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.

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.

Preoperative brachytherapy of early-stage cervical cancer: A multicenter study by the SFRO brachytherapy group.

OBJECTIVE: To report the results of a multicenter cohort of preoperative brachytherapy (PBT) for treatment of early-stage cervical cancer (ESCC). METHODS: A retrospective analysis was conducted among five French comprehensive cancer centers on behalf of the SFRO Brachytherapy Group to examine the outcome of patients with ESCC who received PBT between 2001 and 2019 because of adverse prognostic factors (tumor size >2 cm, presence of lymphovascular invasion, adenocarcinoma).Brachytherapy was followed 4-8 weeks later by surgery. Local relapse free, distant metastasis-free survival, disease-free, and overall survival and adverse effects were examined. Uni- and multivariate analyses were conducted looking for oncological prognostic factors. RESULTS: A total of 451 patients were identified, with a mean tumor size of 24.7 mm. Adenocarcinoma accounted for 43.5% of cases, and lympho-vascular space invasion (LVSI) was present in 15.7%. A complete histological response was observed in 69.6%. With a mean follow-up of 75.4 months, DFS, LRFS, and OS rates at five years were 88% [95% CI (84-91), 98% [95% CI (96-99), and 92% [95% CI (87-95)], respectively. At the last follow-up, 8.2% of patients had died, including 31 (6.8%) from cervical cancer. Severe side effects range from 1.1% to 2%. At multivariate analysis, adenocarcinoma histological type, tumor size ≥2 cm, and the presence of residual tumors were prognosticators for DFS and DMFS. CONCLUSION: PBT shows excellent oncological outcomes in this cohort of patients with adverse histoprognostic factors. Favorable survival rates and low complications rates were observed, supporting this strategy in the management of ESCC.

A computer synoptic operative report versus a report dictated by a surgeon in advanced ovarian cancer.

OBJECTIVE: To evaluate the role of a computer synoptic operative report in enhancing the quality and completeness of surgical reporting for advanced ovarian cancer surgeries. METHODS: The study was conducted at a tertiary cancer center between January 2016 and September 2021, and the computer synoptic operative report was implemented in May 2019. The study compared two cohorts: the first consisted of the 'before computer synoptic operative report (P1)' period, during which the operative reports were dictated freely by the surgeons, and the second consisted of the 'after computer synoptic operative report (P2)' period, during which all surgeons used the computer synoptic operative report. RESULTS: The study analyzed 227 operative reports, with 104 during period 1 (P1) and 123 during period 2 (P2). In the P1 group, more than half of the patients (54 out of 104, 52%) underwent interval surgery after completing six cycles of chemotherapy; In contrast, in the P2 group, all interval debulking surgeries were performed after fewer than six chemotherapy cycles (p<0.001). Although interval debulking surgery after fewer than six chemotherapy cycles was more frequent in P2, the rate of primary debulking surgery was similar between the groups. The median intra-operative peritoneal carcinomatosis index was higher in P2 (2 in P1 vs 4 in P2, p<0.001), and mean blood loss was higher in P1 (308 mL vs 151 mL, p<0.001). The rate of complete cytoreduction was similar between P1 and P2 (97% vs 87%, respectively, p=0.6). The median length of hospital stay was 12 days in the P1 group and 16 days in the P2 group (p=0.5). Compliance with all eight significant items was higher in the P2 group, with all items present in 66% of the operative reports in the P2 group compared with none of the reports in the P1 group. Compliance for the following items was: International Federation of Obstetrics and Gynecology stage (24% vs 100%), histology (76% vs 97%), CA125 (63% vs 89%), type of surgery (38% vs 100%), peritoneal carcinomatosis index (21% vs 100%), complete cytoreduction score 36% vs 99%), Aletti score (0% vs 89%), and blood loss (32% vs 98%) for P1 and P2; respectively. CONCLUSION: The use of the computer synoptic operative report improved the completeness and quality of the surgical information documented in advanced ovarian cancer surgeries.

