Publications by authors named "Anna Fagotti"

241 Publications

The BRCA1 c.788G > T (NM_007294.4) variant in a high grade serous ovarian cancer (HGSOC) patient: foods for thought.

Mol Biol Rep 2021 Mar 3. Epub 2021 Mar 3.

Molecular and Genomic Diagnostics Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

In this report we described the case of a BRCA1/2 (BRCA) molecular testing performed on tumor sample in a High Grade Serous Ovarian Cancer (HGSOC) patient with two different Next Generation Tumor Sequencing (NGTS) pipelines. The two clinical reports leaded to apparently different BRCA status, providing important foods for thought. After NGTS, the gene sequencing information (i.e., reads) are aligned to the reference gene sequences obtained from public databases, in order to provide an uniform nomenclature for unambiguous variant designation. However, the criteria adopted for variant reporting in tissue test are not always univocal. Particularly, this is the case of rare and unclassified BRCA variants for which the molecular evaluation may be a relevant challenge. Here we described a BRCA1 unclassified variant that may be re-evaluated in the context of alternative BRCA1 transcripts due to its different biological effect. We underlined that an in-depth knowledge of BRCA testing is mandatory for its appropriate use.
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http://dx.doi.org/10.1007/s11033-021-06243-xDOI Listing
March 2021

Oncologic and obstetric outcomes after simple conization for fertility-sparing surgery in FIGO 2018 stage IB1 cervical cancer.

Int J Gynecol Cancer 2021 Mar;31(3):452-456

Department of Obstetrics and Gynecology, Gynaecologic Oncology Surgical Unit, ASST-Monza, San Gerardo Hospital, Monza, Italy.

Objective: Conization/simple trachelectomy is feasible in patients with early-stage cervical cancer. Retrospective data suggest that conization with negative lymph nodes could be a safe option for these patients. This study aims to provide oncologic and obstetric outcomes of a large series of patients with 2018 International Federation of Gynecology and Obstetrics (FIGO) stage IB1 cervical cancer managed by conization.

Methods: Patients with early cervical cancer and a desire to preserve fertility who underwent conization and pelvic lymphadenectomy from January 1993 to December 2019 in two Italian centers were included. Inclusion criteria were: age >18 years and ≤45 years, 2018 FIGO stage IB1, no prior irradiation or chemotherapy, absence of pre-operative radiologic evidence of nodal metastases, a strong desire to preserve fertility, and absence of concomitant malignancies. We excluded patients with confirmed infertility, neuroendocrine tumor, clear cell or mucinous carcinoma.

Results: A total of 42 patients were included. The median age was 32 years (range 19-44) and median tumor size was 11 mm (range 8-20). Squamous cell carcinoma was found in 27 (64.3%). Grade 3 tumor was present in 7 (16.7%) patients and lymphovascular space involvement was detected in 15 (35.7%). At a median follow-up of 54 months (range 1-185), all patients were alive without evidence of disease. In the entire series three patients experienced recurrence resulting in an overall recurrence rate of 7.1%. All the recurrences occurred in the pelvis (2 in the cervix and 1 in the lymph nodes), resulting in a 3-year disease-free survival of 91.6%. Twenty-two (52%) patients tried to conceive; 18 pregnancies occurred in 17 patients and 12 live births were reported (6 pre-term and 6 term pregnancies). Two miscarriages were recorded, one first trimester and one second trimester fetal loss.

Conclusions: Our study showed that conization is feasible for the conservative management of women with stage IB1 cervical cancer desiring fertility. Oncologic outcomes appear favorable in this series of patients. Future prospective studies will hopefully provide further insight into this important question.
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http://dx.doi.org/10.1136/ijgc-2020-001750DOI Listing
March 2021

Fertility preservation in patients with BRCA mutations or Lynch syndrome.

Int J Gynecol Cancer 2021 Mar;31(3):332-338

Istituto di Ostetricia e Ginecologia, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.

Guidelines and expert consensus are lacking on fertility preservation in BRCA mutation carriers and in patients with Lynch syndrome. The safety of fertility preservation in this setting is still a topic of debate and multiple factors need to be carefully considered. The aim of this review was to analyze the reproductive potential of women harboring a genetic mutation affecting the DNA repair system and explore the efficacy and safety of existing fertility preservation strategies in these patients.
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http://dx.doi.org/10.1136/ijgc-2020-002071DOI Listing
March 2021

Protective Role of Conization Before Radical Hysterectomy in Early-Stage Cervical Cancer: A Propensity-Score Matching Study.

Ann Surg Oncol 2021 Feb 23. Epub 2021 Feb 23.

Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, UOC Ginecologia Oncologica, IRCCS, Fondazione Policlinico Universitario A. Gemelli, Rome, Italy.

Purpose: The purpose of this study was to assess the prognostic role and the perioperative outcomes of conization performed before radical hysterectomy in early-stage cervical carcinoma.

Methods: This multicenter, retrospective observational cohort study included patients with FIGO 2009 stage IB1 cervical carcinoma treated with radical hysterectomy between June 2004 and June 2019. Patients were divided into two groups according to conization before radical surgery. One-to-one case-control matching was used to adjust the baseline characteristics.

Results: A total of 332 patients were included after propensity matching (166, 50% in each group). Twenty-four of 166 (14.4%) and 142 of 166 (85.6%) conization patients had negative and positive surgical margins on the conization specimen, respectively. No difference in intra- and postoperative complications was noted between the two groups (p = 0.542 and p = 0.180, respectively). Patients undergoing conization before radical hysterectomy received less adjuvant treatment (p < 0.001) and had a better 5-year disease-free survival (DFS) than patients who did not receive conization (89.8% vs. 80.0%, respectively; p = 0.010). No difference in 5-year overall survival (OS) (97.1% vs. 91.4%, respectively; p = 0.114) or recurrence pattern (p = 0.115) was reported between the two groups. Factors independently related to higher risk of recurrence were pathologic tumor diameter >20 mm and no conization before radical hysterectomy (p = 0.011 and p = 0.018, respectively). The only independent variable influencing OS was pathologic tumor diameter >20 mm (p = 0.020).

Conclusions: Conization before radical hysterectomy was associated with improved DFS and lower probability of receiving adjuvant treatment. No difference in perioperative complications and OS was evident. Tumor diameter >20 mm was found to be the only independent risk factor affecting OS in both groups.
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http://dx.doi.org/10.1245/s10434-021-09695-4DOI Listing
February 2021

ESGO/ESTRO/ESP Guidelines for the management of patients with endometrial carcinoma.

