2007, we randomly allocated 279 patients to receive conventional chemoradiotherapy, 280 to accelerated radiotherapy-chemotherapy, and 281 to very accelerated radiotherapy. Median follow-up was 5·2 years (IQR 4·9-6·2); rates of chemotherapy and radiotherapy compliance were good in all groups. Accelerated radiotherapy-chemotherapy offered no PFS benefit compared with conventional chemoradiotherapy (HR 1·02, 95% CI 0·84-1·23; p=0·88) or very accelerated radiotherapy (0·83, 0·69-1·01; p=0·060); conventional chemoradiotherapy improved PFS compared with very accelerated radiotherapy (0·82, 0·67-0·99; p=0·041). 3-year PFS was 37·6% (95% CI 32·1-43·4) after conventional chemoradiotherapy, 34·1% (28·7-39·8) after accelerated radiotherapy-chemotherapy, and 32·2% (27·0-37·9) after very accelerated radiotherapy. More patients in the very accelerated radiotherapy group had RTOG grade 3-4 acute mucosal toxicity (226 [84%] of 268 patients) compared with accelerated radiotherapy-chemotherapy (205 [76%] of 271 patients) or conventional chemoradiotherapy (180 [69%] of 262; p=0·0001). 158 (60%) of 265 patients in the conventional chemoradiotherapy group, 176 (64%) of 276 patients in the accelerated radiotherapy-chemotherapy group, and 190 (70%) of 272 patients in the very accelerated radiotherapy group were intubated with feeding tubes during treatment (p=0·045). Interpretation: Chemotherapy has a substantial treatment effect given concomitantly with radiotherapy and acceleration of radiotherapy cannot compensate for the absence of chemotherapy. We noted the most favourable outcomes for conventional chemoradiotherapy, suggesting that acceleration of radiotherapy is probably not beneficial in concomitant chemoradiotherapy schedules. Funding: French Ministry of Health. © 2012 Elsevier Ltd.


Martin F.,University of Burgundy | Ladoire S.,University of Burgundy | Ladoire S.,Center clerc | Mignot G.,University of Burgundy | And 3 more authors.
Oncogene | Year: 2010

FOXP3 is a transcription factor necessary and sufficient for induction of the immunosuppressive functions in regulatory T lymphocytes. Its expression was first considered as specific of this cell type, but FOXP3 can also be transiently expressed in T-cell antigen receptor-activated human nonregulatory T cells. Recent data indicate that FOXP3 is also expressed by some nonlymphoid cells, in which it can repress various oncogenes that are restored following FOXP3 deletion or mutation. This review summarizes major advances in (1) the understanding of Foxp3 functions in human regulatory T cells, (2) the prognostic significance of Foxp3-expressing T cells in human malignancies and (3) the significance of Foxp3 expression in human tumor cells. © 2010 Macmillan Publishers Limited All rights reserved.


PubMed | Medical Oncology and Radiation, University of Barcelona, Sharp Corporation, St. John's University and 5 more.
Type: Journal Article | Journal: Journal of pain and symptom management | Year: 2014

Demographic, personal, clinical, and behavioral factors predicting chemotherapy-induced nausea and vomiting (CINV) have been assessed in the past, but inconsistencies exist in the literature, studies have methodological shortcomings, and many risk factors have been examined in cross-sectional studies and univariate analyses.To evaluate the predictive power of personal and treatment-related characteristics in the development of CINV, using a large and prospectively evaluated sample of a heterogeneous group of cancer patients receiving routine chemotherapy.This was a multicountry, multisite prospective study over three cycles of chemotherapy. Adult patients from eight European countries about to receive highly and moderately emetogenic chemotherapy were recruited. Clinicians completed a case report form at or before the initial chemotherapy treatment, recording patient demographic and baseline clinical characteristics. Participants completed a daily patient diary for six days per chemotherapy cycle describing their CINV experience. Baseline patient data also included a history of nausea/vomiting (yes/no), patient expectation of nausea (0-100mm visual analogue scale [VAS]), prechemotherapy anxiety (0-100mm VAS), and prechemotherapy nausea (0-100mm VAS) measured during the 24-hour period before chemotherapy initiation.There were 991 evaluable patients with complete Cycle 1 data, 888 for Cycle 2 data, and 769 for Cycle 3 data. A complex picture of predictor variables was shown, with different contribution of variables to the acute, delayed, and overall phases of CINV. Key predictor variables included the use of antiemetics inconsistent with international guidelines, younger age, prechemotherapy nausea, and no CINV complete response in an earlier cycle (all at P<0.05). Anxiety, history of nausea/vomiting, and expectations of nausea were important predictors for some phases and cycles but not consistently across the CINV pathway.The results of this study provide clarity for the relative contribution of a set of characteristics in the development of CINV. Following evidence-based clinical antiemetic guidelines is of paramount importance, alongside treating patients with increased risk for CINV more aggressively, which both could lead to more optimal CINV management. These data can assist clinicians in making decisions about the antiemetic management of their patients.


