Management of women with abnormal uterine bleeding: Clinical practice guidelines of the French National College of Gynaecologists and Obstetricians (CNGOF).

OBJECTIVE: To provide French guidelines for the management of women with abnormal uterine bleeding (AUB). DESIGN: A consensus committee of 26 experts was formed. A formal conflict-of-interest policy was developed at the beginning of the process and enforced throughout. The entire guidelines process was conducted independently of any industry funding (i.e. pharmaceutical or medical device companies). The authors were advised to follow the rules of the Grading of Recommendations Assessment, Development and Evaluation (GRADE®) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasized. METHODS: The last guidelines from the Collège National des Gynécologues et Obstétriciens Français on the management of women with AUB were published in 2008. The literature seems now sufficient for an update. The committee studied questions within 7 fields (diagnosis; adolescents; idiopathic AUB; endometrial hyperplasia and polyps; type 0-2 fibroids; type 3 or higher fibroids; and adenomyosis). Each question was formulated in a PICO (Patients, Intervention, Comparison, Outcome) format and evidence profiles were compiled. The GRADE® methodology was applied to the literature review and the formulation of recommendations. RESULTS: The experts' synthesis work and the application of the GRADE method resulted in 36 recommendations. Among the formalized recommendations, 19 are strong and 17 weak. No response was found in the literature for 14 questions. We chose to abstain from recommendations rather than providing advice based solely on expert clinical experience. CONCLUSIONS: The 36 recommendations make it possible to specify the diagnostic and therapeutic strategies for various clinical situations practitioners encounter, from the simplest to the most complex.

PIPAC nebulizer: How to test the new devices in the market, expert recommendations.

Pressurized intraperitoneal aerosol chemotherapy, named PIPAC, is now used in many centers around the world and as an intraperitoneal drug delivery system for treatment of peritoneal carcinomatosis. Recently, many of us have encountered problems during PIPAC procedures due to changes in material and production features of the original PIPAC nebulizer. Concomitantly, new PIPAC nebulizers proposed by other manufacturers are being launched on the market; which claim that they are the same as the original device in delivering PIPAC. However, these new devices are all different in terms of materials, technical characteristics and costs. We have considered that, to maintain the acquired results of PIPAC, we must ensure that the new systems are equivalent. The characteristics deemed essential by the expert group are as follows: 1: The nebulizer must be able to create droplets through an injector pressure between 10 and 20 bars, 2: The mean droplet size must be 3 micrometers, with 95% of the droplets between 0 and 10 micrometers, 3: The diffusion angle must be 70 degrees, which is the minimum.

[Management of women with abnormal uterine bleeding: Clinical practice guidelines of the French National College of Gynecologists and Obstetricians (CNGOF)]. / Prise en charge des ménorragies : recommandations pour la pratique clinique du Collège national des gynécologues et obstétriciens français (CNGOF).

OBJECTIVE: To provide French guidelines for the management of women with abnormal uterine bleeding (AUB). DESIGN: A consensus committee of 26 experts was formed. A formal conflict-of-interest (COI) policy was developed at the beginning of the process and enforced throughout. The entire guidelines process was conducted independently of any industrial funding (i.e. pharmaceutical, or medical devices). The authors were advised to follow the rules of the Grading of Recommendations Assessment, Development and Evaluation (GRADE®) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasized. METHODS: The last guidelines from the Collège national des gynécologues et obstétriciens français (CNGOF) on the management of women with AUB was published in 2008. The literature seems now sufficient for an update. The committee studied questions within 7 fields (diagnosis; adolescent; idiopathic AUB; endometrial hyperplasia and polyps; fibroids type 0 to 2; fibroids type 3 and more; adenomyosis). Each question was formulated in a PICO (Patients, Intervention, Comparison, Outcome) format and the evidence profiles were produced. The literature review and recommendations were made according to the GRADE® methodology. RESULTS: The experts' synthesis work and the application of the GRADE method resulted in 36 recommendations. Among the formalized recommendations, 19 present a strong agreement and 17 a weak agreement. Fourteen questions did not find any response in the literature. We preferred to abstain from recommending instead of providing expert advice. CONCLUSIONS: The 36 recommendations made it possible to specify the diagnostic and therapeutic strategies of various clinical situations managed by the practitioner, from the simplest to the most complex.