Virchows Arch 2021 Feb 19. Epub 2021 Feb 19.

Department of Pathology, Hospital Universitari Arnau de Vilanova, University of Lleida, CIBERONC, Irblleida, Spain.

A European consensus conference on endometrial carcinoma was held in 2014 to produce multidisciplinary evidence-based guidelines on selected questions. Given the large body of literature on the management of endometrial carcinoma published since 2014, the European Society of Gynaecological Oncology (ESGO), the European SocieTy for Radiotherapy & Oncology (ESTRO) and the European Society of Pathology (ESP) jointly decided to update these evidence-based guidelines and to cover new topics in order to improve the quality of care for women with endometrial carcinoma across Europe and worldwide. ESGO/ESTRO/ESP nominated an international multidisciplinary development group consisting of practicing clinicians and researchers who have demonstrated leadership and expertise in the care and research of endometrial carcinoma (27 experts across Europe). To ensure that the guidelines are evidence-based, the literature published since 2014, identified from a systematic search was reviewed and critically appraised. In the absence of any clear scientific evidence, judgment was based on the professional experience and consensus of the development group. The guidelines are thus based on the best available evidence and expert agreement. Prior to publication, the guidelines were reviewed by 191 independent international practitioners in cancer care delivery and patient representatives. The guidelines comprehensively cover endometrial carcinoma staging, definition of prognostic risk groups integrating molecular markers, pre- and intra-operative work-up, fertility preservation, management for early, advanced, metastatic, and recurrent disease and palliative treatment. Principles of radiotherapy and pathological evaluation are also defined.
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http://dx.doi.org/10.1007/s00428-020-03007-zDOI Listing
February 2021

Minimally invasive surgical staging for early stage ovarian cancer: A long-term follow up.

Eur J Surg Oncol 2021 Feb 5. Epub 2021 Feb 5.

Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy; Università Cattolica del Sacro Cuore Sede di Roma, Roma, Italy.

Introduction: The standard treatment for epithelial early stage ovarian cancer (eEOC) includes laparotomic surgical staging, according to ESGO-ESMO guidelines. In the last decade, many investigators have assessed the safety and feasibility of minimally invasive surgery (MIS) staging in properly selected patients. However, survival data related to different surgical approaches (open versus MIS) are extremely limited. The aim of this study is to analyze the long-term oncological outcomes in eEOC patients treated with MIS.

Materials And Methods: This is a multicenter observational retrospective study conducted in two tertiary oncological centers. We selected all consecutive women who underwent a laparoscopic or robotic staging for eEOC.

Results: From January 2008 to December 2016, 254 eEOC patients underwent a MIS staging (188 laparoscopic staging and 66 robotic staging). Overall, 18.1% of patients were upstaged due to pathological findings. A total of 203 (79.9%) patients received platinum-based adjuvant chemotherapy. After a median follow-up of 61 months (range 13-118), 39 (15.3%) patients experienced recurrence. The 5-years progression free survival (PFS) and overall survival rates were 84.0% and 93.8%, respectively. In the univariate analysis, favorable variables influencing PFS were young age (≤45 years), non-serous histotype, tumor grade 1-2, and FIGO stage IA/IB. In the multivariate analysis, only grade 3 was shown to keep its negative independent prognostic value (HR = 3.47; p = 0.004), whereas FIGO stage ≥ IC showed a trend toward significance (HR = 1.75; p = 0.099).

Conclusion: This retrospective study represents the longest follow-up of eEOC patients managed by MIS. The MIS is a valuable therapeutic option in appropriately selected patients, although a randomized controlled trial is needed.
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http://dx.doi.org/10.1016/j.ejso.2021.01.033DOI Listing
February 2021

Extreme complications related to bevacizumab use in the treatment of ovarian cancer: a case series from a III level referral centre and review of the literature.

Ann Transl Med 2020 Dec;8(24):1687

Division of Gynecologic Oncology, Gemelli-Molise, Università Cattolica del Sacro Cuore, Campobasso, Italia.

In patients undergoing debulking surgery for ovarian cancer (OC), bevacizumab-combined chemotherapy has been reported to be associated with an increased incidence of adverse events (AEs). Reports in the literature have noted the overall morbidity of bevacizumab to be between 3.7% and 9%. The aim of this study is to report uncommon and unusual manifestations of morbidity in surgical cases performed at our third level referral centers for gynecologic oncology. Additionally, we review the rare and severe bevacizumab-related complications that have been described in the literature. We defined as "extreme", the particularly rare and/or severe complications up to determining a life-threatening condition or death, which are related to the use of bevacizumab. A case-series of extreme complications registered at our institutions were reported. In addition, a literature search of the PubMed, MEDLINE and EMBASE electronic databases was performed for this review. The studies collected included: 8 randomized controlled trials (RCT) and 5 prospective observational, 1 prospective phase-IV, 10 prospective phase-II, 2 prospective phase-I, and 20 retrospective studies, as well as 9 case reports. Bevacizumab was administered as primary treatment in adjuvant and neo-adjuvant setting in 16 and 5 studies respectively, as treatment for recurrence in 36 trials, and for secondary cytoreductive surgery (SCS) in 3 studies. The overall population administered with bevacizumab numbered 7,096 women. Extreme complications were observed in 591 patients, with a morbidity rate of the 8.3%. Overall, central nervous system (CNS), cardiovascular, gastrointestinal (GI) and primary infectious complications were seen in 22 patients (0.3%), 261 patients (3.7%), 159 patients (2.2%), and 8 patients (0.13%), respectively. Hemorrhagic and wound complications occurred in 18 women (0.25%), and 112 women (1.6%), respectively. Extreme complications related to the use of bevacizumab are rare, and often go unrecognized. The recognition and immediate management of such rare and life-threatening complications in patients treated at third level referral centers could significantly improve patient survival.
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http://dx.doi.org/10.21037/atm-20-4448DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7812204PMC
December 2020

REPLY: SCORPION study: is it time to call primary debulking surgery superior?

Int J Gynecol Cancer 2021 Feb 18;31(2):311-312. Epub 2020 Dec 18.

Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario A Gemelli IRCCS, Roma, Italy.

