Prognostic impact of cytoreductive surgery conducted with primary intent, versus cytoreductive surgery after neoadjuvant chemotherapy, in the management of patients with advanced epithelial ovarian cancers: a multicentre, propensity score-matched study from the FRANCOGYN group.

OBJECTIVE: To compare survival and morbidity rates between primary cytoreductive surgery (pCRS) and interval cytoreductive surgery (iCRS) for epithelial ovarian cancer (EOC), using a propensity score. DESIGN: We conducted a propensity score-matched cohort study, using data from the FRANCOGYN cohort. SETTING: Retrospective, multicentre study of data from patients followed in 15 French department specialized in the treatment of ovarian cancer. SAMPLE: Patients included were those with International Federation of Gynaecology and Obstetrics (FIGO) stage III or IV EOC, with peritoneal carcinomatosis, having undergone CRS. METHODS: The propensity score was designed using pre-therapeutic variables associated with both treatment allocation and overall survival (OS). MAIN OUTCOME MEASURES: The primary outcome was OS. Secondary outcomes included recurrence-free survival (RFS), quality of CRS and other variables related to surgical morbidity. RESULTS: A total of 513 patients were included. Among these, 334 could be matched, forming 167 pairs. No difference in OS was found (hazard ratio, HR = 0.8, p = 0.32). There was also no difference in RFS (median = 26 months in both groups) nor in the rate of CRS leaving no macroscopic residual disease (pCRS 85%, iCRS 81.4%, p = 0.76). The rates of gastrointestinal tract resections, stoma, postoperative complications and hospital stay were significantly higher in the pCRS group. CONCLUSIONS: Analysis of groups of patients made comparable by propensity score matching showed no difference in survival, but lower postoperative morbidity in patients treated with iCRS.

Adherence to ESGO guidelines and impact on survival in obese patients with endometrial cancer: a multicentric retrospective study.

OBJECTIVES: Obesity is known to be both a major risk factor for endometrial cancer and associated with surgical complexity. Therefore, the management of patients with obesity is a challenge for surgeons and oncologists. The aim of this study is to assess the adherence to European Society of Gynaecological Oncology (ESGO) guidelines in morbidly obese patients (body mass index (BMI) >40 kg/m2). The secondary objectives were the impact on overall survival and recurrence-free survival. METHODS: All the patients who were treated for an endometrial cancer in the 11 cancer institutes of the FRANCOGYN group were included and classified into three weight groups: morbid (BMI >40 kg/m2), obese (BMI 30-40), and normal or overweight (BMI <30). Adherence to guidelines was evaluated for surgical management, lymph node staging, and adjuvant therapies. RESULTS: In total, 2375 patients were included: 1330 in the normal or overweight group, 763 in the obese group, and 282 in the morbid group. The surgical management of the morbid group was in accordance with the guidelines in only 30% of cases, compared with 44% for the obese group and 48% for the normal or overweight group (p<0.001); this was largely because of a lack of lymph node staging. Morbid group patients were more likely to receive the recommended adjuvant therapy (61%) than the obese group (52%) or the normal or overweight group (46%) (p<0.001). Weight had no impact on overall survival (p=0.6) and morbid group patients had better recurrence-free survival (p=0.04). CONCLUSION: Adherence to international guidelines for surgical management is significantly lower in morbid group patients, especially for lymph node staging. However, morbidly obese patients had more often the adequate adjuvant therapies. Morbid group patients had a better recurrence-free survival likely because of better prognosis tumors.

Operative Hysteroscopy vs Vacuum Aspiration for Incomplete Spontaneous Abortion: A Randomized Clinical Trial.