Ergonomic Assessment of the Surgeon's Physical Workload During Robot-Assisted Versus Standard Laparoscopy in a French Multicenter Randomized Trial (ROBOGYN-1004 Trial).

BACKGROUND: Standard laparoscopy (SL) is responsible for musculoskeletal disorders in surgeons because of poor ergonomic positions, which could be reduced by robot-assisted laparoscopy (RAL) owing to the surgeons' seated position. One of the aims of the ROBOGYN-1004 study (NCT01247779) was to evaluate surgeons' workloads during real-time procedures of gynecological oncological surgery. METHODS: Patients with gynecological cancer eligible for minimally invasive surgery were recruited from 13 French centers between December 2010 and December 2015. Physical workload was evaluated using the Borg scale every hour over the surgery duration and the perception of workload evaluated using NASA-TLX at the end of surgery. RESULTS: A total of 369 patients were recruited, of whom 176 underwent RAL and 193 underwent SL (per-protocol analysis). Posture during SL was significantly more challenging for all body parts except the back. There was an increase in discomfort over time (up to 4 h) for the hands and arms, neck, and legs in SL compared with RAL. Perceived physical activity and abilities were rated higher in SL than in RAL (p < 0.01), whereas perceived personal performance was higher in SL (p < 0.01). Perceived physical effort during surgery was lower in RAL than in SL. CONCLUSIONS: RAL improves the perception of physical workload. Compared with SL, the perceived effort is lower in RAL regardless of the complexity of the surgery.

Factors Associated with 1-Year Mortality in Elderly Patients (Age ≥ 80 Years) with Cancer Undergoing Major Abdominal Surgery: A Retrospective Cohort Study.

BACKGROUND: The number of elderly patients undergoing major abdominal surgery is increasing, but the factors affecting their postoperative outcomes remain unclear. This study aimed to identify the factors associated with 1-year mortality among elderly patients (age ≥ 80 years) with cancer undergoing major abdominal surgery. METHODS: This retrospective cohort study was conducted from March 2009 to December 2020. The study enrolled 378 patients 80 years old or older who underwent major abdominal surgery. The main outcome was 1-year mortality, and the factors associated with mortality were analyzed. RESULTS: Of the 378 patients, 92 died at 1 year (24.3%), whereas the 30-day mortality rate was 4% (n = 15). In the multivariate analysis, the factors independently associated with 1-year mortality were preoperative Eastern Cooperative Oncology Group (ECOG) performance status (PS) score higher than 1 (odds ratio [OR], 3.189; 95% confidence interval [CI], 1.595-6.377; p = 0.001), preoperative weight loss greater than 3 kg (OR, 2.145; 95% CI, 1.044-4.404; p = 0.038), use of an intraoperative vasopressor (OR, 3.090; 95% CI, 1.188-8.042; p = 0.021), and postoperative red blood cell units (OR, 1.212; 95% CI, 1.045-1.405; p = 0.011). Survival was associated with perioperative management according to an enhanced recovery after surgery (ERAS) protocol (OR, 0.370; 95% CI, 0.160-0.854; p = 0.006) and supramesocolic surgery (OR, 0.371; 95% CI, 0.158-0.871; p = 0.023). CONCLUSION: The study identified several factors associated with an encouraging 1-year mortality rate in this setting. These results highlight the need for identification of suitable targets to optimize pre-, intra-, and postoperative management in order to improve outcomes for this vulnerable population.

Lymph node dissection in uterine leiomyosarcomas: A matched-pair study.