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http://dx.doi.org/10.1136/ijgc-2020-002295DOI Listing
February 2021

Oregovomab: an investigational agent for the treatment of advanced ovarian cancer.

Expert Opin Investig Drugs 2021 Feb 11;30(2):103-110. Epub 2021 Jan 11.

Scientific Directorate, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome, Italy.

: Ovarian cancer (OC) represents the leading cause of death among gynecological cancers. Despite novel compound classes like vascular endothelial growth factor (VEGF) inhibitors or poly-ADP ribose polymerase (PARP) inhibitors are available, which improve significantly efficacy of platinum-based chemotherapy, OC prognosis remains poor and innovative strategies are needed. The induction of tumor specific immune response with a therapeutic intent is a very challenging approach. Oregovomab is a murine monoclonal antibody direct to the tumor-associated antigen CA125 that stimulate a host cytotoxic immune response against tumor cells expressing CA125. : This paper reviews the preclinical and clinical published data underlying the use of oregovomab in advanced OC. A literature search was performed in PubMed for oregovomab, ovarian cancer, anti-CA125, and on ClinicalTrials.gov for currently ongoing trials. : Oregovomab demonstrated a significant improvement in progression-free and overall survival in advanced OC treatment when administered simultaneously with first-line chemotherapy. This promising schedule is currently investigated in a phase III trial. Since oral treatments as PARP-inhibitors have recently been approved in the OC first-line setting, the possible role of oregovomab needs still to be defined, also considering the intravenous route of administration. The easy to manage toxicity profile makes oregovomab an ideal candidate for association strategies.
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http://dx.doi.org/10.1080/13543784.2021.1868436DOI Listing
February 2021

ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma.

Int J Gynecol Cancer 2021 Jan 18;31(1):12-39. Epub 2020 Dec 18.

Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands.

A European consensus conference on endometrial carcinoma was held in 2014 to produce multi-disciplinary evidence-based guidelines on selected questions. Given the large body of literature on the management of endometrial carcinoma published since 2014, the European Society of Gynaecological Oncology (ESGO), the European SocieTy for Radiotherapy and Oncology (ESTRO), and the European Society of Pathology (ESP) jointly decided to update these evidence-based guidelines and to cover new topics in order to improve the quality of care for women with endometrial carcinoma across Europe and worldwide.
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http://dx.doi.org/10.1136/ijgc-2020-002230DOI Listing
January 2021

BRCA testing delay during the COVID-19 pandemic: How to act?

Mol Biol Rep 2021 Jan 12;48(1):983-987. Epub 2020 Dec 12.

Molecular and Genomic Diagnostics Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Recently, our lab, part of a referral center in Italy, reported its experience regarding the execution of germline BRCA1/2 (gBRCA) testing during the first months of the coronavirus disease-2019 (COVID-19) pandemic, which highlights a substantial reduction (about 60%) compared with the first 2 months of the current year. This evidence appeared to be a lockdown effect due to extraordinary restriction measures to slow down the spread of SARS-CoV-2. In this study, we aimed to evaluate the overall effects of the ongoing pandemic on gBRCA testing in our institution and to understand how COVID-19 has influenced testing after the complete lockdown (March 8-May 5, 2020). Additionally, we compared this year's trend with trends of the last 3 years to better monitor gBRCA testing progress. This detailed analysis highlights two important findings: (1) gBRCA testing did not increase significantly after the lockdown period (May-October 2020) compared with the lockdown period (March-April 2020), emphasizing that even after the lockdown period testing remained low. (2) Comparing the total tests per year (January-October 2017, 2018, 2019, with 2020), the impact of COVID-19 on gBRCA testing is apparent, with similarities of trends registered in 2017. These evidences reveal a gBRCA testing delay for cancer patients and healthy patients at this moment, and the new era of gBRCA testing in the management of ovarian, breast, pancreas and prostate cancer patients has been seriously questioned due to the COVID-19 pandemic. As consequence, we underline that measures to guarantee oncogenetic testing (e.g., gBRCA testing) along with new diagnostic/clinic strategies are mandatory. For these reasons, several proposals are presented in this study.
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http://dx.doi.org/10.1007/s11033-020-06060-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7733534PMC
January 2021

Update on new imaging technologies in sentinel node detection.

Minerva Ginecol 2020 Dec 11;72(6):404-412. Epub 2020 Dec 11.

Department of Women's and Children's Health Sciences and Public Health, IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy.

In most cancers, lymph node status is the most critical factor impacting the evolution of the disease and the overall survival. Identifying potential nodal metastasis allows the oncologist to adjust the stage and, consequently, the patient's treatment. For this reason, a precise evaluation of the regional nodes is mandatory. In gynecological cancers, pelvic, paraaortic, and inguinal nodes are the region most frequently interested by metastasis. In the past years, comprehensive lymphadenectomy was the standard of care for endometrial, cervical, ovarian, and vulvar cancers. However, after introducing the sentinel lymph node (SNL) biopsy in breast cancers, this technique has gained much more interest in gynecology oncology. Several studies have shown that SLN allows an evaluation of the node status without the complications related to the lymphadenectomy that impacts the patient's quality of life. In this review, we discuss the role of SNL biopsy in gynecological cancers and the technique's evolution over the years. Moreover, we debate the OSNA method for SLN analysis that is recently introduced for uterine cancer.
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http://dx.doi.org/10.23736/S0026-4784.20.04707-3DOI Listing
December 2020

Droplet digital PCR for large genomic rearrangements detection: A promising strategy in tissue BRCA1 testing.

Clin Chim Acta 2021 Feb 7;513:17-24. Epub 2020 Dec 7.

Department of Molecular Medicine and Medical Biotechnology, Federico II University, 80131 Naples, Italy; Federico II University, CEINGE, Advanced Biotechnology, 80131 Naples, Italy. Electronic address:

Background And Aims: With the introduction of Olaparib as target therapy for High Grade Serous Ovarian Cancer (HGSOC) patients with germline and somatic BRCA1/2 mutations, the genetic test performed on tumor tissue has become important like the germline test. In somatic testing the evaluation of Large Genomic Rearrangements (LGRs) represents the main challenge. We describe a droplet digital PCR (ddPCR) assay for the evaluation of target BRCA1 LGRs on blood and formalin-fixed paraffin-embedded (FFPE)/Fresh Frozen Tissue (FFT) samples.