Importance: Vacuum aspiration is commonly used to remove retained products of conception in patients with incomplete spontaneous abortion. Scarring of the uterine cavity may occur, potentially impairing future fertility. A procedural alternative, operative hysteroscopy, has gained popularity with a presumption of better future fertility. Objective: To assess the superiority of hysteroscopy to vacuum aspiration for subsequent pregnancy in patients with incomplete spontaneous abortion who intend to have future pregnancy. Design, Setting, and Participants: The HY-PER randomized, controlled, single-blind trial included 574 patients between November 6, 2014, and May 3, 2017, with a 2-year duration of follow-up. This multicenter trial recruited patients in 15 French hospitals. Individuals aged 18 to 44 years and planned for surgery for an incomplete spontaneous abortion with plans to subsequently conceive were randomized in a 1:1 ratio. Interventions: Surgical treatment by hysteroscopy (n = 288) or vacuum aspiration (n = 286). Main Outcomes and Measures: The primary outcome was a pregnancy of at least 22 weeks' duration during 2-year follow-up. Results: The intention-to-treat analyses included 563 women (mean [SD] age, 32.6 [5.4] years). All aspiration procedures were completed. The hysteroscopic procedure could not be completed for 19 patients (7%), 18 of which were converted to vacuum aspiration (8 with inability to completely resect, 7 with insufficient visualization, 2 with anesthetic complications that required a shortened procedure, 1 with equipment failure). One hysteroscopy failed due to a false passage during cervical dilatation. During the 2-year follow-up, 177 patients (62.8%) in the hysteroscopy group and 190 (67.6%) in the vacuum aspiration (control) group achieved the primary outcome (difference, -4.8% [95% CI, -13% to 3.0%]; P = .23). The time-to-event analyses showed no statistically significant difference between groups for the primary outcome (hazard ratio, 0.87 [95% CI, 0.71 to 1.07]). Duration of surgery and hospitalization were significantly longer for hysteroscopy. Rates of new miscarriages, ectopic pregnancies, Clavien-Dindo surgical complications of grade 3 or above (requiring surgical, endoscopic, or radiological intervention or life-threatening event or death), and reinterventions to remove remaining products of conception did not differ between groups. Conclusions and Relevance: Surgical management by hysteroscopy of incomplete spontaneous abortions in patients intending to conceive again was not associated with more subsequent births or a better safety profile than vacuum aspiration. Moreover, operative hysteroscopy was not feasible in all cases. Trial Registration: ClinicalTrials.gov Identifier: NCT02201732.

Status of Surgical Management of Borderline Ovarian Tumors in France: are Recommendations Being Followed? Multicentric French Study by the FRANCOGYN Group.

BACKGROUND: Borderline ovarian tumors (BOTs) are tumors with a favorable prognosis but whose management by consensus is essential to limit the risk of invasive recurrence. This study aimed to conduct an inventory of surgical practices for BOT in France and to evaluate the conformity of the treatment according to the current French guidelines. METHODS: This retrospective, multicenter cohort study included nine referral centers of France between January 2001 and December 2018. It analyzed all patients with serous and mucinous BOT who had undergone surgery. A peritoneal staging in accordance with the recommendations was defined by performance of a peritoneal cytology, an omentectomy, and at least one peritoneal biopsy. RESULTS: The study included 332 patients. A laparoscopy was performed in 79.5% of the cases. Treatment was conservative in 31.9% of the cases. The recurrence rate was significantly increased after conservative treatment (17.3% vs 3.1%; p < 0.001). Peritoneal cytology was performed for 95.5%, omentectomy for 83.1%, and at least one biopsy for 82.2% of the patients. The overall recurrence rate was 7.8%, and the recurrence was invasive in 1.2% of the cases. No link was found between the recurrence rate and the conformity of peritoneal staging. The overall rate of staging noncompliance was 22.9%. CONCLUSION: The current standards for BOT management seem to be well applied.

Pressurized intra-peritoneal aerosol chemotherapy (PIPAC): increased intraperitoneal pressure does not affect distribution patterns but leads to deeper penetration depth of doxorubicin in a sheep model.

