BRCA Mutation Patients: Are There Other Predisposing Factors for Ovarian Cancer Occurrence? A Multicenter Retrospective Study.

OBJECTIVES: The objective of this multicenter retrospective study aimed to evaluate the association of clinical variables and the incidence of ovarian cancer in patients with BRCA 1-2 mutation carriers who underwent risk-reducing salpingo-oophorectomy (RRSO). DESIGN: Patients with a pathogenic mutation of BRCA 1-2 genes and with no evidence of disease are considered eligible. The exclusion criterion was the refusal to undergo the surgery. The retrospective study included all RRSO performed from May 2015 to April 2022 in the three gynecological Institutions of Southern Italy for were included in this retrospective study. PARTICIPANTS/MATERIALS, SETTING, METHODS: Age, menarche age, BMI, menopause at time of RRSO, breast cancer first- and second-degree relatives, ovarian cancer first- and second-degree relatives, estroprogestin use, pregnancy normal full-term delivery, history of endometriosis, previous breast cancer and histologic type, previous abdominal/pelvic surgery, BRCA 1 or BRCA 2 status, preoperative serum CA-125 levels (IU/mL), age at time of RRSO and histological analysis were collected. RESULTS: 184 were recruited. One was excluded. To assess cancer risk, the outcome variable was classified into three classes: no event, cancer, and other conditions excluding cancer. 14 women presented ovarian cancer and tubal intraepithelial carcinoma (STIC) on histopathologic final report. Ovarian cancer was found in 8 patients, whereas the presence of STIC was found in 6 of them. LIMITATIONS: The low incidence of patients diagnosed with ovarian cancer or STIC compared with the total number of patients undergoing RRSO is a potential bias. CONCLUSIONS: Our study did not demonstrate a correlation between clinical features and the occurrence of precancerous or cancerous lesions in BRCA mutation carrier patients.

Consensus statements and treatment algorithm to guide clinicians in the selection of maintenance therapy for patients with newly diagnosed, advanced ovarian carcinoma: Results of a Delphi study.

INTRODUCTION: Standard treatment of newly diagnosed, advanced ovarian carcinoma (OC) consists of cytoreductive surgery followed by platinum-based chemotherapy with or without bevacizumab. Maintenance therapy with PARP inhibitors and olaparib-bevacizumab has recently shown to significantly improve progression-free survival in the first-line setting. Some practical aspects of maintenance therapy, however, are still poorly defined. AIM OF THE STUDY: To provide guidance to clinicians in the selection of maintenance therapy for newly diagnosed, advanced ovarian carcinoma. METHODS: A board of six gynecologic oncologists with expertise in the treatment of OC in Italy convened to address issues related to the new options for maintenance treatment. Based on scientific evidences, the board produced practice-oriented statements. Consensus was reached via a modified Delphi study that involved a panel of 22 experts from across Italy. RESULTS: Twenty-seven evidence- and consensus-based statements are presented, covering the following areas of interest: use of biomarkers (BRCA mutations and presence of homologous recombination deficiency); timing and outcomes of surgery; selection of patients eligible for bevacizumab; definition of response to treatment; toxicity and contraindications; evidence of synergy of bevacizumab plus PARP inhibitor. Two treatment algorithms are also included, for selecting maintenance therapy based on timing and outcomes of surgery, response to platinum-based chemotherapy and biomarker status. A score for the assessment of response to chemotherapy is proposed, but its validation is ongoing. CONCLUSIONS: We provide here consensus statements and treatment algorithms to guide clinicians in the selection of appropriate and personalized maintenance therapy in the first-line setting of advanced OC management.

Clinical Impact of Pathologic Residual Tumor in Locally Advanced Cervical Cancer Patients Managed by Chemoradiotherapy Followed by Radical Surgery: A Large, Multicenter, Retrospective Study.

BACKGROUND: Exclusive chemoradiation (E-CT/RT) represents the standard of treatment for locally advanced cervical cancer (LACC). Chemoradiation (CT/RT) followed by radical surgery (RS) may play a role for patients with a suboptimal response to CT/RT or in low-income countries with limited access to radiotherapy. Histologic assessment of residual tumor after CT/RT and RS allows accurate definition of prognostic categories. METHODS: Data on patients with FIGO stages 1B2 to 4A cervical cancer managed by CT/RT and RS from June 1996 to March 2020 were retrospectively analyzed. Pathologic response on the cervix was defined as complete (pCR), microscopic (persistent tumor foci ≤ 3 mm) (pmicroR), or macroscopic (persistent tumor foci > 3 mm) (pmacroR). Lymph node (LN) residual tumor was classified as absent or present. RESULTS: The 701 patients in this study underwent CT/RT and RS. Of the 701 patients, 293 (41.8%) had pCR, 188 (26.8%) had pmicroR, and 220 (31.4%) had pMacroR. Residual tumor was found in the pelvic lymph nodes of 66 (9.4%) patients and the aortic lymph nodes of 29 (4.1%) patients. The 5-year DFS and OS were respectively 86.6% and 92.5% in the pCR cases, 80.3% and 89.1% in the pmicroR cases, and 56.2% and 68.8% in the pmacroR cases. Among the patients with lymph node residual tumor, the 5-year DFS and OS were respectively 16.7% and 40% in the pCR cases, 35.4% and 53.3% in the pmicroR cases, and 31.7% and 31.1% in the pmacroR cases. Cervical residual tumor,, positive pelvic LNs, and positive aortic LNs were associated with worse DFS and OS in both the uni- and multivariate analyses. CONCLUSIONS: Persistence of pathologic residual tumor on the cervix and LNs after CT/RT are reliable predictors of survival for LACC patients undergoing CT/RT and adjuvant surgery.

