Diagnostic performance of ultrasound in assessing the extension of disease in advanced ovarian cancer.

BACKGROUND: Surgical exploration remains the gold standard for evaluating the extension of disease and predicting resectability. A laparoscopy-based scoring model was developed by Fagotti and colleagues in 2006 and updated in 2015, based on the intraoperative presence or absence of some specific cancer features. The model proved an overall accuracy rate of 77% to 100% and is considered the reference test for assessing resectability in our institution. OBJECTIVE: The primary aim of the study was to analyze the agreement between preoperative ultrasound examination and laparoscopic findings in assessing the extension of intraabdominal disease using 6 parameters described by Fagotti's score. STUDY DESIGN: This was a prospective single-center observational study. Between January 2019 and June 2020, consecutive patients with clinical or radiological suspicion of ovarian or peritoneal cancer were assessed with preoperative ultrasound examination and assigned a score based on the 6 Fagotti score parameters (great omentum, liver surface, lesser omentum/stomach/spleen, parietal peritoneum, diaphragms, bowel disease). Presence of mesenteral retraction of the small bowel and miliary carcinomatosis on the serosa were also evaluated. Each parameter was correlated with laparoscopic findings. Concordance was calculated between ultrasound and laparoscopic parameters using Cohen's kappa. RESULTS: Cohen's kappa ranged from 0.70 to 0.90 for carcinomatosis on the small or large bowel, supracolic omentum, liver surface, and diaphragms. Cohen's kappa test was lower for carcinomatosis on the parietal peritoneum (k=0.63) and on the lesser omentum or lesser curvature of the stomach or spleen (k=0.54). The agreement between ultrasound and surgical predictive index value (score) was k=0.74. For the evaluation of mesenteral retraction and miliary carcinomatosis, the agreement was low (k=0.57 and k=0.36, respectively). CONCLUSION: The results of ultrasound and laparoscopy in the assessment of intraabdominal tumor spread were in substantial agreement for almost all the parameters. Ultrasound examination can play a useful role in the preoperative management of patients with ovarian cancer when used in dedicated referral centers.

Ultrasound, macroscopic and histological features of serous epithelial ovarian carcinomas.

We present a video showing two cases of serous epithelial ovarian carcinomas. The first video shows clinical, ultrasound, macroscopic, and histological features of a patient with high grade serous ovarian carcinoma. The second video presents clinical, ultrasound, macroscopic, and histological features of a patient with low grade serous ovarian carcinoma.

Management of ovarian masses in pregnancy: patient selection for interventional treatment.

OBJECTIVE: The management of pregnant women with an adnexal tumor is still challenging and in the literature few data are available. The aim of this study was to describe the management and outcome of patients with ovarian masses detected during pregnancy. As secondary aims, we evaluated the prevalence of malignancy in the International Ovarian Tumor Analysis (IOTA) morphological classes of ovarian masses diagnosed during pregnancy, and created an algorithm for the management of patients with adnexal masses during pregnancy. METHODS: This was a retrospective single centered study including patients with adnexal masses detected at any trimester during pregnancy between January 2000 and December 2019. Clinical, ultrasound, surgical, and histological data were retrieved from medical records as well as information on management (ultrasound follow-up vs surgery). Indications for surgery were recorded in terms of suspicion of malignancy based on pattern recognition of the ultrasound examiner or on symptoms or prevention of complications, such as torsion, rupture, or obstacle to normal full-term pregnancy. All masses were described using IOTA terminology. RESULTS: A total of 113 patients were selected for the analysis. Of these, 48 (42%) patients had surveillance and 65 (58%) patients underwent surgery (11 primary ovarian tumors, one recurrence of ovarian cancer, four metastases to the ovary, 20 borderline tumors, and 29 benign lesions). Indications for surgery were suspicious malignancy in 41/65 (63.1%) cases and symptoms or prevention of complications in 24/65 (36.9%) cases. All patients in the surveillance group showed no morphological changes of the ovarian lesions at 6 months after delivery. According to the IOTA ultrasound morphological category, the prevalence of malignancy was 0% (0/37) in the unilocular cyst group, 27% (4/15) in the multilocular group, 35% (11/31) in the unilocular solid group, 70% (14/20) in the multilocular solid group, and 70% (7/10) in the solid group. Neither obstetric nor neonatal complications were reported for patients in the surveillance group or in those with benign, borderline, or primary epithelial invasive histology. In contrast, two neonatal deaths were observed in patients with ovarian choriocarcinoma and ovarian metastases. Three of the four patients with ovarian metastases died after pregnancy. CONCLUSIONS: IOTA ultrasound morphological classification seems useful in the characterization of ovarian masses during pregnancy. A clinical and morphological based algorithm for counseling patients has been designed.

