P Morice

CHU de Lyon - Hôpital Femme-Mère-Enfant , Lyon, Rhone-Alpes, France

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Publications (170)454.31 Total impact

  • Article: Lymphadenectomy for pregnant women with stage I cervical cancer - Authors' reply.
    C Uzan, S Gouy, C Haie Meder, P Morice
    The Lancet 05/2012; 379(9830):1949-50. · 38.28 Impact Factor
  • Article: [The age of the patient over 70 is a contraindication to perform para-aortic lymphadenectomy for ovarian cancer].
    Gynécologie Obstétrique & Fertilité 04/2012; 40(5):330-2. · 0.52 Impact Factor
  • Article: Recommandations pour la pratique clinique: Standards, Options: Recommandations 2007 pour la prise en charge des patientes atteintes de tumeurs épithéliales malignes de l’ovaire. Traitement chirurgical (rapport abrégé)
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    ABSTRACT: ContexteLa mise à jour de ces recommandations a été élaborée par la Fédération nationale des centres de lutte contre le cancer (FNCLCC) en partenariat avec les secteurs public, privé et l’Institut national du cancer. ObjectifActualiser les recommandations du chapitre «Traitement chirurgical» issu du rapport intégral validé en 1999. MéthodsL’actualisation des Standards, Options: Recommandations (SOR) repose sur une revue et une analyse critique des données scientifiques disponsibles et sur le jugement argumenté des experts au sein d’un groupe de travail représentatif des modes et lieux d’exercice et des disciplines concernées par la prise en charge des patients atteints de cancer. RésultatsCet article présente les recommandations SOR 2007 relatives au traitement chirurgical des stades précoces et des stades avancés, établies à l’issue du processus d’actualisation. ContextThe French federation of comprehensive cancer centres (FNCLCC) initiated the update of these recommendations in collaboration with the French national cancer institute and with specialists from French public universities, general hospitals and private clinics. ObjectivesTo update the recommendations of the “surgical treatment” chapter in the complete report validated in 1999. MethodsThe guideline updating process is based on a systematic literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. The Standards, Options: Recommendations are thus based on the best available evidence and expert agreement. ResultsThis article presents the 2007 updated recommendations concerning the surgical treatment of early-stage and advanced-stage epithelial ovarian cancers.
    Oncologie 04/2012; 10(4):283-288. · 0.17 Impact Factor
  • Article: Management and prognosis of endometrioid borderline tumors of the ovary.
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    ABSTRACT: The Endometrioid Borderline ovarian tumor (EBOT) is the third most common histological subtype of borderline ovarian tumors. Very little is known about the prognosis and management of this entity. This paper consists of a review of the literature and an analysis of clinical series. A review of the literature on this topic was conducted identifying series reporting consecutive cases of EBOT using 2 search engines (MEDLINE and Pubmed). Personal data on this topic have been included and concern a series of patients treated between 1985 and 2009 for EBOT. These cases included in this series had complete data concerning patient management and follow-up > 12 months. 16 patients were studied: 7 had been treated conservatively and 9 radically. All 16/16 patients had stage I disease at the initial diagnosis but one patient had also developed synchronous endometrioid adenocarcinoma of the uterine corpus. After a median time of 24 months (range, 12-132) post treatment, one (1/16) patient had developed two recurrences. She remains disease-free 42 months after the end of treatment of the last recurrence. These data were compared to the results of 4 series previously reported in the literature. In fact, the present series reports on the first recurrence in EBOT (which was an invasive lesion). Endometrioid borderline ovarian tumors carry a good prognosis. Most EBOT tumors are stage I, therefore surgical staging is not necessary in most of the cases. However, uterine curettage is required in cases of uterine preservation.
    Surgical Oncology 03/2012; 21(3):178-84. · 2.44 Impact Factor
  • Article: [Outcome of cervical carcinoma with locoregional lymph node involvement by FDG-PET].