Materials And Methods: We analyzed blood, FFPE and FFT samples in a validation setting of n = 78 HGSOC patients. We applied the ddPCR to BRCA1 exons 2, 20 and 21 as some of the most common BRCA1 exons involved in LGRs in our cohort of patients.

Results: The ddPCR custom assays allowed the identification of LGRs in all sample types, including FFPE specimens. Moreover, we were able to clearly detect LGRs accounted as somatic event.

Conclusion: The introduction of ddPCR in a comprehensive workflow, encompassing both germline and somatic tests, represents an improvement in BRCA1/2 testing. ddPCR can overcome challenges related to BRCA testing, especially on FFPE analysis. Finally, ddPCR represents a promising alternative strategy to the established standard methods currently used in clinical setting.
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http://dx.doi.org/10.1016/j.cca.2020.12.001DOI Listing
February 2021

Perspectives, fears and expectations of patients with gynaecological cancers during the COVID-19 pandemic: A Pan-European study of the European Network of Gynaecological Cancer Advocacy Groups (ENGAGe).

Cancer Med 2021 01 18;10(1):208-219. Epub 2020 Nov 18.

Department of Gynecology, Imperial College London, NHS Trust London, London, UK.

Background: The impact of the COVID-19 pandemic on European gynaecological cancer patients under active treatment or follow-up has not been documented. We sought to capture the patient perceptions of the COVID-19 implications and the worldwide imposed treatment modifications.

Methods: A patient survey was conducted in 16 European countries, using a new COVID-19-related questionnaire, developed by ENGAGe and the Hospital Anxiety & Depression Scale questionnaire (HADS). The survey was promoted by national patient advocacy groups and charitable organisations.

Findings: We collected 1388 forms; 592 online and 796 hard-copy (May, 2020). We excluded 137 due to missing data. Median patients' age was 55 years (range: 18-89), 54.7% had ovarian cancer and 15.5% were preoperative. Even though 73.2% of patients named cancer as a risk factor for COVID-19, only 17.5% were more afraid of COVID-19 than their cancer condition, with advanced age (>70 years) as the only significant risk factor for that. Overall, 71% were concerned about cancer progression if their treatment/follow-up was cancelled/postponed. Most patients (64%) had their care continued as planned, but 72.3% (n = 892) said that they received no information around overall COVID-19 infection rates of patients and staff, testing or measures taken in their treating hospital. Mean HADS Anxiety and Depression Scores were 8.8 (range: 5.3-12) and 8.1 (range: 3.8-13.4), respectively. Multivariate analysis identified high HADS-depression scores, having experienced modifications of care due to the pandemic and concern about not being able to visit their doctor as independent predictors of patients' anxiety.

Interpretation: Gynaecological cancer patients expressed significant anxiety about progression of their disease due to modifications of care related to the COVID-19 pandemic and wished to pursue their treatment as planned despite the associated risks. Healthcare professionals should take this into consideration when making decisions that impact patients care in times of crisis and to develop initiatives to improve patients' communication and education.
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http://dx.doi.org/10.1002/cam4.3605DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7753798PMC
January 2021

Diet and Chemotherapy: The Effects of Fasting and Ketogenic Diet on Cancer Treatment.

Chemotherapy 2020 16;65(3-4):77-84. Epub 2020 Nov 16.

Department of Obstetrics and Gynaecology, Campus Bio-Medico, University of Rome, Rome, Italy.

Introduction: Diet may influence various aspects of human health. In fact, it is well known that diet can favour or not the development of various human pathologies, like diabetes, hypertension, and hypercholesterolaemia. Interestingly, diet has an influence in cancer development too (e.g., this relation has been studied for pancreatic, colonic, gastric, and breast cancers). Between the mechanisms that could explain this relation, there is epigenetic. In fact, thanks to epigenetic reprogramming, certain substances introduced with diet could affect gene expression, especially of those genes involved in cells' proliferation and growth. In recent years, some studies have been published about the role that diet could have on chemotherapy outcome. Especially, various studies have analysed the effects of fasting and ketogenic diet (KD) during chemotherapy. The aim of this study is to summarize scientific evidences about diet and its effects on chemotherapy on humans and to better understand if these approaches deserve to be further investigated and might be suitable and beneficial during cancer treatment.

Materials And Methods: We performed an electronic literature search of the PubMed database, using the combination of following terms: "fasting" or "ketogenic" with "chemotherapy," "cancer treatment." We included studies on humans about fasting and KD during chemotherapy, excluding reviews, case series including <10 patients, studies conducted on animals or limited to radiotherapy treatment, and studies that were mostly about molecular mechanisms. Results/Discussion In our analysis we included 4 studies (1 randomized controlled trial, 1 retrospective study, and 2 prospective pilot studies) about KD and 4 studies (1 prospective cohort study, 1 case series report, and 2 randomized trials) about fasting during oncological treatments. Authors suggested an improvement of quality of life (QoL) and fatigue in patients under chemotherapy, especially in the 8 days after chemotherapy treatment. We found that both fasting and KD demonstrated to be tolerable and feasible during oncological treatments. Conversely, data about survival outcomes are still controversial, but it should be underlined that it was not the outcome of these preliminary studies.

Conclusions: All comparatives studies have demonstrated that even fasting then KD results in a reduction of collateral effects of adjuvant chemotherapy (due to reduction of drugs toxicity) and a better QoL than in patients that follow no diet. Unfortunately, despite the fact that various laboratory and animal studies confirm advantages from KD and fasting, few data are today disposable on humans: further studies are needed to confirm data exposed in this review.
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http://dx.doi.org/10.1159/000510839DOI Listing
November 2020

Pembrolizumab for advanced cervical cancer: safety and efficacy.

Expert Rev Anticancer Ther 2021 Feb 26;21(2):221-228. Epub 2020 Nov 26.

Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

: Pembrolizumab is an immune checkpoint inhibitor with high specificity for binding to the programmed cell death 1 (PD-1) receptor. It has been approved by the FDA in patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express the programmed cell death ligand 1 (PD-L1).: Clinical studies of pembrolizumab in cervical cancer were analyzed and discussed. Data were obtained by searching for English peer-reviewed articles on PubMed, clinical trials registered on clincaltrials.gov and related abstracts on the ASCO meeting library. The aim was to review the status of pembrolizumab, the published and ongoing trials, and its safety and efficacy.: Pembrolizumab may ultimately represent a treatment of choice for advanced cervical cancer with PD-L1 expression, both in metastatic and recurrent setting. However, it is essential to better identify and characterize patients that will benefit the most.
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http://dx.doi.org/10.1080/14737140.2021.1850279DOI Listing
February 2021

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

Int J Gynecol Cancer 2020 Nov 10. Epub 2020 Nov 10.

