Publications by authors named "Maria Teresa Giudice"

9 Publications

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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.

Int J Gynecol Cancer 2021 Feb 7;31(2):279-285. Epub 2020 Sep 7.

Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy.

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).
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http://dx.doi.org/10.1136/ijgc-2020-001606DOI Listing
February 2021

Value of pre-existent bacterial colonization in patients with advanced/relapsed ovarian neoplasms undergoing cytoreductive surgery: a multicenter observational study (BONSAI).

Int J Gynecol Cancer 2020 Oct 18;30(10):1562-1568. Epub 2020 Aug 18.

Istituto di Ginecologia e Ostetricia, Università Cattolica del Sacro Cuore, Rome, Italy.

Objective: As an increasing number of patients with advanced/relapsed ovarian cancer need extensive cytoreductive procedures, there is an increasing number of complex cases collected in accredited tertiary cancer centers. With nosocomial infections and bacterial colonizations being a significant challenge in these patient cohorts, we aimed to evaluate the risk such infections pose to surgical outcome.

Methods: Prospective assessment of pathological bacterial colonization (vaginal, umbilical/groin, intraperitoneal, urine, oral/nose cavity) in patients who underwent open cytoreductive surgery for advanced/relapsed ovarian cancer in two large European tertiary referral centers for gynecologic malignancies. We recruited patients at initial diagnosis with International Federation of Gynecology and Obstetrics (FIGO) stage III and IV ovarian cancer and patients undergoing surgery for relapse. Swabs or cultures were taken from the following sites: vagina, groin and/or umbilicus, urine, intraperitoneal, mouth and/or nose. Only evidence of pathogenic bacteria was considered positive for bacterial colonization.

Results: A total of 172 primary advanced (70.9%) or relapsed (29.1%) ovarian cancer patients were included; 63.4% of them had received chemotherapy±additional targeted agents (16.3%) by the time of cytoreduction. 39.5% of the patients had a long-term vascular access line in situ. A bowel resection was performed in 44.8% and a splenectomy in 16.3% of the patients. Predefined surgical morbidity and mortality were 22.3% and 0%, respectively. Forty-one patients (23.8%) screened positive for pathogenic bacterial colonization with the presence of long-term intravenous access as the only independent risk factor identified (OR 2.34; 95% CI 1.05 to 5.34; p=0.04). Type of systemic treatments, previous bowel resections, previous hospitalizations, and patient demographics did not appear to significantly impact the risk of bacterial colonization. Furthermore, pathogenic bacterial colonization was shown to have no significant effect on peri-operative infection-related complications such as abscesses, wound infection, pneumonia, relaparotomy, or anastomotic leak.

Conclusions: A total of 24% of patients undergoing cytoreductive surgery for ovarian cancer were confirmed positive for pathogenic bacterial colonization. The presence of long-term intravenous access was identified as the only significant risk factor for that, however the presence of pathogenic bacterial colonization per se did not seem to adversely affect outcome of cytoreductive effort or increase perioperative infection related complications.
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http://dx.doi.org/10.1136/ijgc-2020-001475DOI Listing
October 2020

The role of robotic aortic lymphadenectomy in gynecological cancer: surgical and oncological outcome in a single institution experience.

J Surg Oncol 2019 Mar 16;119(3):355-360. Epub 2018 Dec 16.

Division of Gynecologic Oncology, Department of Women's and Children's Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Background And Objective: This study aims to investigate the surgical outcomes observed in robotic transperitoneal aortic lymphadenectomy (AL) in gynecological cancer patients.

Methods: Retrospective data were collected and analyzed on 71 patients undergoing robotic surgical procedures for gynecological cancers, including transperitoneal AL, between December 2014 and February 2018 at the Catholic University of the Sacred Heart, Rome, Italy.

Results: Median age of the sample population was 50 years (range, 26-76 years). The median operative time was 210 minutes (range, 75-480 minutes), the median estimated blood loss was 50 ml (range, 20-300 ml). The number of para-aortic nodes removed was 12 (range, 7-43). In the whole series, 13 patients (18.3%) had at least one metastatic node. Overall, 10 patients (14.1%) experienced any grade early postoperative complications. Three patients experienced more than one complication. Three intraoperative complications occurred with two cases of vascular injury. Conversion to laparotomy was necessary for one patient (1.4%).

Conclusions: The present study shows the safety and adequacy of robotic transperitoneal AL as surgical staging step for gynecological cancers in terms of perioperative and postoperative outcomes.
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http://dx.doi.org/10.1002/jso.25335DOI Listing
March 2019

Secondary cytoreduction in ovarian cancer: who really benefits?

Arch Gynecol Obstet 2018 11 25;298(5):873-879. Epub 2018 Sep 25.

Gynecologic and Obstetric Clinic, Department of Clinical and Experimental Medicine, University of Sassari, Sassari, Italy.

Purpose: To identify women affected by recurrent ovarian cancer who benefit from secondary cytoreductive surgery (SCS), analyse their clinical and biological features and investigate the role of minimally invasive surgery (MIS) and hyperthermic intraperitoneal-based chemotherapy (HIPEC) in this subset of patients.