[CNGOF clinical practice guidelines: Evaluation one year after revision of the methodology]. / Recommandations pour la pratique clinique du CNGOF : évaluation un an après révision de la méthodologie.

OBJECTIVES: To evaluate the revision of methodology of the clinical practice guidelines (CPG) of the French National College of Gynecologists and Obstetricians (CNGOF). METHOD: Three CPGs were organized in 2020 on the topics of severe preeclampsia, menorrhagia, and prophylactic surgery according to AGREE II (Apraisal of Guidelines for Research & Evaluation). Questions were presented in PICO (Population, Intervention, Comparison, Outcome) format and the grading of scientific evidence was based on the GRADE (Grading of Recommendation Assessment, Development and Evaluation) method. RESULTS: All three CPGs groups adhered to this new methodology. However, the presentation of the arguments, the formulation of the recommendations and the development of the GRADE tables were heterogeneous from one group to another. A homogenization of the presentation is proposed, as well as a guide to the critical analysis of the literature to help the experts to rate the evidence. CONCLUSION: Adherence to these quality criteria should make it easier to apply the recommendations at the national level and improve international recognition of the work done by the CNGOF.

How to predict para-aortic node involvement in advanced cervical cancer? Development of a predictive score. A FRANCOGYN study.

INTRODUCTION: Node involvement is one of the main prognostic factors for cervical cancer. Para-aortic lymph node (PALN) assessment is crucial for treating advanced cervical cancer, to define irradiation fields. Objective of this study was to develop a score predicting para-aortic lymph node involvement in patients with advanced cervical cancer. PATIENTS AND METHOD: We performed a multicenter, retrospective, study on 9 French centers from 2000 to 2015, including patients with advanced squamous cell cervix carcinoma who had PALN status assessed by imaging and/or by surgery. Factors associated with a risk of PALN involvement were determined by univariate and multivariate analysis using a logistic regression model. A score was then developed and validated. RESULTS: A total of 1446 patients treated for cervical cancer were included. Of these, 498 had an advanced squamous cell cervical cancer. Ninety-one patients (18.3%) had positive PALN. After univariate and multivariate analysis, tumor size on pelvic MRI, initial SCC, and suspected pelvic node involvement on PET-CT were included in our score. This model allowed the population to be divided into 3 risk groups. Area under the ROC curve of the score was 0.81 (95%CI = 0.72-0.90). In the low-risk group, 9% (28/287) had PALN involvement, whereas in the high-risk group, 43% (22/51) had PALN involvement. CONCLUSION: We developed a simple score predicting PALN involvement in advanced cervical cancers. Three risk groups can be defined, and patients considered to be at low risk may avoid para-aortic staging as well as extensive field irradiation.

[Para-arortic lymhadenectomy and pelvic gynecological cancers: Extraperitoneal or transperitoneal laparoscopy?] / Curage lombo-aortique et cancers gynécologiques pelviens : cœlioscopie rétroperitonéale ou transpéritonéale ?

INTRODUCTION: Para-aortic lymphadenectomy plays a fundamental role in the surgical management of pelvic gynecological cancers. Two laparoscopic approaches exist: the transperitoneal (TP) and the extraperitoneal (EP). The aim of this study was to compare these 2 approaches in terms of surgical outcomes, specially the number of removed lymph nodes according to the surgical technique, and morbidity. MATERIALS AND METHOD: A single-center retrospective study was carried out at the Lariboisiere University Hospital between January 2011 and March 2020 including all patients who underwent para-aortic lymphadenectomy for the management of a pelvic gynecological cancer (cervix, endometrium, ovary). Univariate and multivariate analysis (logistic regression) were performed to compare the TP and the EP groups. RESULTS: 143 patients were included: 74 in the TP group and 69 in the RP group. The total duration of surgery was 220.8minutes in the TP group and 166.4minutes in the EP group (P<0.001 in multivariate analysis). No significant difference between groups were found in the average total number of lymph nodes removed but there was a statistically significant difference in the average latero-aortic number of lymph nodes removed: 8.5 lymph nodes in the TP group and 11.3 lymph nodes in the group RP (P<0.001 in multivariate analysis). There was no difference between groups in peri and postoperative morbidity. CONCLUSION: EP para-aortic lymphadenectomy reduces duration of surgery and increases the average latero-aortic number of lymph nodes removed with same morbidity compared to TP para-aortic lymphadenectomy, this confirming its preferred indication in endometrial and in cervical cancers.