OBJECTIVE: To assess the impact of the lymph node dissection (LND) in the disease-free (DFS) and overall survival (OS) of the women treated surgically of uterine leiomyosarcoma (ULMS). MATERIAL AND METHODS: A multicentric retrospective study was conducted among European countries collecting patients diagnosed of uterine sarcoma (SARcoma of the UTerus - SARCUT study). A total of 390 ULMS were selected for the present study to compare patients who underwent LND and those who did not. A further matched-pair subanalysis identified 116 women, 58 pairs (58 with LND and 58 without it) comparable in age, tumor size, surgical procedures, extrauterine disease and adjuvant treatment. Demographic data, pathology results and follow-up were abstracted from medical records and analyzed. Disease-free (DFS) and overall survival (OS) were studied using Kaplan-Meier curves and Cox regression analysis. RESULTS: Among the 390 patients, the 5-year DFS was significantly higher in no-LDN group comparing to the LDN group (57.7% vs. 33.0%; HR 1.75, 95% CI 1.19-2.56; p = 0.007), but not the 5-year OS (64.6% vs. 64.3%; HR 1,10 95% CI 0,77-1,79; p = 0.704). In the matched-pair subanalysis, there were no statistical differences between the study groups. The 5- year DFS was 50.5% in the no-LND and 33.0% in the LND group (HR 1.38; 95% CI 0,83-2.31; p = 0,218) and the 5-year OS was 59.7% and 64.3% respectively (HR 0.81; 95% CI 0,45-1,49; p = 0,509). CONCLUSIONS: LND performed in women diagnosed of ULMS have no impact neither in the disease-free nor in the overall survival compared to patients without LDN in a complete homogeneous group.

PET-MRI for evaluation of response to radiochemotherapy in patients with locally advanced cervical cancer.

OBJECTIVE: We aimed to analyze the diagnostic test accuracy of positron emission tomography and a magnetic resonance imaging scan (PET-MRI) fusion in evaluating tumor response after radiochemotherapy in patients with locally advanced cervical cancer. METHODS: Patients treated at two institutes between January 2008 and December 2016 were studied retrospectively. Re-evaluation by positron emission tomography (PET) and magnetic resonance imaging (MRI) was performed in a non-concurrent way 4-8 weeks after treatment. A nuclear medicine doctor and a radiologist (subsequently referred as "radiologists"), both experts in gynecological oncology, re-examined the post-treatment MRI and positron emission tomography-computed tomography (PET-CT) separately, and then performed a fusion of these examinations. In this study we describe this "a posteriori fusion methodology", with two levels, enabling limitation of anatomical shifts. The gold standard was anatomical pathology analysis of the surgical specimen, since all patients underwent surgery following this radiological re-evaluation. The radiologists' degree of certainty in their diagnoses, and the impact of fusion on their diagnostic confidence were assessed by the radiologists, using two Likert judgment scales. They also adjudicated on possible changes of interpretation after the fusion. RESULTS: Thirty-one patients were included. The PET-MRI fusion has a sensitivity of 79% and a specificity of 90%. The positive predictive value (PPV) was 94%, and the negative predictive value (NPV) was 69%. In 45% of cases (n=13), radiologists reported an improvement in their degree of certainty in their diagnosis using a Likert judgment scale, due to inspecting the PET and MRI fused. A change in interpretation of tumor response was observed using a Likert judgment scale in 31% of cases. CONCLUSION: PET-MRI fusion improves the radiologist's own diagnostic confidence in assessing response to concurrent radiochemotherapy in locally advanced cervical cancer. More studies using a latest generation hybrid system will be necessary to further compare to MRI and PET-CT.

The impact of modern preoperative high-dose-rate brachytherapy in early-stage cervical cancer.

