Comparison of clinical and ultrasound examinations in assessing the parametria in patients with deep infiltrating endometriosis: a multicentre prospective study.

RESEARCH QUESTION: How do clinical rectovaginal examination and transvaginal ultrasound examination perform in the diagnosis of parametrial infiltration in patients with endometriosis? DESIGN: This was a multicentre prospective observational study. Patients with suspected deep endometriosis at clinical examination and/or at ultrasound evaluation and scheduled for surgery were included. Following multicentre multidisciplinary meetings, consensus was obtained on terms and methodology to define the parametrium at pelvic anatomy, ultrasound and surgery. Sensitivity, specificity, accuracy, and positive and negative likelihood ratios were calculated for clinical and ultrasound examinations with respect to surgery. RESULTS: In total, 195 women were selected for the present study and 164 were included in the analysis. Ultrasound examination had good to high specificity (>80%) for all parameters, except the left lateral parametrium (78.8%). The sensitivity of ultrasound examination was good to high for fixity of the right and left ovaries, uterosacral ligaments, retrocervix and rectovaginal space; and low for the anterior and lateral parametria, vagina, bladder and bowel. Clinical examination had good to high specificity for fixity of the left ovary, anterior parametrium, right uterosacral ligament, retrocervix and vagina; and low specificity for fixity of the right ovary, lateral parametrium, left uterosacral ligament and rectovaginal space. The sensitivity of clinical examination was good for the uterosacral ligaments and rectovaginal space, and low for the remaining parameters. CONCLUSION: Ultrasound examination provided good specificity for all the parameters, but sensitivity was low for the anterior and lateral parametria. Clinical examination provided good specificity for the anterior and posterior parametria, but sensitivity was low for the anterior and lateral parametria. Further prospective studies are needed to validate this methodology and confirm the results.

Comparison of the ADNEX and ROMA risk prediction models for the diagnosis of ovarian cancer: a multicentre external validation in patients who underwent surgery.

BACKGROUND: Several diagnostic prediction models to help clinicians discriminate between benign and malignant adnexal masses are available. This study is a head-to-head comparison of the performance of the Assessment of Different NEoplasias in the adneXa (ADNEX) model with that of the Risk of Ovarian Malignancy Algorithm (ROMA). METHODS: This is a retrospective study based on prospectively included consecutive women with an adnexal tumour scheduled for surgery at five oncology centres and one non-oncology centre in four countries between 2015 and 2019. The reference standard was histology. Model performance for ADNEX and ROMA was evaluated regarding discrimination, calibration, and clinical utility. RESULTS: The primary analysis included 894 patients, of whom 434 (49%) had a malignant tumour. The area under the receiver operating characteristic curve (AUC) was 0.92 (95% CI 0.88-0.95) for ADNEX with CA125, 0.90 (0.84-0.94) for ADNEX without CA125, and 0.85 (0.80-0.89) for ROMA. ROMA, and to a lesser extent ADNEX, underestimated the risk of malignancy. Clinical utility was highest for ADNEX. ROMA had no clinical utility at decision thresholds <27%. CONCLUSIONS: ADNEX had better ability to discriminate between benign and malignant adnexal tumours and higher clinical utility than ROMA. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov NCT01698632 and NCT02847832.

Prediction of the Risk of Malignancy of Adnexal Masses during Pregnancy Comparing Subjective Assessment and Non-Contrast MRI Score (NCMS) in Radiologists with Different Expertise.

