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128 result(s) for "Buda, Alessandro"
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Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer
In this prospective randomized trial, minimally invasive radical hysterectomy resulted in lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy among women with early-stage cervical cancer. A prospective randomized trial and an epidemiologic study that used large cancer databases (National Cancer Database and SEER) both showed that minimally invasive radical hysterectomy was associated with shorter survival in early cervical cancer than open abdominal radical hysterectomy.
Quality of life in patients with cervical cancer after open versus minimally invasive radical hysterectomy (LACC): a secondary outcome of a multicentre, randomised, open-label, phase 3, non-inferiority trial
In the phase 3 LACC trial and a subsequent population-level review, minimally invasive radical hysterectomy was shown to be associated with worse disease-free survival and higher recurrence rates than was open radical hysterectomy in patients with early stage cervical cancer. Here, we report the results of a secondary endpoint, quality of life, of the LACC trial. The LACC trial was a randomised, open-label, phase 3, non-inferiority trial done in 33 centres worldwide. Eligible participants were women aged 18 years or older with International Federation of Gynaecology and Obstetrics (FIGO) stage IA1 with lymphovascular space invasion, IA2, or IB1 adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the cervix, with an Eastern Cooperative Oncology Group performance status of 0 or 1, who were scheduled to have a type 2 or 3 radical hysterectomy. Participants were randomly assigned (1:1) to receive open or minimally invasive radical hysterectomy. Randomisation was done centrally using a computerised minimisation program, stratified by centre, disease stage according to FIGO guidelines, and age. Neither participants nor investigators were masked to treatment allocation. The primary endpoint of the LACC trial was disease-free survival at 4·5 years, and quality of life was a secondary endpoint. Eligible patients completed validated quality-of-life and symptom assessments (12-item Short Form Health Survey [SF-12], Functional Assessment of Cancer Therapy–Cervical [FACT-Cx], EuroQoL-5D [EQ-5D], and MD Anderson Symptom Inventory [MDASI]) before surgery and at 1 and 6 weeks and 3 and 6 months after surgery (FACT-Cx was also completed at additional timepoints up to 54 months after surgery). Differences in quality of life over time between treatment groups were assessed in the modified intention-to-treat population, which included all patients who had surgery and completed at least one baseline (pretreatment) and one follow-up (at any timepoint after surgery) questionnaire, using generalised estimating equations. The LACC trial is registered with ClinicalTrials.gov, NCT00614211. Between Jan 31, 2008, and June 22, 2017, 631 patients were enrolled; 312 assigned to the open surgery group and 319 assigned to the minimally invasive surgery group. 496 (79%) of 631 patients had surgery completed at least one baseline and one follow-up quality-of-life survey and were included in the modified intention-to-treat analysis (244 [78%] of 312 patients in the open surgery group and 252 [79%] of 319 participants in the minimally invasive surgery group). Median follow-up was 3·0 years (IQR 1·7–4·5). At baseline, no differences in the mean FACT-Cx total score were identified between the open surgery (129·3 [SD 18·8]) and minimally invasive surgery groups (129·8 [19·8]). No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]). Since recurrence rates are higher and disease-free survival is lower for minimally invasive radical hysterectomy than for open surgery, and postoperative quality of life is similar between the treatment groups, gynaecological oncologists should recommend open radical hysterectomy for patients with early stage cervical cancer. MD Anderson Cancer Center and Medtronic.
A Philosophical Framework for Data-Driven Miscomputations
This paper introduces a first approach to miscomputations for data-driven systems. First, we establish an ontology for data-driven learning systems and categorize various computational errors based on the Levels of Abstraction ontology. Next, we consider computational errors which are associated with users’ evaluation and requirements and consider the user level ontology, identifying two additional types of miscomputation.
