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"Gauthier, Tristan"
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First external validity study of the Fagotti score in ovarian cancer
2024
Epithelial ovarian cancer is mostly discovered at the stage of peritoneal carcinosis. Complete cytoreductive surgery improves overall survival. The Fagotti score is a predictive score of resectability based on peritoneal laparoscopic exploratory. Our aim was to study the inter-observer concordance in an external validation of the Fagotti score. An observational, prospective, multicenter study was conducted using the Francogyn research network. The primary outcome was inter-observer concordance of the Fagotti score. 15 patients in which an ovarian mass was discovered were included. For each patient, the first exploratory laparoscopy before any treatment/chemotherapy was recorded. This bank of 15 videos was subject to blind review accompanied by a Fagotti score rating by 11 gynecological surgeons specializing in oncology. A total of 165 blind reviews were performed. Inter-observer concordance was very good for the Fagotti score with an intraclass correlation coefficient (ICC) of 0.83 [95% CI 0.71; 0.93]. Inter-observer concordance for the adjusted Fagotti score, which accounts for unexplorable areas with extensive carcinomatosis, resulted in an ICC of 0.64 [95% CI 0.46; 0.82]. According to the reviewers, the three least explorable parameters were mesentery involvement, stomach infiltration and liver damage. The ICC of the explorable Fagotti score, i.e. score with deletion of the parameters most often unexplored by laparoscopy, was 0.86 [0.75–0.94]. This study confirms the reproducibility of the Fagotti score during first assessment laparoscopies in cases of advanced ovarian cancer. The explorable Fagotti score has an equivalent or better inter-observer concordance than the Fagotti score.
Journal Article
Fetal growth restriction, low birth weight, and preterm birth: Effects of active or passive smoking evaluated by maternal expired CO at delivery, impacts of cessation at different trimesters
by
Delcroix, Michel-Henri
,
Marquet, Pierre
,
Delcroix-Gomez, Conchita
in
expired carbon monoxide
,
fetal growth restriction
,
pregnancy
2022
The objectives of this study were to evaluate the effect of cessation of active smoking during the 1st, 2nd, and 3rd trimesters of pregnancy on the risk of reduced birth weight and prematurity using an exhaled carbon monoxide biomarker with a cut-off value ≥3 ppm as well as the effects of passive smoking.INTRODUCTIONThe objectives of this study were to evaluate the effect of cessation of active smoking during the 1st, 2nd, and 3rd trimesters of pregnancy on the risk of reduced birth weight and prematurity using an exhaled carbon monoxide biomarker with a cut-off value ≥3 ppm as well as the effects of passive smoking.This was a multicenter prospective cohort study involving pregnant smokers and non-smokers. Pregnant smokers were identified at the first prenatal visit before 15 weeks of amenorrhea by the number of cigarettes smoked per day and by the carbon monoxide breath test. Women were classified into 6 groups: non-smokers, passive smokers, first trimester cessation, second trimester cessation, third trimester cessation, and smoking throughout pregnancy. Smoking cessation was defined if the pregnant woman reported quitting smoking and if she achieved an exhaled CO level of <3 ppm. The association between smoking cessation and fetal growth restriction or prematurity was assessed by multivariate logistic regression. Passive smoking was defined for non-smoking women on declarative smoking status and exhaled CO ≥3 ppm. The association between passive smoking and fetal growth restriction or prematurity was assessed by multivariate logistic regression.METHODSThis was a multicenter prospective cohort study involving pregnant smokers and non-smokers. Pregnant smokers were identified at the first prenatal visit before 15 weeks of amenorrhea by the number of cigarettes smoked per day and by the carbon monoxide breath test. Women were classified into 6 groups: non-smokers, passive smokers, first trimester cessation, second trimester cessation, third trimester cessation, and smoking throughout pregnancy. Smoking cessation was defined if the pregnant woman reported quitting smoking and if she achieved an exhaled CO level of <3 ppm. The association between smoking cessation and