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

2020 ◽  
pp. ijgc-2020-001606
Author(s):  
Maria Cristina Moruzzi ◽  
Giulia Bolomini ◽  
Francesca Moro ◽  
Floriana Mascilini ◽  
Silvia Ficarelli ◽  
...  

BackgroundA 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 objectiveTo 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 hypothesisWhen performed by expert examiners, ultrasound can be an accurate technique to assess tumor spread in ovarian cancer and therefore to predict surgical resectability.Trial designThis 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 criteriaEligible 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 endpointsSensitivity 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 size240 patients.Estimate dates for completing accrual and presenting resultsThe accrual started in January 2019. Enrollment should be completed approximately by October 2020 and the results will be analyzed by December 2020.Trial registrationThe study received the Ethical Committee approval on July 19 2018 (Protocol 28967/18 ID:2172).

2016 ◽  
Vol 15 (4) ◽  
pp. 26-32
Author(s):  
N. V. Vyatkina ◽  
I. G. Frolova ◽  
L. A. Kolomiets ◽  
S. V. Molchanov ◽  
A. B. Villert

Diagnostics ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. 85
Author(s):  
Maciej Stukan ◽  
Antonio Bugalho ◽  
Amanika Kumar ◽  
Julita Kowalewska ◽  
Dariusz Świetlik ◽  
...  

A detailed transabdominal and transvaginal ultrasound examination, performed by an expert examiner, could render a similar diagnostic performance to computed tomography for assessing pelvic/abdominal tumor spread disease in women with epithelial ovarian cancer (EOC). This study aimed to describe and assess the feasibility of lung and intercostal upper abdomen ultrasonography as pretreatment imaging of EOC metastases of supradiaphragmatic and subdiaphragmatic areas. A preoperative ultrasound examination of consecutive patients suspected of having EOC was prospectively performed using transvaginal, transabdominal, and intercostal lung and upper abdomen ultrasonography. A surgical-pathological examination was the reference standard to ultrasonography. Among 77 patients with histologically proven EOC, supradiaphragmatic disease was detected in 13 cases: pleural effusions on the right (n = 12) and left (n = 8) sides, nodular lesions on diaphragmatic pleura (n = 9), focal lesion in lung parenchyma (n = 1), and enlarged cardiophrenic lymph nodes (n = 1). Performance (described with area under the curve) of combined transabdominal and intercostal upper abdomen ultrasonography for subdiaphragmatic areas (n = 77) included the right and left diaphragm peritoneum (0.754 and 0.575 respectively), spleen hilum (0.924), hepatic hilum (0.701), and liver and spleen parenchyma (0.993 and 1.0 respectively). It was not possible to evaluate the performance of lung ultrasonography for supradiaphragmatic disease because only some patients had this region surgically explored. Preoperative lung and intercostal upper abdomen ultrasonography performed in patients with EOC can add valuable information for supradiaphragmatic and subdiaphragmatic regions. A reliable reference standard to test method performance is an area of future research. A multidisciplinary approach to ovarian cancer utilizing lung ultrasonography may assist in clinical decision-making.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13029-13029
Author(s):  
E. Gallerani ◽  
S. Cresta ◽  
D. Tosi ◽  
C. Sessa ◽  
G. Capri ◽  
...  