Diagnostic performance of ultrasound in assessing the extension of the disease in patients with suspicion of malignant ovarian tumor: correlation between ultrasound parameters and Fagotti's score.

BACKGROUND: A radical surgical approach represents the mainstay treatment for gynecological malignancy, and preoperative staging of ovarian cancer is crucial. Ultrasound evaluation is widely recognized as the gold standard technique for the characterization of ovarian masses due to a high sensitivity for malignancy. In addition, its accuracy in defining intra-abdominal ovarian cancer spread has been previously proposed. PRIMARY OBJECTIVE: To analyze the agreement between preoperative ultrasound examination and laparoscopic findings in assessing the extension of intra-abdominal disease using six parameters as described by Fagotti's score. STUDY HYPOTHESIS: When performed by expert examiners, ultrasound can be an accurate technique to assess tumor spread in ovarian cancer and therefore to predict surgical resectability. TRIAL DESIGN: This is a single-center prospective observational study. Patients with clinical and/or radiological suspicion of advanced ovarian or peritoneal cancer will be assessed with preoperative ultrasound and assigned a score based on the six Fagotti's laparoscopic score parameters. Each parameter will then be correlated with laparoscopic findings. MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients include women 18-75 years of age with clinical and/or imaging suggestive of advanced ovarian or peritoneal cancer, and an ECOG performance status 0-3. PRIMARY ENDPOINTS: Sensitivity and specificity of ultrasound in detecting carcinomatosis, using the parameters of Fagotti's score as a reference standard. Agreement between preoperative ultrasound examination and laparoscopic findings in assessing the extension of intra-abdominal disease as described in Fagotti's score. SAMPLE SIZE: 240 patients. ESTIMATE DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: The accrual started in January 2019. Enrollment should be completed approximately by October 2020 and the results will be analyzed by December 2020. TRIAL REGISTRATION: The study received the Ethical Committee approval on July 19 2018 (Protocol 28967/18 ID:2172).

Role of transvaginal ultrasound-guided biopsy in gynecology.

BACKGROUND: Ultrasound-guided biopsy is an easy technique for obtaining tissue samples. It is commonly used for different types of tumors, such as breast and prostate cancers, in order to plan early and adequate treatment. OBJECTIVE: To evaluate the indications, adequacy, and safety of transvaginal ultrasound-guided biopsy in women with pelvic lesions suspected of gynecologic malignancy. METHODS: A retrospective study including all patients who had undergone transvaginal ultrasound-guided biopsy between April 2015 and May 2018 was carried out at the division of gynecologic oncology. Inclusion criteria were the presence at imaging of abdominal or pelvic tumors in patients considered not ideal candidates for primary gynecological surgery, or the origin and/or nature of the tumor was unclear and further management required histological verification. Patients with planned surgery were excluded from the study. Transvaginal biopsies were performed with a 18 G/25 cm core-cut biopsy needle and histology was obtained. Tru-cut biopsies were performed using an automatic bioptic gun with a 18 G/25 cm core-cut biopsy needle. Results are presented as absolute frequency (percentage) for nominal variables and as median (range) for continuous variables. RESULTS: A total of 62 women were analyzed. An adequate sample for histological analysis was obtained in all cases. Histopathological examinations showed 24 (38.7%) benign lesions (fibrosis, inflammation, uterine or ovarian myoma) and 38 (61.3%) malignant tumors, distributed as follows: 34 (89.5%) malignant gynecological lesions and 4 (10.5%) non-gynecological malignant tumors. Among the malignant lesions, there were 12/38 (31.6%) primary tumors, 24/38 (63.2%) recurrent tumors, and 2/38 (5.3%) metastases from non-genital cancer. Ten patients eventually underwent surgery. Final histology was not in agreement with the results from transvaginal ultrasound-guided biopsy in 2 of 10 patients (20%); in particular, benign disease at transvaginal ultrasound-guided biopsy was malignant at final histology (two cases of recurrence of cervical cancer). Three patients (4.8%) had pain during the procedure, which was controlled by oral analgesic therapy and lasted for no longer than 10 min. No major complications were registered. CONCLUSIONS: Transvaginal ultrasound-guided biopsy is a minimally invasive method to obtain adequate material for histological diagnosis and could avoid unnecessary surgical procedures, costly CT-guided procedures, or prolonged waiting times.