Risk factors for recurrence of borderline ovarian tumors in France: A multicenter retrospective study by the FRANCOGYN group.

INTRODUCTION: Borderline ovarian tumors (BOTs) although rare, have shown an increase in the incidence worldwide. Although the survival rate is high, the recurrence rate is estimated to be between 5% and 34%. The objective of this study was to identify risk factors for recurrence of BOTs. METHODS: This retrospective multicenter study included 493 patients treated surgically for BOT between January 2001 and December 2018. RESULTS: Thirty-seven patients showed recurrence (group R, 7.5%), while 456 did not (group NR, 92.5%). With an average follow-up of 30.5 months (1-276), the overall recurrence rate was 7.5%. Recurrence rates for the BOT and invasive types were 5.7% (n = 28) and 1.4% (n = 7), respectively. The mean time to recurrence was 44.1 (3-251) months. Univariate analysis showed that age at diagnosis, type of surgical procedure, histological type, and FIGO stage were factors influencing recurrence. Multivariate analysis showed that the risk factors for recurrence of BOT were conservative treatment (OR = 7 [95% CI 3.01-16.23]; p < 0.05) and advanced FIGO stage (OR = 5.86 [95% CI 2.21-15.5]; p < 0.05). DISCUSSION: To the best of our knowledge, this multicenter study was one of the largest studies on the risk factors for BOT recurrence. Conservative treatment and advanced FIGO stage were identified as risk factors for BOT recurrence. These results reinforce the need for restaging of patients who did not have an optimal initial surgical staging so as not to avoid missing a tumor in the advanced stage. Referral to a surgical oncology center is suggested to optimize overall patient management.

Borderline ovarian tumors: Guidelines from the French national college of obstetricians and gynecologists (CNGOF).

It is recommended to classify Borderline Ovarian Tumors (BOTs) according to the WHO classification. Transvaginal and suprapubic ultrasonography are recommended for the analysis of an ovarian mass (Grade A). In case of an undetermined ovarian lesion on ultrasonography, it is recommended to perform a pelvic MRI (Grade A) with a score for malignancy (ADNEX MR/O-RADS) (Grade C) included in the report and to formulate a histological hypothesis (Grade C). Pelvic MRI is recommended to characterize a tumor suspected of being BOT (Grade C). It is recommended to evaluate serum levels of HE4 and CA125 and to use the ROMA score for the diagnosis of indeterminate ovarian mass on imaging (grade A). If there is a suspicion of a mucinous BOT on imaging, serum levels of CA 19-9 may be proposed (Grade C). For Early Stages (ES) of BOT, if surgery without risk of tumor rupture is possible, laparoscopy with protected extraction is recommended over laparotomy (Grade C). For treatment of a bilateral serous ES BOT with a strategy to preserve fertility and/or endocrine function, bilateral cystectomy is recommended where possible (Grade B). For mucinous BOTs with a treatment strategy of fertility and/or endocrine function preservation, unilateral salpingo-oophorectomy is recommended (grade C). For mucinous BOTs treated by initial cystectomy, unilateral salpingo-oophorectomy is recommended (grade C). For serous or mucinous ES BOTs, routine hysterectomy is not recommended (Grade C). For ES BOTs, lymphadenectomy is not recommended (Grade C). For ES BOTs, appendectomy is recommended only in case of a macroscopically pathological appendix (Grade C). Restaging surgery is recommended in cases of serous BOTs with micropapillary architecture and an incomplete abdominal cavity inspection during initial surgery (Grade C). Restaging surgery is recommended for mucinous BOTs after initial cystectomy or in cases where the appendix was not examined (Grade C). If restaging surgery is decided for ES BOTs, the following procedures should be performed: peritoneal washing (grade C), omentectomy (grade B), complete exploration of the abdominal cavity with peritoneal biopsies (grade C), visualization of the appendix and appendectomy in case of a pathological macroscopic appearance (grade C) as well as unilateral salpingo-oophorectomy in case of a mucinous BOT initially treated by cystectomy (grade C). In advanced stages (AS) of BOT, it is not recommended to perform a lymphadenectomy as a routine procedure (Grade C). For AS BOT in a patient with a desire to fall pregnant, conservative treatment involving preservation of the uterus and all or part of the ovary may be proposed (Grade C). Restaging surgery aimed at removing all lesions, not performed initially, is recommended for AS BOTs (Grade C). After treatment, follow-up for a duration greater than 5 years is recommended due to the median recurrence time of BOTs (Grade B). It is recommended that a systematic clinical examination be carried out during follow-up of a treated BOT (Grade B). If the determination of tumor markers is normal preoperatively, the routine dosage of tumor markers in BOT follow-up is not recommended (Grade C). In case of an initial elevation in serum CA 125 levels, it is recommended to monitor CA 125 during follow up (Grade B). In case of conservative treatment, it is recommended to use transvaginal and transabdominal ultrasound during follow up of a treated BOT (Grade B). In the event of a BOT recurrence in a woman of childbearing age, a second conservative treatment may be proposed (Grade C). A consultation with a physician specialized in Assisted Reproductive Technique (ART) should be offered in the case of BOTs in women of childbearing age (Grade C). When possible, a conservative surgical strategy is recommended to preserve fertility in women of childbearing age (Grade C). In the case of optimally treated BOT, there is no evidence to contraindicate the use of ART. The use of hormonal contraception after serous or mucinous BOT is not contraindicated (Grade C). After management of mucinous BOT, for women under 45 years, given the benefit of Hormonal Replacement Therapy (HRT) on cardiovascular and bone risks, and the lack of hormone sensitivity of mucinous BOTs, it is recommended to offer HRT (Grade C). Over 45 years of age, HRT can be prescribed in case of a climacteric syndrome after individual benefit to risk assessment (Grade C).