PURPOSE: To analyze the clinical outcomes and the safety of preoperative high-dose-rate (HDR) image-guided adaptive brachytherapy (IGABT) followed by minimally invasive surgery (MIS) in the multidisciplinary management of early-stage cervical cancer. METHODS AND MATERIALS: Medical records of all consecutive patients with early-stage cervical cancer treated at our institution between 2012 and 2018 with preoperative IGABT in a multidisciplinary approach were reviewed. Treatment schedule was pelvic node dissection, preoperative IGABT followed 6-8 week later by MIS hysterectomy. RESULTS: Seventy patients with cervical cancer FIGO stages (IB1 18.6%, IB2 75.7% and IIA1 5.7%) were treated by preoperative HDR brachytherapy. With a median follow-up of 37.4 months [95% confidence interval, 32.1-39.7 months] isolated vaginal vault recurrence was not observed, 3 pelvic relapses were reported (4.3%). None of patients received postoperative radiotherapy (EBRT) or radiochemotherapy. The estimated 3-year local and pelvis relapse free survival for the entire population were respectively 98% [95% confidence interval, 89%-100%] and 90% [80%-96%]. The estimated 3-year disease-free survival (DFS) for the entire population was 88% [77-94%]. The 3-year overall survival (OS) rate was 97% [88%-99%]. Microscopic vaginal resection margin (R1) was observed in one patient ([1].4%). Lymph-vascular space invasion (LVSI) was found found in 6 (8.6%) patients. Forty-eight late complications in 36 patients (51.4%) were observed. Five (7.1%) grade 3 vaginal wound dehiscence toxicities were observed. Urinary and gastrointestinal toxicities were grade 1-2. No grade 4-5 complications were observed. CONCLUSIONS: Preoperative image-guided adaptive brachytherapy followed by minimally invasive surgery allows high local control, reduces positive surgical margins and rates of lymph-vascular space invasion avoiding adjuvants treatments. Surgical approaches must be discussed with patients including preoperative brachytherapy as a down-staging treatment.

Laparoscopic management of advanced epithelial ovarian cancer after neoadjuvant chemotherapy: a phase II prospective multicenter non-randomized trial (the CILOVE study).

OBJECTIVE: The aim of this study was to explore the feasibility and safety of the laparoscopic approach after neoadjuvant chemotherapy among selected chemosensitive patients with advanced ovarian cancer. METHODS: The CILOVE study was a phase II prospective non-randomized multicenter study. It aimed to enroll 47 women with unresectable disease at the time of initial diagnosis (International Federation of Gynecology and Obstetrics (FIGO) stage IV and/or diffuse extensive carcinomatosis for advanced FIGO stage IIIC or patients unfit to withstand radical primary surgery), in response to chemotherapy and fit to undergo laparoscopy. RESULTS: Among the 48 patients enrolled in the trial, 44 (92%) patients underwent exploratory staging laparoscopy and, as a result, 41 patients were eligible for cytoreductive surgery. Among them, 32 were intended to be managed by laparoscopy and nine patients were managed by laparotomy. The conversion rate to laparotomy was 9.4% (3/32) and the reasons were multiple surgical adhesions (n=1), miliary carcinomatosis and adhesion to the intraperitoneal mesh (n=1), and poor laparoscopic evaluation of transverse colon involvement (n=1). All except one patient had optimal cytoreduction (97% complete cytoreduction, 3% incomplete cytoreduction (residual tumor <2.5 mm)). The median operative time was 267 min (range 146-415) and the median estimated blood loss was 150 mL (range 0-500). Two patients had intra-operative complications: one diaphragm rupture that was repaired during laparoscopy and one bradycardia. Six patients experienced early post-operative complications (<1 month), but there were no grade 3 and 4 complications (3 infections, 1 lymphoedema, 2 hemorrhage). After cytoreductive laparoscopy, the percentage of patients without progression at 12 months was 87.5%. CONCLUSIONS: Interval ovarian cytoreduction by a laparoscopic approach is safe and feasible for patients with a favorable response to chemotherapy. With the widespread use of neoadjuvant chemotherapy in the management of advanced ovarian cancer, a minimally invasive approach may be a potential option.

TRAINING-Ovary 01 (connecTed pRehabiliAtIoN pelvIc caNcer surGery): multicenter randomized study comparing neoadjuvant chemotherapy for patients managed for ovarian cancer with or without a connected pre-habilitation program.