BACKGROUND: Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) is an innovative treatment against peritoneal carcinomatosis. Doxorubicin is a common intra-venous chemotherapy used for peritoneal carcinomatosis and for PIPAC. This study evaluated the impact of increased PIPAC intraperitoneal pressure on the distribution and cell penetration of doxorubicin in a sheep model. METHODS: Doxorubicin was aerosolized using PIPAC into the peritoneal cavity of 6 ewes (pre-alpes breed): N = 3 with 12 mmHg intraperitoneal pressure ("group 12") and N = 3 with 20 mmHg ("group 20"). Samples from peritoneum (N = 6), ovarian (N = 1), omentum (N = 1) and caecum (N = 1) were collected for each ewe. The number of doxorubicin positive cells was determined using the ratio between doxorubicine fluorescence-positive cell nuclei (DOXO+) over total number of DAPI positive cell nuclei (DAPI+). Penetration depth (µm) was defined as the distance between the luminal surface and the location of the deepest DOXO+ nuclei over the total number of cell nuclei that were stained with DAPI. Penetration depth (µm) was defined as the distance between the luminal surface and the location of the deepest DOXO+ nuclei. RESULTS: DOXO+ nuclei were identified in 87% of samples. All omental samples, directly localized in front of the nebulizer head, had 100% DOXO+ nuclei whereas very few nuclei were DOXO+ for caecum. Distribution patterns were not different between the two groups but penetration depth in ovary and caecum samples was significantly deeper in group 20. CONCLUSIONS: This study showed that applying a higher intra-peritoneal pressure during PIPAC treatment leads to a deeper penetration of doxorubicin in ovarian and caecum but does not affect distribution patterns.

Adherence to European ovarian cancer guidelines and impact on survival: a French multicenter study (FRANCOGYN).

OBJECTIVE: The primary objective of the study was to validate the European Society for Medical Oncology (ESMO)-European Society of Gynecologic Oncology (ESGO) ovarian cancer guideline as a method of assessing quality of care, and to identify patient characteristics predictive of non-adherence to European guideline care. The secondary objectives were to analyze the evolution of practices over the years and to evaluate heterogeneity between centers. METHODS: This retrospective multicenter cohort study of invasive epithelial ovarian cancer reported to the FRANCOGYN database included data from 12 French centers between January 2000 and February 2017. The main outcome was adherence to ESMO-ESGO guidelines, defined by recommended surgical procedures according to the International Federation of Gynecology and Obstetrics (FIGO) stage and appropriate chemotherapy. Mixed multivariable logistic regression analysis with a random center effect was performed to estimate the probability of adherence to the guidelines. Survival analysis was carried out using the Kaplan-Meier method and a mixed Cox proportional hazards model. RESULTS: 1463 patients were included in the study. Overall, 317 (30%) patients received complete guideline adherent care. Patients received appropriate surgical treatment in 69% of cases, while adequate chemotherapy was administered to 44% of patients. Both patient demographics and disease characteristics were significantly associated with the likelihood of receiving guideline adherent care, such as age, performance status, FIGO stage, and initial burden of disease. In univariate and multivariate survival analysis, adherence to the guidelines was a statistically significant and independent predictor of decreased overall survival. Patients receiving suboptimal care experienced an increased risk of death of more than 100% compared with those treated according to the guidelines (hazard ratio 2.14, 95% confidence interval 1.32 to 3.47, p<0.01). In both models, a significant random center effect was observed, confirming the heterogeneity between centers (p<0.001). CONCLUSIONS: Adherence to ESMO-ESGO guidelines in ovarian cancer was associated with a higher overall survival and may be a useful method of assessing quality of care.

Lymphovascular space invasion as a prognostic factor of epithelial ovarian cancer: a multicenter study by the FRANCOGYN group.

BACKGROUND: The presence of lymphovascular space invasion (LVSI) is not yet included in international recommendations neither as a prognostic factor nor as a parameter for the decision to use adjuvant chemotherapy in FIGO stage I/IIa ovarian cancer (OC). OBJECTIVE: This study set out to evaluate the impact of LVSI on Overall Survival (OS) and Recurrence-Free Survival (RFS) in patients managed for epithelial OC. DESIGN: Retrospective multicenter study by the research group FRANCOGYN between January 2001 and December 2018. All patients managed for epithelial OC surgery and for whom histological slides for the review of LVSI were available, were included. The characteristics of patients with LVSI (LVSI group) were compared to those without LVSI (No-LVSI group). A Cox analysis for OS and RFS analysis was performed in all the populations. SETTING: French multicenter tertiary care centers RESULTS: Over the study period, 852 patients were included in the 13 institutions. Among them, 289 patients had LVSI (33.9%). There was a significant difference in the distribution of LVSI between early and advanced stages (p < 0.001). LVSI was an independent predictive factor for poorer Overall and Recurrence-Free Survival. LVSI affected OS (p < 0.001) and RFS (p < 0.001), LVSI affected OS and RFS for early stages (p = 0.001; p = 0.001, respectively) and also for advanced stages (p = 0.01; p = 0.009, respectively). CONCLUSION: The presence of LVSI in epithelial ovarian epithelial tumors has an impact on OS and RFS and should be included in the routine pathology examination to adapt therapeutic management, especially for women in the early stages of the disease.