Prognostic value of isolated tumor cells in sentinel lymph nodes in low risk endometrial cancer: results from an international multi-institutional study
ObjectiveThe prognostic significance of isolated tumor cells (≤0.2 mm) in sentinel lymph nodes (SLNs) of endometrial cancer patients is still unclear. Our aim was to assess the prognostic value of isolated tumor cells in patients with low risk endometrial cancer who underwent SLN biopsy and did not receive adjuvant therapy. Outcomes were compared with node negative patients.MethodsPatients with SLNs–isolated tumor cells between 2013 and 2019 were identified from 15 centers worldwide, while SLN negative patients were identified from Mayo Clinic, Rochester, between 2013 and 2018. Only low risk patients (stage IA, endometrioid histology, grade 1 or 2) who did not receive any adjuvant therapy were included. Primary outcomes were recurrence free, non-vaginal recurrence free, and overall survival, evaluated with Kaplan–Meier methods.Results494 patients (42 isolated tumor cells and 452 node negative) were included. There were 21 (4.3%) recurrences (5 SLNs–isolated tumor cells, 16 node negative); recurrence was vaginal in six patients (1 isolated tumor cells, 5 node negative), and non-vaginal in 15 (4 isolated tumor cells, 11 node negative). Median follow-up among those without recurrence was 2.3 years (interquartile range (IQR) 1.1–3.0) and 2.6 years (IQR 0.6–4.2) in the SLN–isolated tumor cell and node negative patients, respectively. The presence of SLNs-isolated tumor cells, lymphovascular space invasion, and International Federation of Obstetrics and Gynecology (FIGO) grade 2 were significant risk factors for recurrence on univariate analysis. SLN–isolated tumor cell patients had worse recurrence free survival (p<0.01) and non-vaginal recurrence free survival (p<0.01) compared with node negative patients. Similar results were observed in the subgroup of patients without lymphovascular space invasion (n=480). There was no difference in overall survival between the two cohorts in the full sample and the subset excluding patients with lymphovascular space invasion.ConclusionsPatients with SLNs–isolated tumor cells and low risk profile, without adjuvant therapy, had a significantly worse recurrence free survival compared with node negative patients with similar risk factors, after adjusting for grade and excluding patients with lymphovascular space invasion. However, the presence of SLNs–isolated tumor cells was not associated with worse overall survival.
Surgical treatment of complete uterovaginal prolapse and concomitant vaginal cancer: a video case report
Introduction and hypothesisThe concurrence of vaginal cancer with irreducible uterine prolapse is rare. Reports about the management of vaginal cancer and concomitant irreducible prolapse are scanty in the literature, and there is no consensus on optimal treatment. In this video case report, we show surgical management of vaginal cancer and concomitant stage IV uterovaginal prolapse.MethodsThe featured video shows surgical management of vaginal cancer and concomitant stage IV uterovaginal prolapse through anterior colpectomy and retrograde hysterectomy en bloc plus transvaginal levator ani plication as a non-obliterative native-tissue technique for apical support.ResultsFinal examination revealed good apical support and vaginal “habitability” preservation. The patient underwent five sessions of intracavity brachytherapy for a total of 20 Gy as adjuvant therapy.ConclusionSurgical management of vaginal cancer and concomitant stage IV uterovaginal prolapse was successfully achieved without complications. Transvaginal levator ani plication can provide a versatile non-obliterative native-tissue technique for apical support, allowing subsequent adjuvant brachytherapy.