13029 Background: Proteasome inhibition blocks the chemotherapy-induced activation of NF-кB increasing chemosensitivity to anticancer agents due to increased apoptosis. NF-кB is frequently aberrantly activated in primary human carcinomas and over-expressed in aggressive breast cancer lines1 supporting the rationale for combining B with P. We designed a phase I-II and PD trial to determine the recommended dose (RD) of the B&P combination, to screen for antitumor activity in patients with potentially taxane-sensitive tumors, to search for drug-induced changes and to identify potential surrogate markers of drug activity and toxicity in peripheral blood mononuclear cells (PBMC). Methods: Eligibility included ECOG performance status < 2, neurotoxicity < 2 and adequate organ functions. Treatment was given Q21 days: B on days 1,4, 8 and 11 and P on days 1 and 8. PBMC for gene expression profiling have been collected on day 1 and 4 before and after therapy. RECIST for response was applied. Results: Twenty-nine patients (20 female, median age 60 yrs) were accrued and 25 are evaluable (breast cancer: 13, ovarian cancer: 7, prostate cancer 1, other 4) ; 16 pts were treated in 4 escalation levels and the RD defined respectively at 1.3 mg/m2/dose & 100 mg/m2/dose for B&P. Neurotoxicity was the main toxicity (G1 36%, G2 20% and 1 case G3) requiring treatment discontinuation in 2 pts at cy 6 & 7. Other toxicities (all grades) were nausea and vomiting (68%), diarrhea (56%, G3 12%), alopecia (52%), asthenia (36%, G2 4%), and myalgia (32%, G2 8%). Antitumor activity consisted of 3 PR in pts with ovarian cancer lasting respectively 14, 8+ and 16 wks; 2 PRs in pts with breast cancer (12+ wks,14+ wks) and 1 PR in a pt with prostate cancer. Conclusions: Thus far the regimen has acceptable toxicity with evidence of antitumor activity. The trial will continue until accrual of four additional patients as planned. Footnotes 1 Adams J Current Opin Oncol 2002, 14:628–634. [Table: see text]


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15070-15070
Author(s):  
M. Mokhlesuddin ◽  
P. S. Akhter ◽  
D. U. Ahmed ◽  
M. A. Khan ◽  
M. A. Rahman ◽  
...  

15070 Background: Docetaxel is an active agent in the treatment of recurrent advanced ovarian cancer. We conducted a multi-center phase II study to evaluate the response rate, toxicity and survival of docetaxel-cisplatin regimen as first-line treatment of advanced ovarian cancer in Bangladeshi population. Methods: Forty chemotherapy-naïve patients of advanced epithelial ovarian cancer were recruited between October 1999 to March 2002. Eligibility criteria included stage Ic-IV patients, age 18–75 years, an ECOG performance status of 0–3 with adequate hepatic, renal and bone marrow function. Docetaxel 60 mg/m2 as 1 hour IV infusion and cisplatin 75 mg/m2 were given on day 1 every 3 weeks for a maximum of 6 cycles (average 5 cycles). Tumor responses and toxicities were evaluated by relevant investigations and survival was documented. Results: A total of 40 patients were enrolled. Median age was 44 years (age range 18–75 years). All the patients were evaluable for response. Overall response was observed in 32 patients (80%) with complete response rate 38% (12 patients), partial response rate 62% (20 patients). Stable disease was seen in 5 patients (12.5%) and progressive disease was in 3 patients (7.5%).Two years survival was documented in 62% patients. Toxicities were limited with grade 3 neutropenia in 10 patients (25%) and some non-hematological toxicities (including nausea, vomiting and fluid retention) in twenty-six patients (65%). No severe febrile neutropenia and no events of death were observed. Conclusions: The combination of docetaxel and cisplatin appears to be effective with manageable toxicities in patients with advanced epithelial ovarian cancer in Bangladeshi population. No significant financial relationships to disclose.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 16021-16021 ◽  
Author(s):  
J. Beaumont ◽  
S. Yount ◽  
D. Lalla ◽  
D. Lubeck ◽  
M. Derynck ◽  
...  