Patients with stage IV epithelial ovarian cancer: understanding the determinants of survival.

BACKGROUND: The most appropriate management for patients with stage IV ovarian cancer remains unclear. Our objective was to understand the main determinants associated with survival and to discuss best surgical management. METHODS: Data of 1038 patients with confirmed ovarian cancer treated between 1996 and 2016 were extracted from maintained databases of 7 French referral gynecologic oncology institutions. Patients with stage IV diseases were selected for further analysis. The Kaplan-Meier method was used to estimate the survival distribution. A Cox proportional hazards model including all the parameters statistically significant in univariable analysis, was used to account for the influence of multiple variables. RESULTS: Two hundred and eight patients met our inclusion criteria: 65 (31.3%) never underwent debulking surgery, 52 (25%) underwent primary debulking surgery (PDS) and 91 (43.8%) neoadjuvant chemotherapy and interval debulking surgery (NACT-IDS). Patients not operated had a significantly worse overall survival than patients that underwent PDS or NACT-IDS (p < 0.001). In multivariable analysis, three factors were independent predictors of survival: upfront surgery (HR 0.32 95% CI 0.14-0.71, p = 0.005), postoperative residual disease = 0 (HR 0.37 95% CI 0.18-0.75, p = 0.006) and association of Carboplatin and Paclitaxel regimen (HR 0.45 95% CI 0.25-0.80, p = 0.007). CONCLUSIONS: Presence of distant metastases should not refrain surgeons from performing radical procedures, whenever the patient is able to tolerate. Maximal surgical efforts should be done to minimize residual disease as it is the main determinant of survival.

Fertility and prognosis of borderline ovarian tumor after conservative management: Results of the multicentric OPTIBOT study by the GINECO & TMRG group.

OBJECTIVES: Description of fertility and prognosis of patients with borderline ovarian tumor (BOT) treated by fertility-sparing surgery through a longitudinal study from the French national cancer network. METHODS: All consecutive patients diagnosed with BOT from the French National Network dedicated to Ovarian Malignant Rare Tumors from 2010 and 2017 were selected. In 2018, an update was made by sending a questionnaire regarding recurrence and fertility to patients aged under 43 years at diagnosis and treated conservatively. We compared the characteristics of the patients with/without recurrence and with/without live birth. RESULTS: Fifty-two patients aged 18 to 42 years presented a desire of pregnancy. Thirty patients (58%) presented a FIGO IA tumor, and 20 patients were treated by bilateral cystectomies (38%). We observed at least one live birth for 33 patients (63%) and local recurrences in 20 patients (38%). Both recurrence and live birth in 17 patients (33%) were reported, with recurrence occurring before pregnancy, after a second fertility-sparing treatment, in half of the cases. No factors associated with recurrence or live birth in this study were identified. Moreover, in this population, both recurrence and live birth were independent of age, with a linear risk along time. Disease-free survival was worse for patients treated with bilateral cystectomy (n = 20, 38%), with no difference in terms of fertility. CONCLUSION: Two third of the patients experienced life birth after conservation surgery. We did not highlight an age/time from surgery for which the risk of recurrence outweighs the chance of pregnancy and to radicalize surgery. Moreover, almost a quarter of the live birth occurred after recurrence, with no more further event to date in these patients. The results encourage to consider a second fertility-sparing surgery after local borderline recurrence in the case of pregnancy desire. All these decisions must be discussed in specialized multidisciplinary boards.