Methods: This narrative review examines the data available from the updated literature. An electronic literature search was conducted in PubMed Medline databases for articles published from 1990 to 2018.

Results: Retrospective studies and preliminary data from the AGO-Desktop III trial show that cytoreductive surgery is associated with improved post-relapse survival in patients with platinum-sensitive relapse, compared to chemotherapy alone. This benefit is more evident in patients treated with complete or optimal primary debulking surgery at referral centres, who did not receive bevacizumab in first-line chemotherapy, and who present a localized pattern of disease. MIS has been proven to be a favourable approach to achieve a complete secondary debulking, reducing peri- and postoperative comorbidities. The application of HIPEC to SCS is associated with an improvement in oncological outcomes by preliminary results.

Conclusions: While waiting for the final results of the ongoing randomized controlled trials, SCS seems feasible and safe in selected patients with recurrent ovarian cancer. Recently, more attention has been focused on the biological features of ovarian tumours, such as BRCA status. Further studies and molecular research should be conducted to identify individualized and targeted therapies in the treatment of ovarian cancer recurrences.
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http://dx.doi.org/10.1007/s00404-018-4915-1DOI Listing
November 2018

Minimally invasive salvage lymphadenectomy in gynecological cancer patients: A single institution series.

Eur J Surg Oncol 2018 10 17;44(10):1568-1572. Epub 2018 Aug 17.

Division of Gynecologic Oncology, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy; Division of Gynecologic Oncology, Università Cattolica del Sacro Cuore, Rome, Italy.

Background: to assess the feasibility of minimally invasive surgery in the management of lymph-nodal recurrences of gynecological cancers, in terms of surgical and oncological outcomes.

Methods: we retrospectively collected patients with isolated lymph-nodal recurrent disease of gynecological malignancies who underwent to minimally invasive lymphadenectomy at Catholic University of the Sacred Hearth in Rome (Italy), from January 2013 to November 2017.

Results: Forty patients were considered eligible (31 LPS, 9 Robot); 24 (60.0%) with an ovarian cancer, 8 (20.0%) with a cervical cancer and 8 (20.0%) with an endometrial cancer recurrence. The most frequent site of lymph-nodal recurrence was represented by the aortic region (47.5%), while 18 patients (45.0%) experiencing pelvic lymph-nodal recurrence, 2 (5.0%) both pelvic and aortic relapse, and only 1 (2.5%) had an hepato-celiac lymph node recurrence. No patient required a laparotomic conversion. Median operative time was 220 min, median EBL was 80 mL, and median post-operative hospital stay was 2 days. There were 2 (5.0%) intra-operative and 4 (10.0%) post-operative complications, of which 2 were grade 3. The median follow-up was 22.5 months, and during this time 15 patients showed another relapse with a median time to progression of 12 months. Seven women died because of the disease. The 2-year post-relapse disease-free survival (PR-DFS) was 54.7%, and the 2-year post-relapse overall survival (PR-OS) was 79.3%.

Conclusions: In our experience minimally invasive surgery is a valid therapeutic approach in very select patients with localized lymph-nodal recurrence of gynecological cancers, with benefits about peri and post-operative morbidities and without compromising their oncological outcome.
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http://dx.doi.org/10.1016/j.ejso.2018.08.006DOI Listing
October 2018

Robotic Splenectomy for Isolated Splenic Recurrence of Endometrial Adenocarcinoma.

J Minim Invasive Gynecol 2018 Jul - Aug;25(5):774-775. Epub 2017 Nov 8.

Department of Women's and Children's Health, Catholic University of the Sacred Heart, Rome, Italy.

Study Objective: To demonstrate management of a rare case of an isolated intraparenchymal splenic metastasis of endometrial cancer with robotic-assisted surgery.

Design: Case report (Canadian Task Force Classification III).

Setting: A 55-year-old patient with a history of endometrial cancer was found to have a splenic lesion on a follow-up examination. She underwent surgical staging, involving total hysterectomy, bilateral salpingo-oopherectomy, pelvic lymphadenectomy, and peritoneal washing, in 2014, and the final pathological findings showed an endometrioid endometrial adenocarcinoma, International Federation of Gynecology and Obstetrics stage IB G2. Multidisciplinary counseling was provided, and the patient opted for strict medical surveillance. At 20 months after the primary treatment, the patient experienced a vaginal cuff recurrence and refused radiation therapy. She instead underwent robotic surgery, followed by 6 cycles of carboplatin 6 AUC and paclitaxel 175 mg/m. Seventeen months later, a positron emission tomography/computed tomography scan revealed a 3-cm intraparenchymal lesion of the spleen, and robotic splenectomy was scheduled. The Institutional Review Board approved this study.

Intervention: The operative time was 90 minutes, and blood loss was <50 mL. The operation was performed successfully, with no intraoperative and postoperative complications. Histopathological analysis showed a 3-cm intraparenchymal splenic lesion. The patient was discharged on day +2, and 46 days later started adjuvant chemotherapy based on carboplatin 6 AUC and doxorubicin (Caelyx) 30 mg/m. At a 2-month follow-up, the patient was disease-free and in good general condition.