Penault-Llorca F.,Center Jean Perrin | Penault-Llorca F.,University dAuvergne | Arnould L.,Center clerc
Bulletin du Cancer | Year: 2010

To refine available epidemiological data in early breast cancer, a national and retrospective study analyzed 1,934 cases listed between May and July 2007 by 88 French centers. More than one third of patients had less than 50 years old (26%) or more than 74 (15%). The anatomopathological tumors' characteristics were as following: ≤ 2 cm in 62% of cases, lymphatic invasion in 35% of cases, positive hormone receptors in 85% of cases, and SBR grade III in 18% of cases. The assessment of HER2 status, performed in 1,899 cases (98%), showed at least 12.1% of early stage HER2 positive tumors. HER2 overexpression was higher before 50 years old (15.9 versus 11.5% between 50 and 70 years, and 10.0% if ≥ 70 years old), for the largest tumors (pT2/3/4:15.9%, ≤ 1 cm: 11.4%, between 1 and 2 cm: 9.0%) or for a high SBR grade (III: 24.7%, II: 12.1%, I: 3.5%). This study allowed to emphasize the prevalence of HER2 overexpression in elderly patients and for small size tumors. © John Libbey Eurotext.


Chibon F.,Institute Bergonie | Chibon F.,French Institute of Health and Medical Research | Lagarde P.,Institute Bergonie | Lagarde P.,French Institute of Health and Medical Research | And 21 more authors.
Nature Medicine | Year: 2010

Sarcomas are heterogeneous and aggressive mesenchymal tumors. Histological grading has so far been the best predictor for metastasis-free survival, but it has several limitations, such as moderate reproducibility and poor prognostic value for some histological types. To improve patient grading, we performed genomic and expression profiling in a training set of 183 sarcomas and established a prognostic gene expression signature, complexity index in sarcomas (CINSARC), composed of 67 genes related to mitosis and chromosome management. In a multivariate analysis, CINSARC predicts metastasis outcome in the training set and in an independent 127 sarcomas validation set. It is superior to the Fédération Francaise des Centres de Lutte Contre le Cancer grading system in determining metastatic outcome for sarcoma patients. Furthermore, it also predicts outcome for gastrointestinal stromal tumors (GISTs), breast carcinomas and lymphomas. Application of the signature will permit more selective use of adjuvant therapies for people with sarcomas, leading to decreased iatrogenic morbidity and improved outcomes for such individuals. © 2010 Nature America, Inc. All rights reserved.


Objective: To evaluate the impact of a training workshop on residents and senior registrar skill in repair of anal sphincter and rectal mucosae obstetrical injury. Material and methods: Residents and senior registrar practical and theoretical knowledge were evaluated by a questionnaire sent, using AGOF (association des gynécologues-obstétriciens en formation) mailing list. This questionnaire includes questions about epidemiology, risk factors and sutures types. Scores were compared according to the participation or not at the workshop. Results: There were 106 residents or senior registrar (48.4%) in the workshop group and 113 (51.6%) in the control group. Scores were significantly higher in the workshop group than in the control group for theoretical knowledge (4.1 vs. 3.7), practical knowledge (17.6 vs. 15.9) and global scores (21.7 vs. 19.7). There was no difference according to the participation before or after the third residency semester. Residents global scores were statistically higher in the workshop group compared to the control group (21.8 vs. 19.5) but there was no significant difference between the senior registrar of the two group. Participants in the workshop group estimate themselves significantly more efficient than in the control group concerning anal sphincter injury repair and rectal mucosae repair. Conclusion: A training workshop seems to improve the theoretical and practical skill. Level of evidence: 4. © 2013 Elsevier Masson SAS.