Anatomical distribution of sentinel lymph nodes in patients with endometrial cancer: a multicenter study.

OBJECTIVE: Sentinel lymph node (SLN) mapping represents the standard approach in uterine confined endometrial cancer patients. The aim of this study was to evaluate the anatomical distribution of SLNs and the most frequent locations of nodal metastasis. METHODS: This was an observational retrospective multicenter study involving eight high volume gynecologic cancer centers in Italy. We reviewed 1576 patients with a histologically confirmed diagnosis of endometrial cancer from September 2015 to June 2020. All patients underwent total hysterectomy with salpingo-ophorectomy and SLN mapping. RESULTS: A total of 3105 SLNs were mapped and removed, 2809 (90.5%) of these were bilateral and 296 (9.5%) unilateral. The overall detection rate was 93.4% (77.9% bilateral and 15.5% unilateral). The majority of SLNs (80%) and positive SLNs (77.8%) were found at the external iliac and obturator level in both endometrioid and non-endometrioid endometrial cancer. Negative SLNs were more frequent in patients with endometrioid compared with non-endometrioid cancer (91.9% vs 86.1%, p<0.0001). Older patients, a higher body mass index, and non-endometrioid histology were more likely to have 'no mapping' (p<0.0001). Univariate and multivariate analysis showed that higher body mass index and age at surgery were independent predictive factors of empty node packet and fat tissue (p=0.029 and p<0.01, respectively). CONCLUSION: The most frequent sites of SLNs and metastases were located in the pelvic area below the iliac vessel bifurcation. Our findings showed that older age, a higher body mass index, and non-endometrioid histology had a negative impact on mapping.

Laparoscopic sacrocolpopexy versus pelvic organ prolapse suspension for surgical management of pelvic organ prolapse: a retrospective study.

This retrospective surgical clinical study compares clinical and functional effects of laparoscopic sacrocolpopexy (LSC) and laparoscopic pelvic organ prolapse suspension (L-POPS) for anterior and central prolapse correction. Thirty patients enrolled were affected by a symptomatic vaginal central compartment stage 2-3 prolapse and vaginal anterior compartment stage 1-3 prolapse without vaginal posterior compartment prolapse. A successful correction of anterior and central compartments prolapse without relapses were observed in both groups (LSC group versus L-POPS group). In patients who underwent L-POPS, a de novo posterior compartment prolapse was recorded. In this group, 7/15 patients complained more bowel symptoms and underwent vaginal colpoperineoplasty. In 20% (group LSC) and in 13.3% (group L-POPS) of cases, a condition of de novo urinary stress incontinence was described. LSC seems to remain the gold standard for pelvic organ prolapse correction, while further preventive strategies should be carried out in L-POPS to avoid a de novo posterior compartment prolapse.Impact StatementWhat is already known on this subject? Laparoscopic sacrocolpopexy is the gold standard technique for the correction of pelvic organ prolapse; however, laparoscopic pelvic organ prolapse suspension, based on the surgical technique of lateral suspension, is an innovative surgical method for the treatment of POP.What do the results of this study add? L-POPS could be considered a valid alternative to LSC for women with multiple comorbidities because of less operative time and reduced surgical risks. However, in the long follow-up period, some patients underwent L-POPS complained rectal discomfort and dysfunction on quality of life questionnaire and on clinical evaluation from six to twelve months after surgery probably due to the post-operative appearance of posterior compartment prolapse.What are the implications of these findings for clinical practice and/or further research? Considering the retrospective design and the small sample size the major limits of this study, larger, prospective, randomized studies could be encouraged to better compare a modified technique of L-POPS with posterior mesh apposition (preventing the post-operative appearance of posterior compartment prolapse) with the gold standard LSC for the correction of multi-compartment POP.

Surveillance alone in stage I malignant ovarian germ cell tumors: a MITO (Multicenter Italian Trials in Ovarian cancer) prospective observational study.