Ovarian cancer represents 7% of all cancers in pregnant women. Characterising an ovarian mass during pregnancy is essential to avoid unnecessary treatment and, if treatment is required, to plan it accordingly. Although ultrasonography (US) is the first-line modality to characterise adnexal masses, MRI is indicated when adnexal masses are indeterminate at the US examination. An MRI risk stratification system has been proposed to assign a malignancy probability based on the adnexal lesion's MRI, but features of the scoring system require the administration of intravenous gadolinium-based contrast agents, a method that might have a limited use in pregnant women. The non-contrast MRI score (NCMS) has been used and evaluated in non-pregnant women to characterise adnexal masses indeterminate at the US examination. Therefore, we evaluated the diagnostic accuracy of the NCMS in pregnant women, analysing 20 cases referred to our specialised institution. We also evaluated the diagnostic agreement between two radiologists with different expertise. The two readers classified ovarian masses as benign or malignant using both subjective assessment (SA), based on the interpretive evaluation of imaging findings derived from personal experience, and the NCMS, which includes five categories where 4 and 5 indicate a high probability of a malignant mass. The expert radiologist correctly classified 90% of the diagnoses, using both SA and the NCMS, relying on a sensitivity of 85.7% and a specificity of 92.3%, with a false positive rate of 7.7% and a false negative rate of 14.3%. The non-expert radiologist correctly identified patients at a lower rate, especially using the SA. The analysis of the inter-observer agreement showed a K = 0.47 (95% CI: 0.48-0.94) for the SA (agreement in 71.4% of cases) and a K = 0.8 (95% CI: 0.77-1.00) for the NCMS (agreement in 90% of cases). Although in pregnant patients, non-contrast MRI is used, our results support the use of a quantitative score, i.e., the NCMS, as an accurate tool. This procedure may help less experienced radiologists to reduce the rate of false negatives or positives, especially in centres not specialised in gynaecological imaging, making the MRI interpretation easier and more accurate for radiologists who are not experts in the field, either.

Evaluating the Risk of Inguinal Lymph Node Metastases before Surgery Using the Morphonode Predictive Model: A Prospective Diagnostic Study in Vulvar Cancer Patients.

Ultrasound examination is an accurate method in the preoperative evaluation of the inguinofemoral lymph nodes when performed by experienced operators. The purpose of the study was to build a robust, multi-modular model based on machine learning to discriminate between metastatic and non-metastatic inguinal lymph nodes in patients with vulvar cancer. One hundred and twenty-seven women were selected at our center from March 2017 to April 2020, and 237 inguinal regions were analyzed (75 were metastatic and 162 were non-metastatic at histology). Ultrasound was performed before surgery by experienced examiners. Ultrasound features were defined according to previous studies and collected prospectively. Fourteen informative features were used to train and test the machine to obtain a diagnostic model (Morphonode Predictive Model). The following data classifiers were integrated: (I) random forest classifiers (RCF), (II) regression binomial model (RBM), (III) decisional tree (DT), and (IV) similarity profiling (SP). RFC predicted metastatic/non-metastatic lymph nodes with an accuracy of 93.3% and a negative predictive value of 97.1%. DT identified four specific signatures correlated with the risk of metastases and the point risk of each signature was 100%, 81%, 16% and 4%, respectively. The Morphonode Predictive Model could be easily integrated into the clinical routine for preoperative stratification of vulvar cancer patients.

Transvaginal ultrasound-guided biopsy in patients with suspicious primary advanced tubo-ovarian carcinoma.

OBJECTIVE: To assess the accuracy of pathological diagnosis by transvaginal ultrasound-guided biopsy versus surgery in patients with suspicious primary advanced tubo-ovarian carcinoma. The Feasibility, adequacy, and safety of the procedure were also evaluated. METHODS: Consecutive women with pre-operative suspicious primary advanced tubo-ovarian carcinoma presenting between July 2019 and September 2021 were enrolled. Accuracy was calculated including only cases who underwent surgery. Feasibility was defined as the number of cases in which ultrasound-guided biopsy was possible according to tumor characteristics (morphology and site). Adequacy was defined as the number of conclusive diagnoses out of the samples collected. Safety was defined by the number of major complications which were defined as hospitalization, surgery, and/or blood transfusion. RESULTS: A total of 278 patients were eligible for the study; 158 were enrolled, while 120 were excluded for logistic reasons or patient refusal. Ultrasound-guided biopsy was not feasible in 30 (19%) patients. The samples obtained in the remaining 128 patients were all adequate (100%), and no major complications were noted. A total of 26 (20%) patients started neoadjuvant chemotherapy on the basis of the diagnosis obtained by ultrasound, whereas 102 (80%) patients underwent surgery. Accuracy of ultrasound-guided biopsy versus surgery was 94% (96/102), with six false negative cases at ultrasound (6%). Site (prevesical peritoneum) and size (<8 mm) of the nodules resulted as major predictive factors for ultrasound-guided biopsy failure (false negative). Ultrasound-guided biopsy correctly identified 86 primary invasive tubo-ovarian carcinomas and 10 metastatic tumors. CONCLUSION: Ultrasound-guided biopsy is a feasible, safe, and accurate method to provide histological diagnosis in suspicious advanced tubo-ovarian cancer patients.

