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author:("daran, Emile")
1.  Evaluation of the Effects of Pasireotide LAR Administration on Lymphocele Prevention after Axillary Node Dissection for Breast Cancer: Results of a Randomized Non-Comparative Phase 2 Study 
PLoS ONE  2016;11(6):e0156096.
Objective
The aim of this study was to assess the efficacy (response rate centered on 80%) of a somatostatin analog with high affinity for 4 somatostatin receptors in reducing the postoperative incidence of symptomatic lymphocele formation following total mastectomy with axillary lymph node dissection.
Setting
This prospective, double-blind, randomised, placebo-controlled, phase 2 trial was conducted in two secondary care centres.
Participants
All female patients for whom mastectomy and axillary lymph node dissection were indicated were eligible for the study, including patients who had received neo-adjuvant chemotherapy. Main exclusion criteria were related to diabetes, cardiac insufficiency, disorder of cardiac conduction or hepatic failure.
Interventions
Patients were randomised to receive one injection of either prolonged-release pasireotide 60 mg or placebo (physiological serum), which were administered intramuscularly 7 to 10 days before the scheduled surgery. The study was conducted in a double-blind manner.
Primary and Secondary Outcome Measures
The primary outcome measure was the percentage of patients who did not develop post-operative axillary symptomatic lymphoceles during the 2 postoperative months. Secondary endpoints were the total quantity of lymph drained, duration and daily volume of drainage and aspirated volumes of lymph.
Results
Ninety-one patients were randomised. Ninety patients were evaluable: 42 patients received pasireotide, and 48 patients received placebo. The mean estimated response rate were 62.4% (95% Credibility Interval [CrI]: 48.6%-75.3%) in the treatment group and 50.2% (95% CrI: 37.6%-62.8%) in the placebo group. Overall safety was comparable across groups, and one serious adverse event occurred. In the treatment group, one patient with known insulin-depe*ndent diabetes required hospitalization for hyperglycaemia.
Conclusions
With this phase 2 preliminary study, even if our results indicate a trend towards a reduction in symptomatic lymphocele, pre-operative injection of pasireotide failed to achieve a response rate centered on 80%. Pharmacokinetics analysis suggests that effect of pasireotide could be optimised.
Trial Registration
ClinicalTrials.gov NCT01356862
doi:10.1371/journal.pone.0156096
PMCID: PMC4900597  PMID: 27280398
2.  Management of pregnancy in woman with suspected malignant deep infiltrating endometriosis fistulised to the uterine cervix 
BMJ Case Reports  2014;2014:bcr2014204978.
Deep infiltrating endometriosis (DIE) is a well-known cause of pelvic pain and infertility. Malignant transformation of DIE is rare but can be suggested by MRI. We report a case of a spontaneous pregnancy in a woman with suspicion of malignant transformation of DIE with fistulisation to the posterior uterine isthmus through to the cervical canal. The pregnancy was closely monitored and an uneventful caesarian section was performed at 34 weeks of gestation. This case raises the issue of the relevance of imaging techniques and management of pregnancy.
doi:10.1136/bcr-2014-204978
PMCID: PMC4054261  PMID: 24899016
3.  Spontaneous hymeneal endometriosis: a rare cause of dyspareunia 
BMJ Case Reports  2014;2014:bcr2013202299.
Vulvar endometriosis can occur after surgery or trauma and cause dyspareunia. A 30-year-old woman presented with orificial dyspareunia lasting for 5 months. Her history was marked by a vaginal birth without perineal injury and the removal of a cyst from the left Bartholin’s gland. On examination, we observed a selectively painful, superficial and retractile lesion, 5 mm in diameter at the junction of the hymen at some distance from the bartholinitis scar. Endometriosis was suspected due to the exacerbation of pain during menses. The surgery consisted of excision of the hymenal area of the painful lesion. Pathological examination confirmed the presence of endometrial tissue. The painful symptoms resolved and no additional treatment was administered. Any vulvar lesion, regardless of its appearance and location, can be related to endometriosis. Surgical resection is recommended to relieve the symptoms and provide histological proof.
doi:10.1136/bcr-2013-202299
PMCID: PMC3975491  PMID: 24671316
4.  Are Early Relapses in Advanced-Stage Ovarian Cancer Doomed to a Poor Prognosis? 
PLoS ONE  2016;11(1):e0147787.
Objective
Early recurrence (ER) after completion of therapeutic regimen in advanced-stage ovarian cancer is a challenging clinical situation. Patients are perceived as invariably having a poor prognosis. We investigated the possibility of defining different prognostic subgroups and the parameters implicated in prognosis of ER patients.