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    ABSTRACT: To assess the outcome of cervical carcinoma with positive nodes on fluorodesoxyglucose positon emission tomography scans (FDG-PET). Patients with cervical carcinoma who had pelvic and/or para-aortic lymph nodes involvement by FDG-PET and treated with a curative intent from 2003 to 2007 were retrospectively studied. All patients received pelvic (and possibly para-aortic) radiotherapy with chemotherapy, followed by brachytherapy, and possibly surgery. The first site of relapse was classified as follows: local, nodal (pelvic or para-aortic) or metastatic. Forty patients were included the study. Median age was 47 years (range: 28-78). Thirty patients had nodal involvement limited to pelvic area and ten had a para-aortic involvement. Median follow-up was 42.5 months (range: 11-85). There were 22 relapses and 20 deaths: 20 due to relapse and one due to late toxicity. Three-year survival is 50 % (95 % confidence interval [CI]: 36-65). First relapse was: metastatic for 33 % (13/40), local for 20 % (8/40) and isolated nodal for 5 % (2/40). Multivariate analysis has revealed that only staging according to International Federation of Gynecology and Obstetrics (FIGO) and para-aortic involvement had a significant impact on survival. Three-year survival was 58 % (CI: 39-74) and 24 % (CI: 7-57) (P=0.009) in patient without and with para-aortic involvement, respectively. Para-aortic involvement by FDG-PET is a significant prognostic factor for overall survival. Local control at primary site remains of paramount importance for patient with nodal involvement. Isolated nodal failures are scarce.
    Cancer/Radiothérapie 03/2012; 16(3):183-9. · 1.49 Impact Factor
  • Article: [Laparoscopic para-aortic lymphadenectomy in advanced cervical cancer: morbidity and impact on therapy].
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    ABSTRACT: Laparoscopic para-aortic lymphadenectomy (PAL) is being used increasingly to stage patients with locally advanced cervical cancer (LACC) and to define radiation field limits before chemoradiation therapy (CRT). This study aimed to define clinical implications, review complications, and determine whether surgical complications delayed the start of CRT. We retrospectively reviewed a continuous series of patients with LACC, with no positive para-aortic (PA) nodes on positron emission tomography-computed tomography (PET-CT) and who had undergone a primary laparoscopic PAL. From November 2007 to June 2010, 98 patients with LACC underwent pretherapeutic PAL. Two patients did not undergo PAL: extensive carcinomatosis was discovered in one case and a technical problem arose in the other. No perioperative complications occurred. Seven patients had a lymphocyst requiring an imaging-guided (or laparoscopic) puncture. Eight patients (8.4%, which corresponds to the false-negative PET-CT rate) had metastatic disease within PA lymph nodes. In cases of suspicious pelvic nodes on PET-CT, the risk for PA nodal disease was greater (24.0% versus 2.9%). When patients with and without surgical morbidity were compared, the median delay to the start of treatment was not significantly different (15 days; range, 3-49 days versus 18 days; range, 3-42 days). The morbidity of laparoscopic PAL was limited and the completion of treatment was not delayed when complications occurred. Nevertheless, if PET-CT of the pelvic area is negative, the interest in staging PAL could be discussed because the risk for PA nodal disease is very low.
    Gynécologie Obstétrique & Fertilité 02/2012; 40(3):153-7. · 0.52 Impact Factor
  • Article: [Malignant melanoma of the vagina: pejorative location].