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

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.
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http://dx.doi.org/10.1136/ijgc-2020-001996DOI Listing
November 2020

Is there any therapeutic role of pelvic and para-aortic lymphadenectomy in apparent early stage epithelial ovarian cancer?

Gynecol Oncol 2021 Jan 7;160(1):56-63. Epub 2020 Nov 7.

Fondazione Policlinico Universitario A. Gemelli, IRCCS, UOC Ginecologia Oncologica, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.

Objective: The therapeutic role of pelvic and para-aortic lymphadenectomy in surgical staging of apparent early-stage epithelial ovarian cancer (eEOC) is still under debate. The aim of this study was to evaluate the potential therapeutic role of systematic lymphadenectomy in patients with eEOC.

Methods: Multi-center retrospective cohort study, comparing women with apparent eEOC who underwent comprehensive bilateral pelvic and para-aortic lymphadenectomy (defined as ≥20 lymph nodes) versus patients receiving no lymphadenectomy or lymph node sampling, from 05/1985 to 12/2016. Patients with bulky nodes at CT-scan and those without complete intra-peritoneal surgical staging were excluded. Only patients who received at least 3 cycles of platinum-based adjuvant chemotherapy were included.

Results: Out of 2559 patients with FIGO stage IA-IIIA1 ovarian cancer, 639 (25.0%) met inclusion criteria. 360 (56.3%) underwent comprehensive lymphadenectomy, 150 (23.5%) lymph node sampling and 129 (20.2%) no lymphadenectomy. Patients who underwent comprehensive lymphadenectomy were younger (p < 0.001), experienced a higher number of severe post-operative complications (p = 0.008) and had a longer time to start chemotherapy (p = 0.034). There was no difference in intra-operative complications. Median follow-up was 63 months (range, 5-342). The 5-year disease-free survival (DFS) was 79.7% vs. 76.5% vs. 68.3% (p = 0.006), and 5-year overall survival (OS) was 92.3% vs. 94.5% vs. 89.8% (p = 0.165) in women who received comprehensive lymphadenectomy vs. lymph node sampling vs. no lymphadenectomy, respectively. Lymphadenectomy represented an independent factor for DFS improvement, HR 0.52 (95%CI 0.37-0.73) (p < 0.001).

Conclusion: Pelvic and para-aortic lymphadenectomy in surgical staging of eEOC improves DFS for the price of increasing post-operative complications and time to chemotherapy but does not affect OS. Better understanding of tumor biology may help to identify those patients in whom lymphadenectomy should still play a role.
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http://dx.doi.org/10.1016/j.ygyno.2020.10.028DOI Listing
January 2021

Peritoneal HPV-DNA test in cervical cancer (PIONEER study): A proof of concept.

Int J Cancer 2021 Mar 27;148(5):1197-1207. Epub 2020 Nov 27.

Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, UOC Ginecologia Oncologica, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.

The aim of this study was to investigate the prevalence of peritoneal human papillomavirus (HPV) infection in different clinical cervical cancer (CC) settings, and its association with potential clinical and/or histological factors. This is a single-center, prospective, observational study. Consecutive patients with newly diagnosed or recurrent/persistent CC, between March 2019 and April 2020, were included. A group of patients undergoing surgery for benign gynecological conditions was included as control group. All patients underwent HPV-DNA test in the cervix and in the peritoneal cavity simultaneously at time of surgery. Two-hundred seventy-two patients had cervical and peritoneal HPV test analyzed. Cervical and peritoneal HPV positivity (PHP) was found in 235 (88.0%) and 78 (28.7%) patients, respectively; the prevalence of PHP was 17.7% in early stage, 28.8% in locally advanced cervical cancer (LACC) and 46.6% in the metastatic/persistent/recurrent setting (P = .001). No control patient was found to have peritoneal HPV infection. Higher frequency of PHP was documented in patients with larger tumor size (P = .003), presence of cervical HPV 16/18 genotypes (P < .001), higher number of cervical high-risk (HR)-HPV per patient (P = .018) and peritoneal carcinomatosis (P < .001). Multivariate analysis demonstrated that lack of preoperative cervical conization in early stages (P = .030), while higher International Federation of Gynecology and Obstetrics (FIGO) stage (P = .021) and presence of cervical HPV 16/18 (P = .001) in LACC, was associated with PHP. This is a proof-of-concept study. A number of potential clinical implications, including prognosis, could be obtained by further studies.
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http://dx.doi.org/10.1002/ijc.33380DOI Listing
March 2021

Standard ultrastaging compared to one-step nucleic acid amplification (OSNA) for the detection of sentinel lymph node metastases in early stage cervical cancer.

Int J Gynecol Cancer 2020 Dec 30;30(12):1871-1877. Epub 2020 Oct 30.

Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Unità di Ginecopatologia e Patologia Mammaria, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy

Objective: We compared ultrastaging and one-step nucleic acid amplification (OSNA) examination of sentinel lymph nodes in two homogeneous patient populations diagnosed with early stage cervical cancer. The primary aim of our study was to evaluate the rate and type of sentinel lymph node metastases detected by ultrastaging and OSNA assay. Secondary aims were to define the sensitivity and the negative predictive value of sentinel lymph node biopsy assessed with OSNA and ultrastaging and to define the role of sentinel lymph node assessment in predicting non-sentinel lymph node status.

Methods: Consecutive patients who underwent surgery (radical hysterectomy or trachelectomy or cervical conization) at our institution, between January 2018 and March 2020, were enrolled. All patients had a preoperative diagnosis of early-stage cervical carcinoma (International Federation of Gynecology and Obstetrics (FIGO) 2018 stages IA-IIB) and underwent sentinel lymph node assessment with ultrastaging or OSNA. Patients with advanced FIGO stages and special histology subtypes (other than squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma) or patients with sentinel lymph nodes analyzed only with hematoxylin and eosin were excluded. Clinical data were compared using the χ test and Fisher's exact test. A κ coefficient was determined with respect to lymph node assessment. A p value <0.05 was considered statistically significant.