Study Design
We analyzed a multi-centric database of 527 FIGO stage IIIC and IV ovarian cancer patients. We defined patients relapsing within 12 months as ER and investigated using Cox logistic regression the prognostic factors in ER group. We subsequently divided ER patients into good and poor prognosis groups according to a lower or higher overall survival (OS) at 12 months after relapse and determined parameters associated to poor prognosis.
Results
The median follow up was 49 months. One hundred and thirty eight patients recurred within 12 months. OS and Disease Free Survival (DFS) were 24.6 and 8.6 months, respectively, in this group of patients. Among the ER patients, 73 had a poor prognosis with an OS after relapse below 12 months (mean OS = 5.2 months) and 65 survived after one year (mean OS = 26.9 months). Residual disease (RD) after debulking surgery and mucinous histological subtype negatively impacted prognosis (HR = 1.758, p = 0.017 and HR = 8.641, p = 0.001 respectively). The relative risk of death within 12 months following relapse in ER patients was 1.61 according to RD status. However, RD did not affect DFS (HR = 0.889, p = 0.5).
Conclusion
ER in advanced-stage ovarian cancer does not inevitably portend a short-term poor prognosis. RD status after initial cytoreduction strongly modulates OS, that gives additional support to the concept of maximum surgical effort even in patients who will experience early recurrence. The heterogeneity in outcomes within the ER group suggests a role for tumor biology in addition to classical clinical parameters.
doi:10.1371/journal.pone.0147787
PMCID: PMC4731146  PMID: 26820579
5.  Pregnancy Rate after First Intra Cytoplasmic Sperm Injection- In Vitro Fertilisation Cycle in Patients with Endometrioma with or without Deep Infiltrating Endometriosis  
Background:
To evaluate the impact of the association of endometrioma with or without deep infiltrating endometriosis (DIE) after a first intra cytoplasmic sperm injection- in vitro fertilization (ICSI-IVF) cycle on pregnancy rate.
Materials and Methods:
In this retrospective study, women with endometrioma who underwent a first ICSI-IVF cycle from January 2007 to June 2010 were reviewed for pregnancy rate. The main outcome measure was the clinical pregnancy rate. A multiple logistic regression (MLR) was performed; including all variables that were correlated to the conception rate. Only independent factors of pregnancy rate were included in a Recursive Partitioning (RP) model.
Results:
The study population consisted of 104 patients (37 without DIE and 67 patients with associated DIE). Using multivariable analysis, a lower pregnancy rate was associated with the presence of DIE (OR=0.24 (95% CI: 0.085-0.7); p=0.009) and the use of ICSI (OR=0.23 (95% CI: 0.07-0.8); p=0.02). A higher pregnancy rate was associated with an anti-mullerian hormone (AMH) serum level over 1 ng/ml (OR=4.3 (95% CI: 1.1-19); p=0.049). A RP was built to predict pregnancy rate with good calibration [ROC AUC (95% CI) of 0.70 (0.65-0.75)].
Conclusion:
Our data support that DIE associated with endometrioma in infertile patients has a negative impact on pregnancy rate after first ICSI-IVF cycle. Furthermore, our predictive model gives couples better information about the likelihood of conceiving.
PMCID: PMC3914494  PMID: 24520488
Endometrioma; Assisted Reproductive Technology; Endometriosis; Probabilistic Model
6.  Expression of MMP-2, −7, −9, MT1-MMP and TIMP-1 and −2 has no prognostic relevance in patients with advanced epithelial ovarian cancer 
Oncology Reports  2012;27(4):1049-1057.
Matrix metalloproteinases (MMPs) and their tissue inhibitors (TIMPs) are involved in tumor invasion, but their prognostic significance is still under discussion. We set out to analyze the epithelial and stromal expression of MMP-2, MMP-7, MMP-9, MT1-MMP, TIMP-1 and TIMP-2 in advanced epithelial ovarian cancers and to assess their prognostic value. A tissue microarray of malignant ovarian tumors from 69 patients was constructed. Immunostaining results were scored using the HSCORE and assessed by univariate analysis with Bonferroni correction and classical multidimensional scaling (CMDS). Kaplan-Meier survival curves calculated with regard to patient and tumor characteristics were compared by the log-rank test. Patients treated by primary surgery (n=43) had a higher tumor size and a trend toward higher epithelial MMP and TIMP expression than those treated by interval surgery (n=26). Optimal cytoreduction (residue ≤1 cm) was obtained in 27 and 18 patients, respectively. Clinical and histological characteristics were not different in patients with optimal cytoreduction and those with suboptimal cytoreduction. The expression of epithelial MMP-9 (P=0.002) and TIMP-2 (P=0.026) were higher in the latter group. CMDS failed to demonstrate any influence of MMP and TIMP expression with regard to cytoreduction outcome. MMP and TIMP expression did not influence survival. Their prognostic values were outweighed by histological type, lymph node involvement and cytoreduction. Standard statistical analysis adjusted after Bonferroni correction and CMDS reduced the relevance of MMPs and TIMPs in the prognosis of patients with advanced ovarian cancer.
doi:10.3892/or.2011.1608
PMCID: PMC3583568  PMID: 22200690
matrix metalloproteinase; prognosis; ovarian neoplasms
7.  Potential relevance of pre-operative quality of life questionnaires to identify candidates for surgical treatment of genital prolapse: a pilot study 
BMC Urology  2012;12:9.