OBJECTIVE: The aim of this study was to analyze the oncological outcome of stage I malignant ovarian germ cell tumors patients included in the MITO-9 study to identify those who might be recommended routine surveillance alone after complete surgical staging. METHODS: MITO-9 was a prospective observational study analyzing data collected between January 2013 and December 2019. Three groups were identified: group A included 13 patients stage IA dysgerminoma and IAG1 immature teratoma; group B included 29 patients with stage IB-C dysgerminomas, IA-C G2-G3 immature teratomas and stage IA mixed malignant ovarian germ cell tumors and yolk sac tumors; and group C included five patients (two patients with stage IC1 and one patient with stage IC2 yolk sac tumors and two patients with mixed-stage IC2 malignant ovarian germ cell tumors). RESULTS: A total of 47 patients with stage I conservatively treated malignant ovarian germ cell tumors were analyzed. Two patients in group B were excluded from the routine surveillance alone group due to positive surgical restaging. Therefore, a total of 45 patients were included in the study. Median follow-up was 46.2 months (range; 6-83). In total, 14 of 45 patients (31.1%) received chemotherapy, while 31 (68.9%%) underwent surveillance alone. One patient in group A, with stage IA dysgerminoma had a relapse, successfully managed with conservative surgery and chemotherapy. None of the patients in group B and C relapsed. All patients were alive at completion of the study. Overall, among 31 patients (68.9%) who underwent surveillance alone, only one patient relapsed but was treated successfully. CONCLUSIONS: Our data showed that close surveillance alone could be an alternative option to avoid adjuvant chemotherapy in properly staged IB-C dysgerminomas, IA-IC G2-G3 immature teratomas, and IA mixed malignant ovarian germ cell tumors with yolk sac tumor component.

Comparison of absorbable and permanent sutures for laparoscopic sacrocervicopexy: A randomized controlled trial.

INTRODUCTION: Pelvic organ prolapse is a common cause of morbidity and decreased quality of life among women and is treatable by laparoscopic sacrocolpopexy. Recent data suggest that absorbable sutures are a feasible and appealing option for mesh attachment given a potential decreased risk of complications related to mesh erosion. The aim of the present study was to demonstrate the non-inferiority of absorbable sutures to permanent sutures for laparoscopic sacrocervicopexy. MATERIAL AND METHODS: We performed a randomized, single-blinded, non-inferiority trial comparing late-absorbable sutures (group A) to non-absorbable sutures (group B) for anterior and posterior vaginal mesh fixation during laparoscopic sacrocervicopexy at a single center in Italy. The primary outcome was prolapse correction at 12 months after surgery, defined as the absence of a pelvic organ prolapse leading edge reaching or extending below the level of the hymen and the absence of bulge symptoms. Secondary outcomes included intraoperative parameters, postoperative characteristics, and long-term morbidity. Statistical analyses were performed using STATA version 16. RESULTS: A total of 150 patients with pelvic organ prolapse were prospectively randomized 1:1 into two groups (A or B). Baseline characteristics and intraoperative parameters including blood loss, operation time, and intraoperative complications were comparable between groups. The success rate was 100% in both groups and no differences in prolapse correction were observed. The rates of de novo urinary incontinence and persistent urinary incontinence were also similar between groups. The rate of mesh erosion at 12 months was 0% in group A and 4% in group B (P = .24). CONCLUSIONS: Late absorbable sutures are non-inferior to non-absorbable sutures for laparoscopic sacrocervicopexy in terms of procedural success. Moreover we did not see any differences in terms of operative parameters, or intraoperative and postoperative characteristics, although the study was not powered to these outcomes.

Clinical outcome of recurrent endometrial cancer: analysis of post-relapse survival by pattern of recurrence and secondary treatment.

INTRODUCTION: Recurrence of endometrial cancer is an important clinical challenge, with median survival rarely exceeding 12 months. The aim of this study was to analyze patterns of endometrial cancer recurrence and associations of these patterns with clinical outcome. METHODS: The study included patients with endometrial cancer who underwent primary surgical treatment with or without adjuvant treatment between July 2004 and June 2017 at the Gynaecologic Oncology Unit of one of three tertiary hospitals of the Catholic University Network in Italy with complete follow-up data available. Information on the date and pattern of recurrence was retrieved for each relapse. Post-relapse survival was recorded as the time from the date of recurrence to the date of death or last follow-up. Survival probabilities were compared using log rank tests, and associations of clinico-pathological characteristics with post-relapse survival were tested using Cox's regression models. RESULTS: A total of 1503 patients were included in the analysis. We identified 210 recurrences (14.0%) and 105 deaths (7.0%) at a median follow-up of 34 months (range 1-162). One hundred and fifty-eight recurrences (78.1%) occurred during the first two years of follow-up. Most recurrences were multifocal (n=121, 57.6%) and involved extrapelvic sites (n=38, 65.7%). Parameters associated with post-relapse survival in the univariate analysis included histotype, grade, time to recurrence, pattern of recurrence, number of relapsing lesions, and secondary radical surgery. Only the pattern of recurrence and secondary radical surgery were independent predictors of post-relapse survival in the multivariate analysis (p=0.025 and p=0.0001, respectively). CONCLUSION: Lymph node recurrence and the feasibility of secondary radical surgery were independent predictors of post-relapse survival in patients with recurrent endometrial cancer.