Management of borderline ovarian tumours during pregnancy: Results of a French multi-centre study.

OBJECTIVE: To assess the diagnostic and prognostic characteristics of borderline ovarian tumours (BOTs) detected during pregnancy, and to establish an inventory of French practices. MATERIALS AND METHODS: A retrospective multi-centre case study of 14 patients treated for BOTs, diagnosed during pregnancy between 2005 and 2017, in five French pelvic cancerology expert centres, including data on clinical characteristics, histological tumour characteristics, surgical procedure, adjuvant treatments, follow-up and fertility. RESULTS: The mean age of patients was 29.3 [standard deviation (SD) 6.2] years. Most BOTs were diagnosed on ultrasonography in the first trimester (85.7 %), and most of these cases (78.5 %) also underwent magnetic resonance imaging to confirm the diagnosis (true positives 54.5 %). Most patients underwent surgery during pregnancy (57 %), with complete staging surgery in two cases (14.3 %). Laparoscopy was performed more frequently than other procedures (50 %), and unilateral adnexectomy was more common than cystectomy (57.5 %). Tumour size influenced the surgical approach significantly (mean size 7.5 cm for laparoscopy, 11.9 cm for laparoconversion, 14 cm for primary laparotomy; P = 0.08), but the type of resection did not. Most patients were initially diagnosed with International Federation of Gynecology and Obstetrics stage IA (92.8 %) tumours, but many were upstaged after complete restaging surgery (57.1 %). Most BOTs were serous (50 %), two cases had a micropapillary component (28.5 %), and one case had a micro-invasive implant. BOTs were bilateral in two cases (14.2 %). Mean follow-up was 31.4 (SD 14.8) months. Recurrent lesions occurred in two patients (14.2 %) and no deaths have been recorded to date among the study population. CONCLUSION: BOTs remain rare, but this study - despite its small sample size - supports the hypothesis that BOTs during pregnancy have potentially aggressive characteristics.

Prognostic Value and Risk Factors of Peritoneal Carcinomatosis Recurrence for Patients with Endometrial Cancer: A Multicenter Study from the FRANCOGYN Group.