The impact of hysterectomy on oncological outcomes in postmenopausal patients with borderline ovarian tumors: A multicenter retrospective study.

Data about the oncological outcomes in women with borderline ovarian tumor (BOT) undergoing uterine-sparing surgery without ovarian preservation are poor. We aimed to assess the oncological outcomes in women with BOT undergoing uterine-sparing surgery without ovarian preservation. A multi-center observational retrospective cohort study was performed including all consecutive postmenopausal patients who underwent surgical treatment for BOT at three tertiary level referral centers for gynecologic oncology from January 2005 to December 2016. Patients were divided into two groups for comparisons: patients undergoing hysterectomy (hysterectomy group) and patients undergoing uterine-sparing surgery (no hysterectomy group). Study outcomes were disease-free survival (DFS), overall survival (OS), disease-specific survival (DSS) and surgical complications rate. Ninety-eight patients were included: 44 in the hysterectomy group and 54 in the no hysterectomy group. The 5- and 10-year DFS rates were 97.7% (95% CI: 84.9-99.7) and 92.3% (95% CI: 69.7-98.2), in the hysterectomy group, and 86.8% (95% CI: 74.3-93.5) and 86.8% (95% CI: 74.3-93.5), in the no hysterectomy group, respectively, without significant differences (p=0.16). Hazard ratio for DFS was 0.26 (95% CI: 0.06-1.68) for the hysterectomy group. The 5- and 10-year OS rates were 100.0% (95% CI: -) and 100.0% (95% CI: -), in the hysterectomy group, and 98.2% (95% CI: 87.6-99.7) and 94.4% (95% CI: 77.7-98.7), in the no hysterectomy group, respectively, without significant differences (p=0.23). No significant difference in complication rate was reported among the groups (p=0.48). As hysterectomy appears to not impact survival outcomes of women with BOT, it might be avoided in the surgical staging.

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.

A Laparoscopic Adjusted Model Able to Predict the Risk of Intraoperative Capsule Rupture in Early-stage Ovarian Cancer: Laparoscopic Ovarian Cancer Spillage Score (LOChneSS Study).

STUDY OBJECTIVE: To identify preoperative/intraoperative patient and tumor characteristics associated with an increased risk of tumor spillage during minimally invasive surgery (MIS) for early-stage ovarian cancer (OC). The secondary end point was to develop a score system able to estimate the risk of tumor rupture during MIS. DESIGN: Retrospective observational study. SETTING: Patients with International Federation of Gynecology and Obstetrics stage I OC. PATIENTS: Patients aged ≥18 years old, with International Federation of Gynecology and Obstetrics stage IA to IC1 OC of any histology. INTERVENTIONS: Preoperative and intraoperative characteristics of patients treated with MIS for early-stage OC at Policlinico Universitario Agostino Gemelli, IRCCS in Rome, Italy, from January 1, 2001, to December 31, 2017, were collected. MEASUREMENTS AND MAIN RESULTS: A total of 151 patients were included. Previous pelvic surgery was more represented in patients with nonruptured tumors (46.0% vs 63.4%; p = .042). In addition, a larger tumor diameter (p <.001), a higher body mass index (p = .032), ultrasound characteristics (p = .029), and adhesions to large bowel (14% vs 2.0%; p = .003), uterus (44% vs 6.9%; p <.001), contralateral ovary (8.0% vs 0%; p = .004), ovarian fossa (64% vs 14.9%; p <.001), and pouch of Douglas peritoneum (32% vs 4.0%; p <.001) increased rupture rate. At multivariate analysis, a larger tumor diameter (p <.001) and adhesions to ovarian fossa peritoneum (p = .007) were independently associated with intraoperative cancer spillage and included in the score calculation. A disease-free survival (DFS) difference between the rupture group and the no-rupture group was detected (5-year DFS, 74.9% vs 94.4%; p = .011), with superimposable overall survival (5-year overall survival, 91.2% vs 97.9%; p = .089). CONCLUSION: Some preoperative/intraoperative characteristics increase the risk of tumor rupture during MIS for early-stage OC. A laparoscopic predictive model of capsule disruption could be considered to intraoperatively tailor surgical approach to prevent tumor spillage and avoid affecting patient's DFS.

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.

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).