16021 Background: The FOSI is a very brief(8-item) index derived from the FACT-O to measure symptom response to treatment for ovarian cancer(OC). We evaluated its performance in a single arm Phase II clinical trial. Methods: The FOSI was administered to patients with advanced OC participating in a single arm Ph II clinical trial of pertuzumab(Gordon et al, JCO (2006) v24:4324;2006)). Pertuzumab, a humanized HER2 antibody is the first in a new class of investigational agents known as HER dimerization inhibitors(HDIs). Patients completed the FOSI at D1 of each 3 week cycle, up to 17 cycles. Validation analyses focused on data from the first 4 cycles and included Cronbach's alpha coefficients plus cross-sectional and longitudinal comparisons of groups defined by ECOG performance status (PS). Results: 62 patients completed the FOSI at baseline (B), 54 at cycle 2, 44 at cycle 3 and 27 at cycle 4. The FOSI showed acceptable internal consistency reliability with alphas of 0.73 to 0.80. The FOSI differentiated patients with PS 0 from those with PS =1 at each cycle (Table). There was a difference in FOSI scores in patients with worsened PS from those whose PS improved or was unchanged at cycle 2 only (p<0.001). The ES (mean change/ SD of change scores) for the group with worsened PS was -0.77. The minimally important difference was estimated to be 2–3 points. Conclusions: The FOSI is a valid symptom measure in this population of OC patients, demonstrating acceptable reliability, validity and responsiveness to clinical change. [Table: see text] No significant financial relationships to disclose.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS5613-TPS5613 ◽  
Author(s):  
R. Wendel Naumann ◽  
Lucy Gilbert ◽  
Anthonette M. Miller ◽  
Hong Ma ◽  
Sharad A. Ghamande ◽  
...  

TPS5613 Background: Folate receptor (FR) is expressed on the majority of epithelial ovarian cancers and FR expression appears to be a negative prognostic factor in this setting. Vintafolide (EC145) is a folate-conjugate designed to selectively deliver desacetylvinblastine monohydrazide (DAVLBH) to FR-expressing cells. 99mTc-Etarfolatide (EC20) is a technetium-labeled folate that identifies FR-expressing tumors. In a phase 2 study comparing vintafolide + PLD with PLD alone, the combination demonstrated a statistically and clinically significant delay in PFS (5.0 months) compared with PLD alone (2.7 months) in women with platinum-resistant ovarian cancer (Naumann et al, ASCO 2011). Data also indicated that 99mTc-etarfolatide may have utility for selecting patients most likely to benefit from vintafolide therapy. Methods: This is an international, randomized, double-blind, placebo-controlled phase 3 study of PLD ± vintafolide therapy compared in patients with primary or secondary platinum-resistant ovarian cancer (NCT01170650). Key eligibility criteria include: ≥18 years, pathology-confirmed epithelial ovarian, fallopian tube or primary peritoneal carcinoma, prior platinum-based chemotherapy, a RECIST v1.1 measureable lesion, and ECOG performance status 0 or 1. At baseline, patients undergo 99mTc-Etarfolatide imaging to identify FR-positive lesions and are subsequently randomized to the vintafolide ± PLD. PLD (50 mg/m2) adjusted for Ideal Body weight is administered on day 1 of a 4-week cycle and treatment continues until the maximum allowable cumulative dose (550 mg/m2) is reached or until disease progression or intolerable toxicity. Vintafolide (2.5 mg) or placebo is administered on days 1, 3, 5, 15, 17, and 19 of a 4-week cycle and treatment can continue for up to 20 cycles or until unacceptable toxicity or disease progression. The primary objective is to assess PFS based on investigator assessment (RECIST v1.1) in FR positive patients. Secondary objectives include OS, safety/tolerability, overall response rate, and disease control rate. Enrollment to the study is currently ongoing. Clinical trial information: NCT01170650.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16564-e16564
Author(s):  
P. Skowronek ◽  
M. Kuhberg ◽  
F. Chen ◽  
J. Schwarz ◽  
W. Lichtenegger ◽  
...  