BACKGROUND: The prognosis for patients with endometrial cancer (EC) peritoneal carcinomatosis (PC) recurrence has received little study. This study aimed to determine specific risk factors and prognosis of EC with PC recurrence (PCR) versus no PC recurrence (NPCR). METHODS: Data of all patients with EC who received primary surgical treatment between January 2000 and February 2017 were abstracted from the French FRANCOGYN Research Group database. Clinical and pathologic variables were compared between the two groups (PCR vs. NPCR). Multivariate analysis was performed to define prognostic factors for peritoneal recurrence. Overall survivals (OS) of patients after recurrence were compared using the Kaplan-Meier method. RESULTS: The study analyzed 1466 patients, and 257 of these patients (17.5%) had recurrence. At presentation, 63 of these patients had PC. International Federation of Gynecology and Obstetrics (FIGO) stages 3 and 4 disease were significantly associated with PCR versus NPCR (odds ratio 2.24; 95% confidence interval 1.23-4.07; p = 0.008). The death rate for the patients with PC was 47.6%, with a median survival of 12 months after diagnosis of recurrence. According to the histologic subtype, OS was 29 months (Q1-Q3, 13-NA) for endometrioid carcinomas, 7.5 months (Q1-Q3, 4-15) for serous carcinomas, and 10 months (Q1-Q3, 5-15) for clear cell carcinomas. Chemotherapy for treatment of PCR was associated with improved OS after recurrence (OSAR; p = 0.0025). CONCLUSION: An initial advanced stage of EC is a risk factor for PCR. For women with PCR, a diagnosis of type 1 EC recurrence more than 12 months after the initial treatment and management of PCR with chemotherapy is associated with improved OSAR. Prospective studies are needed to determine the precise optimal management required in this clinical situation and to assess the relevance of biomarkers to predict the risk of PCR for EC patients.

Prognostic factors of overall survival for patients with FIGO stage IIIc or IVa ovarian cancer treated with neo-adjuvant chemotherapy followed by interval debulking surgery: A multicenter cohort analysis from the FRANCOGYN study group.

INTRODUCTION: The aim of this study was to identify prognostic factors of overall survival in patients with FIGO stage IIIc or IVa ovarian cancer (OC) treated by neo-adjuvant chemotherapy (NAC) followed by interval debulking surgery. MATERIALS AND METHODS: Data from 483 patients with ovarian cancer were retrospectively collected, from January 1, 2000 to December 31, 2016, from the FRANCOGYN database, regrouping data from 11 centers specialized in ovarian cancer treatment. Median overall survival was determined using the Kaplan-Meier method. Univariate and multivariate analysis were performed to define prognostic factors of overall survival. RESULTS: The median overall survival was 52 after a median follow up of 30 months. After univariate analysis, factors significantly associated with decreased overall survival were; no pelvic and/or para-aortic lymphadenectomy (p = 0.002), residual disease (CC1/CC2/CC3) after surgery (p < 0.001), positive cytology after NAC (p < 0.001), omental disease after NAC (p = 0.002), no pathologic complete response (pCR) (p = 0.002). In multivariate analysis, factors significantly associated with decreased overall survival were; residual disease after surgery (HR = 1.93; CI95% (1.16-3.21), p = 0.01) and positive cytology after NAC (HR = 1.59; CI95% (1.01-2.55), p = 0.05). Patients with no residual disease after surgery had a median overall survival of 64 months versus 35 months for patients with residual disease. Patients with negative cytology after NAC had a median overall survival of 71 months versus 43 months for patients with positive cytology after NAC. CONCLUSION: In this first and largest French based retrospective study, complete cytoreductive surgery in ovarian cancer remains the main prognostic factor of overall survival.

Impact of surgical restaging on recurrence in patients with borderline ovarian tumors: A meta-analysis.

OBJECTIVE: The benefits of restaging surgery for patients with a borderline ovarian tumor (BOT) discovered on initial surgery are debatable. We performed a meta-analysis to evaluate the role of restaging surgery on recurrence in patients with BOTs. STUDY DESIGN: We systematically reviewed published studies comparing restaging surgery and incomplete surgery in BOT patients from January 1985 to December 2017. Endpoints were recurrence and mortality rates. Study design features that possibly affected participant selection, reporting of recurrence and death, and manuscript publication were assessed. For pooled estimates of the effect of restaging surgery on recurrence, fixed-effect meta-analytical models were used. RESULTS: Of the 577 articles initially selected, four retrospective observational studies (Restaging group: 166 patients; Non-Restaging group: 394 patients) met our research criteria. No significant differences in terms of recurrence between the two groups were observed (pooled Peto Odds Ratio [OR] = 0.88; 95 % confidence interval [CI]: 0.41-1.92). The number of deaths was insufficient for statistical analysis. CONCLUSIONS: This meta-analysis based on retrospective studies, suggests that restaging surgery does not significantly reduce recurrence in patients with BOT.