Sexual Function following Laparoscopic versus Transvaginal Closure of the Vaginal Vault after Laparoscopic Hysterectomy: Secondary Analysis of a Randomized Trial by the Italian Society of Gynecological Endoscopy Using a Validated Questionnaire.

STUDY OBJECTIVE: The effect of the different types of vaginal cuff closures on posthysterectomy sexual function has not been investigated in depth. We evaluated if there is a difference between transvaginal versus a laparoscopic closure after total laparoscopic hysterectomy (TLH) on female sexual function, using a validated questionnaire. DESIGN: Secondary analysis of a prospective randomized controlled trial. SETTING: Three academic research centers. PATIENTS: Women consenting to telephone interviews on their sexual life before and after undergoing TLH were included. INTERVENTIONS: Patients were randomly assigned to a laparoscopic or transvaginal approach for vaginal cuff closure at the end of TLH for benign indications. MEASUREMENTS AND MAIN RESULTS: A validated questionnaire (the Female Sexual Function Index [FSFI]) was used to explore sexuality before and after the operation. Of the 1408 patients enrolled in the primary study, 400 patients were asked to complete the questionnaire. Of them, 182 (41.4%) were eligible and accepted enrollment in the present analysis. No difference was found in terms of pre- and postoperative FSFI scores between groups. Patients with a low preoperative FSFI score (<26.55) had a significantly higher likelihood of having a postoperative sexual disorder (p <.001). Women who received bilateral adnexectomy before menopause and those with postoperative vaginal cuff hematoma had a significantly lower postoperative FSFI score (p = .001 and p = .04, respectively). After multivariable analysis, both variables maintained at least a tendency toward an association with a lower postoperative FSFI score (odds ratio, 2.696; 95% confidence interval, 1.010-7.194; p = 0.048 and p = 0.053; odds ratio, 13.2; 95% confidence interval, .966-180.5, respectively). CONCLUSION: Transvaginal and laparoscopic cuff closures after TLH have similar sexual postoperative outcomes. A patient with sexual problems before TLH is more likely to have a low FSFI score postoperatively. Premenopausal patients undergoing bilateral ovariectomy and those with postoperative vaginal cuff hematoma have a worse postoperative sexual life. (Clinicaltrials.gov, protocol number NCT02453165, registration date May 25, 2015.).

Laparoscopic vs transvaginal cuff closure after total laparoscopic hysterectomy: a randomized trial by the Italian Society of Gynecologic Endoscopy.

BACKGROUND: Vaginal cuff dehiscence following hysterectomy is considered an infrequent but potentially devastating complication. Different possible techniques for cuff closure have been proposed to reduce this threatening adverse event. OBJECTIVE: The aim of the present randomized study was to compare laparoscopic and transvaginal suture of the vaginal vault at the end of a total laparoscopic hysterectomy, in terms of incidence of vaginal dehiscence and vaginal cuff complications. Factors associated with vaginal dehiscence were also analyzed. This article presents the results of the interim analysis of the trial. STUDY DESIGN: Patients undergoing total laparoscopic hysterectomy for benign indications were randomized at the time of colpotomy to receive vaginal closure through transvaginal vs laparoscopic approach using a 1:1 ratio. Allocation concealment was obtained using a password-protected randomization database. Monopolar energy for colpotomy was set at 60W. Vaginal closure was performed with a single-layer running braided and coated 0-polyglactin suture. In all cases an attempt was performed to include the posterior peritoneum in the suture. Laparoscopic knots were tied intracorporeally. All patients were scheduled for a postoperative follow-up visit 3 months after surgery, to detect possible vaginal cuff complications. Univariate and multivariable analyses were performed to identify independent predictors of vaginal cuff dehiscence after total laparoscopic hysterectomy. RESULTS: After enrollment of 1408 patients, a prespecified interim analysis was conducted. Thirteen (0.9%) women did not undergo the postoperative assessment and were excluded. Baseline characteristics of the 1395 patients included (695 in the transvaginal group and 700 in the laparoscopic group) were similar between groups. Patients in the transvaginal group had a significantly higher incidence of vaginal dehiscence (2.7% vs 1%; odds ratio, 2.78; 95% confidence interval, 1.16-6.63; P = .01) and of any cuff complication (9.8% vs 4.7%; odds ratio, 2.19; 95% confidence interval, 1.43-3.37; P = .0003). Based on these findings, the data monitoring committee recommended that the trial be terminated early. After multivariable analysis, transvaginal closure of the vault was independently associated with a higher incidence of vaginal dehiscence and any vaginal complication; premenopausal status and smoking habit were independently associated with a higher risk of dehiscence. CONCLUSION: Laparoscopic closure of the vaginal cuff at the end of total laparoscopic hysterectomy is associated with a significant reduction of vaginal dehiscence, any cuff complication, vaginal bleeding, vaginal cuff hematoma, postoperative infection, need for vaginal resuture, and reintervention.

