Joué-lés-Tours, France
Joué-lés-Tours, France

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Senat M.-V.,Center for Research in Epidemiology and Population Health | Porcher R.,French Institute of Health and Medical Research | Deruelle P.,Hopital Jeanne de Flandre | Perrotin F.,Hopital Bretonneau | And 4 more authors.
American Journal of Obstetrics and Gynecology | Year: 2013

Objective: The objective of the study was to evaluate the use of 17 alpha-hydroxyprogesterone caproate (17P) to reduce preterm delivery in women with a twin pregnancy and short cervix. Study Design: This open-label, multicenter, randomized controlled trial included women with a twin pregnancy between 24+0 and 31+6 weeks of gestation who were asymptomatic and had a cervical length of 25 mm or less measured by routine transvaginal ultrasound. Women were randomized to receive (or not) 500 mg of intramuscular 17P, repeated twice weekly until 36 weeks or preterm delivery. The primary outcome was time from randomization to delivery. Analysis was performed according to the intent-to-treat principle. Results: The 17P and control groups did not differ significantly for median [interquartile range] time to delivery: 45 (26-62) and 51 (36-66) days, respectively. However, treatment with 17P was associated with a significant increase in the rate of preterm delivery before 32 weeks. Conclusion: Twice-weekly injections of 17P did not prolong pregnancy significantly in asymptomatic women with a twin pregnancy and short cervix. © 2013 Mosby, Inc.


Fizazi K.,Institute Gustave Roussy | Faivre L.,Institute Gustave Roussy | Lesaunier F.,Center Francois Baclesse | Delva R.,Institute Of Cancerologie Of Louest | And 27 more authors.
The Lancet Oncology | Year: 2015

Background: Early risk-stratified chemotherapy is a standard treatment for breast, colorectal, and lung cancers, but not for high-risk localised prostate cancer. Combined docetaxel and estramustine improves survival in patients with castration-resistant prostate cancer. We assessed the effects of combined docetaxel and estramustine on relapse in patients with high-risk localised prostate cancer. Methods: We did this randomised phase 3 trial at 26 hospitals in France. We enrolled patients with treatment-naive prostate cancer and at least one risk factor (ie, stage T3-T4 disease, Gleason score of ≥8, prostate-specific antigen concentration >20 ng/mL, or pathological node-positive). All patients underwent a staging pelvic lymph node dissection. Patients were randomly assigned (1:1) to either androgen deprivation therapy (ADT; goserelin 10·8 mg every 3 months for 3 years) plus four cycles of docetaxel on day 2 at a dose of 70 mg/m2 and estramustine 10 mg/kg per day on days 1-5, every 3 weeks, or ADT only. The randomisation was done centrally by computer, stratified by risk factor. Local treatment was administered at 3 months. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was relapse-free survival in the intention-to-treat population. Follow-up for other endpoints is ongoing. This study is registered with ClinicalTrials.gov, number NCT00055731. Findings: We randomly assigned 207 patients to the ADT plus docetaxel and estramustine group and 206 to the ADT only group. Median follow-up was 8·8 years (IQR 8·1-9·7). 88 (43%) of 207 patients in the ADT plus docetaxel and estramustine group had an event (relapse or death) versus 111 (54%) of 206 in the ADT only group. 8-year relapse-free survival was 62% (95% CI 55-69) in the ADT plus docetaxel and estramustine group versus 50% (44-57) in the ADT only group (adjusted hazard ratio [HR] 0·71, 95% CI 0·54-0·94, p=0·017). Of patients who were treated with radiotherapy and had data available, 31 (21%) of 151 in the ADT plus docetaxel and estramustine group versus 26 (18%) of 143 in the ADT only group reported a grade 2 or higher long-term side-effect (p=0·61). We recorded no excess second cancers (26 [13%] of 207 vs 22 [11%] of 206; p=0·57), and there were no treatment-related deaths. Interpretation: Docetaxel-based chemotherapy improves relapse-free survival in patients with high-risk localised prostate cancer. Longer follow-up is needed to assess whether this benefit translates into improved metastasis-free survival and overall survival. Funding: Ligue Contre le Cancer, Sanofi-Aventis, AstraZeneca, Institut National du Cancer. © 2015 Elsevier Ltd.