Role of Intraoperative Ultrasound to Extend the Application of Minimally Invasive Surgery for Treatment of Recurrent Gynecologic Cancer.

STUDY OBJECTIVE: To describe the potential role of intraoperative ultrasound (IOUS) in the detection and localization of recurrent disease in gynecologic cancer patients during minimally invasive surgery (MIS). DESIGN: A prospective cohort study (Canadian Task Force classification II-1). SETTING: A university hospital. PATIENTS: Fifty-one gynecologic cancer patients with isolated recurrent disease. INTERVENTIONS: IOUS during secondary cytoreductive surgery (SCS) by MIS. MEASUREMENTS AND MAIN RESULTS: From November 2015 to February 2017 51 gynecologic cancer patients with isolated recurrent disease and candidates for SCS were treated by MIS. Recurrent tumor was preoperatively assessed at clinical examination, transvaginal and transabdominal sonography, and radiologic evaluation in all women. Twelve of 51 women (23.5%) needed IOUS. Type of disease was ovarian in 5 women (42%), endometrial in 4 (33%), cervical in 1 (8%), vaginal cancer in 1 (8%), and uterine sarcoma in 1 (8%). Recurrence was localized deep in the pelvis in 7 cases (58%), lymph nodes in 3 (25%), and extraperitoneal in 2 cases (17%). Recurrence was dimmed in the surgical field, due to either presence of adherences, deep anatomic position, small size, and/or lack of tactile feeling. IOUS was able to identify the lesions in all women, allowing MIS (83% laparoscopy and 17% robotic) complete cytoreduction, with no conversion to laparotomy. Median operative time was 150 minutes (range, 77-280). No intraoperative/postoperative complications occurred. Histologic examination confirmed the presence of recurrence in 11 of 12 cases (92%), whereas the remaining case showed inflammatory tissue. With a median follow-up time of 15 months (range, 6-19), all patients except 2 were still alive. CONCLUSIONS: About 1 of 4 patients (25%) with single gynecologic cancer recurrence needs IOUS to benefit from MIS for complete secondary cytoreduction.

Ovarian volume and gluco-insulinaemic markers in the diagnosis of PCOS during adolescence.

OBJECTIVE: To evaluate the role of mean ovarian volume (MOV) in the diagnosis of polycystic ovary syndrome (PCOS) during adolescence, and its relationship with metabolic and endocrine parameters. DESIGN: Observational study. PATIENTS: A total of 134 young girls, including 86 adolescents with PCOS and 48 controls, were studied. MEASUREMENTS: During the early follicular phase, a pelvic ultrasound examination was performed to measure the ovarian volume of both ovaries and to calculate the MOV. All subjects underwent hormonal assessment and an ultrasound examination. PCOS subjects were submitted to an oral glucose tolerance test. The homeostasis model assessment for insulin resistance (HOMA-IR) and several insulin resistance indexes were also determined. RESULTS: Androgens, free androgen index (FAI), LH and insulin resistance indexes were higher in the PCOS group. MOV was significantly different between the two groups: control group 4·6 ± 1·9 cm(3) , adolescent PCOS group 9·6 ± 4·4 cm(3) . The MOV threshold of 5·596 cm(3) offered the best compromise between sensitivity and specificity based on the characteristics of the operating receiver curve analysis. Therefore, an ovarian volume higher than 5·6 increased the risk of PCOS by about 15 times (OR 16·25 IC 95% 6·3-41·3). In adolescent PCOS girls, the ovarian volume was significantly associated with circulating testosterone and insulin, and indices of insulin resistance. CONCLUSIONS: During early adolescence MOV evaluation may offer an effective means to screen and follow up young girls with irregular cycles in order to prevent the long-term metabolic disturbances of the polycystic ovary syndrome.

Phase 2 trial of nonpegylated doxorubicin (Myocet) as second-line treatment in advanced or recurrent endometrial cancer.