Clinical and ultrasound characteristics of vaginal lesions.

OBJECTIVE: Ultrasound examination represents the most important diagnostic method to preoperatively assess gynecological diseases. However, the ultrasound characteristics of vaginal pathologies are poorly investigated. The aim of this study was to describe the clinical and ultrasound characteristics of vaginal lesions detected at ultrasound. METHODS: This was a single center, prospective, observational study including patients with vaginal masses examined from January 2017 to May 2019. Morphologic sonographic characteristics of the lesions were described as unilocular, multilocular, unilocular-solid, multilocular-solid, and solid. For the analysis, patients were grouped into a 'malignant group', including patients with confirmed malignancy at final histology, and a 'benign group', including patients with a confirmed benign pathology at final histology and patients without a histological diagnosis but with a lesion that manifested no changes during follow-up. RESULTS: 44 patients were enrolled. 22 (50%) of 44 lesions were benign: 12 (54.5%) of these underwent ultrasound follow-up and did not show any changes at the 12 month follow-up whereas 10 (45.5%) lesions had surgical excision which confirmed the benign nature. The remaining 22 (50%) of 44 lesions underwent surgery because of suspicion of malignancy: histology confirmed a malignancy in 20 (90.9%) of 22 cases. Benign lesions were described as follow: 11/24 (45.8%) unilocular, 3/24 (12.5%) multilocular with two locules, and 10/24 (41.7%) solid lesions. Malignant lesions were solid in 19/20 (95%) cases and multilocular-solid in 1/20 (5%). Most benign lesions had a color score of 1-2 (20/24, 83.4%) while malignant lesions had a color score of 3-4 (18/20, 90%). CONCLUSION: A typical ultrasound image of a benign lesion was a unilocular cyst or hypoechoic solid mass with no or minimal vascularization on color Doppler examination. Malignant vaginal lesions were hypoechoic solid tumors with irregular margins and moderate/rich vascularization or multilocular-solid. Ultrasound should be used to supplement the clinician in the management of vaginal lesions.

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.

Ultrasound features and clinical outcome of patients with malignant ovarian masses diagnosed during pregnancy: experience of a gynecological oncology ultrasound center.

OBJECTIVE: The number of women diagnosed with ovarian masses during pregnancy has increased in recent years and the management of these women can be controversial. We aim to describe ultrasound characteristics and clinical outcomes of patients with malignant ovarian masses diagnosed during pregnancy. METHODS: Patients with a histological diagnosis of malignant ovarian mass detected during pregnancy who underwent pre-operative ultrasound by experienced ultrasound examiners between December 2000 and November 2017 were included in this retrospective observational study. Ultrasound characteristics of the masses were described using International Ovarian Tumor Analysis terminology. Patients with ovarian masses but without histopathological reports were excluded. Results are presented as absolute frequency (percentage) for nominal variables and as median (range) for continuous variables. Results A total of 22 patients were included in the analysis. The median age was 32.5 (range 23-42) years and median gestational age at diagnosis was 13.5 (range 4-30) weeks. Eight (36.4%) patients had a serous/endocervical-type borderline tumor, seven (31.8%) patients had a primary epithelial ovarian carcinoma, five (22.8%) patients had a metastatic tumor to the ovary, and two (9%) patients had a mucinous borderline tumor. At ultrasound, mucinous borderline tumors were multilocular (1/2, 50%) or multilocular-solid (1/2, 50%) lesions. Serous/endocervical-type borderline tumors were unilocular-solid (3/8, 37.5%) or multilocular-solid (5/8, 62.5%) masses and all had papillary projections. Most invasive epithelial ovarian cancers were multilocular-solid masses (5/7, 71.4%). All metastatic tumors appeared as solid masses. No patients with borderline tumors had a cesarean section due to disease, whereas most patients with epithelial ovarian carcinomas (4/7, 57.2%) and with ovarian metastases (3/5, 60%) had a cesarean section due to disease. No neonatal complication was reported for patients with borderline tumors or epithelial ovarian carcinomas, whereas two of three newborns of patients with metastatic tumor died of the disease. CONCLUSION: At ultrasound, morphological features of malignant ovarian masses detected during pregnancy are similar to those described in non-pregnant patients. The likelihood of undergoing cesarean section increases with malignant disease in the ovary.