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    ABSTRACT: The aim of this study was to describe the clinical features of vaginal melanoma and treatments available. This is a retrospective review of patients with primary vaginal melanoma operated from 2000 to 2010 at Gustave-Roussy Institute. Six patients had surgery for a vaginal melanoma out of 37 patients operated for vaginal cancer in our institute in the same period (13.6%). Median age was 53.5 years [48-66]. The melanoma presented as a macroscopically visible nodular tumor in all case. Median tumour size was 5.4cm [1.5-15]. Five of the six patients had a [18F] fluoro-deoxy-glucose positron-emission tomography combined with integrated computed tomography (FDG-PET/CT) before surgery. Initial management included two conservative treatments and four colpectomy with one anterior exenteration. Two sigmoidcolpoplasties were performed. Lymph node metastases were found in only one patient. Median progression free survival was 10.5 months [4-51]. All patients have relapsed, three of them in the 6 months following surgery. Recurrences were local in three patients and distant in three patients. Local recurrences were surgically treated. In one case, electrochemotherapy was performed. One patient with locoregional disease underwent a pelvic isolated perfusion. One patient had a KIT mutation. Two patients died at 12 and 83 months. Vaginal melanoma had a poor prognosis. The 5-year overall survival is under 20% from literature data. Local and/or distant recurrences are frequent and new local and adjuvant treatments are currently evaluated.
    Gynécologie Obstétrique & Fertilité 02/2012; 40(5):273-8. · 0.52 Impact Factor
  • Article: Prognostic factors for and prognostic value of mesenteric lymph node involvement in advanced-stage ovarian cancer.
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    ABSTRACT: To determine the prognosis of and prognostic factors for mesenteric node involvement in patients undergoing a bowel resection at the time of debulking surgery for primary treatment of advanced-stage ovarian cancer (ASOC). A retrospective review of patients treated between 2005 and 2008 for ASOC and undergoing initial and interval debulking surgery with bowel resection (whatever the bowel segment). The characteristics and prognostic impact of mesenteric node involvement were studied. During the study period, 52 patients underwent debulking surgery for ASOC with bowel resection. Eighteen and 34 patients underwent initial or interval debulking surgery respectively. The most frequent site of the bowel resection was the rectosigmoid colon (38 patients; 73%) and 12 patients had resection of at least 2 intestinal segments. All patients had a complete macroscopic resection of peritoneal disease. Nineteen patients (37%) had mesenteric node involvement with a median of 4 involved nodes (range, 1-12). The degree of involvement of the intestinal wall and retroperitoneal node involvement (pelvic or para-aortic) had no impact on the risk of mesenteric node involvement. Overall survival and the location of recurrent disease were similar in patients with or without spread to mesenteric nodes. This study suggests that mesenteric node involvement is frequent in patients undergoing bowel resection in ASOC. Such spread does not appear to have an impact on patient survival. Modifying peroperative (particularly the extent of the mesocolon resection) or postoperative management is therefore unnecessary.
    European journal of surgical oncology: the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology 11/2011; 38(2):170-5. · 2.56 Impact Factor
  • Article: [Prevention of lymphoceles and gynaecologic cancers].
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    ABSTRACT: Lymphoceles are the most frequent complications following systematic lymphadenectomy in gynaecologic cancers. Some of them may have clinical significance with high morbidity. Through a review of literature, we describe surgical methods (way of surgery, lymphadenectomy type, sentinel lymph node, peritonization, drainages, lymphostasis, surgical patch) and medical methods (somatostatin analogs and nutrition treatment) which could prevent lymphoceles formation after pelvic and lumboaortic lymphadenectomy.
    Gynécologie Obstétrique & Fertilité 11/2011; 39(12):698-703. · 0.52 Impact Factor
  • Article: Borderline ovarian tumors diagnosed during pregnancy exhibit a high incidence of aggressive features: results of a French multicenter study.