Results: A total of 116 patients were included in this retrospective analysis (53 ultrastaging, 63 OSNA). Overall, 531 and 605 lymph nodes were removed in the ultrastaging and OSNA groups, respectively, and 140 and 129 sentinel lymph nodes were analyzed in the ultrastaging and OSNA groups, respectively. 22 patients had metastatic sentinel lymph nodes: 6 (11.3%) of 53 patients in the ultrastaging group and 16 (25.4%) of 63 patients in the OSNA group. The total amount of positive SLNs was 7 (5%) of 140 in the ultrastaging group and 21 (16.3%) of 129 in the OSNA group, respectively (p=0.0047). Pelvic lymphadenectomy was performed in 26 (49.1%) of 53 patients in the ultrastaging group and in 34 (54%) of 63 patients in the OSNA group due to comorbidities. Metastatic non-sentinel lymph nodes were found in 4 patients: 2 (7.7%) of 26 patients in the ultrastaging group and 2 (5.9%) of 34 patients in the OSNA group, respectively. The total amount of positive pelvic lymph nodes was 3 (0.6%) of 531 in the ultrastaging group and 4 (0.7%) of 605 in the OSNA group (p=0.61). In the OSNA group, only 2 patients with negative sentinel lymph nodes had metastatic disease in the pelvic lymph nodes. By contrast, no patients with OSNA-positive sentinel lymph nodes had metastases in the pelvic lymph nodes. In the ultrastaging group, all patients with negative sentinel lymph nodes did not have metastatic disease in other pelvic lymph nodes.

Conclusions: OSNA assessment of sentinel lymph nodes was associated with a negative predictive value of 91% but poor reliability in detecting node metastases in non-sentinel pelvic lymph nodes. Of note, the ultrastaging protocol revealed higher sensitivity and more reliability in predicting pelvic non-sentinel lymph node status.
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http://dx.doi.org/10.1136/ijgc-2020-001710DOI Listing
December 2020

ASO Author Reflections: Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer.

Ann Surg Oncol 2020 Oct 29. Epub 2020 Oct 29.

Department of Radiotherapy, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.

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http://dx.doi.org/10.1245/s10434-020-09260-5DOI Listing
October 2020

Neoadjuvant chemotherapy followed by conization in stage IB2-IIA1 cervical cancer larger than 2 cm: a pilot study.

Fertil Steril 2021 Jan 20;115(1):148-156. Epub 2020 Oct 20.

Università Cattolica del Sacro Cuore, Rome, Italy; Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Fondazione Policlinico Universitario A. Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Objective: To evaluate feasibility of neoadjuvant chemotherapy (NACT) followed by cold-knife conization (CKC) in patients with 2018 FIGO stage IB2-IIA1 cervical cancer who desired to maintain fertility.

Design: Pilot study of conization after chemotherapy in stage IB2-IIA1 >2 cm cervical cancer.

Setting: University hospital.

Patient(s): From 2014 to 2018, 25 patients, <40 years of age, were enrolled.

Interventions(s): After laparoscopic pelvic lymph-node assessment, NACT with cisplatin/paclitaxel q21 was administered to eligible patients. Responsive patients were treated with CKC.

Main Outcome Measure(s): Obstetrical outcome: pregnancy rate. Oncologic outcome.

Result(s): Thirteen out of 25 patients were eligible for fertility-sparing treatment. Oncologic outcome: The clinical overall response rate was 84.5% (11 out of 13 patients). One patient achieved stable disease, was managed by radical surgery, and is still alive; another one experienced progression of disease and died after 15 months. The optimal pathologic response was 69.1%. In the setting of fertility preservation patients, the median follow-up was 37 months (range 18-76). In this group we registered one distant recurrence, 12 months after CKC, in the liver; the patient is still alive and without evidence of disease. Obstetrical outcome: Among the nine patients amenable, three tried to conceive, and two spontaneous pregnancy occurred a few months after the end of treatment, for a pregnancy rate of 66.7%.

Conclusion(s): This pilot study supports the feasibility of CKC after NACT as conservative treatment in stage IB2-IIA1 cervical cancer, with oncologic outcomes similar to those reported for trachelectomy in the same stage and with potential benefits in terms of obstetrical outcomes.

Clinical Trial Registration Number: NCT02323841.
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http://dx.doi.org/10.1016/j.fertnstert.2020.07.006DOI Listing
January 2021

The Role of Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer: A Systematic Review and Meta-Analysis.

Ann Surg Oncol 2020 Oct 16. Epub 2020 Oct 16.

Department of Radiotherapy, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.

Background: Phase 3 randomized clinical trials have been designed to compare secondary cytoreductive surgery followed by systemic therapy with systemic therapy alone for management of patients with recurrent ovarian cancer. This study aimed to compare differences in clinical outcomes between these two treatment approaches.

Methods: The PRISMA statement was applied. Only phase 3 randomized clinical trials were included in the final analysis.

Results: Three randomized clinical trials (n = 1250 patients) were identified. Secondary cytoreductive surgery was associated with significantly better progression-free survival (PFS) improvement than systemic therapy alone (hazard ratio [HR], 95% CI, 0.61-0.78; p < 0.001). The PFS benefit was greater for the complete resection subpopulation (HR, 0.56; 95% CI, 0.48-0.66; p < 0.001). The HR of overall survival (OS) was similar between the groups (HR, 0.93; 95% CI, 0.78-1.10; p = 0.37), but it was 0.73 (95% CI, 0.59-0.91) in favor of the complete resection subpopulation.

Conclusion: This meta-analysis showed secondary cytoreductive surgery as superior to systemic therapy alone in terms of PFS. The PFS and OS benefits were particularly observed for complete surgical resection. The impact on OS in the general population remains to be proven.
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http://dx.doi.org/10.1245/s10434-020-09226-7DOI Listing
October 2020

Is a Vaginectomy Enough or is a Pelvic Exenteration Always Required for Surgical Treatment of Recurrent Cervical Cancer? A Propensity-Matched Study.

Ann Surg Oncol 2020 Oct 15. Epub 2020 Oct 15.

Department of Obstetrics and Gynecology, University of Messina, Messina, Italy.

Purpose: Reporting the perioperative and survival outcomes of vaginectomy with respect to a matched series of pelvic exenteration (PE) in women with isolated recurrent cervical cancer.