Conclusion: This case demonstrates the successful robotic management of recurrent endometrial cancer.
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http://dx.doi.org/10.1016/j.jmig.2017.10.034DOI Listing
August 2019

Secondary Laparoscopic Cytoreduction in Recurrent Ovarian Cancer: A Large, Single-Institution Experience.

J Minim Invasive Gynecol 2018 May - Jun;25(4):644-650. Epub 2017 Nov 13.

Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy.

Study Objective: To analyze the feasibility and safety of laparoscopic secondary cytoreductive surgery in a retrospective series of patients with platinum-sensitive recurrent ovarian cancer.

Design: Retrospective cohort study (Canadian Task Force classification II-2).

Setting: Catholic University of the Sacred Heart, Rome, Italy.

Patients: Between October 2010 and October 2016, 58 patients with recurrent ovarian cancer were selected for a retrospective analysis of data.

Interventions: All patients underwent a laparoscopic secondary cytoreduction with single or multiple procedures.

Results: The most frequent pattern of recurrence was peritoneal (48.3%); 6 patients (10.3%) experienced parenchymal disease (spleen, n = 5; liver, n = 1), and 24 patients (41.4%) had lymph node recurrence. Complete debulking was achieved in all patients. The median operative time was 204 minutes (range, 55-448 minutes), median estimated blood loss was 70 mL (range, 20-300 mL), and the median length of hospital stay was 4 days (range, 1-21 days). Four patients (6.8%) experienced intraoperative complications. Early postoperative complications were documented in 6 patients (10.3%), but only 1 G3 complication was noted. The median duration of follow-up since secondary cytoreduction was 24 months (range, 9-71 months). Twenty-one patients (36.2%) experienced a second disease relapse. The median progression-free survival (PFS) was 28 months, and the 2-year PFS was 58.7%. Five patients died (8.6%); the 2-year overall survival was 90.7%.

Conclusions: For selected patients, laparoscopy is a feasible and safe approach to optimal cytoreduction for patients with recurrent ovarian cancer.
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http://dx.doi.org/10.1016/j.jmig.2017.10.024DOI Listing
May 2019

Tumor regression grades, K-RAS mutational profile and c-MET in colorectal liver metastases.

Pathol Res Pract 2017 Aug 21;213(8):1002-1009. Epub 2017 Apr 21.

Surgical and Medical Department of Traslational Medicine, University of Rome "La Sapienza", Sant'Andrea Hospital of Rome, Italy.

Introduction: Recently TRG, necrosis grade and the rate of viable cancer cells of colorectal liver metastases were correlated with the response to chemotherapy treatments, whereas K-RAS mutations and c-MET over-expression were correlated with the prognosis.

Methods: 58 resection specimens were assessed for regression grades. Patients undergone neo-adjuvant treatments were compared to patients who underwent therapy exclusively adjuvantly. We investigated the K-RAS mutational profile, the c-MET over-expression along with patients' survivals curves.

Results: Patients undergone neo-adjuvant treatment presented significant higher fibrosis rates and lower rates of viable cells. 36.7% of the patients had a K-RAS mutation and the 26.7% presented c-MET over-expression, but these features did not correlate with patients' clinical/pathological data. Survival analysis documented that K-RAS WT patients presenting c-MET over-expression had worse outcomes.

Conclusion: Fibrosis and the rate of viable cells significantly correlate with the response to chemotherapy treatments. c-MET is a promising marker in K-RAS WT patients.
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http://dx.doi.org/10.1016/j.prp.2017.04.013DOI Listing
August 2017

The interaction of native DNA with iron(III)- N ,N'-ethylene-bis(salicylideneiminato)-chloride.

J Inorg Biochem 2004 Apr;98(4):589-94

Dipartimento di Chimica Inorganica e Analitica "S Cannizzaro", Università di Palermo, Viale delle Scienze, Parco d'Orleans II, I-90128, Palermo, Italy.

The interaction between native calf thymus deoxyribonucleic acid (DNA) and Fe(III)- N ,N'-ethylene-bis (salicylideneiminato)-chloride, Fe(Salen)Cl, was investigated in aqueous solutions by UV-visible (UV-vis) absorption, circular dichroism (CD), thermal denaturation and viscosity measurements. The results obtained from CD, UV-vis and viscosity measurements exclude DNA intercalation and can be interpreted in terms of an electrostatic binding between the Fe(Salen)(+) cation and the phosphate groups of DNA. The trend of the UV-vis absorption band of the Fe(Salen)Cl complex at different ratios [DNA(phosphate)]/[Fe(Salen)Cl] and the large increase of the melting temperature of DNA in the presence of Fe(Salen)Cl, support the hypothesis of an external electrostatic interaction between the negatively charged DNA double helix and the axially stacked positively charged Fe(Salen)(+) moieties, analogously to what reported for a number of porphyrazines and metal-porphyrazine complexes interacting with DNA.
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http://dx.doi.org/10.1016/j.jinorgbio.2004.01.010DOI Listing
April 2004