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    ABSTRACT: The purpose of the current study was to evaluate the characteristics of borderline ovarian tumors (BOTs) diagnosed during pregnancy. We conducted a retrospective multicenter study of 40 patients with BOTs diagnosed during pregnancy between 1997 and 2009 at five tertiary universitary departments of Gynecology and Obstetrics and one French cancer center. The medical records were reviewed to determine surgical procedure, histology, restaging surgery and recurrence. Mean patient age was 30.2 ± 5.4 years. Most BOTs were diagnosed during the first trimester of pregnancy (62%). Salpingo-oophorectomy (N = 24) was more frequently performed than cystectomy (N = 11) during pregnancy (P = 0.01). Only two patients had an initial complete staging. BOTs were mucinous, serous and mixed in 48%, 42% and 10% of patients, respectively. Twenty-one percent of mucinous BOTs exhibited intraepithelial carcinoma or microinvasion. Forty-seven percent of serous BOTs exhibited micropapillary features, noninvasive implants or microinvasion. Restaging surgery performed in 52% patients resulted in upstaging in 24% of cases. Recurrence rate in patients with serous BOT with micropapillary features or peritoneal implants was 7.5%. BOTs diagnosed during pregnancy exhibit a high incidence of aggressive features and are rarely completely staged initially. Given this setting, up-front salpingo-oophorectomy should be considered and restaging planned.
    Annals of Oncology 10/2011; 23(6):1481-7. · 6.43 Impact Factor
  • Article: Behavior of serous borderline ovarian tumors with and without micropapillary patterns: results of a French multicenter study.
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    ABSTRACT: Behavior of serous borderline ovarian tumors with micropapillary patterns (MP-SBOT) is thought to be worse than those without micropapillary patterns, but few cohort studies have compared epidemiological characteristics, surgical management, and recurrence rates between these two groups. In a French retrospective multicenter study of 475 borderline ovarian tumors (BOT) treated from 1990 to 2009, we studied patients with a serous BOT and treated after 2000 including 20 patients with and 77 patients without micropapillary patterns. Patients with MP-SBOT were younger (P = 0.01), often asymptomatic (P = 0.04), and with abnormal CA 125 serum levels (P = 0.04). Peritoneal implants were more frequently observed in these patients (P = 0.01); also, they underwent conservative treatment more frequently (P = 0.002), had a higher risk of misdiagnosis with invasive carcinoma by intraoperative histology (P < 0.05), and had more frequent restaging surgery (P = 0.001). No difference in recurrence was noted between the groups. No disease-related mortality was observed. Patients with MP-SBOT represent a heterogeneous population in terms of presence of invasive peritoneal implants. Conservative surgery could be a suitable option for MP-SBOT patients without implants and who wish to conserve childbearing potential, without increasing the risk of recurrence.
    Annals of Surgical Oncology 08/2011; 19(3):941-7. · 4.17 Impact Factor
  • Article: [Adjuvant radiotherapy in patients with endometrial cancers].
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    ABSTRACT: The treatment of patients with endometrial cancer has been extensively modified in recent years. Several randomized studies have redefined the indications for adjuvant therapy in tumours staged 1. In the absence of poor prognostic factors, the management tends to be less aggressive than before, often limited to vaginal brachytherapy. Conversely, for more advanced lesions, for which prognosis is poor, combinations of chemoradiation are currently being evaluated. This literature review aims to provide an update on recent developments in the management of adjuvant radiotherapy for endometrial carcinoma.
    Cancer/Radiothérapie 05/2011; 15(4):323-9. · 1.49 Impact Factor
  • Article: [Survival and prognostic factors after completion surgery in patients undergoing initial chemoradiation therapy for locally advanced cervical cancer].
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    ABSTRACT: The aim of this study was to evaluate the prognostic factors of patients undergoing completion surgery for locally advanced-stage cervical cancer after initial chemoradiation therapy (CRT). Patients fulfilling the following inclusion criteria were studied: stage IB2-IVA cervical carcinoma; tumour initially confined to the pelvic cavity on conventional imaging; pelvic external radiation therapy with delivery of 45 Gy to the pelvic cavity and concomitant chemotherapy (cisplatin 40 mg/m(2) per week) followed by utero-vaginal brachytherapy; completion surgery after the end of radiation therapy including at least a hysterectomy. One-hundred and fifty patients treated between 1998 and 2007 fulfilled inclusion criteria. Nineteen patients had pelvic nodes involved and 19 had para-aortic nodes involved. Seventy-two patients (48%) had complete surgical sterilization of the cervix. Prognostic factors for overall survival in the multivariable analysis were the presence and level of nodal spread (positive pelvic nodes alone: HR = 2.03, positive para-aortic nodes: HR = 5.46; P < 001) and the presence and size of residual disease (RD) in the cervix (RD ≤ 1 cm: HR = 1.92, RD > 1cm: HR = 3.85; P = 02). In this series, the presence and size of RD and histologic nodal involvement were the strongest prognostic factors. Such results suggest that the survival of these patients could potentially be enhanced by improving the rate of complete response in the irradiated area and by initially detecting patients with para-aortic spread.