Schmitz S.,Catholic University of Leuven | Kaminsky-Forrett M.-C.,Center Alexis Vautrin | Henry S.,Catholic University of Leuven | Zanetta S.,Center clerc | And 9 more authors.
Annals of Oncology | Year: 2012

Background: Preclinical studies suggest that insulin-like growth factor-1 receptor (IGF-1R) blockage could be a promising therapeutic target in squamous cell carcinoma of the head and neck (SCCHN). Therefore, we investigated the efficacy and toxicity of figitumumab, an anti-IGF-1R monoclonal antibody, in palliative SCCHN. Patients and methods: Patients with palliative SCCHN progressing after platinum-based therapy were treated with figitumumab i.v. 20 mg/kg, every 3 weeks. The primary end point was the disease control rate at 6-8 weeks after treatment initiation. Tumor biopsies and plasma samples were collected before and after figitumumab administration to monitor the molecular response. Results: Seventeen patients were included. Only two patients achieved stable disease at 6-8 weeks. Median overall survival and progression-free survival were 63 and 52 days, respectively. The main grade 3-4 adverse event was hyperglycemia (41%). Translational research showed that figitumumab downregulated IGF-1R at the surface of tumor cells with activation of the epidermal growth factor receptor (EGFR) pathway, as shown by the upregulation of p-EGFR in tumor cells (P = 0.016), and an increase in the plasma level of tumor growth factor-alpha (P = 0.006). Conclusion: Figitumumab monotherapy has no clinically significant activity in unselected palliative SCCHN. © The Author 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.


PubMed | Toulouse University Hospital Center, AGOF, Center clerc, Nimes University Hospital Center and University of Montréal
Type: Journal Article | Journal: Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie | Year: 2014

To evaluate the impact of a training workshop on residents and senior registrar skill in repair of anal sphincter and rectal mucosae obstetrical injury.Residents and senior registrar practical and theoretical knowledge were evaluated by a questionnaire sent, using AGOF (association des gyncologues-obsttriciens en formation) mailing list. This questionnaire includes questions about epidemiology, risk factors and sutures types. Scores were compared according to the participation or not at the workshop.There were 106 residents or senior registrar (48.4%) in the workshop group and 113 (51.6%) in the control group. Scores were significantly higher in the workshop group than in the control group for theoretical knowledge (4.1 vs. 3.7), practical knowledge (17.6 vs. 15.9) and global scores (21.7 vs. 19.7). There was no difference according to the participation before or after the third residency semester. Residents global scores were statistically higher in the workshop group compared to the control group (21.8 vs. 19.5) but there was no significant difference between the senior registrar of the two group. Participants in the workshop group estimate themselves significantly more efficient than in the control group concerning anal sphincter injury repair and rectal mucosae repair.A training workshop seems to improve the theoretical and practical skill.4.


Molassiotis A.,Hong Kong Polytechnic University | Aapro M.,Medical Oncology and Radiation | Dicato M.,Luxembourg Medical Center | Gascon P.,University of Barcelona | And 5 more authors.
Journal of Pain and Symptom Management | Year: 2014

Context Demographic, personal, clinical, and behavioral factors predicting chemotherapy-induced nausea and vomiting (CINV) have been assessed in the past, but inconsistencies exist in the literature, studies have methodological shortcomings, and many risk factors have been examined in cross-sectional studies and univariate analyses. Objectives To evaluate the predictive power of personal and treatment-related characteristics in the development of CINV, using a large and prospectively evaluated sample of a heterogeneous group of cancer patients receiving routine chemotherapy. Methods This was a multicountry, multisite prospective study over three cycles of chemotherapy. Adult patients from eight European countries about to receive highly and moderately emetogenic chemotherapy were recruited. Clinicians completed a case report form at or before the initial chemotherapy treatment, recording patient demographic and baseline clinical characteristics. Participants completed a daily patient diary for six days per chemotherapy cycle describing their CINV experience. Baseline patient data also included a history of nausea/vomiting (yes/no), patient expectation of nausea (0-100 mm visual analogue scale [VAS]), prechemotherapy anxiety (0-100 mm VAS), and prechemotherapy nausea (0-100 mm VAS) measured during the 24-hour period before chemotherapy initiation. Results There were 991 evaluable patients with complete Cycle 1 data, 888 for Cycle 2 data, and 769 for Cycle 3 data. A complex picture of predictor variables was shown, with different contribution of variables to the acute, delayed, and overall phases of CINV. Key predictor variables included the use of antiemetics inconsistent with international guidelines, younger age, prechemotherapy nausea, and no CINV complete response in an earlier cycle (all at P < 0.05). Anxiety, history of nausea/vomiting, and expectations of nausea were important predictors for some phases and cycles but not consistently across the CINV pathway. Conclusion The results of this study provide clarity for the relative contribution of a set of characteristics in the development of CINV. Following evidence-based clinical antiemetic guidelines is of paramount importance, alongside treating patients with increased risk for CINV more aggressively, which both could lead to more optimal CINV management. These data can assist clinicians in making decisions about the antiemetic management of their patients. © 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

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