Association between miR-200c and the survival of patients with stage I epithelial ovarian cancer: a retrospective study of two independent tumour tissue collections
International Federation of Gynecology and Obstetrics stage I epithelial ovarian cancer (EOC) has a significantly better prognosis than stage III/IV EOC, with about 80% of patients surviving at 5 years (compared with about 20% of those with stage III/IV EOC). However, 20% of patients with stage I EOC relapse within 5 years. It is therefore crucial that the biological properties of stage I EOCs are further elucidated. MicroRNAs (miRNAs) have shown diagnostic and prognostic potential in stage III and IV EOCs, but the small number of patients diagnosed with stage I EOC has so far prevented an investigation of its molecular features. We profiled miRNA expression in stage I EOC tumours to assess whether there is a miRNA signature associated with overall and progression-free survival (PFS) in stage I EOC. We analysed tumour samples from 144 patients (29 of whom relapsed) with stage I EOC gathered from two independent tumour tissue collections (A and B), both with a median follow-up of 9 years. 89 samples from tumour tissue collection A were stratified into a training set (51 samples, 15 of which were from patients who relapsed) for miRNA signature generation, and into a validation set (38 samples, seven of which were from patients who relapsed) for signature validation. Tumour tissue collection B (55 samples, seven of which were from patients who relapsed) was used as an independent test set. The Cox proportional hazards model and the log-rank test were used to assess the correlation of quantitative reverse transcription PCR (qRT-PCR)-validated miRNAs with overall survival and PFS. A signature of 34 miRNAs associated with survival was generated by microarray analysis in the training set. In both the training set and validation set, qRT-PCR analysis confirmed that 11 miRNAs (miR-214, miR-199a-3p, miR-199a-5p, miR-145, miR-200b, miR-30a, miR-30a*, miR-30d, miR-200c, miR-20a, and miR-143) were expressed differently in relapsers compared with non-relapsers. Three of these miRNAs (miR-200c, miR-199a-3p, miR-199a-5p) were associated with PFS, overall survival, or both in multivariate analysis. qRT-PCR analysis in the test set confirmed the downregulation of miR-200c in relapsers compared with non-relapsers, but not the upregulation of miR-199a-3p and miR-199a-5p. Multivariate analysis confirmed that downregulation of miR-200c in the test set was associated with overall survival (HR 0·094, 95% CI 0·012–0·766, p=0·0272) and PFS (0·035, 0·004–0·311; p=0·0026), independent of clinical covariates. miR-200c has potential as a predictor of survival, and is a biomarker of relapse, in stage I EOC. Nerina and Mario Mattioli Foundation, Cariplo Foundation (Grant Number 2010-0744), and the Italian Association for Cancer Research.
Radiomics of the primary tumour as a tool to improve 18F-FDG-PET sensitivity in detecting nodal metastases in endometrial cancer
BackgroundA radiomic approach was applied in 18F-FDG PET endometrial cancer, to investigate if imaging features computed on the primary tumour could improve sensitivity in nodal metastases detection. One hundred fifteen women with histologically proven endometrial cancer who underwent preoperative 18F-FDG PET/CT were retrospectively considered. SUV, MTV, TLG, geometrical shape, histograms and texture features were computed inside tumour contours. On a first group of 86 patients (DB1), univariate association with LN metastases was computed by Mann-Whitney test and a neural network multivariate model was developed. Univariate and multivariate models were assessed with leave one out on 20 training sessions and on a second group of 29 patients (DB2). A unified framework combining LN metastases visual detection results and radiomic analysis was also assessed.ResultsSensitivity and specificity of LN visual detection were 50% and 99% on DB1 and 33% and 95% on DB2, respectively. A unique heterogeneity feature computed on the primary tumour (the zone percentage of the grey level size zone matrix, GLSZM ZP) was able to predict LN metastases better than any other feature or multivariate model (sensitivity and specificity of 75% and 81% on DB1 and of 89% and 80% on DB2). Tumours with LN metastases are in fact generally characterized by a lower GLSZM ZP value, i.e. by the co-presence of high-uptake and low-uptake areas. The combination of visual detection and GLSZM ZP values in a unified framework obtained sensitivity and specificity of 94% and 67% on DB1 and of 89% and 75% on DB2, respectively.ConclusionsThe computation of imaging features on the primary tumour increases nodal staging detection sensitivity in 18F-FDG PET and can be considered for a better patient stratification for treatment selection. Results need a confirmation on larger cohort studies.