BACKGROUND: Patients undergoing neoadjuvant chemotherapy before surgery for advanced ovarian cancer may have impaired functional capacity, nutritional status, and emotional well-being. PRIMARY OBJECTIVES: TRAINING-01 aims to determine if a connected pre-habilitation program during neoadjuvant chemotherapy for patients treated for an advanced ovarian cancer will improve physical capacity before major abdomino-pelvic surgery. STUDY HYPOTHESIS: A pre-habilitation program during neoadjuvant chemotherapy will bring a fitter patient to surgery and will decrease treatment morbidity and improve oncological outcomes. TRIAL DESIGN: This study is a prospective, multi-center, phase III study. The pre-habilitation program consists of providing multi-dimensional support during neoadjuvant chemotherapy using connected devices. The control group will receive usual care. MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients will be women with International Federation of Gynecology and Obstetrics stage III-IV advanced ovarian cancer undergoing neoadjuvant chemotherapy. Patients must be able to perform a cardiopulmonary exercise test. PRIMARY ENDPOINTS: The primary endpoint will be the comparison of the variation in maximum oxygen uptake (VO2 max) between baseline and surgery in the pre-habilitation group and control groups. SAMPLE SIZE: 136 patients (68 per arm) will be recruited to demonstrate a medium standardized effect d=0.5 in the variations of VO2 max between baseline and surgery. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: The duration of the study includes 24 months of recruitment and 5 years of follow up. We anticipate reporting primary endpoint results in 2024. TRIAL REGISTRATION: TRAINING-01-IPC 2018-039 (NCT04451369).

Lessons from radiochemotherapy and modern image-guided adaptive brachytherapy followed by hysterectomy.

PURPOSE: To analyze the clinical outcomes and the safety of radiochemotherapy (RCT) and image-guided adaptive brachytherapy (IGABT) and to evaluate the impact of hysterectomy (HT) as completion of treatment for cervical cancer. METHODS AND MATERIALS: 145 patients with locally advanced cervical cancer were treated at our institution. Patients underwent RCT and IGABT, then hysterectomy (HT) as completion of treatment was performed, with the exception of patients with surgical contraindications, para aortic metastatic disease or patients who refused surgery. Clinical outcomes and morbidity were retrospectively reviewed in both groups. Local relapse free survival (LRFS), pelvic relapse free survival (PRFS) and overall survival (OS) were analyzed. RESULTS: Completion HT was performed in 90 (62.1%) patients. Complete histological response and microscopic disease were found in 77 patients (85.6%). Local relapse was observed in 14 patients (9.6%) without differences between completion HT group and the definitive RCT and IGABT group (Odds Ratio OR = 1.73 [0.57-5.23], p = 0.33). The estimated 3-year LRFS and PRFS for the entire population were respectively 90% [84%-94%] and 93% [87%-96%], with no significant differences between them (respectively Hazard Ratio HR = 0.57 [0.20-1.64], p = 0.30 and HR = 0.37 [0.10-1.31], p = 0.12). The estimated 3-year OS rate for the whole population was 84% [75%-91%] with no significant differences between groups (HR = 0.81 [0.32-2.06], p = 0.65). Regarding morbidity, grade ≥ 2 vaginal toxicity was more frequent in the definitive RCT and IGABT group (43.6% vs 26.7%, p = 0.04). All grade 4 toxicity events were reported in the completion HT group. CONCLUSIONS: Due to high severe toxicity, RCT and IGABT with dose escalation followed by completion hysterectomy don't seem compatible. No benefit and increased severe late morbidity were observed. Combined intracavitary/interstitial technique is mandatory in large target volume at brachytherapy.

Severe perioperative morbidity after robot-assisted versus conventional laparoscopy in gynecologic oncology: Results of the randomized ROBOGYN-1004 trial.