Therapeutic value of surgical paraaortic staging in locally advanced cervical cancer: a multicenter cohort analysis from the FRANCOGYN study group.

BACKGROUND: The prognostic impact of surgical paraaortic staging remains unclear in patients with locally advanced cervical cancer (LACC). The objective of our study was to evaluate the survival impact of surgical staging in patients with LACC and no evidence of paraaortic lymph node (PALN) metastasis on pre-operative imaging work-up. METHODS: Data of 1447 patients with cervical cancer treated between 1996 and 2016 were extracted from maintained databases of 10 French University hospitals. Patients with locally advanced disease (IB2 or more) treated by concurrent chemoradiation therapy (CRT) and no evidence of paraaortic metastasis on pre-operative imaging work-up were selected for further analysis. The Kaplan-Meier method was used to estimate the survival distribution. A Cox proportional hazards model was used to account for the influence of multiple variables. RESULTS: Six hundred and forty-seven patients were included, 377 (58.3%) with surgical staging and 270 (41.7%) without, with a mean follow up of 38.1 months (QI 13.0-56.0). Pathologic analysis revealed positive lymph nodes in 47 patients (12.5%). In multivariate model analysis, surgical staging remained an independent prognostic factor for DFS (OR 0.64, CI 95% 0.46-0.89, p = 0.008) and OS (OR 0.43, CI 95% 0.27-0.68, p < 0.001). The other significant parameter in multivariate analysis for both DFS and OS was treatment by intracavitary brachytherapy (OR respectively of 0.7 (0.5-1.0) and 0.6 (0.4-0.9), p < 0.05). CONCLUSION: Nodal surgical staging had an independent positive impact on survival in patients with LACC treated with CRT with no evidence of metastatic PALN on imaging.

Identification of a low risk population for parametrial invasion in patients with early-stage cervical cancer.

BACKGROUND: Recent studies have challenged radical procedures for less extensive surgery in selected patients with early-stage cervical cancer at low risk of parametrial invasion. Our objective was to identify a subgroup of patients at low risk of parametrial invasion among women having undergone surgical treatment. METHODS: Data of 1447 patients with cervical cancer treated between 1996 and 2016 were extracted from maintained databases of 10 French University hospitals. Patients with early-stage (IA2-IIA) disease treated by radical surgery including hysterectomy and trachelectomy, were selected for further analysis. The Kaplan-Meier method was used to estimate the survival distribution. A Cox proportional hazards model including all the parameters statistically significant in univariate analysis, was used to account for the influence of multiple variables. RESULTS: Out of the 263 patients included for analysis, on final pathology analysis 28 (10.6%) had parametrial invasion and 235 (89.4%) did not. Factors significantly associated with parametrial invasion on multivariate analysis were: age > 65 years, tumor > 30 mm in diameter measured by MRI, lymphovascular space invasion (LVSI) on pathologic analysis. Among the 235 patients with negative pelvic lymph nodes, parametrial disease was seen in only 7.6% compared with 30.8% of those with positive pelvic nodes (p < 0.001). In a subgroup of patients presenting tumors < 30 mm, negative pelvic status and no LVSI, the risk of parametrial invasion fell to 0.6% (1/173 patients). CONCLUSION: Our analysis suggests that there is a subgroup of patients at very low risk of parametrial invasion, potentially eligible for less radical procedures.

A Proposal for a Classification for Recurrent Endometrial Cancer: Analysis of a French Multicenter Database From the FRANCOGYN Study Group.