Cognard C.,Hopital Purpan | Herbreteau D.,Hopital Bretonneau | Fransen H.,AZ Sint Lukas and Volkskliniek | Van Rooij W.J.,Elisabeth Ziekenhuis | And 8 more authors.
European Radiology | Year: 2013

Objectives: To evaluate the safety and efficacy of a new liquid embolic agent in brain arteriovenous malformation (bAVMs) embolisation. Methods: A prospective, multicentre series was conducted at 11 interventional centres in Europe to evaluate embolisation of bAVMs with the new liquid embolic agent. Technical conditions, complications, clinical outcome and anatomical results were independently analysed. Results: From December 2005 to December 2008, 117 patients (72 male; 45 female, aged 18-75 years) were included. Clinical presentation was mostly haemorrhage (34.2 %) and seizures (28.2 %). Most AVMs were located in the brain hemispheres (85.5 %). AVMs were <3 cm in 52.1 % of patients and ≥3 cm in 47.9 %. Morbidity was observed in 6/117 patients (5.1 %), related to haemorrhagic events in 2 cases and non-haemorrhagic complications in 4 cases. Five patients (4.3 %) died in relation to the treatment (bleeding in 4 patients and extensive venous thrombosis in 1). Complete occlusion of the AVM by embolisation alone was obtained in 23.5 % of patients. Complementary treatment was performed in 82.3 % of patients with partial AVM occlusion, mostly radiosurgery. Conclusions: In this prospective, multicentre, European, observational series, the new liquid embolic agent proved to be suitable for BAVM embolisation, with acceptable morbidity and mortality and good efficacy. Key Points: • Numerous interventional techniques have been used to embolise brain arteriovenous malformations (AVMs). • This prospective multicentre study demonstrates the suitability of a liquid embolic agent. • The safety of treatment using Onyx is acceptable. • Such embolisation leads to complete AVM occlusion in 23.5 % of patients. © 2013 European Society of Radiology.


Toledano I.,Center Jean Perrin | Graff P.,Center Alexis Vautrin | Graff P.,University of Lorraine | Serre A.,Center Val dAurelle | And 11 more authors.
Radiotherapy and Oncology | Year: 2012

Background and purpose: In 2003, the French Authority for Health (HAS) recommended the use of intensity modulated radiotherapy (IMRT) in prospective trial before its routine use. The Oncology and Radiotherapy Group for Head and Neck Cancer (GORTEC) proposed to evaluate prospectively acute and late toxicities, locoregional control and overall survival for patients treated for head and neck cancer (HNC) with IMRT and bilateral neck irradiation. Materials and methods: Between 2002 and 2008, 208 patients with HNC were treated with IMRT in 8 centres. There were 38 nasopharynx, 117 oropharynx, 25 pharyngo-larynx, 24 oral cavity and 4 unknown primary (28.5% stage I-II and 71% Stage III-IV). Ninety-three patients (46%) had postoperative IMRT and 78 patients (37.5%) received concurrent chemotherapy. The doses were 70 Gy to the gross tumour, 66 Gy to the high-risk postoperative sites and 50 Gy to the subclinical disease. Toxicities were graded according to the RTOG-EORTC scales. Results: The median follow-up was 25.3 months (range: 0.4-72 months). There were 29 local-regional failures: 24 were in-field, three were marginal and one was out-field. The two-year loco-regional control and overall survival were 86% and 86.7%, respectively. At 18 months, grade ≥2 xerostomia was 16.1%. A mean dose to the spared parotid below 28 Gy led to significantly less grade ≥2 xerostomia (8.5% vs 24%) with a relative risk of 1.2 [95% CI: 1.02-1.41, p = 0.03]. Grade ≥2 xerostomia increased by approximately 3% per Gy of mean parotid dose up to 28, Gy then 7% per Gy above 33 Gy. Conclusions: IMRT for HN cancer seems to reduce late toxicities without jeopardising local control and overall survival. © 2012 Elsevier Ireland Ltd. All rights reserved.