Comparison of Different Surgical Approaches for Stage IB1 Cervical Cancer Patients: A Multi-institution Study and a Review of the Literature.

OBJECTIVE: The aim of this retrospective study was to assess the surgical and oncological outcome of 3 different surgical approaches (laparotomy, laparoscopy, and robotic surgery) in the treatment of early-stage cervical cancer International Federation of Gynecology and Obstetrics (FIGO) stage IB1. METHODS: All patients with a histologically confirmed diagnosis of early-stage cervical cancer, FIGO stage IB1, who underwent abdominal radical hysterectomy (ARH), laparoscopic radical hysterectomy, or robotic radical hysterectomy with or without pelvic and aortic lymphadenectomy were included in the study. A review of the literature was conducted. RESULTS: Three hundred forty-one patients, between January 2001 and December 2016, were included in this study: 101 patients were submitted to ARH, 152 to laparoscopic radical hysterectomy, and 88 to robotic radical hysterectomy. In 97% and 11.5% of cases, bilateral pelvic and aortic lymph node dissections were performed, respectively. The 3 groups were similar in regard to clinical characteristics. Compared with ARH, the minimally invasive surgery group was safer in terms of estimated blood loss, transfusion rates, and hospital stay. Above all, robotic surgery was equivalent to laparoscopy in terms of intraoperative and postoperative complications, hospital stay, conversions, and reintervention. On the other hand, robotic surgery had better outcomes compared with laparoscopy in terms of transfusion rates and was equivalent to abdominal surgery and laparoscopy in regard to oncological outcomes. CONCLUSIONS: Our study confirmed that minimally invasive surgery (laparoscopy or robotics) was as adequate and effective as abdominal surgery in terms of surgical and oncological outcomes in the surgical treatment of EEC FIGO stage IB1.

Robotic Surgery in Elderly and Very Elderly Gynecologic Cancer Patients.

STUDY OBJECTIVE: To investigate the feasibility, safety, and short-term outcomes of robotic surgery (RS) for gynecologic oncologic indications (cervical, endometrial, and ovarian cancer) in elderly patients, especially women age 65 to 74 years (elderly group [EG]) compared with women age ≥75 years (very elderly group [VEG]). DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: Catholic University of the Sacred Heart, Rome, Italy. PATIENTS: Between May 2013 and April 2017, 204 elderly and very elderly patients underwent RS procedures for gynecologic malignancies. RESULTS: The median age was 71 years (range, 65-74 years) in the EG and 77 years (range, 75-87 years) in the VEG. The incidence of cardiovascular disease was higher in the VEG (p = .038). The EG and VEG were comparable in terms of operative time, blood loss, and need for blood transfusion. Almost all (98.5%) of the patients underwent total/radical hysterectomy, 109 patients (55.6% of the EG vs 48.3% of the VEG) underwent pelvic lymphadenectomy, and 19 patients (10.5% of the EG vs 6.7% of the VEG) underwent aortic lymphadenectomy. A total of 7 (3.4%) conversions to open surgery were registered. Only 3 patients required postoperative intensive care unit admission. The median length of hospital stay was 2 days in each group. A total of 11 patients (5.6%) had early postoperative complications. Four patients (2.8%) in the EG and 2 patients (3.3%) in the VEG experienced grade ≥2 complications. At the time of analysis, median follow-up was 18 months (range, 6-55 months). Eleven patients (5.6%) experienced disease relapse, 2 (1%) died of disease, and 3 (1.5%) died of cardiovascular disease. CONCLUSIONS: This study demonstrates the feasibility, safety, and good short-term outcomes of RS in elderly and very elderly gynecologic cancer patients. No patient can be considered too old for a minimally invasive robotic approach, but a multidisciplinary approach is the best management pathway; efforts to reduce associated morbidity are essential.

Nerve-Sparing Laparoscopic Colposacropexy Using a Percutaneous Surgical System: A Case Report.