[Guidelines for surgical management of gynaecological cancer during pandemic COVID-19 period - FRANCOGYN group for the CNGOF]. / Prise en charge chirurgicale des cancers gynécologiques en période de pandémie COVID-19 ­ Recommandations du Groupe FRANCOGYN pour le CNGOF.

INTRODUCTION: Recommendations for the management of patients with gynecological cancer during the COVID-19 pandemic period. MATERIAL AND METHOD: Recommendations based on the consensus conference model. RESULTS: In the case of a COVID-19 positive patient, surgical management should be postponed for at least 15 days. For cervical cancer, the place of surgery must be re-evaluated in relation to radiotherapy and Radio-Chemotherapy-Concomitant and the value of lymph node staging surgeries must be reviewed on a case-by-case basis. For advanced ovarian cancers, neo-adjuvant chemotherapy should be favored even if primary cytoreduction surgery could be envisaged. It is lawful not to offer hyperthermic intraperitoneal chemotherapy during a COVID-19 pandemic. In the case of patients who must undergo interval surgery, it is possible to continue the chemotherapy and to offer surgery after 6 cycles of chemotherapy. For early stage endometrial cancer, in case of low and intermediate preoperative ESMO risk, hysterectomy with bilateral annexectomy associated with a sentinel lymph node procedure should be favored. It is possible to consider postponing surgery for 1 to 2 months in low-risk endometrial cancers (FIGO Ia stage on MRI and grade 1-2 endometrioid cancer on endometrial biopsy). For high ESMO risk, it ispossible to favor the MSKCC algorithm (combining PET-CT and sentinel lymph node biopsy) in order to omit pelvic and lumbar-aortic lymphadenectomies. CONCLUSION: During COVID-19 pandemic, patients suffering from cancer should not lose life chance, while limiting the risks associated with the virus.

[Borderline Ovarian Tumours: CNGOF Guidelines for Clinical Practice - Short Text]. / Tumeurs frontières de l'ovaire. Recommandations pour la pratique clinique du CNGOF ­ Texte court.

This work was carried out under the aegis of the CNGOF (Collège national des gynécologues et obstétriciens français) and proposes guidelines based on the evidence available in the literature. The objective was to define the diagnostic and surgical management strategy, the fertility preservation and surveillance strategy in Borderline Ovarian Tumor (BOT). No screening modality can be proposed in the general population. An expert pathological review is recommended in case of doubt concerning the borderline nature, the histological subtype, the invasive nature of the implant, for all micropapillary/cribriform serous BOT or in the presence of peritoneal implants, and for all mucinous or clear cell tumors (grade C). Macroscopic MRI analysis should be performed to differentiate the different subtypes of BOT: serous, seromucinous and mucinous (intestinal type) (grade C). If preoperative biomarkers are normal, follow up of biomarkers is not recommended (grade C). In cases of bilateral early serous BOT with a desire to preserve fertility and/or endocrine function, it is recommended to perform a bilateral cystectomy if possible (grade B). In case of early mucinous BOT, with a desire to preserve fertility and/or endocrine function, it is recommended to perform a unilateral adnexectomy (grade C). Secondary surgical staging is recommended in case of serous BOT with micropapillary appearance and uncomplete inspection of the abdominal cavity during initial surgery (grade C). For early-stage serous or mucinous BOT, it is not recommended to perform a systematic hysterectomy (grade C). Follow up after BOT must be pursued for more than 5 years (grade B). Conservative treatment involving at least the conservation of the uterus and a fragment of the ovary in a patient wishing to conceive may be proposed in advanced stages of BOT (grade C). A new surgical treatment that preserves fertility after a first non-invasive recurrence may be proposed in women of childbearing age (grade C). It is recommended to offer a specialized consultation for Reproductive Medicine when diagnosing BOT in a woman of childbearing age. Hormonal contraceptive use after serous or mucinous BOT is not contraindicated (grade C).

[Borderline Ovarian Tumours: CNGOF guidelines for Clinical Practice - Methods & Organization]. / Tumeurs frontières de l'ovaire. Recommandations pour la pratique clinique du CNGOF ­ Méthodes et organisation.