Conservative Resolution of a Vesicovaginal Fistula Including Laser Therapy in a Patient Who Underwent Recurrent Surgery After Prior Radiotherapy for Endometrial Cancer
Background Isolated vaginal vault recurrence of endometrial cancer can be treated with rescue radiotherapy. However, in previously irradiated patients, surgical resection can be considered the treatment of choice. Vesicovaginal fistulas (VVFs) sometimes complicate the surgical intervention because of the presence of massive ischemia and fibrosis of pelvic tissue from previous irradiation. Traditional strategies for the treatment of VVFs include endoscopic treatment (when feasible) or a laparoscopic, robotic, or open abdominal approach in some experiences through a transvesical route. The last approach can be associated with long inpatient hospital stays, postoperative complications, and failure, especially in obese patients. Our report proposes a conservative approach with prolonged catheterization and placement of nephrostomy tubes to treat a VVF with laser therapy of the fistula. Case We present the case of a woman with a second relapse of endometrial cancer at the level of the vaginal vault, after a hysterectomy and then radiotherapy for a first relapse, who underwent robotic partial colpectomy, with an intraoperative bladder lesion, which was repaired with interrupted stitches. However, the patient developed a vesicovaginal fistula. A conservative approach was initially undertaken as an alternative to the surgical repair of the fistula. After the clinical and radiological confirmation of the fistula andconsidering the patient's clinical condition, the multidisciplinary team proposed a conservative management of the fistula as an alternative to fistula surgical repair. Bladder catheter Ch 20 and bilateral nephrostomy did not completely resolve the fistula, with a minor residual linkage between the bladder and the vaginal vault after 8 months from the robotic surgery. A single/month diode laser application for 3 months was added to the conservative treatment. Cystography was negative at the end of laser sessions, and both nephrostomies were removed 1 week later. After 6 months, clinical and radiological follow‐up was negative, and no further vaginal urine loss was recorded. Conclusion We believe that conservative management of a complex vesicovaginal fistula after multiple treatments for endometrial cancer is possible. In this scenario, laser therapy can be a valuable clinical tool to improve the outcome, with reduced invasiveness for the patient.
872 ERAS protocol in gynecologic oncology in Italy: where are we? Evaluation of the state of the art and challenge to improvement
Introduction/BackgroundERAS pathways aim to standardise and optimise perioperative care and modulate postoperative metabolic and inflammatory response linked with adverse outcomes after surgery. Utilization of ERAS protocol has been shown to decrease complications, length of hospital stay and costs.Benefits of ERAS pathway include shorter length of stay, decreased postoperative pain and need for analgesia, more rapid return of bowel function, decreased complication and readmission rates, and increased patient satisfaction. Implementation of ERAS protocols has not been shown to increase readmission, mortality, or reoperation rates. These benefits have been replicated across the spectrum of gynecologic surgeries, including open and minimally invasive approaches and benign and oncologic surgeries. Implementation of ERAS program requires collaboration from all members of the surgical team. ERAS is a comprehensive program, and data demonstrate success when multiple components are implemented together.Although ERAS is associated with significant clinical outcome improvements and cost savings in numerous surgical specialties, several opportunities and challenges deserve further discussion.MethodologyWe plan a first retrospettive phase using a form with the 20 principals ERAS variable (in pre, intra and post operative).We are evaluating data of patients surgically treated for gynecological malignancies in 2023 at Ferrero Hospital in Verduno, Italy.After this first phase we will begin a prospective phase scheduled with periodical updating meeting (each 2 months) of all the ’actors ’ (surgeons, nurses and social-health operators) with esperts in Gynecologic oncology and ERAS protocol. Final analysis using the same form after 12 months of prospective phase testing the goodness of our pathway of improvement.ResultsWe started the retrospective analys and we are recruiting centers in Italy that want to join us in this challenge.ConclusionERAS protocol Is really the standard of care in gynecologic oncology in Italy? Let’s see the current situation and if our proposal can be usefull to improve clinic practice.DisclosuresNo.