OBJECTIVE: In gynecologic oncology, minimally invasive surgery using conventional laparoscopy (CL) decreases the incidence of severe morbidity compared to open surgery. In 2005, robot-assisted laparoscopy (RL) was approved for use in gynecology in the US. This study aimed to assess whether RL is superior to CL in terms of morbidity incidence. METHODS: ROBOGYN-1004 (ClinicalTrials.gov, NCT01247779) was a multicenter, phase III, superiority randomized trial that compared RL and CL in patients with gynecologic cancer requiring minimally invasive surgery. Patients were recruited between 2010 and 2015. The primary endpoint was incidence of severe perioperative morbidity (severe complications during or 6 months after surgery). RESULTS: Overall, 369 of 385 patients were included in the as-treated analysis: 176 and 193 underwent RL and CL, respectively. The median operating time for RL was 190 (range, 75-432) minutes and for CL was 145 (33-407) minutes (p < 0.001). The blood loss volumes for the corresponding procedures were 100 (0-2500) and 50 (0-1000) mL (p = 0.003), respectively. The overall rates of conversion to open surgery for the corresponding procedures were 7% (10/176) and 5% (10/193), respectively (p = 0.52). Severe perioperative morbidity occurred in 28% (49/176) and 21% (41/192) of patients who underwent RL and CL, respectively (p = 0.15). At a median follow-up of 25.1 months (range, 0.6-78.2), no significant differences in overall and disease-free survival were observed between the groups. CONCLUSIONS: RL was not found superior to CL with regard to the incidence of severe perioperative morbidity in patients with gynecologic cancer. In addition, RL involved a longer operating time than CL.

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.

EVAN-G score in patients undergoing minimally invasive gynecology oncologic surgery in an Enhanced Recovery After Surgery (ERAS) program.

INTRODUCTION: Enhanced Recovery After Surgery (ERAS) has been proven to decrease the length of hospital stay without increasing re-admission rates or complications. There are limited data on the satisfaction of patients undergoing minimally invasive surgery for gynecologic malignancy within ERAS programs. The aim of this study was to evaluate patient satisfaction after minimally invasive surgery for gynecologic malignancy within the ERAS program using the 'Evaluation du Vécu de l'Anésthésie Génerale (EVAN-G)' questionnaire. METHODS: This observational retrospective study was conducted at the Paoli-Calmettes Institute between June 2016 and December 2018. All the included patients underwent minimally invasive surgery for a gynecologic malignancy. EVAN-G, a validated questionnaire, was used to measure peri-operative patient satisfaction. This questionnaire consists of 26 items assessing six elements: attention, privacy, information, pain, discomfort, and waiting time. Each element is assessed via a 5-step numerical scale and then transformed to a 0-100 scale according to the degree of satisfaction. The EVAN-G questionnaire was given to patients before surgery and collected during the post-operative consultation (2-3 weeks after surgery). RESULTS: A total of 175 patients underwent minimally invasive surgery for gynecologic malignancy within the ERAS program. Of these, 92 patients were included in the study and 83 patients were excluded. The overall patient compliance rate with our ERAS program was 90%. The analysis of the EVAN-G score of all participants showed an overall high level of satisfaction with a mean score of 81.9 (range 41.6-100). Patients with peri-operative complications or having prolonged hospitalization also showed high levels of satisfaction with a mean score of 80.5 (41.6-100) and 83.2(55-100), respectively. CONCLUSION: In this study we showed a high patient satisfaction with the ERAS program. When comparing length of stay and complications, neither extended length of stay nor development of complications after minimally invasive surgery impacted patient satisfaction.

Prediction of early discharge after gynaecological oncology surgery within ERAS.