fetal growth restriction or prematurity was assessed by multivariate logistic regression. Passive smoking was defined for non-smoking women on declarative smoking status and exhaled CO ≥3 ppm. The association between passive smoking and fetal growth restriction or prematurity was assessed by multivariate logistic regression.The number of patients included was 5244. The incidence of fetal growth restriction below the 10th percentile was 10.6%, 12.1%, 8.5%, 9.1%, 21.1%, and 22.9%, respectively, for the non-smoking, passive smoking, first, second, third trimester cessation, and full-pregnancy smoking, groups. The risk of FGR compared to non-smokers was OR=2.3 (95% CI: 1.18-4.30, p=0.014) for patients who quit smoking in the third trimester, OR=2.5 (95% CI: 2.03-3.12, p<0.001) for women who smoked throughout pregnancy. After logistic regression, FGR (AOR=1.9; 95% CI: 0.96-3.82) for women who quit smoking in the 3rd trimester (AOR=1.8; 95% CI: 1.38-2.31, p<0.001). The risk of FGR <5th percentile was AOR=1.96 (95% CI: 1.36-2.48, p<0.001).RESULTSThe number of patients included was 5244. The incidence of fetal growth restriction below the 10th percentile was 10.6%, 12.1%, 8.5%, 9.1%, 21.1%, and 22.9%, respectively, for the non-smoking, passive smoking, first, second, third trimester cessation, and full-pregnancy smoking, groups. The risk of FGR compared to non-smokers was OR=2.3 (95% CI: 1.18-4.30, p=0.014) for patients who quit smoking in the third trimester, OR=2.5 (95% CI: 2.03-3.12, p<0.001) for women who smoked throughout pregnancy. After logistic regression, FGR (AOR=1.9; 95% CI: 0.96-3.82) for women who quit smoking in the 3rd trimester (AOR=1.8; 95% CI: 1.38-2.31, p<0.001). The risk of FGR <5th percentile was AOR=1.96 (95% CI: 1.36-2.48, p<0.001).Active or passive smoking during pregnancy is associated with an increased risk of intrauterine growth restriction and low birth weight. Cessation in the 1st and 2nd trimester reduces the risk of intrauterine growth restriction or low birth weight. Passive smoking has a deleterious impact on fetal development, intermediate to that of active smoking.CONCLUSIONSActive or passive smoking during pregnancy is associated with an increased risk of intrauterine growth restriction and low birth weight. Cessation in the 1st and 2nd trimester reduces the risk of intrauterine growth restriction or low birth weight. Passive smoking has a deleterious impact on fetal development, intermediate to that of active smoking.
Journal Article
Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node
by
Villet, Richard
,
Dhainaut-Speyer, Caroline
,
Houvenaeghel, Gilles
in
Adult
,
Aged
,
Aged, 80 and over
2018
Background
Three randomized trials have concluded at non inferiority of omission of complementary axillary lymph node dissection (cALND) for patients with involved sentinel node (SN). However, we can outline strong limitations of these trials to validate this attitude with a high scientific level. We designed the SERC randomized trial (
ClinicalTrials.gov
, number NCT01717131) to compare outcomes in patients with SN involvement treated with ALND or no further axillary treatment. The aim of this study was to analyze results of the first 1000 patients included.
Methods
SERC trial is a multicenter non-inferiority phase 3 trial. Multivariate logistic regression analysis was used to identify independent factors associated with adjuvant chemotherapy administration and non-sentinel node (NSN) involvement.
Results
Of the 963 patients included in the analysis set, 478 were randomized to receive cALND and 485 SLNB alone. All patient demographics and tumor characteristics were balanced between the two arms. SN ITC was present in 6.3% patients (57/903), micro metastases in 33.0% (298), macro metastases in 60.7% (548) and 289 (34.2%) were non eligible to Z0011 trial criteria.
Whole breast or chest wall irradiation was delivered in 95.9% (896/934) of patients, adjuvant chemotherapy in 69.5% (644/926), endocrine therapy in 89.6% (673/751) and the proportions were similar in the two arms. The overall rate of positive NSN was 19% (84/442) for patients with cALND. Crude rates of positive NSN according to SN status were 4.5% for ITC (1/22), 9.5% for micro metastases (13/137), 23.9% for macro metastases (61/255) and were respectively 29.36% (64/218), 9.33% (7/75) and 7.94% (10/126) when chemotherapy was administered after cALND, before cALND and for patients without chemotherapy.