    Gynécologie Obstétrique & Fertilité 05/2011; 39(5):274-80. · 0.52 Impact Factor
  • Article: [The accuracy of FDG-PET/CT in early-stage cervical and vaginal cancers].
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    ABSTRACT: [(18)F]fluoro-deoxy-glucose positron-emission tomography combined with integrated computed tomography (FDG-PET/CT) is commonly used for advanced stage cervical cancer but its efficiency is discussed in early stage. The aim of this study was to evaluate false negative rate of FDG-PET/CT in early-stage cervical and vaginal cancer. Patients treated between 2005 and 2008 for stage IB1 cervical cancer and stage I vaginal cancer who underwent a FDG-PET/CT followed by a pelvic lymphadenectomy were studied. Eighteen patients were included with bilateral pelvic lymphadenectomy (16 cervical cancer, two vaginal cancer). The median age of patients was 41 years. Radical hysterectomy was performed for 16 patients, by a laparoscopic approach in 15 cases and by a laparotomic approach in one case. One patient had a simple hysterectomy and one had exclusive radiotherapy. No patient had pelvic or para-aortic fixation on FDG-PET/CT. Three patients have proven pelvic involvement and one had para-aortic metastases. The false-negative rate and negative predictive value of FDG-PET/CT were 17% and 83% respectively. The accuracy of FDG-PET/CT imaging in predicting the pelvic nodal status is very low in patients with early-stage cervical and vaginal cancer and is not able to replace surgical exploration.
    Gynécologie Obstétrique & Fertilité 03/2011; 39(4):193-7. · 0.52 Impact Factor
  • Article: How to follow up advanced-stage borderline tumours? Mode of diagnosis of recurrence in a large series stage II-III serous borderline tumours of the ovary.
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    ABSTRACT: The aim of this study was to describe how recurrences were diagnosed in the largest series of patients treated for an advanced-stage serous borderline ovarian tumour. From 1973 to 2006, 45 patients with a serous borderline tumour and peritoneal implants relapsed among 162 patients with a follow-up exceeding 1 year. Data concerning recurrences and the mode of diagnosis were reviewed. The median follow-up interval was 8.2 years (range 19-286 months). The mode of diagnosis of recurrences was imaging (n = 19), clinical symptoms (n = 8), cancer antigen (CA) 125 elevation (n = 7), secondary surgery (n = 5) and unknown (n = 6). The median time to recurrence was 31 months (range 4-242 month). The type of recurrence was invasive low-grade serous carcinoma in 14 patients. Five patients died of recurrent tumour. Among the 39 patients with a known mode of diagnosis of recurrence, the most frequent diagnostic method for invasive recurrences was blood CA 125 elevation (6 of 13) and the majority of noninvasive recurrences were diagnosed by imaging (16 of 23). This study demonstrates that ultrasound is the most relevant follow-up procedure in this context. Nevertheless, the blood CA 125 test is of particular interest for detecting invasive recurrent disease, which is the most crucial event.
    Annals of Oncology 03/2011; 22(3):631-5. · 6.43 Impact Factor
  • Article: Morbidity of diaphragmatic surgery for advanced ovarian cancer: retrospective study of 148 cases.