Background
To evaluate prolapse-related symptoms, quality of life and sexuality of patients with validated questionnaires before and after surgery for genital prolapse and assess relevance of such an evaluation to select women for surgery.
Methods
From November 2009 to April 2010, 16 patients operated on for genital prolapse of grade greater than or equal to 2 (POP-Q classification) were evaluated prospectively by three questionnaires of quality of life Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7) and Pelvic Organ Prolaps/Urinary Incontinence Sexual Questionnaire (PISQ-12). Data were collected the day before surgery and 6 weeks postoperatively.
Results
Eleven patients had laparoscopic surgery and five vaginal surgery. There was a significant decrease in pelvic heaviness, vaginal discomfort and urinary symptoms after surgery. The score of symptoms of prolapse, the PFDI-20 score was 98.5 preoperatively and 31.8 postoperatively (p < 0.0001). The score for quality of life, the PFIQ-7 score was 54.5 preoperatively and 7.4 postoperatively (p = 0.001). The score of sexuality, the PISQ-12 score was 35.3 preoperatively and 37.5 postoperatively (p = 0.1). Two of the 3 patients with a PFIQ 7 under or equal to 20 were not improved while all the women with a preoperative PFIQ-7 over 20 were improved after surgery.
Conclusions
This study suggests that surgery improves quality of life of patients with genital prolapse. Quality of life questionnaires could help select good candidates for surgery. Further studies are required to determine threshold to standardize indications of surgery.
doi:10.1186/1471-2490-12-9
PMCID: PMC3350396  PMID: 22452922
Genital prolapse; Quality of life questionnaire; Surgery
8.  Does the use of the 2009 FIGO classification of endometrial cancer impact on indications of the sentinel node biopsy? 
BMC Cancer  2010;10:465.
Background
Lymphadenectomy is debated in early stages endometrial cancer. Moreover, a new FIGO classification of endometrial cancer, merging stages IA and IB has been recently published. Therefore, the aims of the present study was to evaluate the relevance of the sentinel node (SN) procedure in women with endometrial cancer and to discuss whether the use of the 2009 FIGO classification could modify the indications for SN procedure.
Methods
Eighty-five patients with endometrial cancer underwent the SN procedure followed by pelvic lymphadenectomy. SNs were detected with a dual or single labelling method in 74 and 11 cases, respectively. All SNs were analysed by both H&E staining and immunohistochemistry. Presumed stage before surgery was assessed for all patients based on MR imaging features using the 1988 FIGO classification and the 2009 FIGO classification.
Results
An SN was detected in 88.2% of cases (75/85 women). Among the fourteen patients with lymph node metastases one-half were detected by serial sectioning and immunohistochemical analysis. There were no false negative case. Using the 1988 FIGO classification and the 2009 FIGO classification, the correlation between preoperative MRI staging and final histology was moderate with Kappa = 0.24 and Kappa = 0.45, respectively. None of the patients with grade 1 endometrioid carcinoma on biopsy and IA 2009 FIGO stage on MR imaging exhibited positive SN. In patients with grade 2-3 endometrioid carcinoma and stage IA on MR imaging, the rate of positive SN reached 16.6% with an incidence of micrometastases of 50%.
Conclusions
The present study suggests that sentinel node biopsy is an adequate technique to evaluate lymph node status. The use of the 2009 FIGO classification increases the accuracy of MR imaging to stage patients with early stages of endometrial cancer and contributes to clarify the indication of SN biopsy according to tumour grade and histological type.
doi:10.1186/1471-2407-10-465
PMCID: PMC2940804  PMID: 20804553
9.  Ultrastaging of lymph node in uterine cancers 
Background
Lymph node status is an important prognostic factor and a criterion for adjuvant therapy in uterine cancers. While detection of micrometastases by ultrastaging techniques is correlated to prognosis in several other cancers, this remains a matter of debate for uterine cancers. The objective of this review on sentinel nodes (SN) in uterine cancers was to determine the contribution of ultrastaging to detect micrometastases.