Conclusion
The main objective of SERC trial is to demonstrate non inferiority of cALND omission. A strong interaction between timing of cALND and chemotherapy with positive NSN rate was observed.
Trial registration
This study is registered with
ClinicalTrials.gov
, number NCT01717131 October 19, 2012.
Journal Article
Training for next generation surgeons: a pilot study of robot-assisted hysterectomy managed by resident using dual console
2021
Purpose
To assess feasibility of a standardized robot-assisted hysterectomy managed by resident and supervised by senior surgeon using dual-console on a 21-step grid (max score = 42) assessing resident autonomy.
Methods
A total of seven patients managed between September 2019 and March 2020 by six residents in gynecology and obstetrics were included. Standardized robot-assisted hysterectomy for endometrial cancer or adenomyosis was performed.
Results
No conversion to laparotomy, no intra- or post-operative incidents were reported. Mean score on the evaluation scale was 29.8 out of 42 (SD = 7.3). Mean operative time was 104 min (SD = 23). Mean average suturing time was, respectively, 335 s (SD = 57 s) and 270 s (SD = 53 s) for the first and the fourth knot. There was a 65 s improvement between the first and the fourth intracorporeal knot (
p
= 0.043). The perceived workload evaluated with the NASA TLX score showed a low level of stress (Temporal demand = 1.6 /10), and a low level of frustration (Frustration level = 3.6/10). Experience gained during the surgery was felt to be important (Commitment = 8.6/10).
Conclusion
Standardized robot-assisted hysterectomy managed by a resident supervised by a senior surgeon using the dual-console seems feasible. This tool could be useful to assess residents’ surgical skills.
Journal Article
CHRONO: randomized trial of the CHROnology of surgery after Neoadjuvant chemotherapy for Ovarian cancer
by
Anota, Amélie
,
Ouldamer, Lobna
,
Gauthier, Tristan
in
Abdomen
,
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
,
Cancer therapies
2022
BackgroundIn patients treated for advanced ovarian cancer not suitable for complete primary surgery, interval surgery after three courses of neoadjuvant chemotherapy has been considered standard management since the EORTC randomized trial published in 2010. An alternative approach with delayed surgery after six courses of neoadjuvant chemotherapy was reported in retrospective series.Primary ObjectivesTo assess the efficacy on progression free survival of interval cytoreduction surgery after three cycles of neoadjuvant chemotherapy compared with delayed surgery after six cycles of neoadjuvant chemotherapy.Study HypothesisIn women with ovarian cancer not suitable for primary surgical cytoreduction, surgery after six cycles of neoadjuvant chemotherapy will prove better disease-free survival than cytoreductive surgery after only three cycles.Trial DesignCHRONO is a multicenter, randomized phase III trial. After three courses of neoadjuvant chemotherapy, eligible patients will be randomized (1:1) to either completion surgery followed by an additional five cycles of chemotherapy (control arm) or an additional three cycles of neoadjuvant chemotherapy followed by completion surgery and then two additional cycles of chemotherapy (experimental arm). Patients in both groups will receive eight total cycles of chemotherapy.Major Inclusion/Exclusion CriteriaThe main inclusion criteria are histologically confirmed epithelial high-grade serous or endometrioid ovarian cancer, documented FIGO stage IIIB–IVA unsuitable for complete primary surgery but considered resectable after three courses of neoadjuvant chemotherapy. The main exclusion criteria are mucinous, clear cell, carcinosarcoma, or low-grade serous histologies.Primary EndpointThe primary endpoint is progression-free survival.Sample Size210 eligible patientsEstimated Dates for Completing Accrual and Presenting ResultsThe estimated date for completing accrual will be Q2 2023. The estimated date for presentation of the first results is Q3 2028.Trial Registration Number NCT03579394.