Mallet Y.,Center Oscar Lambret | Moriniere S.,Hopital Bretonneau | Ceruse P.,Hopital Lyon Sud | El Bedoui S.,Center Oscar Lambret
Bulletin du Cancer | Year: 2010

Robotic assisted surgery is a new field of developing program for many specialities. As to head and neck oncology, the new procedure potentially offers alternatives to conventional surgery with decreased morbidity. The aim of this article is a description of the state of the art via a review of the literature. We emphasize limits and future prospects on this topic with a special focus on dependability. Transoral robotic surgery (TORS) is a promising surgical procedure contingent on the development of new associated functions like an image guidance system or a force feedback control. The good developing of this new tool will also depend on the quality of clinical works and research programs. ©John Libbey Eurotext.


Attal M.,Hopital Purpan | Lauwers-Cances V.,Hopital Purpan | Marit G.,Hopital Haut Leveque | Caillot D.,Center Hospitalier Le Bocage | And 19 more authors.
New England Journal of Medicine | Year: 2012

BACKGROUND: High-dose chemotherapy with autologous stem-cell transplantation is a standard treatment for young patients with multiple myeloma. Residual disease is almost always present after transplantation and is responsible for relapse. This phase 3, placebocontrolled trial investigated the efficacy of lenalidomide maintenance therapy after transplantation. METHODS:We randomly assigned 614 patients younger than 65 years of age who had nonprogressive disease after first-line transplantation to maintenance treatment with either lenalidomide (10 mg per day for the first 3 months, increased to 15 mg if tolerated) or placebo until relapse. The primary end point was progression-free survival. RESULTS:Lenalidomide maintenance therapy improved median progression-free survival (41 months, vs. 23 months with placebo; hazard ratio, 0.50; P<0.001). This benefit was observed across all patient subgroups, including those based on the β 2- microglobulin level, cytogenetic profile, and response after transplantation. With a median follow-up period of 45 months, more than 70% of patients in both groups were alive at 4 years. The rates of grade 3 or 4 peripheral neuropathy were similar in the two groups. The incidence of second primary cancers was 3.1 per 100 patient-years in the lenalidomide group versus 1.2 per 100 patient-years in the placebo group (P = 0.002). Median event-free survival (with events that included second primary cancers) was significantly improved with lenalidomide (40 months, vs. 23 months with placebo; P<0.001). CONCLUSIONS:Lenalidomide maintenance after transplantation significantly prolonged progression-free and event-free survival among patients with multiple myeloma. Four years after randomization, overall survival was similar in the two study groups. (Funded by the Programme Hospitalier de Recherche Clinique and others; ClinicalTrials.gov number, NCT00430365.) Copyright © 2012 Massachusetts Medical Society.


Chassagnon G.,Hopital Bretonneau | Favelle O.,Hopital Bretonneau | Marchand-Adam S.,Hopital Bretonneau | De Muret A.,Hopital Trousseau | Revel M.P.,University of Paris Descartes
Clinical Radiology | Year: 2015

Diffuse idiopathic pulmonary neuroendocrine cell hyperplasia (DIPNECH) is an under-recognized disease characterized by proliferation of neuroendocrine cells in the bronchial wall. It is considered a pre-invasive lesion for lung carcinoid tumours and is found in 5.4% of patients undergoing surgical resection for lung carcinoid tumours. Other manifestations of DIPNECH include bronchial obstruction and formation of tumorlets. DIPNECH preferentially affects middle-aged women. Patients are either asymptomatic or present with long-standing dyspnoea due to obstructive syndrome that can be mistaken for asthma. At CT, mosaic attenuation with multiple small nodules is very suggestive of DIPNECH. The aim of this review is to describe DIPNECH-related CT features and correlate them with histology, in order to help radiologists suggest this diagnosis and distinguish DIPNECH from other causes of mosaic perfusion. © 2014 The Royal College of Radiologists.