OBJECTIVE: Endometrial cancer (EC) recurrences are relatively common with no standardized way of describing them. We propose a new classification for them called locoregional, nodal, metastasis, carcinomatosis recurrences (rLMNC). PATIENTS AND METHODS: The data of 1230 women with EC who were initially treated by primary surgery were included in this French multicenter retrospective study. Recurrences were classified based on dissemination pathways: (1) locoregional recurrence (rL); (2) nodal recurrence (rN) for lymphatic pathway; (3) distant organ recurrence (rM) for hematogenous pathway; and (4) carcinomatosis recurrence (rC) for peritoneal pathway. These pathways were further divided into subgroups. We compared recurrence free survival and overall survival (OS) between the 4 groups (rL/rN/rM/rC). RESULTS: The median follow-up was 35.6 months (range, 1.70-167.60). One hundred ninety-eight women (18.2%) experienced a recurrence: 150 (75.8%) experienced a single-pathway recurrence and 48 (24.2%) a multiple-pathway recurrence. The 5-year OS was 34.1% (95% confidence interval [CI], 27.02%-43.1%), and the median time to first recurrence was 18.9 months (range, 0-152 months). The median survival after recurrence was 14.8 months (95% CI, 11.7-18.8). Among women with single pathway of recurrence, a difference in 5-year OS (P < 0.001) and survival after recurrence (P < 0.01) was found between the 4 rLNMC groups. The carcinomatosis group had the worst prognosis compared with other single recurrence pathways. Women with multiple recurrences had poorer 5-year OS (P < 0.001) and survival after recurrence (P < 0.01) than those with single metastasis recurrence, other than women with peritoneal carcinomatosis. CONCLUSIONS: This easy-to-use and intuitive classification may be helpful to define EC recurrence risk groups and develop guidelines for the management of recurrence. Its prognosis value could also be a tool to select homogenous populations for further trials.

Preoperative clinical pathway of breast cancer patients: determinants of compliance with EUSOMA quality indicators.

BACKGROUND: The European Society of Breast Cancer Specialists (EUSOMA) has defined quality indicators for breast cancer (BC). The aim of this study was to describe the preoperative clinical pathway of breast cancer patients and evaluate the determinants of compliance with EUSOMA quality indicators in the Optisoins01 cohort. METHODS: Optisoins01 is a prospective, multicentric study. Data from operable BC patients were collected, including results from before surgery to 1 year follow-up. Seven preoperative EUSOMA quality indicators were compared with the clinical pathways Optisoins01. RESULTS: Six hundred and four patients were included. European Society of Breast Cancer Specialists targets were reached for indicator 1 (completeness of clinical and imaging diagnostic work-up), 3 (preoperative definitive diagnosis) and 5 (waiting time). For indicator 8 (multidisciplinary discussion), the minimum standard of 90% of the patients was reached only in general hospitals and comprehensive cancer centres. Having more than 1 medical examination within the centre was associated with an increased waiting time for surgery, whereas it was reduced by having an outpatient breast biopsy. The comprehensive cancer centre type was the only parameter associated with the other quality indicators. CONCLUSIONS: European Society of Breast Cancer Specialists quality indicators are a useful tool to evaluate care organisations. This study highlights the need for a standardised and coordinated preoperative clinical pathway.

Management and Survival of Elderly and Very Elderly Patients with Endometrial Cancer: An Age-Stratified Study of 1228 Women from the FRANCOGYN Group.

BACKGROUND: Little data exist about the clinical management and survival of elderly patients with endometrial cancer. This study aimed to evaluate the management of elderly and very elderly patients with endometrial cancer as well as the overall survival (OS) rate, disease-free survival (DFS) rate, and cancer-specific survival (CSS) rate in a multicenter cohort. METHODS: Data from 1228 patients with endometrial cancer who received primary treatment between January 2001 and December 2012 were collected from a multicenter database. Clinical management, DFS, CSS, and OS were analyzed. RESULTS: Based on the international endometrial cancer risk classification, 36% (212/582) of women age 65 years or younger, 42% (220/526) of women ages 65-80 years, and 48% (58/120) of women older than 80 years showed high-risk endometrial cancer (p < 0.001). Pelvic lymphadenectomy was performed for 85% (230/271) of the women age 65 years or younger and 46% (33/71) of the women older than 80 years (p < 0.001). Radiotherapy was performed for 27% (33/120) of the very elderly and 40% (233/582) of the young patients (p = 0.009). The 3-year CSS rates were 95% (95% confidence interval [CI], 93-97%) for the women age 65 years or younger, 90% (95% CI, 87-94%) for the women ages 65-80 years, and 82% (95% CI, 73-93%) for the women older than 80 years (p < 0.001). CONCLUSIONS: The elderly and very elderly patients with endometrial cancer showed poorer prognosis than young patients. The significant lower CSS rate for the elderly patients could have be due to both the higher rate of high-risk endometrial cancer and undertreatment. Specific guidelines for the management of elderly and very elderly patients with endometrial cancer are needed to improve their prognosis.