OBJECTIVES: Enhanced recovery after surgery programs (ERAS) have been proven to decrease the length of hospital stay without increasing readmission rates or complications. However, the patient and operative characteristics that improve the chance of a successful early hospital discharge are not well established. The aim of this study was to design a nomogram which could be used before surgery, using the characteristics of patients, to establish who could benefit from early discharge (POD ≤ 2 days). METHODS: This observational study has been prospectively conducted. All the included patients were referred for surgical treatment of gynecologic cancer. We defined two sub-groups of patients on surgical procedure characteristics: isolated procedures (hysterectomy or lymphadenectomy) and combined procedures (at least the association of two procedures). RESULTS: 230 patients were enrolled during the study protocol. 83.9% of patients were treated with a minimally invasive surgery (MIS). 159 patients (69.1%) were discharged on or before POD 2. On multivariate analysis, the surgical approach (open surgery vs. laparoscopy, OR 0.02 (95% CI [0-0.07]), p < 0.001) and the type of surgery (combined procedure versus isolated procedure, OR 0.41 (95% CI [0.18-0.91]), p = 0.028) were found to be significant predictors of increased hospital stay. A nomogram has been built for the purpose of predicting eligible patients for early post-operative discharge based on the multivariate analysis results (AUC = 0.86, 95% CI [0.81-0.92]). CONCLUSION: The use of MIS for isolated procedures in oncologic indications constitutes an independent factor of early discharge in a setting of ERAS. These promising preliminary results still require to be validated on a prospective cohort.

Comparison of postoperative complications and quality of life between patients undergoing continent versus non-continent urinary diversion after pelvic exenteration for gynecologic malignancies.

BACKGROUND: Pelvic exenteration and its reconstructive techniques have been associated with high postoperative morbidity and a negative impact on patient quality of life. The aim of our study was to compare postoperative complications and quality of life in patients undergoing continent compared with non-continent urinary diversion after pelvic exenteration for gynecologic malignancies. METHODS: We designed a multicenter study of patients from 10 centers who underwent an anterior or total pelvic exenteration with urinary reconstruction for histologically confirmed persistent or recurrent gynecologic malignancy after previous treatment with radiotherapy. From January 2005 to September 2008, we included patients retrospectively, and from September 2008 to May 2009, patients were included prospectively which allowed collection of quality of life data. Demographic, surgical, and follow-up data were analyzed. Postoperative complications were classified according to the Clavien-Dindo classification. Quality of life was assessed using the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30 (V.3.0) and EORTC-QLQ-OV28 quality of life questionnaires. We compared patients who underwent a continent urinary diversion with those who underwent a non-continent reconstruction. RESULTS: We included 148 patients, 92 retrospectively and 56 prospectively. Among them, 77.4% had recurrent disease and 22.6% persistent disease after the primary treatment. In 70 patients, a urinary continent diversion was performed, and 78 patients underwent a non-continent diversion. Median age of the continent and incontinent groups was 53.5 (range 33-78) years and 57 (26-79) years, respectively. There were no significant differences between the continent and non-continent groups in median length of hospitalization (28.5 vs 26 days, P=0.19), postoperative grade III-IV complications (42.9% vs 42.3%, P=0.95), complications needing surgical (27.9% vs 34.6%, P=0.39) or radiological (14.7% vs 12.8%, P=0.74) intervention, and complication type (digestive (23.2% vs 16.7%, P=0.32) and urinary (15.9% vs 16.7%, P=0.91)). There were no significant differences between the groups in global health, global quality of life, and body image perception scores 1 year after surgery. CONCLUSION: Continent and incontinent urinary reconstructions are equivalent in terms of postoperative complications and quality of life scores.

Robotic Nipple-Sparing Mastectomy and Immediate Breast Reconstruction With Robotic Latissimus Dorsi Flap Harvest: Technique and Results.