e16564 Background: The purpose of this study was to examine an influence of poor nutritional status on surgical outcome in patients with ovarian cancer. Methods: Data from 152 consecutive patients with histologically confirmed ovarian cancer were prospectively analyzed. Overall 79 suffered from primary and 73 from recurrent disease. All patients received a systematic nutritional assessment prior to cytoreductive surgery and postoperative all complications were analyzed in detail. The Nutritional Risk Score (NRS-2002) was used to identify patients at high nutritional risk (NRS≥3). Intraoperatively, a standardized documentation script (IMO) was applied including tumor localization, surgical interventions, and postoperative residual tumor mass. Results: 29 patients (19%) were classified as malnourished, including 19 (24%) with primary and 10 (14%) with recurrent disease. These patients showed a significantly poorer performance status preoperatively compared to patients with NRS<3 (p < 0.05), which was assessed according to the American Society of Anesthesiologists (ASA). Also an intra-operatively documented tumor spread was significantly more extended in group with NRS≥3 than among patients with NRS<3 (p < 0.05). In malnourished patients complete resection rate was significantly decreased (31% vs. 69%, p < 0.001) and they required more often a colo- or ileostoma (17% vs. 6%, p = 0.041). Malnourished patients suffered more often from post-operative complications (62% vs. 37%, p < 0.05), especially infectious like pneumonia or sepsis. All postoperative mortality events (3 cases) occurred in the malnourished group. Conclusions: Malnourished ovarian cancer patients have significantly more often post-operative complications. They suffer from more extended tumor spread and were less frequently postoperatively tumor-free. Based on our results further prospective trials of preoperative nutritional therapy to improve surgical outcome are warranted. No significant financial relationships to disclose.


2019 ◽  
Vol 29 (2) ◽  
pp. 227-233 ◽  
Author(s):  
Juan Luis Alcázar ◽  
María Caparros ◽  
Maria Arraiza ◽  
José Ángel Mínguez ◽  
Stefano Guerriero ◽  
...  

ObjectiveTo compare the diagnostic performance of ultrasound and computed tomography (CT) for detecting pelvic and abdominal tumor spread in women with epithelial ovarian cancer.MethodsAn observational cohort study of 93 patients (mean age 57.6 years) with an ultrasound diagnosis of adnexal mass suspected of malignancy and confirmed histologically as epithelial ovarian cancer was undertaken. In all cases, transvaginal and transabdominal ultrasound as well as CT scans were performed to assess the extent of the disease within the pelvis and abdomen prior to surgery. The exploration was systematic, analyzing 12 anatomical areas. All patients underwent surgical staging and/or cytoreductive surgery with an initial laparoscopy for assessing resectability. The surgical and pathological findings were considered as the 'reference standard'. Sensitivity and specificity of ultrasound and CT scanning were calculated for the different anatomical areas and compared using the McNemar test. Agreement between ultrasound and CT staging and the surgical stage was estimated using the weighted kappa index.ResultsThe tumorous stage was International Federation of Gynecology and Obstetrics (FIGO) stage I in 26 cases, stage II in 11 cases, stage III in 47 cases, and stage IV in nine cases. Excluding stages I and IIA cases (n=30), R0 (no macroscopic residual disease) was achieved in 36 women (62.2%), R1 (macroscopic residual disease <1 cm) was achieved in 13 women (25.0%), and R2 (macroscopic residual disease >1 cm) debulking surgery occurred in three women (5.8%). Eleven patients (11.8%) were considered not suitable for optimal debulking surgery during laparoscopic assessment. Overall sensitivity of ultrasound and CT for detecting disease was 70.3% and 60.1%, respectively, and specificity was 97.8% and 93.7%, respectively. The agreement between radiological stage and surgical stage for ultrasound (kappa index 0.69) and CT (kappa index 0.70) was good for both techniques. Overall accuracy to determine tumor stage was 71% for ultrasound and 75% for CT.ConclusionDetailed ultrasound examination renders a similar diagnostic performance to CT for assessing pelvic/abdominal tumor spread in women with epithelial ovarian cancer.


2021 ◽  
Vol 12 (2) ◽  
pp. 278-282
Author(s):  
Francesca Arezzo ◽  
Gerardo Cazzato ◽  
Vera Loizzi ◽  
Giuseppe Ingravallo ◽  
Leonardo Resta ◽  
...  