Evaluation and Selection of Quality Indicators for the Management of Endometrial Cancer.

OBJECTIVE: The aim of this study was to evaluate 36 quality indicators (QIs) for monitoring the quality of care of uterine cancer to be implemented in the EFFECT (effectiveness of endometrial cancer treatment) project. METHODS: The 36 QIs were evaluated in the first 10 patients diagnosed with endometrial cancer and managed in 14 French hospitals in 2011. To assess the status of each QI, a questionnaire detailing the 36 QIs was sent to each hospital, and the information was cross-checked with information from the multidisciplinary staff meeting, surgical reports, and pathological reports. The QIs were evaluated in terms of measurability and improvability. The remaining QIs were evaluated with a multiple correspondence analysis to highlight the interrelationships between qualitative variables describing a population. RESULTS: Thirteen of the 14 institutions responded to the survey for a total of 130 patients. Twenty-five of the 36 QIs affected less than 80% of the patients. Thirteen QIs were found not to be improvable because they reached more than 95% of the theoretical target. Finally, 5 QIs concerning more than 80% of the patients were found to be improvable. The multiple correspondence analysis finally identified 3 dimensions-outcome, safety, and perioperative management-that included the 5 QIs. CONCLUSIONS: In the present study, 5 of the 36 QIs suggested by the EFFECT project seem to be sufficient to report on the quality of endometrial cancer management. Further studies are needed to correlate the information provided by those 5 questions and the relevant outcomes reflecting quality of care in endometrial cancer.

Development of a French version of the Endometriosis Health Profile 5 (EHP-5): cross-cultural adaptation and psychometric evaluation.

PURPOSE: The Endometriosis Health Profile 5 (EHP-5) is a short version of an endometriosis-specific quality of life questionnaire. The objective of the study was to assess the psychometric validity of its French version. METHODS: A total of 125 patients with histologically proven endometriosis who underwent surgery for painful symptoms and 80 asymptomatic controls completed the EHP-5. Principal components analysis was performed to determine the dimensions of the instrument. Internal consistency was assessed using Cronbach's alpha. Construct validity was assessed by testing the relationship between the EHP-5 and the characteristics of endometriosis. RESULTS: For each item of EHP-5, endometriosis patients scored significantly higher than control women (p > 0.0001). Eleven items of the EHP-5 were unidimensional with excellent internal consistency (Cronbach's alpha = 0.92), and a summary aggregated index was then constructed. The EHP-5 index was sensitive to the presence of endometriosis, the type, location, severity of the disease, and pain or infertility as the main complaint with effect sizes ranging from 0.48 (95 % CI 0.11-0.85) for superficial endometriosis to 2.56 (95 % CI 2.18-2.93) for deeply infiltrating endometriosis. CONCLUSION: The French version of EHP-5 is valid and can be used for reporting patient-orientated outcome in future studies of French-speaking patients with endometriosis.

Characteristics and prognosis of patients with early-stage endometrial cancer who refuse adjuvant radiotherapy.

OBJECTIVE: To investigate the risk factors for refusing adjuvant radiotherapy in patients who have undergone surgery for early-stage endometrial cancer, and to compare their survival rates with patients who have undergone adjuvant radiotherapy. METHODS: Data from the Surveillance, Epidemiology, and End Results database for patients operated on for histologically-proven early-stage endometrioid endometrial cancer, between 1988 and 2012, were screened. Univariate and multivariate logistic regression analyses tested the associations between refusal of adjuvant radiotherapy and demographic, tumoral, and management characteristics. Overall and cancer-related survival rates were compared between 376 patients who refused adjuvant radiotherapy and 752 patients who received adjuvant radiotherapy, matched for demographics (age, race, year of diagnosis, marital status, region), tumoral (grade, FIGO stage, size), and management (lymphadenectomy performed) criteria. RESULTS: 434 of the 16,014 patients (2.7%) who were proposed adjuvant radiotherapy refused this treatment. Older, widowed, divorced, or separated patients, who were recently diagnosed and managed in the Northern plains or Pacific coast (USA), with limited tumoral extension, were more likely to refuse adjuvant radiotherapy. Five-year cancer-related survival was significantly lower in patients who refused adjuvant radiotherapy (88.9% vs. 95.7%, p<0.001) whereas overall survival did not significantly differ between the two groups (76.4% vs. 83.7%, p=0.23). CONCLUSIONS: We have identified the patients' characteristics related to refusal of adjuvant radiotherapy. Refusing adjuvant radiotherapy increased cancer-related death but probably does not reduce overall survival.