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    ABSTRACT: Treatment of Advanced Ovarian Cancer (AOC) includes surgery with complete cytoreduction, one of the strongest prognostic factors. To achieve complete cytoreduction, diaphragmatic surgery is often required. There is currently a lack of information in the literature regarding the morbidity and impact of this type of surgery. The aim of this study is to report specific pulmonary morbidity and overall morbidity associated with diaphragmatic surgery in patients with AOC. We conducted a multicentric (6 centres), retrospective study that included 148 patients operated on between 2004 and 2008. Patient characteristics, surgical course and postoperative complications were collected. The complete cytoreduction rate was 84%. The surgery was categorised by timing as initial, interval or recurrence surgery in 38%, 51% and 11% of patients, respectively. In 69% of patients, one or more postoperative complications occurred: pulmonary complication (42%), digestive fistula (7%) or lymphocyst (18%). The pulmonary complications were pleural effusion (37%), pulmonary embolism (5%), pneumothorax (4%) and pulmonary infection (2%). These complications required revision surgery, pleural evacuation, or lymphocyst evacuation in 13%, 14%, and 11% of the cases, respectively. Postoperative mortality was 3%. Risk factors for pulmonary complications were the addition of extensive upper surgery to the diaphragmatic surgery (p = 0.014) and the size of the diaphragmatic resection (p = 0.012). Diaphragmatic surgery achieved complete removal of the tumour but resulted in pulmonary complications in addition to complications of radical surgery.
    European journal of surgical oncology: the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology 02/2011; 37(2):175-80. · 2.56 Impact Factor
  • Article: Accuracy of 18-fluoro-2-deoxy-D-glucose positron emission tomography in the pretherapeutic detection of occult para-aortic node involvement in patients with a locally advanced cervical carcinoma.
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    ABSTRACT: Patients with locally advanced cervical cancer (LACC) are usually treated with concurrent chemoradiotherapy. Extended-field chemoradiotherapy is indicated in case of para-aortic node involvement at initial assessment. 18-Fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography (18-FDG PET/CT) is currently considered to be the most accurate method of detection of node or distant metastases. The goal of this study was to evaluate the accuracy of PET at detecting para-aortic lymph node metastases in LACC patients with a negative morphological imaging. Patients from five French institutions with LACC and both negative morphologic (magnetic resonance imaging, CT scan) and functional (PET or PET/CT) findings at the para-aortic level and distantly were submitted to a systematic infrarenal para-aortic node dissection either by laparoscopy or laparotomy. On the basis of pathological results, sensitivity, specificity, and positive and negative predictive values of PET/CT were assessed for para-aortic lymph node involvement. A total of 125 LACC patients (stage IB2-IVA disease with two local recurrences) fulfilled the inclusion criteria. All had an ilio-infrarenal para-aortic lymphadenectomy, either by laparoscopy (n = 117) or laparotomy (n = 8). Twenty-one patients (16.8%) had pathologically proven para-aortic metastases. Among them, 14 (66.7%) had negative PET/CT. Overall morbidity of surgery was 7.2%. All but one of the complications were mild and did not delay chemoradiotherapy. Sensitivity, specificity, and positive and negative predictive value of the PET/CT were 33.3, 94.2, 53.8, and 87.5%, respectively, for the detection of microscopic lymph node metastases. Laparoscopic staging surgery seems warranted in LACC patients with negative PET scan who are candidates for definitive concurrent chemoradiotherapy or exenteration.
    Annals of Surgical Oncology 02/2011; 18(8):2302-9. · 4.17 Impact Factor
  • Article: [Para-aortic lymphadenectomy in advanced-stage cervical cancer: standard procedure in 2010?].
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    ABSTRACT: With tumour size, node involvement is the most important prognosis factor in advanced stage cervical cancer. Para-aortic (PA) disease is observed in 15 to 30% of these patients. CT scan and magnetic resonance imaging (MRI) are not efficient enough to detect these lesions and PET CT have false negatives. Surgical staging is useful to detect carcinosis associated and to adapt therapy (radiotherapy fields are extended if PA nodes are involved). Laparoscopy was crucial to develop this staging because its morbidity associated to chemoradiotherapy is limited. If prognosis impact of PA lymphadenectomy is well established, therapeutic impact is still discussed. The systematic extension of this staging to pelvic nodes that are included in the basic radiotherapy fields is debated because it does not modify therapeutic management and is morbid. Radiotherapy progress, especially with boost and combination to MRI (MRIT), will impact on future therapeutic management.