Peritoneal tuberculosis (TBP) is a very rare condition, accounting for about 1–2% of all tuberculosis cases. The diagnosis of TBP can be easily mistaken for advanced ovarian cancer (AOC) or peritoneal carcinoma because of overlapping laboratory and clinical findings. We reported the ultrasound characteristics of a case of TBP in a 67-year-old woman who presented to our institute with a 1-month history of intermittent lower abdominal pain, fever, and asthenia. Overall, 20 biopsy-retrieved specimen histopathological features were suggestive of peritoneal tuberculosis. Gynecologic ultrasound revealed increased adnexa with multiple nodular formations spread across the surface, suggestive of caseous nodules. Although this is a rare occurrence, clinicians should consider TBP as a differential diagnosis of ovarian or peritoneal cancer.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4225-4225
Author(s):  
Matthew Painschab ◽  
Kate Westmoreland ◽  
Edwards Kasonkanji ◽  
Takondwa Zuze ◽  
Bongani Kaimila ◽  
...  

Abstract INTRODUCTION: Burkitt lymphoma (BL) is the most common pediatric cancer in sub-Saharan Africa (SSA), and also occurs frequently in adolescents and adults, often associated with human immunodeficiency virus (HIV). BL is highly curable in high-income countries, but outcomes are worse for children in SSA due to advanced disease and inability to achieve cytotoxic intensity comparable to high-income countries. Moreover, unlike pediatric BL, there are few high-quality prospective studies describing non-pediatric BL in SSA. METHODS: We prospectively enrolled patients with newly diagnosed BL from 2013 to 2018 in Malawi, a low-income country in SSA, and restricted analyses to patients aged ≥15 years. Diagnoses were confirmed using local performed immunohistochemistry, real-time telepathology, and subsequent secondary review in the United States. Participants received standardized treatment according to local pediatric or adult standards of care, with concurrent antiretroviral therapy (ART) if HIV+. RESULTS: 36 patients ≥15 years with BL were enrolled, with median age 21 years (range 15-61), and 44% being HIV+. Five (14%) participants were over 40 years of age. At diagnosis, 23 (64%) participants presented with abdominal disease, 5 (14%) had CNS disease, and 5/23 (22%) had bone marrow involvement. 25 (69%) participants had B symptoms, 27 (75%) had stage 3/4 disease, and 19 (56%) had ECOG performance status >1. Among 16 HIV+ participants, 9 (56%) were aware of their HIV diagnosis for a median of 1.4 years (range 0.4-9.4) prior to BL diagnosis, and 8 (50%) were on ART for a median of 1.1 years (range 0.4-2.6). Among all HIV+ BL patients, median CD4 count was 134 (range 29-2235), and 8 (50%) had HIV VL <400 copies/mL. Four patients (11%) died before chemotherapy initiation. First-line chemotherapy consisted of bolus anthracycline-based chemotherapy (CHOP) in 25 (78%), infusional anthracycline-based chemotherapy (EPOCH) in four (12%), and high-dose methotrexate-based chemotherapy (COPADM) in two (6%). Only one participant received rituximab with CHOP as part of a clinical trial, since rituximab is not otherwise routinely available in Malawi. Participants received a median of 4 cycles of first-line chemotherapy (range 1-8). 14/29 (48%) evaluable participants achieved a complete response, 7 (24%) had a partial response and 8 (28%) were refractory. Median overall survival (OS) was 7 months and one-year OS was 36% (95% CI 20-52%). In a multivariate Cox proportional hazards model, death was associated with stage 3/4 disease (HR 6.3 [95% CI 1.4-27.2]; p=0.01) and ECOG performance status >1 (HR 7.4 [95% CI 1.5-35.1]; p=0.01) with a trend toward worse survival in HIV+ participants (HR 5.9 [95% CI 0.9-39.4]; p=0.07). There were no clear differences in outcome observed based on choice of first-line chemotherapy. Of 23 deaths during the follow-up period, six (26%) were classified as treatment-related. CONCLUSIONS: This is one of the best characterized prospective cohorts of non-pediatric BL in SSA, which occurred primarily among adolescents and young adults. Outcomes were worse than pediatric cohorts from the region, with most deaths due to progressive BL. This study highlights the need to develop effective treatments for non-pediatric BL with and without HIV in resource-limited settings, where high-intensity strategies from high-income countries may have limited applicability. Disclosures Fedoriw: ALEXION PHARMACEUTICALS: Consultancy, Honoraria.


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