STUDY OBJECTIVE: The primary aim of this study was to evaluate the feasibility, efficacy, and safeness of nerve-sparing laparoscopic colposacropexy performed with a minimally invasive approach by using 2.9-mm Percuvance percutaneous surgical system (PSS; The Percuvance System; Teleflex Inc., Wayne, PA). The secondary aim was to investigate the technical performance of these instruments as needle holder in the placement of the mesh. The final aim was to establish the rate of prolapse recurrence. DESIGN: Step-by-step video demonstration of the surgical technique. SETTING: The Internal Department Committee approved this study. PATIENT: The patient was adequately informed about the possible risks and benefits of this experimental technique, and a written consent agreeing to undergo the described procedure was signed. INTERVENTION: Nerve-sparing laparoscopic colposacropexy with positioning of two polypropylene titanized meshes and concomitant subtotal hysterectomy and salpingo-oophorectomy entirely performed with a 2.9-mm PSS. MEASUREMENTS AND MAIN RESULTS: Pelvic organ prolapse is a condition affecting up to 50% of multiparous women. It may be considered a significant public health problem with an important impact on general health-related quality of life. A conservative and/or medical treatment may be considered only for women with a mild degree of prolapse, women with a reproductive desire, or women unable to undergo surgery. In the remaining cases, surgery seems to be the most effective treatment. The surgical approach may be abdominal (colposacropexy by laparotomy, laparoscopy, or robot-assisted) or vaginal (autologous or prosthesic reinforcement). The aims of the surgical procedures include not only the anatomic correction of the prolapse but also the improvement of patient quality of life and prolapse symptom relief, guaranteeing normal bladder, bowel, and sexual functions and avoiding iatrogenic dysfunctional symptoms. At present, the laparoscopic technique of sacral colpopexy offers a number of important advantages, including an excellent visualization of the pelvis, reduction in adhesions formation, and decreased postoperative pain and recovery, with reported success rates of 90% to 96% with a mesh erosion rate of 1% to 8%. CONCLUSION: This case report is the first to report a nerve-sparing laparoscopic colposacropexy performed with a 2.9-mm PSS. The major advance of this technique is the possibility of performing a major gynecologic surgery with a scarless approach, which results in fewer traumas for the patient in the postoperative time. The use of these instruments does not increase the operation time or the rate early or late complications, most of all prolapse recurrence. Considering that this is the first case report in literature, more clinical data are needed to confirm these findings.

Laparoscopic En Bloc Right Diaphragmatic Peritonectomy for Diaphragmatic Endometriosis According to the Sugarbaker Technique.

STUDY OBJECTIVE: To evaluate the feasibility of a novel laparoscopic procedure for complete eradication of diaphragmatic endometriosis (DE). DESIGN: A retrospective multicenter study (Canadian Task Force Classification II-2). SETTING: University tertiary referral centre. PATIENTS: A consecutive series of 9 women with DE. INTERVENTIONS: Laparoscopic en bloc eradication using Sugarbaker's peritonectomy technique with or without diaphragmatic resection for DE. All surgical procedures were performed by the same surgeon in 2 tertiary referral centers (Charitè University, Berlin, Germany, and Catholic University of the Sacred Heart, Foundation John Paul II, Campobasso, Italy). MEASUREMENTS AND MAIN RESULTS: Rate of conversion to laparotomy, perioperative outcomes, intra- and postoperative complications, and recurrence rate. The procedures were successfully performed in all patients laparoscopically without conversion to laparotomy. All patients also presented with multiple endometriotic lesions in the Morison pouch, and in 3 cases a deep infiltration of the right diaphragm was observed that required partial diaphragmatic resection. In 2 women, pulmonary nodules were also detected, and lung laparoscopic resection was attempted to eradicate the disease. A chest drain was placed in 7 women and was removed after a median time of 6 days (range, 4-10 days). No intra- or postoperative complications were recorded. To complete the diaphragmatic peritonectomy, the median operative time required was 180 minutes (range, 90-240 minutes). The median estimated blood loss was 100 mL (range, 50-300 mL), and the median hospital stay was 10 days (range, 5-17 days). After a median follow-up of 6 months, we observed symptomatic relief for all study patients without major surgery-related morbidity. In 1 woman, laparoscopic adhesiolysis was performed after 18 months from surgery without signs of recurrent endometriosis. CONCLUSION: Laparoscopic en bloc eradication of DE with Sugarbaker's peritonectomy is highly effective in the management of symptomatic DE, with no major intra-/postoperative complications and very favorable perioperative outcomes.

Laparoscopic Radical Hysterectomy After Concomitant Chemoradiation in Locally Advanced Cervical Cancer: A Prospective Phase II Study.