Blasinska-Morawiec M.,University of Lodz | Tubiana-Mathieu N.,Limoges University Hospital Center | Fougeray R.,Pierre Fabre | Pinel M.-C.,Pierre Fabre | Bougnoux P.,Hopital Bretonneau
Breast | Year: 2013

Purpose: This open label phase II study evaluated the safety and efficacy of vinflunine in patients with breast cancer previously treated with a vinorelbine-based regimen and who progressed during or within 6 months of completing this chemotherapy. Patients and methods: Thirty eight patients received vinflunine 320 mg/m2 once every 3 weeks. The primary efficacy endpoint was overall response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety. Results: ORR was 8.3% (95% CI: 1.75-22.4) and DCR was 75% (95% CI: 57.8-87.9). PFS was 4.0 months (95% CI: 2.5-6.1) and OS was 13.6 months (95% CI: 8.7-18.9).Toxicities not hampering dose intensity were as expected neutropenia (75.6% of patients), fatigue (44.7%), constipation (28.9%) and abdominal pain (26.3%). Conclusion: Vinflunine demonstrated antitumour activity and can be safely administered in breast cancer patients refractory/resistant to vinorelbine. © 2012 Elsevier Ltd.


Ouldamer L.,Hopital Bretonneau | Marret H.,Hopital Bretonneau
Journal de Gynecologie Obstetrique et Biologie de la Reproduction | Year: 2011

Objectives: To summarize the existing literature on therapeutic alternatives to hysterectomy and myomectomy for management of symptomatic uterine fibroids other than medicinal treatment and embolization. Patients and methods: Pubmed, Cochrane and Embase contents were searched up to December 2010. Results: The Nd:YAG laser appeared to be effective but equipment's cost and postoperative adherence risk limited its development. Bipolar, microwave and cryo-myolysis are still investigational. Radiofrequency thermal ablation is a less aggressive alternative when feasible under ultrasound guidance. Focused ultrasound surgery MR or ultrasound guided is accessible to approximately 10% of uterine fibroids with a rate of 60-70% of long-term symptom relief. Data following laparoscopic uterine artery occlusion suggest that outcomes are similar to those with uterine artery embolization (UAE) but with less long-term durability; by transvaginal way, there seem to be more complications. The efficiency of acupuncture remains uncertain. Conclusion: Numerous technical innovations have been developed. However, comparative studies with validated conservative options are still needed. © 2011 Elsevier Masson SAS. All rights reserved.


Rua C.,Hopital Bretonneau | Body G.,Hopital Bretonneau | Marret H.,Hopital Bretonneau | Ouldamer L.,Hopital Bretonneau
Journal de Gynecologie Obstetrique et Biologie de la Reproduction | Year: 2015

Objectives. - Prevalence assessment of burnout among obstetrics and gynecology residents and predisposing factors.Patients and methods. - Multicentric cross-sectional survey based on a questionnaire sent by email to the residents including demographics data and Maslach Burnout Inventory.Results. - Mean burnout scores were 19.67 ± 10.19 for emotional exhaustion, 33.94 ± 5.01 forpersonal accomplishment and 8.72 ± 6.10 for depersonalization, corresponding to a moderate burnout for each category. High scores of burnout were seen on 19.45 % of residents for emotional exhaustion, 33.33 % for depersonalization and 11.11 % for personal accomplishment. 36.11 %of residents showed evidence of high burnout in emotional exhaustion or depersonalization, and 5.55 % in the three dimensions. The number of semesters is correlated with depersonalization (P = 0.01).Conclusion. - There is a strong personal accomplishment among obstetrics and gynecology residents; however, burnout and emotional exhaustion remains a reality during obstetrics and gynecology residency. © 2013 Elsevier Masson SAS. All rights reserved.

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