GestaTIonal TrophoblAstic NeoplasIa Ultrasound assessMent: TITANIUM study.

BACKGROUND: There are limited data on ultrasound morphologic features of gestational trophoblastic neoplasia. A predictive model to determine predictors of response to therapy would be ideal in the management of patients with this rare disease. PRIMARY OBJECTIVES AND STUDY HYPOTHESIS: TITANIUM is a prospective, multicenter, observational study aiming to describe ultrasound features of gestational trophoblastic neoplasia and to investigate the role of ultrasound in identifying patients at high risk of resistance to single-drug therapy. The study hypothesis is that ultrasound could improve the International Federation of Gynecology and Obstetrics (FIGO) scoring system for early identification of patients predisposed to single-drug resistance. TRIAL DESIGN AND MAJOR INCLUSION/EXCLUSION CRITERIA: Patients eligible have a diagnosis of gestational trophoblastic neoplasia according to FIGO or the criteria set by Charing Cross Hospital, London, UK. At diagnosis, patients are classified as low-risk (score 0-6) or high-risk (score >6) according to the FIGO risk scoring system, and a baseline ultrasound scan is performed. Patients receive treatment according to local protocol at each institution. Follow-up ultrasound examinations are performed at 1, 4, 10, 16, and 22 months after start of chemotherapy, and at each scan, serum human chorionic gonadotropin (hCG) level, and chemotherapy treatment, if any, are recorded. PRIMARY ENDPOINTS: Our aims are to define ultrasound features of gestational trophoblastic neoplasia and to develop a predictive model of resistance to single-drug therapy in low-risk patients. SAMPLE SIZE: The sample size was calculated assuming that 70% of patients with gestational trophoblastic neoplasia are at low risk, and estimating the rate of resistance to single-drug therapy in this group to be 40%. Assuming a dropout rate of 10%, we should recruit at least 120 patients. With this sample size, we can attempt to create a mathematical model with three variables (either two ultrasound parameters in addition to the risk score or three ultrasound variables statistically significant at univariate analysis) to predict resistance to single-drug therapy in low-risk patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: The accrual started in February 2019. Additional referral centers for gestational trophoblastic disease, with similar ultrasound expertise, are welcome to participate in the study. Enrollment should be completed by December 2021, and analysis will be conducted in December 2023. TRIAL REGISTRATION: The study received the Ethical Committee approval of the Coordinator Center (Rome) in January 2019 (Protocol No. 0004668/19).

Role of ultrasound in advanced peritoneal malignancies.

INTRODUCTION: Ovarian cancer is the seventh most common cancer among women in the developed world, and most women with ovarian cancer are diagnosed at an advanced stage of disease, when large intraperitoneal dissemination has already occurred. An accurate preoperative assessment of the tumor dissemination is pivotal for adequate counseling among risks and benefits of an aggressive surgical procedure, often required to achieve a complete cytoreduction. When performed by an experienced sonographer, ultrasound has an invaluable role in the primary diagnosis of gynecological cancer, in the assessment of tumor extent in the pelvis and abdominal cavity; however, there is a paucity of data on its use in the evaluation of the extent of disease of such patients. EVIDENCE ACQUISITION: The search retrieved 208 articles in the best matching results list. Selection by abstract and full-text, yielded 15 publications that contained information on the role of ultrasound examination in the assessment of diffused peritoneal malignancies. EVIDENCE SYNTHESIS: Sonographic appearance of metastatic nodules in peritoneum and omentum were firstly analyzed in preliminar descriptive studies, together with a systematic method to scan the abdomen and pelvis in in the staging of diffused gynecological malignancies. To date, three prospective studies mainly focused on the specific role of ultrasound (without comparison with other imaging modalities) in the evaluation of intra-abdominal tumor extension in ovarian cancer patients. In these studies, authors were in agreement to conclude that ultrasound has a very reliable role in the staging of ovarian cancer. In particular, ultrasound examination showed a high sensitivity (range 81.4-91%) and specificity (range 88-96%) in the diagnosis of peritoneal carcinomatosis, as well as in omental involvement (sense 67-94%, specificity 90%). In a recent prospective study ultrasound shows similar accuracy of CT scan in the staging of ovarian cancer patients (71% vs. 75%) when compared with surgical results. CONCLUSIONS: Even if ultrasound is a largely diffuse and practice imaging technique, there is a paucity of data in literature on its use in the evaluation of the extent of disease in ovarian cancer patiens. Nevertheless, this review has demonstrated that ultrasound has a high accuracy in staging advanced ovarian cancer patients. In certain settings, ultrasound has already replaced CT scan in the pre-operative evaluation of pelvic and abdominal disease. Finally, ultrasound allows to perform a biopsy in patients with peritoneal carcinomatosis obtaining an adequate specimen for histologic diagnosis.