This text presents organizational and methodological aspects of the development of the French guidelines on the management of borderline ovarian tumours.

ENDORECT: a preoperative score to accurately predict rectosigmoid involvement in patients with endometriosis.

STUDY QUESTION: Could we construct and validate a preoperative score to predict rectosigmoid involvement in endometriosis (RE)? SUMMARY ANSWER: We developed a simple preoperative score (ENDORECT) to predict RE. WHAT IS KNOWN ALREADY: Accurate preoperative classification is important to optimize the surgical approach for patients with endometriosis but there is currently no reliable first-line examination to determine RE. STUDY DESIGN SIZE DURATION: This was a single-centre observational study including all women (N = 119) who underwent complete surgery for endometriosis between January 2011 and June 2016 in the Gynaecological Department of the University Hospital of Poissy Saint-Germain en Laye. PARTICIPANTS/MATERIALS SETTING METHODS: Of the 119 women, 47 had RE and 72 did not. Two-thirds of the patients were randomly selected to derive the predictive score based on multiple logistic regression with internal validation by bootstrap. We used information from a self-assessment questionnaire, digital and speculum examination, transvaginal ultrasound and MRI. The score was then applied to the remaining sample of patients for validation. MAIN RESULTS AND THE ROLE OF CHANCE: Four variables were independently associated with RE: palpation of a posterior nodule on digital examination (aOR=5.6; 95%CI [1.7-21.8]); a UBESS score of 3 on ultrasonography (aOR=4.9; 95%CI [1.4-19.8); RE infiltration on MRI (aOR=6.8; 95%CI [2-25.5]); and presence of blood in the stools during menstruation (aOR=5.2; 95%CI [1.3-24.7]). The ROC-AUC of the model was 0.86 (95%CI [0.77-0.94]) and the bootstrap procedure showed that the model was stable. The ENDORECT score was derived from these four criteria and three risk groups were identified: the high-risk group (score>17) had a probability of RE of 100% with an specificity (Sp) of 100%, postive likelihood ratio (Lr+)>10; the intermediate-risk group (score: 7-17) had a probability of RE of 42%; and the low-risk group (score=0), with a sensitivity (Se) of 97%, negative likelihood ratio (Lr-) of 0.07 and a probability of RE of 5%. In the validation cohort, a score >17 predicted RE with an Sp of 96, Lr+ of 9.2, and probability of RE of 83%. Patients in this sample with a score=0, had an Se of 100%, Lr- of 0 and a probability of RE of 0%. LIMITATIONS REASONS FOR CAUTION: The single-centre recruitment and over-representation of RE could constitute a referral bias. WIDER IMPLICATIONS OF THE FINDINGS: The use of a preoperative predictive score could facilitate patient counselling and guide surgical management. Both MRI and transvaginal ultrasound provide independent information and are useful before surgery for RE. STUDY FUNDING/COMPETING INTERESTS: No financial support was specifically received for this study. The authors declare no conflict of interest. TRIAL REGISTRATION NUMBER: N/A.

Management of epithelial cancer of the ovary, fallopian tube, primary peritoneum. Long text of the joint French clinical practice guidelines issued by FRANCOGYN, CNGOF, SFOG, GINECO-ARCAGY, endorsed by INCa. (Part 2: systemic, intraperitoneal treatment, elderly patients, fertility preservation, follow-up).

Adjuvant chemotherapy by carboplatin and paclitaxel is recommended for all high-grade ovarian and tubal cancers (FIGO stages I-IIA) (grade A). After primary surgery is complete, 6 cycles of intravenous chemotherapy (grade A) are recommended, or a discussion with the patient about intraperitoneal chemotherapy, according to her risk-benefit ratio. After complete interval surgery for FIGO stage III, hyperthermic intraperitoneal chemotherapy (HIPEC) can be proposed, in accordance with the modalities of the OV-HIPEC trial (grade B). In cases of postoperative tumor residue or in FIGO stage IV tumors, chemotherapy associated with bevacizumab is recommended (grade A).

Management of epithelial cancer of the ovary, fallopian tube, and primary peritoneum. Long text of the Joint French Clinical Practice Guidelines issued by FRANCOGYN, CNGOF, SFOG, and GINECO-ARCAGY, and endorsed by INCa. Part 1: Diagnostic exploration and staging, surgery, perioperative care, and pathology.