Introduction. Only few cases of robotic latissimus dorsi flap reconstruction (RLDFR) have been reported in indication of reconstruction for breast cancer (BC). We report our experience of combined robotic nipple-sparing mastectomy (R-NSM) and RLDFR, and analyze technique, indications, and reproducibility. Methods. All patients with R-NSM and RLDFR from November 2016 to August 2, 2018, were analyzed, and technics have been described. Complication rate with Clavien-Dindo grading and postoperative hospitalization length (days) are reported. Results. Thirty-five R-NSM with RLDFR were performed in 22 cases for primitive BC and 13 for local recurrence. In 12 patients, another surgical procedure was performed during the same time (axillary lymph node dissection or contralateral breast surgery). R-NSM was realized through a short axillar incision, with inside-only installation for 12 patients (34.3%): 18 nonautologous and 17 autologous RLDFR associated with implant in 9 patients. In logistic regression, mastectomy weight >330 g was significantly associated with the use of implant (odds ratio [OR] = 17, P = .015), and significant factor of the time of anesthesia ≥380 minutes was 2 installations (OR = 10.4, P = .049). The median duration of hospitalization stay was 4 days. Complications rates were 51.4% (18/35; 9 grade-1, 2 grade-2, and 7 grade-3). In logistic regression, associated other surgical procedure was predictive of grade-3 complications (OR = 6.87, P = .053). Conclusion. We confirmed the reproducibility and safety of R-NSM and RLDFR with a decreased complication rate. NSM was performed in 42.8% of our patients after previous radiotherapy. We observed an increase of grade-3 complications when R-NSM and RLDFR was combined to another surgical procedure.

Isolated ipsilateral local recurrence of breast cancer: predictive factors and prognostic impact.

BACKGROUND: Tumour features associated with isolated invasive breast cancer (BC) ipsilateral local recurrence (ILR) after breast conservative treatment (BCT) and consequences on overall survival (OS) are still debated. Our objective was to investigate these points. METHODS: Patients were retrospectively identified from a cohort of patients who underwent BCT for invasive BC in 16 cancer centres. End-points were ILR rate and OS. The impact of ILR on OS was assessed by multivariate analysis (MVA) for all patients and according to endocrine receptors (ERs) and grade or tumour subtypes. RESULTS: Of 15,570 patients, ILR rate was 3.1%. Cumulative ILR rates differed according to ERs/grade (ERs+/Grade2: HR 1.42, p = 0.010; ERs+/Grade3: HR 1.41, p = 0.067; ERs-: HR 2.14, p < 0.0001), endocrine therapy (HR 2.05, p < 0.0001) and age < 40-years old (HR 2.28, p = 0.005) in MVA. When MVA was adjusted on tumour subtype, the latter was the only independent factor. OS-after-ILR was significantly different according to ILR-free intervals (HR 4.96 for ILR-free interval between 2 and 5-years and HR 9.00 when < 2-years, in comparison with ≥ 5-years). CONCLUSION: ERs/Grade status, lack of endocrine therapy and tumour subtypes predict isolated ILR risk in patients treated with BCT. Short ILR-free-intervals represent a strong pejorative factor for OS. These results may help selecting initial treatment as well as tailoring ILR systemic chemotherapy.

Adjuvant chemotherapy in lobular carcinoma of the breast: a clinicopathological score identifies high-risk patient with survival benefit.

BACKGROUND: Invasive lobular carcinomas (ILCs) represent approximately 10% of all breast cancers. Despite this high frequency, benefit of adjuvant chemotherapy (CT) is still unclear. METHODS: Our objective was to investigate the impact of CT on survival in ILC. Patients were retrospectively identified from a cohort of 23,319 patients who underwent primary surgery in 15 French centers between 1990 and 2014. Only ILC, hormone-positive, human epidermal growth factor 2 (HER2)-negative patients who received adjuvant endocrine therapy (ET) were included. End-points were disease-free survival (DFS) and overall survival (OS). A propensity score for receiving CT, aiming to compensate for baseline characteristics, was used. RESULTS: Of a total of 2318 patients with ILC, 1485 patients (64%) received ET alone and 823 (36%) received ET + CT. We observed a beneficial effect of addition of CT to ET on DFS and OS in multivariate Cox model (HR = 0.61, 95% confidence interval, CI [0.41-0.90]; p = 0.01 and 0.52, 95% CI [0.31-0.87]; p = 0.01, respectively). This effect was even more pronounced when propensity score matching was used. Regarding subgroup analysis, low-risk patients without CT did not have significant differences in DFS or OS compared to low-risk patients with CT. CONCLUSION: ILC patients could derive significant DFS and OS benefits from CT, especially for high-risk patients.