Bladder symptoms and urodynamic observations of patients with endometriosis confirmed by laparoscopy.

INTRODUCTION AND HYPOTHESIS: Patients with deep infiltrating pelvic endometriosis (DIE) often describe having lower urinary tract symptoms (LUTS). Bladder pain syndrome in women is also often associated with endometriosis. In this study, we aimed to describe the characteristics of LUTS and urodynamic observations in patients with posterior endometriosis versus those with posterior and anterior endometriosis. METHODS: This was a prospective observational study of 30 patients from two gynecologic surgical settings with experience in DIE surgery. All patients underwent preoperative standardized investigation including detailed evaluation of LUTS and urodynamic studies. During surgery, endometriosis locations were recorded and correlated to symptoms and urodynamic observations. RESULTS: Twenty-three patients (76.7 %) had one or more LUTS symptoms and 29 (96.7 %) had one or more abnormalities at urodynamic examination. At surgery, all patients had posterior endometriosis and ten of them also had anterior endometriosis. Patients with anterior endometriosis had increased bladder sensation (90.0 % versus 45.0 %, p = 0.024) and painful bladder filling (70.0 % versus 30.0, p = 0.04) compared with patients with posterior endometriosis only. Voiding symptoms (60.0 %), impairment of flowmetry (30.0 %), and increased maximum urethral closure pressure (90.0 %) were frequent and not correlated with any specific location. CONCLUSIONS: Endometriosis infiltrating the bladder wall is associated with painful bladder symptoms. Dysfunctional voiding suggests an impairment of the inferior hypogastric plexus by posterior DIE. Clinical preoperative evaluation of bladder function should be systematic; urodynamic tests could be of interest in selected patients with DIE. Endometriosis may be a major cause of bladder pain syndrome.

Management of Stage I Endometrial Cancer in France: A Survey on Current Practice.

PURPOSE: We conducted a survey to assess the performance of preoperative staging and the application of French surgical guidelines in women with presumed stage I endometrial cancer (EC). METHODS: The survey included 26 questions about the number of patients in low-, intermediate-, and high-risk groups operated on in 2012, the proportion of patients upstaged or downstaged by the examination of the uterus, and the proportion of subsequent surgery for lymph node dissection. RESULTS: Thirty-two (70 %) of the 46 French university hospitals responded to the questionnaire. Among 886 patients with EC treated, 661 had stage 1 EC. The rates of presumed preoperative type 1 low-, intermediate-, high-risk EC and type 2 EC were 310 (46.9 %), 218 (33 %), 39 (5.9 %), and 94 (14.2 %) respectively. Among 567 type 1 patients, 35 % were upstaged and 6 % were downstaged. Fair agreement was found between preoperative and postoperative risk assessment (κ = 0.37). Patients with presumed low- and intermediate-risk EC upstaged postoperatively to FIGO stage II/III were more likely to have a restaging operation than patients upstaged to type 1 high-risk FIGO stage I EC: 37/70 (52.8 %) versus 26/75 (34.6 %), p = 0.027. The proportions of patients undergoing the recommended subsequent pelvic and/or para-aortic lymph node dissection were low: 34/85 (40 %) and 47/145 (32.4 %) respectively. Lymph node samplings were mainly performed by laparoscopy: 31/34 (91.2 %) and 40/47 (85.1 %) for pelvic and para-aortic dissection respectively. CONCLUSIONS: Our survey showed that the performance of preoperative assessment of FIGO stage I EC was moderate and that adherence to the guidelines was low.