OBJECTIVE: To assess the feasibility of laparoscopic radical surgery in patients with locally advanced cervical cancer (LACC) who receive chemoradiation therapy (CT/RT). DESIGN: Prospective phase II study (Canadian Task Force classification II-1). INTERVENTION: Patients with LACC (FIGO stage IB2-III) were evaluated for accrual at the Gynecologic Oncology Unit of Catholic University, Rome/Campobasso. Neoadjuvant CT/RT included whole-pelvic irradiation (total dose, 45.0-50.4 Gy) combined with cisplatin and 5-fluorouracil. Objective response to treatment was evaluated according to Response Evaluation Criteria in Solid Tumors criteria. Laparoscopic radical hysterectomy (RH) plus pelvic and/or aortic lymphadenectomy was attempted within 6 to 8 weeks after CT/RT. The feasibility of laparoscopic RH, as well as the rate, pattern, and severity of early and late postoperative complications, were analyzed. RESULTS: Between January 2010 and October 2013, a total of 58 patients were enrolled into the study. After CT/RT, 23 patients (39.6%) underwent type B2 RH, 31 (53.4%) underwent type C1 RH, and 4 (6.9%) underwent type C2 RH. Pelvic lymphadenectomy was performed in all cases. Laparoscopic RH was feasible in 55 of 58 cases (feasibility rate, 94.8%). No intraoperative complications were recorded. During the observation period (median, 22 months; range, 5-50 months), there were 28 complications, of which only 21.4% were grade 2 complications and 14.3% were grade 3 complications. As of January 2015, disease recurrence was documented in 4 cases (6.9%). CONCLUSION: Total laparoscopic radical surgery is feasible in patients with LACC receiving preoperative CT/RT, providing perioperative outcomes comparable to those registered in early-stage disease.

Mesenteric lymph node involvement in advanced ovarian cancer patients undergoing rectosigmoid resection: prognostic role and clinical considerations.

BACKGROUND: The aim of this retrospective study was to investigate the incidence of mesenteric lymph node (MLN) involvement, and its prognostic role in advanced ovarian cancer (OC). METHODS: OC patients undergoing rectosigmoid resection during primary debulking surgery or interval debulking surgery were recorded. Progression-free survival (PFS) and overall survival were calculated from the date of diagnosis to the date of relapse/progression, death of disease, or the date of last follow-up. RESULTS: MLNs were detected in 102/148 cases (68.9 %); the rate of MLN involvement was 47.0 %. The percentage of metastatic MLNs was higher in cases with >5 MLNs removed compared with cases with ≤ 5 MLNs removed (62.7 % vs. 31.3 %; p = 0.0027). A progressive increase in the rate of metastatic MLNs was documented in association with depth of bowel infiltration (p = 0.026). Cases with metastatic MLNs experienced isolated celiac trunk or aortic lymph node recurrences more frequently than patients without MLN involvement (44.8 % vs. 10.7 %; p = 0.0008). PFS did not differ between cases with positive versus negative MLN involvement (2-year PFS = 31 % vs. 43 %; p = 0.58). CONCLUSION: OC patients undergoing rectosigmoid resection showed metastatic MLN involvement in 47.0 % of cases. Metastatic MLN status is associated with a high rate of isolated aortic and celiac trunk lymph node recurrences.

Completion surgery after concomitant chemoradiation in locally advanced cervical cancer: a comprehensive analysis of pattern of postoperative complications.

BACKGROUND: We provided a comprehensive analysis of rate, pattern, and severity of early and late postoperative complications in a very large, single-institution series of locally advanced cervical cancer (LACC) patients administered CT/RT plus radical surgery (RS). METHODS: A total of 362 consecutive LACC (FIGO stage IB2-IVA) patients were submitted to RS after CT/RT at the Gynecologic Oncology Unit of the Catholic University (Rome/Campobasso). At 4 weeks after CT/RT, patients were evaluated for objective response and triaged to radical hysterectomy and pelvic ± aortic lymphadenectomy. Surgical morbidity was classified according to the Chassagne's grading system. RESULTS: Most cases underwent type III-IV radical hysterectomy (N = 313, 86.5 %); pelvic lymphadenectomy was performed in all patients, while 116 patients (32.1 %) were also submitted to aortic lymphadenectomy. A total of 93 patients (25.7 %) experienced any grade postoperative complications, and 60 (16.6 %) had ≥grade 2 complications; grade 3-4 complications occurred in 21 patients (5.8 %). Of all early postoperative complications (N = 100), 31 (31.0 %) were urinary, 9 (9.0 %) were gastrointestinal, and 45 (45.0 %) were vascular. Of all late complications (N = 31), 20 (64.5 %) were urinary, 7 (22.6 %) gastrointestinal, and 2 (6.4 %) were vascular. Multivariate analysis showed that not complete clinical response to treatment retained an independent, unfavorable association with risk of development of postoperative morbidity, while advanced stage, and aortic lymphadenectomy showed only a borderline value. CONCLUSIONS: Failure to achieve clinical complete response to treatment and, to a lesser extent, more advanced stage, and aortic lymphadenectomy, were associated with a higher risk of developing any grade as well as ≥grade 2 complications.

Adjuvant volumetric-modulated arc therapy with simultaneous integrated boost in endometrial cancer. Planning and toxicity comparison.