Methods: The records of vaginal recurrent cervical cancer patients admitted at Fondazione Policlinico "Agostino Gemelli" IRCCS in Rome from January 2010 to June 2019 were retrospectively analyzed. A propensity-matched score analysis was performed by age, clinical stage, disease-free interval, and R0 resection. Postsurgical complications and survival rates were evaluated.

Results: Fifteen women underwent vaginectomy, and 30 patients were submitted to PE. No statistical differences were observed between the two groups at baseline characteristics. The vaginectomy procedures were successfully performed in all women, and no case required conversion to PE. Moreover, a higher rate of major postoperative complications after PE with respect to vaginectomy (p = 0.027) was recorded. Among them, three women required reoperation within 30 postoperative days, and four experienced two or more complications. Twenty-five (55.6%) women experienced recurrence: 8 of 25 (32.0%) in the vaginectomy group, and 17 of 25 (68%) in the PE group, with a median progression-free survival of 20 months and 13 months, respectively (p = 0.169). In total, 5 of 15 (33.3%) died of disease in the vaginectomy group and 13/30 (43.3%) in the PE group, with a median overall survival of 39 and 18 months for vaginectomy and PE, respectively (p = 0.161).

Conclusions: The vaginectomy seems to allow for salvage treatment, such as radiotherapy and/or PE, but with a minimal impact on the quality of life in appropriately selected women with local recurrent cervical cancer.
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http://dx.doi.org/10.1245/s10434-020-09207-wDOI Listing
October 2020

Investigating the possible impact of peritoneal tumor exposure amongst women with early stage cervical cancer treated with minimally invasive approach.

Eur J Surg Oncol 2020 Oct 3. Epub 2020 Oct 3.

Fondazione Policlinico Universitario A. Gemelli, IRCCS, UOC Ginecologia Oncologica, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Roma, Italy; Università Cattolica del Sacro Cuore, Roma, Italy.

Introduction: Recent findings show a detrimental impact of the minimally invasive approach on patients with early stage cervical cancer (ECC). Reasons beyond these results are unclear. The aim of the present article is to investigate the possible role of peritoneal contamination during intracorporeal colpotomy.

Methods: patients with early stage cervical cancer were divided into 2 groups: no intraperitoneal exposure (N-IPE) intraperitoneal exposure (IPE) during minimally invasive surgery. Patients of the 2 groups were propensity-matched according to the major risk factors.

Results: 226 cases of the IPE group had a significant worst prognosis than the 142 cases of the N-IPE group (4.5-years disease free survival: 86.6% vs 95.9% respectively, p = 0.005), while N-IPE had similar survival to open surgery (4.5-years disease free survival: 95.0% vs 90.5% respectively, p = 0.164). Distant recurrence was more frequent among IPE patients with a borderline significance (3.5% vs 0.4% among IPE and N-IPE respectively, p = 0.083). On multivariate analysis, intraperitoneal tumor exposure was an independent prognostic factors for worse survival; patients belonging to the N-IPE group had a risk of recurrence of about 3-fold lower compared to patients of the IPE group (hazard ratio: 0.37, 95% confidence interval: 0.15-0.88, p = 0.025).

Conclusion: it would be advisable that further prospective studies investigating the efficacy of different surgical approach in ECC take into consideration of this issue. Moreover, all other measures that could potentially prevent peritoneal exposure of tumor should be adopted during minimally invasive surgery for early stage cervical cancer to provide higher survival outcomes.
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http://dx.doi.org/10.1016/j.ejso.2020.09.038DOI Listing
October 2020

Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850).

Int J Gynecol Cancer 2020 Nov 7;30(11):1657-1664. Epub 2020 Oct 7.

Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.

Objective: To investigate whether neoadjuvant chemotherapy followed by interval debulking surgery is superior to primary debulking surgery in terms of perioperative complications and progression-free survival, in advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load.

Methods: Patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy. Patients with high tumor load assessed by a standardized laparoscopic predictive index were randomly assigned (1:1 ratio) to undergo either primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy (arm B). Co-primary outcome measures were progression-free survival and post-operative complications; secondary outcomes were overall survival, and quality of life. Survival analyses were performed on an intention-to-treat population.

Results: 171 patients were randomly assigned to primary debulking surgery (n=84) versus neoadjuvant chemotherapy (n=87). Rates of complete resection (R0) were different between the arms (47.6% in arm A vs 77.0% in arm B; p=0.001). 53 major postoperative complications were registered, mainly distributed in arm A compared with arm B (25.9% vs 7.6%; p=0.0001). All patients were included in the intent-to-treat analysis. With an overall median follow-up of 59 months (95% CI 53 to 64), 142 (83.0%) disease progressions/recurrences and 103 deaths (60.2%) occurred. Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56).

Conclusions: Neoadjuvant chemotherapy and primary debulking surgery have the same efficacy when used at their maximal possibilities, but the toxicity profile is different.
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http://dx.doi.org/10.1136/ijgc-2020-001640DOI Listing
November 2020

Germline BRCA 1-2 status prediction through ovarian ultrasound images radiogenomics: a hypothesis generating study (PROBE study).

Sci Rep 2020 10 5;10(1):16511. Epub 2020 Oct 5.

Dipartimento per le Scienze della salute della donna, del bambino e di sanità pubblica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Gynecologic Oncology, Rome, Italy.

Radiogenomics is a specific application of radiomics where imaging features are linked to genomic profiles. We aim to develop a radiogenomics model based on ovarian US images for predicting germline BRCA1/2 gene status in women with healthy ovaries. From January 2013 to December 2017 a total of 255 patients addressed to germline BRCA1/2 testing and pelvic US documenting normal ovaries, were retrospectively included. Feature selection for univariate analysis was carried out via correlation analysis. Multivariable analysis for classification of germline BRCA1/2 status was then carried out via logistic regression, support vector machine, ensemble of decision trees and automated machine learning pipelines. Data were split into a training (75%) and a testing (25%) set. The four strategies obtained a similar performance in terms of accuracy on the testing set (from 0.54 of logistic regression to 0.64 of the auto-machine learning pipeline). Data coming from one of the tested US machine showed generally higher performances, particularly with the auto-machine learning pipeline (testing set specificity 0.87, negative predictive value 0.73, accuracy value 0.72 and 0.79 on training set). The study shows that a radiogenomics model on machine learning techniques is feasible and potentially useful for predicting gBRCA1/2 status in women with healthy ovaries.
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http://dx.doi.org/10.1038/s41598-020-73505-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7536234PMC
October 2020

Sentinel lymph node mapping with indocyanine green in cervical cancer patients undergoing open radical hysterectomy: a single-institution series.