Methods
Review of the English literature on SN procedure in cervical and endometrial cancers and histological techniques including hematoxylin and eosin (H&E) staining, serial sectioning, immunohistochemistry (IHC) and molecular techniques to detect micrometastases.
Results
In both cervical and endometrial cancers, H&E and IHC appeared insufficient to detect micrometastases. In cervical cancer, using H&E, serial sectioning and IHC, the rate of macrometastases varied between 7.1% and 36.3% with a mean value of 25.8%. The percentage of women with micrometastases ranged from 0% and 47.4% with a mean value of 28.3%. In endometrial cancer, the rate of macrometastases varied from 0% to 22%. Using H&E, serial sectioning and IHC, the rate of micrometastases varied from 0% to 15% with a mean value of 5.8%. In both cervical and endometrial cancers, data on the contribution of molecular techniques to detect micrometastases are insufficient to clarify their role in SN ultrastaging.
Conclusion
In uterine cancers, H&E, serial sectioning and IHC appears the best histological combined technique to detect micrometastases. Although accumulating data have proved the relation between the risk of recurrence and the presence of micrometastases, their clinical implications on indications for adjuvant therapy has to be clarified.
doi:10.1186/1756-9966-29-5
PMCID: PMC2828991  PMID: 20092644
10.  Neoadjuvant chemotherapy or primary surgery for stage III/IV ovarian cancer: contribution of diagnostic laparoscopy 
BMC Cancer  2009;9:171.
Background
The aims of this retrospective study were to evaluate laparoscopic triage of patients with advanced ovarian cancer towards primary surgery or neoadjuvant chemotherapy, and to analyze outcome according to the treatment.
Methods
Between January 2001 and December 2006, 55 patients with stage III – IV ovarian cancer underwent diagnostic laparoscopy. Primary surgery was performed when complete cytoreduction was considered feasible, while the other patients received neoadjuvant chemotherapy (platinum-based combination with taxanes) and interval surgery. All the patients received adjuvant chemotherapy.
Results
Patients treated with neoadjuvant chemotherapy (n = 29) had a higher mean body mass index (P = 0.048), higher serum CA 125 levels (P = 0.026), and more metastases (P = 0.045) than patients treated with primary surgery (n = 26). In patients treated with primary surgery, complete cytoreduction and a residual tumour size ≤ 2 cm were obtained in respectively 54% and 77% of cases. Complete cytoreduction was achieved in respectively 100% and 33% of cases when primary surgery was performed by an oncologic gynaecologist and by a non-oncologic gynaecologist (P = 0.002). Interval surgery yielded complete cytoreduction and a residual tumour size ≤ 2 cm in respectively 73% and 85% of cases. With a median follow-up of 24 months (range 7 – 78 months), the survival rates after primary surgery and interval surgery were 61% and 66% respectively.
Conclusion
Diagnostic laparoscopy is useful for identifying patients with stage III/IV ovarian cancer who qualify for primary cytoreduction. Surgeon experience was a determining factor for the success of complete cytoreduction.
doi:10.1186/1471-2407-9-171
PMCID: PMC2701965  PMID: 19500391
11.  Prevention of De Novo Adhesion by Ferric Hyaluronate Gel After Laparoscopic Surgery in an Animal Model 
Background and Objective:
Adhesions remain a major cause of severe long-term complications. Attempts have been made to prevent adhesion formation by using endogenous or exogenous materials with controversial results. Our aim was to evaluate the efficacy of 0.5% ferric hyaluronate gel in the prevention of adhesion formation after laparoscopic surgery.
Methods:
This was a prospective, randomized, experimental study (animal model). The study population comprised 75 female rabbits (Fauve de Bourgogne) weighing over 3 kg. The rabbits were randomized into 3 groups of 25 (hyaluronate, saline, and control) by using a predetermined computer-generated randomization code. All rabbits underwent a peritoneal laparoscopic resection, and the main outcome measure was the adhesion formation after laparoscopic surgery.
Results:
The laparoscopic operating time and the mean interval before second-look surgery were not different among the 3 groups. The number of rabbits with adhesions did not differ among the 3 groups. The bowel adhesion rate was higher at the 10-mm trocar site than at the 5-mm trocar site (P=0.01). The adhesion scores did not differ among the 3 groups. A strong correlation was found between the values of the different adhesion scoring systems used.
Conclusion:
These results obtained in a rabbit model suggest that routine intraperitoneal application of hyaluronate gel does not prevent adhesion formation after laparoscopic surgery.
PMCID: PMC3016805  PMID: 15347116
Adhesion prevention; Postoperative adhesions; Laparoscopy; Ferric hyaluronate gel

Results 1-11 (11)