OBJECTIVE: To report dosimetric and acute toxicity data in prospectively enrolled high-intermediate risk endometrial cancer (HIR-EC) patients postoperatively irradiated by simultaneous integrated boost volumetric modulated arc therapy (SIB-VMAT). METHODS: Thirty prospectively enrolled HIR-EC patients were postoperatively treated by SIB-VMAT. Target coverage, dose homogeneity, and sparing of organs at risk (OARs) were compared with corresponding data retrieved from an historical control (30 consecutive selected matched patients) treated by concomitant boost three-dimensional conformal radiotherapy (3D CRT CB) from a previously published study (ADA-I trial). All patients received 45 Gy on pelvic lymph nodes plus 10 Gy boost on the vaginal vault. RESULTS: The SIB-VMAT technique produced more inhomogeneous plans than 3D CRT CB, but showed significantly better conformity index (CIs) for both PTVs. SIB-VMAT was associated with significant reduction in the irradiated small bowel (SB) volume compared with 3D CRT CB for all dose range > 10 Gy (e.g. V15: 163.5 cm(3) vs. 341.3 cm(3), p = 0.001 and V40: 43.8 cm(3) vs. 85.2 cm(3), p = 0.008). With regard to bladder and rectum, SIB-VMAT showed a significant sparing advantage at all dose levels with respect to 3D CRT CB retrieved plans. Moreover, overall OARs Dmean were significantly reduced by the SIB-VMAT (p = 0.001). According to CTCAE v.4.0, acute (within three months) GI toxicities were more frequent in 3D CRT CB versus SIB-VMAT (90.0% vs. 66.7%; p-value 0.028). CONCLUSIONS: Compared to data from a historical database of patients administered 3D CRT CB, SIB-VMAT significantly improves the dose conformity and sparing of OARs in HIR-EC patients undergoing postoperative radiotherapy. The improvement in terms of acute toxicity justifies further prospective clinical evaluation.

Survival after curative pelvic exenteration for primary or recurrent cervical cancer: a retrospective multicentric study of 167 patients.

OBJECTIVE: Evaluate the survival of patients who underwent pelvic exenteration (PE) with curative intent for primary persistent or recurrent cervical cancer. METHODS: We retrospectively investigated 167 consecutive patients, referred to the gynecological oncology units of 4 centers in Germany or Italy, who underwent PE. Data regarding surgery, histology, and oncologic outcomes were collected and statistically evaluated. Survival was determined from the day of exenteration until last follow-up or death. RESULTS: The median age was 51 years. Twenty-seven patients (16.2%) underwent PE owing to advanced primary tumors (group A), 34 patients (20.4%) underwent PE owing to persistent cancer after chemotherapy or chemoradiation (group B), and 106 patients (63.4%) underwent PE owing to recurrence (group C). The prevalent histologic type was squamous cell cancer. A complete tumor resection (R0), was achieved in 121 patients (72.5%). Forty-nine patients (29.3%) had pelvic lymph node metastases and 44 patients (26.3%) had pelvic sidewall involvement. Overall survival at the end of the study was 40.7%. The cumulative 5-year overall survival for the entire cohort was 38%. Resection margins, pelvic lymph node state, and sidewall involvement were independent prognostic factors in multivariate analysis. CONCLUSION: Pelvic exenteration is a valid therapeutic option for patients with locally advanced primary persistent or recurrent cervical cancer, with a long-term survival in 40% of the patients.

Completion surgery after concomitant chemoradiation in obese women with locally advanced cervical cancer: Evaluation of toxicity and outcome measures.

BACKGROUND: This study aims at comparing the morbidity and oncologic outcomes in normal weight, overweight, and obese women with locally advanced cervical cancers (LACC) submitted to radical surgery after chemoradiation. METHODS: A review of LACC patients with body mass index (BMI) ≥ 18.5 kg/m(2) who underwent neoadjuvant chemoradiation followed by radical surgery between January 1996 and December 2010 was performed. BMI categories were created according to the World Health Organization (WHO) classification. RESULTS: Two hundred sixty-eight women met the inclusion criteria: 118 (44.0%) were normal weight, 100 (37.3%) overweight and 50 (18.7%) obese. The median follow-up was 42 months. Higher BMI was associated with older age (p = 0.0041), while there were no differences among the three groups in Charlson comorbidity score, tumor characteristics, radiotherapy dosing, type of surgery, and pathological response. There were no differences among the three groups in the intraoperative and postoperative complications as well as rate of patients requiring adjuvant treatments: 21 (7.8%) patients experienced grade 3-4 toxicity, including six normal weight, 12 overweight and three obese patients (p = 0.14). Only the rate of grade 1-2 skin toxicity was higher in obese (14%) with respect to overweight (1%) and normal women (0%) (p = 0.00001). There were no differences in the five-year DFS (74%, 77%, and 84% for normal weight, overweight, and obese women, respectively, p = n.s.), and five-year OS (76%, 78%, and 78% for normal weight, overweight, and obese women, respectively, p = n.s.). CONCLUSIONS: The role of obesity should not be overestimated when evaluating the chance of enrolment of LACC patients into preoperative chemoradiation protocols.