J Cancer Res Clin Oncol 2021 Mar 30;147(3):649-659. Epub 2020 Sep 30.

UOC Ginecologia Oncologica, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Largo Agostino Gemelli 8, 00168, Rome, Italy.

Purpose: To assess the rate of bilateral sentinel lymph node (SLN) detection with indocyanine green (ICG), to evaluate the sensitivity and the negative predictive value of cervical cancer patients undergoing open radical hysterectomy; to compare open versus minimally invasive SLN biopsy performance and to assess factors related to no/unilateral SLN mapping.

Methods: We retrospectively reviewed consecutive patients with FIGO 2018 stage IA1 with lymph-vascular space involvement to IIB and IIIC1p cervical carcinoma who underwent SLN mapping with ICG followed by systematic pelvic lymphadenectomy between 05/2017 and 06/2020. Patients were divided according to surgical approach for statistical analysis.

Results: Eighty-five patients met inclusion criteria. Twenty-seven (31.8%) underwent open and 58 (68.2%) underwent minimally invasive SLN mapping. No difference in any SLN mapping (laparotomy 92.6% and minimally invasive 91.4%) or in SLN bilateral detection (laparotomy 72.0% and minimally invasive 84.9%) (p = 0.850 and p = 0.222, respectively), in median number of SLNs mapped and retrieved (2 in both groups, p = 0.165) and in site of SLN mapping per hemi-pelvis (right side, p = 0273 and left side, p = 0.618) was evident between open and minimally invasive approach. Per-patient sensitivity of SLN biopsy in laparotomy was 83.3% (95% CI 35.9-99.6%) and the negative predictive value was 95.0% (95% CI 76.0-99.1%). No difference in per-patient sensitivity was noted between two approaches (p = 0.300). None of the analyzed variables was associated with no/unilateral SLN mapping.

Conclusion: The use of ICG to detect SLN in cervical cancer treated with open surgery allows a bilateral detection, sensitivity and negative predictive value comparable to minimally invasive surgery with potential advantages of ICG compared to other tracers.
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http://dx.doi.org/10.1007/s00432-020-03393-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7873085PMC
March 2021

Hyperthermic intraperitoneal chemotherapy in interval debulking surgery for advanced epithelial ovarian cancer: A single-center, real-life experience.

Cancer 2020 Dec 15;126(24):5256-5262. Epub 2020 Sep 15.

UOC Ginecologia Oncologica, Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica, Policlinico Agostino Gemelli IRCCS, Rome, Italy.

Background: An improvement in survival without increasing perioperative morbidity in patients with advanced epithelial ovarian cancer treated with hyperthermic intraperitoneal chemotherapy (HIPEC) after interval debulking surgery (IDS) has been recently demonstrated in a randomized controlled trial. This study was aimed at assessing the feasibility and perioperative outcomes of the use of HIPEC after IDS at a referral cancer center.

Methods: Over the study period, 149 IDSs were performed. Patients who had at least International Federation of Gynecology and Obstetrics stage III disease, with <2.5 mm of residual disease (RD) at the end of surgery and were not participating in clinical trials received HIPEC. Moreover, specific exclusion criteria were considered. These patients were compared with 51 patients with similar clinical characteristics at the same institution and within the same timeframe who did not receive HIPEC.

Results: No differences in patient or disease characteristics with the exception of the type of neoadjuvant chemotherapy (P = .002) were found between the 2 groups. As for surgical characteristics, significant differences were found in RD after IDS (P = .007) and in the duration of surgery (P < .001), whereas the bowel resection and diversion rates (P = .583 and P = .213, respectively) and the postoperative intensive care unit and hospital stays (P = .567 and P = .727, respectively) were comparable. The times to start adjuvant chemotherapy were also similar (P = .998). Equally, the rates of any grade of both intraoperative complications (P = .189) and early postoperative complications (P = .238) were superimposable.

Conclusions: In the authors' experience, the addition of HIPEC to IDS is feasible in 35% for the population. This value might increase with changes in the inclusion/exclusion criteria. HIPEC does not increase perioperative complications and does not affect a patient's recovery or time to start adjuvant chemotherapy. HIPEC should be offered to select patients listed for IDS.
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http://dx.doi.org/10.1002/cncr.33167DOI Listing
December 2020

Percutaneous-Assisted versus Laparoscopic Hysterectomy: A Prospective Comparison.

Gynecol Obstet Invest 2020 11;85(4):318-326. Epub 2020 Sep 11.

Department of Obstetrics and Gynecology, Fondazione Policlinico Universitario A. Gemelli, IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy.

Objective: To evaluate the feasibility of percutaneous approach, we prospectively compared our experience in percutaneous-assisted hysterectomy (PSS-H) with that in a series of laparoscopic hysterectomies (LPS-Hs).

Methods: In this multicentric cohort study, from May 2015 to October 2017, 160 patients affected by benign and malignant gynecological conditions were considered eligible for minimally invasive surgery (MIS): 80 patients received PSS-H and 80 LPS-H. In each group, 30 cases of low-/intermediate-risk endometrial cancer were enrolled. For both groups, we documented preoperative outcomes, postoperative pain, and cosmetic outcomes.

Results: No statistically significant differences were noted in baseline characteristics or operative time. We observed significant differences in estimated blood loss: median of 50 cc (PSS-H) and 100 cc (LPS-H) (p = 0.0001). In LPS-H, we reported 4 (5.0%) intraoperative complications and 1 (1.3%) in PSS-H. Thirty-day complications were 4 (5%) in PSS-H and 11 (13.8%) in LPS-H (p = 0.058). No significative differences were found in visual analog scale score, despite a relevant disparity in cosmetic outcome (p = 0.0001). For oncological cases, the 2 techniques had comparable intra- and postoperative outcomes and oncological accuracy.

Conclusions: In this study, we reported that PSS-H is comparable to LPS-H for intra- and perioperative outcomes and postoperative pain, while PSS-H seems to be superior in cosmetic outcomes and patient satisfaction. PSS-H may represent a valid alternative in ultra-MIS for benign gynecological conditions and low-/intermediate-risk endometrial cancer.
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http://dx.doi.org/10.1159/000509877DOI Listing
February 2021