BACKGROUND: Advanced or recurrent endometrial cancer is associated with a poor prognosis, and results obtained with systemic therapy are far from being impressive. Myocet is an interesting formulation of citrate conjugated doxorubicin encapsulated in nonpegylated liposomes. This phase 2 study was designed to evaluate the objective response rate and the toxicity profile of Myocet in women with advanced or recurrent endometrial cancer. METHODS: Patients with diagnosis of advanced or recurrent endometrial cancer failing 1 previous carboplatin-paclitaxel chemotherapy were enrolled. Myocet was administered at the dose of 60 mg/m intravenously on day 1 every 4 weeks. RESULTS: Eighteen patients were enrolled in our institution from September 2007 to January 2010. No complete or partial response was observed. Stable disease was registered in 5 patients (27.5%). Median time to progression was 9 weeks. Median time to death was 24 weeks. Grade 3/4 anemia was reported in 2 patients (11%). Grade 3/4 neutropenia was observed in 16.5% and 44% of patients, respectively. The major nonhematologic toxicities (grades 3/4) were fatigue (22%), nausea, and vomiting (5.5%). CONCLUSIONS: Myocet presents no activity, and only few stabilizations of disease of limited duration in this recurrent endometrial carcinoma population previously treated with platinum-taxane chemotherapy are reported.

The video endoscopy inguinal lymphadenectomy for vulvar cancer: A pilot study.

OBJECTIVE: This prospective pilot study aims to validate feasibility, efficacy and safeness of the innovative technique of video endoscopy inguinal lymphadenectomy (VEIL) and compare it to open inguinal lymphadenectomy (OIL) in the staging and treatment of vulvar cancer (VC). MATERIAL AND METHODS: All patients affected by VC suitable for bilateral inguinal-femoral lymphadenectomy were prospectively enrolled and submitted to VEIL on one side and OIL contralaterally, sparing the saphenous vein. The surgical and post-surgical data were collected. Univariate analysis included chi square analysis or Fisher's exact test, when appropriate for categorical variables, and the Student t test and Mann-Whitney test when appropriate for continuous variables. RESULTS: Between October 2014 and June 2015 fifteen patients were valuable for the study. Although nodal retrieval was comparable for both procedures, operative time was higher after VEIL. No intraoperative complications were observed in both techniques. Postoperative complications were observed in 3 and 2 cases for OIL and VEIL respectively. One patient needed reoperation after OIL for wound necrosis and infection. According to Campisi's stage, lymphedema resulted significantly to be lower after VEIL (p = 0.024). CONCLUSIONS: Waiting for larger series and longer follow-up data, the VEIL seems to be feasible allowing a radical removal of inguinal lymph nodes as well as OIL with lower morbidity.

Sexual and Reproductive Outcomes in Early Stage Cervical Cancer Patients after Excisional Cone as a Fertility-sparing Surgery: An Italian Experience.

BACKGROUND: The purpose of this study was to analyze the quality of life in terms of sexual and reproductive outcome in patients suffering from early stage cervical cancer, submitted to an excisional cone as fertility-sparing treatment. METHODS: A multicenter retrospective analysis about specific dimensions of physical, psychological, reproductive and sexual functions after a cold-knife conization plus pelvic laparoscopic lymphadenectomy was conducted at Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome-Italy and at Division of Gynecology, European Institute of Oncology, Milan-Italy. The aim of this study was twofold. It aimed to analyze the quality of life in patients submitted to minimally invasive surgery and to compare these data with radical trachelectomy. RESULTS: Twenty-three patients with an average age of 30 years decided to participate in this study. After the treatment, all women (100%) had regular menstruation, 7 (30.4%) had increased not invalidating dysmenorrhea; 1 (4.4%) experienced a cervical stenosis; 6 among 10 patients that tried to conceive (60%) obtained one spontaneous pregnancy; 4 more (40%) underwent in vitro fertilization and embryo transfer and only 1 of them (25%) was successful. About sexual assessment, 1 patient (4.4%) had trouble in lubricating, 3 (13%) had anxiety about performance, 6 (26.1%) complained of dyspareunia which was resolved within 3 subsequent months. All patients (100%) obtained a complete psychological and physical recovery. CONCLUSION: This study demonstrated preliminary encouraging data about sexual and reproductive outcome after excisional conization. A comparison with trachelectomy surely needs longer follow-ups, more cases and prospective analyses.

Imaging techniques for the evaluation of cervical cancer.

Improvements in the treatment of cervical carcinoma have made it possible to offer optimal and personalised treatment. Cervical cancer staging is based on clinical examination and histological findings. Many diagnostic methods are used in clinical practice. Magnetic resonance imaging is considered the optimal method for staging cervical carcinoma because of its high accuracy in assessing local extension of disease and distant metastases. Ultrasound has gained increased attention in recent years; it is faster, cheaper, and more widely available than other imaging techniques, and is highly accurate in detecting tumour presence and evaluating local extension of disease. Magnetic resonance imaging and ultrasound are often used together with computed tomography or positron emission tomography combined with computed tomography to assess the whole body, a more accurate detection of pathological lymph nodes and metabolic information of the disease.