An MRI is recommended for an ovarian mass that is indeterminate on ultrasound. The ROMA score (combining CA125 and HE4) can also be calculated (grade A). In presumed early-stage ovarian or tubal cancers, the following procedures should be performed: an omentectomy (at a minimum, infracolic), an appendectomy, multiple peritoneal biopsies, peritoneal cytology (grade C), and pelvic and para-aortic lymphadenectomies (grade B) for all histologic types, except the expansile mucinous subtypes, for which lymphadenectomies can be omitted (grade C). Minimally invasive surgery is recommended for early-stage ovarian cancer, when there is no risk of tumor rupture (grade B). For FIGO stages III or IV ovarian, tubal, and primary peritoneal cancers, a contrast-enhanced computed tomography (CT) scan of the thorax/abdomen/pelvis is recommended (grade B), as well as laparoscopic exploration to take multiple biopsies (grade A) and a carcinomatosis score (Fagotti score at a minimum) (grade C) to assess the possibility of complete surgery (i.e., leaving no macroscopic tumor residue). Complete surgery by a midline laparotomy is recommended for advanced ovarian, tubal, or primary peritoneal cancer (grade B). For advanced cancers, para-aortic and pelvic lymphadenectomies are recommended when metastatic adenopathy is clinically or radiologically suspected (grade B). When adenopathy is not suspected and when complete peritoneal surgery is performed as the initial surgery for advanced cancer, the lymphadenectomies can be omitted because they do not modify either the medical treatment or overall survival (grade B). Primary surgery (before other treatment) is recommended whenever it appears possible to leave no tumor residue (grade B).

Management of epithelial cancer of the ovary, fallopian tube, and primary peritoneum. Short text of the French Clinical Practice Guidelines issued by FRANCOGYN, CNGOF, SFOG, and GINECO-ARCAGY, and endorsed by INCa.

An MRI is recommended for an ovarian mass that is indeterminate on ultrasound. The ROMA score (combining CA125 and HE4) can also be calculated (Grade A). In presumed early-stage ovarian or tubal cancers, the following procedures should be performed: an omentectomy (at a minimum, infracolic), an appendectomy, multiple peritoneal biopsies, peritoneal cytology (grade C), and pelvic and para-aortic lymphadenectomies (Grade B) for all histologic types, except the expansile mucinous subtypes, for which lymphadenectomies can be omitted (grade C). Minimally invasive surgery is recommended for early-stage ovarian cancer, when there is no risk of tumor rupture (grade B). Adjuvant chemotherapy by carboplatin and paclitaxel is recommended for all high-grade ovarian and tubal cancers (FIGO stages I-IIA) (grade A). For FIGO stage III or IV ovarian, tubal, and primary peritoneal cancers, a contrast-enhanced computed tomography (CT) scan of the thorax/abdomen/pelvis is recommended (Grade B), as well as laparoscopic exploration to take multiple biopsies (grade A) and a carcinomatosis score (Fagotti score at a minimum) (grade C) to assess the possibility of complete surgery (i.e., leaving no macroscopic tumor residue). Complete surgery by a midline laparotomy is recommended for advanced ovarian, tubal, or primary peritoneal cancers (grade B). For advanced cancers, para-aortic and pelvic lymphadenectomies are recommended when metastatic adenopathy is clinically or radiologically suspected (grade B). When adenopathy is not suspected and when complete peritoneal surgery is performed as the initial surgery for advanced cancer, the lymphadenectomies can be omitted because they do not modify either the medical treatment or overall survival (grade B). Primary surgery (before other treatment) is recommended whenever it appears possible to leave no tumor residue (grade B). After primary surgery is complete, 6 cycles of intravenous chemotherapy (grade A) are recommended, or a discussion with the patient about intraperitoneal chemotherapy, according to her risk-benefit ratio. After complete interval surgery for FIGO stage III disease, hyperthermic intraperitoneal chemotherapy (HIPEC) can be proposed, in accordance with the modalities of the OV-HIPEC trial (grade B). In cases of postoperative tumor residue or in FIGO stage IV tumors, chemotherapy associated with bevacizumab is recommended (grade A).