Journal Article
Uterine Factor Infertility, a Systematic Review
2022
Uterine factor infertility (UFI) is defined as a condition resulting from either a complete lack of a uterus or a non-functioning uterus due to many causes. The exact prevalence of UFI is currently unknown, while treatments to achieve pregnancy are very limited. To evaluate the prevalence of this condition within its different causes, we carried out a worldwide systematic review on UFI. We performed research on the prevalence of UFI and its various causes throughout the world, according to the PRISMA criteria. A total of 188 studies were included in qualitative synthesis. UFI accounted for 2.1 to 16.7% of the causes of female infertility. We tried to evaluate the proportion of the different causes of UFI: uterine agenesia, hysterectomies, uterine malformations, uterine irradiation, adenomyosis, synechiae and Asherman syndrome, uterine myomas and uterine polyps. However, the data available in countries and studies were highly heterogenous. This present systematic review underlines the lack of a consensual definition of UFI. A national register of patients with UFI based on a consensual definition of Absolute Uterine Factor Infertility and Non-Absolute Uterine Factor Infertility would be helpful for women, whose desire for pregnancy has reached a dead end.
Journal Article
The Influence of Surgical Complexity and Center Experience on Postoperative Morbidity After Minimally Invasive Surgery in Gynecologic Oncology: Lessons Learned from the ROBOGYN-1004 Trial
2024
Background
This study was a secondary analysis of the ROBOGYN-1004 trial conducted between 2010 and 2015. The study aimed to identify factors that affect postoperative morbidity after either robot-assisted laparoscopy (RL) or conventional laparoscopy (CL) in gynecologic oncology.
Methods
The study used two-level logistic regression analyses to evaluate the prognostic and predictive value of patient, surgery, and center characteristics in predicting severe postoperative morbidity 6 months after surgery.
Results
This analysis included 368 patients. Severe morbidity occurred in 49 (28 %) of 176 patients who underwent RL versus 41 (21 %) of 192 patients who underwent CL (
p
= 0.15). In the multivariate analysis, after adjustment for the treatment group (RL vs CL), the risk of severe morbidity increased significantly for patients who had poorer performance status, with an odds ratio (OR) of 1.62 for the 1-point difference in the WHO performance score (95 % CI 1.06–2.47;
p
= 0.027) and according to the type of surgery (
p
< 0.001). A focus on complex surgical acts showed significant more morbidity in the RL group than in the CL group at the less experienced centers (OR, 3.31; 95 % CI 1.0–11;
p
= 0.05) compared with no impact at the experienced centers (OR, 0.87; 95 % CI 0.38–1.99;
p
= 0.75).
Conclusion
The findings suggest that the center’s experience may have an impact on the risk of morbidity for patients undergoing complex robot-assisted surgical procedures.
Journal Article
Para-aortic Lymph Node Invasion in High-risk Endometrial Cancer: Performance of 18FDG PET-CT
2019
Aim: 18F-Fluorodeoxyglucose positron-emission tomography integrated with computed tomography (18FDG PET-CT) is a non-invasive examination that could be helpful for the management of endometrial cancer. This study investigated the performance of 18FDG PET-CT in assessing para-aortic (PA) lymph-node involvement in high-risk endometrial cancer. Materials and Methods: This was a retrospective, single-center study carried out between 2009 and 2018. The inclusion criteria were high-risk and locally advanced type 1 or 2 endometrial cancer with 18FDG PET-CT before PA lymphadenectomy. Results: During the study period, among 142 patients with high-risk endometrial cancer, 35 patients (24.6%) underwent 18FDG PET-CT followed by PA lymphadenectomy. In 25% of cases, PA lymphadenectomy was not performed due to the discovery of metastasis. 18FDG PET-CT had a sensitivity of 50%, a specificity of 100%, a positive predictive value of 100%, a negative predictive value of 75%, accuracy of 80% and an area under the curve of 0.75 for the evaluation of PA involvement. Conclusion: According to its high specificity in PA lymph-node evaluation, a positive PET scan might allow PA lymphadenectomy to be avoided.
Journal Article