EROS study: evaluation between high-dose-rate and low-dose-rate vaginal interventional radiotherapy (brachytherapy) in terms of overall survival and rate of stenosis.

PURPOSE: To compare the survival and toxicity outcomes in patients with endometrial cancer treated with either high-dose-rate (HDR) or low-dose-rate (LDR) vaginal brachytherapy (VBT) following external beam radiotherapy (EBRT). MATERIAL AND METHODS: From January 2000 to December 2014, patients with endometrial cancer after radical hysterectomy with/without pelvic and/or para-aortic lymphadenectomy were treated with adjuvant EBRT (45 Gy, 1.8 Gy/day to the whole pelvis) and subsequent VBT boost (HDR dose of 7 Gy in one fraction or LDR VBT dose of 25 Gy). The dose was prescribed at 0.5 cm from the surface of the applicator and the proximal half to two-thirds of the vagina was irradiated. The outcomes of patients were evaluated in terms of local control (LC), overall survival (OS), and rates of adverse events. RESULTS: We analyzed data of 200 patients treated with EBRT followed by HDR VBT boost in 78 patients and LDR VBT boost in 122 patients. With a median follow-up of 25 months (range, 6-163), 5-year OS was 98% and 97% in the LDR and HDR groups, respectively (p = 0.37). The 5-year LC was similar (93% in both groups) (p = 0.81). In multivariate analyses, none of the factors assessed (age, stage, grade) impacted OS (p = 0.37) or LC (p = 0.81). Patients treated with LDR VBT after EBRT had higher rates of acute gastrointestinal toxicity. No differences were found in acute genitourinary or hematological toxicities. Late toxicity such as vaginal stenosis was registered during regular follow-up visits and was similar in the two groups (p = 0.67). CONCLUSIONS: In our analysis, there were no differences in terms of OS and late toxicity outcomes for patients receiving LDR or HDR VBT. HDR VBT is a safe technique in comparison to LDR VBT.

Endometrial cancer off-line staging using two-dimensional transvaginal ultrasound and three-dimensional volume contrast imaging: Intermethod agreement, interrater reliability and diagnostic accuracy.

OBJECTIVES: The aim is to estimate agreement between two-dimensional transvaginal ultrasound (2D-TVS) and three-dimensional volume contrast imaging (3D-VCI) in diagnosing deep myometrial invasion (MI) and cervical stromal involvement (CSI) of endometrial cancer and to compare the two methods regarding inter-rater reliability and diagnostic accuracy. METHODS: Fifteen ultrasound experts assessed off-line de-identified 3D-VCI volumes and 2D-TVU video clips from 58 patients with biopsy-confirmed endometrial cancer regarding the presence of deep (≥50%) MI and CSI. Video clips and 3D volumes were assessed independently. Interrater reliability was measured using kappa statistics. Histological diagnosis after hysterectomy served as gold standard. Accuracy measurements were correlated to rater experience using Spearman's rank correlation coefficient (ρ). RESULTS: Agreement between 2D-TVU and 3D-VCI for diagnosing MI was median 76% (range 64-93%) and for CSI median 88% (range 79-97%). Interrater reliability was better for 2D-TVU than for 3D-VCI (Fleiss' kappa 0.41 vs. 0.31 for MI and 0.55 vs. 0.45 for CSI). Median accuracy for diagnosing deep MI was 76% (range 59-84%) with 2D-TVU and 69% (range 52-83%) for 3D-VCI; the corresponding figures for CSI were 88% (range 81-93%) and 86% (range 72-95%). Accuracy was significantly correlated to how many cases the raters assessed annually. CONCLUSIONS: Off-line assessment of MI and CSI in women with endometrial cancer using 3D-VCI has lower interrater reliability and lower accuracy than 2D-TVU video clip assessment. Since accuracy was correlated to the number of cases assessed annually it is advised to centralize these examinations to high-volume centres.