    Gynécologie Obstétrique & Fertilité 10/2010; 38(11):668-71. · 0.52 Impact Factor
  • Article: [Postoperative morbidity after completion surgery following homogeneous chemoradiation therapy in locally advanced cervical cancer].
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    ABSTRACT: To evaluate the morbidity rate in patients following completion surgery (hysterectomy±lymphadenectomy) after chemoradiation therapy (CRT) for an advanced stage cervical cancer. Patients fulfilling the following inclusion criteria were studied: (1) stage IB2-IVA cervical carcinoma; (2) tumor initially confined to the pelvic cavity; (3) pelvic external radiation therapy with delivery of 45Gy with concomitant chemotherapy (cisplatin 40mg/m(2)/week) followed by utero-vaginal brachytherapy; (4) completion surgery after the end of radiation therapy including at least a hysterectomy. One-hundred and fifty patients treated between 1998 and 2007 fulfilled inclusion criteria. Thirty-seven (25%) patients had 55 post-operative complications (17 had severe complications requiring surgical or radiological treatment). Two deaths related to postoperative morbidity had occurred. The risk of complications was increased with a radical hysterectomy (OR=2.4; P=0.04) and the presence of residual cervical disease (≤1cm: OR=4.3, >1cm: OR=2.5; P=0.01). In the present study, the morbidity of completion surgery (based on hysterectomy with or without lymphadenectomy) is very high in patients treated with initial CRT for locally advanced cervical cancer whereas the therapeutic value of such surgery remains unproven.
    Journal de Gynécologie Obstétrique et Biologie de la Reproduction 10/2010; 39(8):624-31. · 0.42 Impact Factor
  • Article: [Institutional review board of the French college of obstetricians and gynecologists (CEROG).].
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    ABSTRACT: To report the rules and the activity of the institutional review board of the French college of obstetricians and gynecologists (Comité d'éthique de la recherche en obstétrique et gynécologie [CEROG]) created in 2008. The submission requirements are also described. Retrospective study. The Ethical Review Committee [institutional review board of the French college of obstetricians and gynecologists (CNGOF)] CEROG have examined 65 project studies in 2008. The median number of submitted studies was 5.5 per month (IQR: 3.75-6.25). The origins of the submission were as follows: tertiary care university hospitals (n=63, 97 %), Inserm (n=1), INRA (n=1). Researches were found to be in conformity with the French laws and regulations, to conform to generally accepted scientific principles and medical research ethical standards in 44 cases (68 %). In 13 cases (20 %), the study has been forwarded to the Persons Protection Committee (PPC) since it concerned biomedical research or "usual care research" (soin courant). In six cases (9 %), the investigators have not responded to IRB suggestions. In two cases (3 %), the information form has been judged unsatisfactory. The CEROG is the first national IRB in obstetrics and gynecology. This new committee clarifies IRB submission procedure in France concerning non-interventional studies in the field of obstetrics and gynecology.
    Journal de Gynécologie Obstétrique et Biologie de la Reproduction 09/2010; 39(5):401-8. · 0.42 Impact Factor

Institutions

  • 2012
    • CHU de Lyon - Hôpital Femme-Mère-Enfant
      Lyon, Rhone-Alpes, France
  • 1997–2012
    • Institut de Cancérologie Gustave Roussy
      • Department of Radiotherapy
      Villejuif, Ile-de-France, France
  • 2007–2011
    • Université Paris-Sud 11
      • Département de Chimie
      Paris, Ile-de-France, France
  • 2009
    • Université François Rabelais
      Tours, Centre, France
  • 2008
    • Institut Claudius Regaud
      Toulouse, Midi-Pyrenees, France