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"Malzoni, M"
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EPV140/#62 Survival outcomes in endometrial cancer patients having lymphadenectomy, sentinel node mapping plus back-up lymphadenectomy and sentinel node mapping alone
2021
ObjectivesSentinel node mapping (SNM) has replaced lymphadenectomy for staging surgery in apparent early-stage endometrial cancer (EC). Here, we evaluate the long-term survival of three different approaches of nodal assessment in low, intermediate, and high-risk EC.MethodsThis is a multi-institutional retrospective study evaluating long-term outcomes (at least 3 years of follow-up) of EC patients having nodal assessment between 2006 and 2016. In order to reduce possible confounding factors, we applied a propensity-matched algorithm.ResultsCharts of 940 patients were evaluated: 174 (18.5%), 187 (19.9%), and 579 (61.6%) having SNM, SNM followed by backup lymphadenectomy and lymphadenectomy, respectively. Applying a propensity score matching algorithm (1:1:2) we selected 500 patients: 125 SNM vs. 125 SNM plus backup lymphadenectomy vs. 250 lymphadenectomy. Baseline characteristics of the study population were similar between groups. The prevalence of nodal disease was 14%, 16%, and 12% in patients having SNM, SNM followed by backup lymphadenectomy and lymphadenectomy, respectively. Overall, 19 (7.6%) patients were diagnosed with low volume nodal disease (7 and 12 patients with micrometastasis and isolated tumor cells). The mean (SD) follow-up time was 62 (±11) months. The survival analysis comparing the three techniques did not show statistical differences in terms of disease-free (p=0.750) and overall survival (p=0.899). Similarly, the type of nodal assessment did not impact survival outcomes after stratification on the basis of uterine risk factors.ConclusionsSNM provides similar long-term oncologic outcomes than lymphadenectomy. Further evidence is warranted to assess the prognostic value of low-volume disease detected by ultrastaging and the role of molecular/genomic profiling
Journal Article
63 Surgical staging for high-grade uterine serous carcinoma: is lymphadenectomy required?
2019
OBJECTIVESTo assess the role of a systematic lymphadenectomy for surgical staging of high-grade uterine serous carcinoma (USC).
METHODSData of consecutive patients with apparent early stage USC surgically treated at six Italian tertiary referral cancer centers were analyzed. Data was compared between patients who had retroperitoneal staging including at least pelvic lymphadenectomy “LND” (±para-aortic) vs. patients who underwent hysterectomy alone “NO-LND”. Baseline, surgical and oncological outcomes were analyzed. Survival curves were estimated, and the significant predictive prognostic variables were assessed.
RESULTS140 patients were analyzed, 106 LND and 34 NO-LND. NO-LND group (compared to LND) included older patients (median age 73 vs. 67 years), and with higher comorbidities (median CCI 6 vs. 5) (all p-values <0,001). Surgical related outcomes and complications did not significantly differ between the groups. Similar recurrence rates were registered (LND 33,1% vs. NO-LND 41,4%; p=0,240) and no significant difference in Disease-Free survival (DFS) was estimated (Log-Rank test, p=0,084) among the groups, while overall survival (OS) was significantly poorer in NO-LND group (p<0,001). Multivariable Cox proportional hazards regression analysis showed the presence of extra-uterine disease as independent predictor of DFS (HR 1,530 – 7,828, p= 0,003). Regarding OS, both age (1,044 -1,150) and extra-uterine disease (1,406 – 4,701) were found as independent predictors.(Table is included in full-text article.)
CONCLUSIONSThis large retrospective series showed no association between the systematic performance of lymphadenectomy and survival in patients undergoing surgical staging for apparent early-stage USC.
Journal Article
SUCCOR study. An international european cohort observational study comparing minimally invasive surgery versus open abdominal radical hysterectomy in patients with stage IB1 (FIGO 2009, <4 cm) cervical cancer operated in 2013–2014
2019
Introduction/BackgroundMinimally invasive surgery (MIS) was adopted as an alternative to laparotomy for radical hysterectomy in patients with early-stage cervical cancer before obtaining solid evidence regarding its effect on survival. We studied what was the outcome of patients that underwent Radical hysterectomy for stage IB1 cervical cancer, depending on the different approaches.MethodologyWe performed a cohort study involving women who underwent radical hysterectomy for stage IB1 cervical cancer during the 2013–2014 period in 89 centers belonging to 23 European countries. The study included patients with a histologic subtype of squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Either preoperative pelvic MRI or vaginal ultrasound indicating tumor diameter <4 cm and no parametrial invasion was mandatory. The primary outcome was the rate of disease-free survival at 4.5 years between MIS vs. open surgery. Patients with history of previous conization were also analyzed separately. A propensity matching score was applied to balance all the relevant variables that were found significant to modify the rate of relapse. Inverse probability weighting-adjusted disease-free survival evaluated the impact of the use of uterine manipulator in MIS.Results624 patients were registered of whom 582 fulfilled all the inclusion criteria.With a median follow up of 58 months, patients that underwent open surgery showed a DFS at 4,5y of 93% vs. 82% in the group of MIS (p=0,023, HR 3.48; 95% CI: 1.17–9.48). The use of manipulator was associated with a worse DFS in the MIS group (HR 2.38; 95% CI: 1.32–4.29). Overall survival at 4.5y was significantly lower (96% vs.88%) in the group of MIS (p=0,016). Patients with previous conization did not show differences between both approaches.ConclusionThe risk of relapse and death in the group of MIS was significantly higher. The use of manipulator worsened the outcome among MIS patients.DisclosureNothing to disclose.Abstract – Figure 1DFS in both groups open and MIS after propensity matching scoreAbstract – Figure 2Impact of the use of manipulator in the DFS of the MIS approachAbstract – Table 1Characteristics of both groups before the propensity matching scoreVARIABLESOPENMISMean BMI (kg/m2)2624Mean original tumor size by clinical evaluation20.8 mm17.6 mmMean MRI largest diameter20.6 mm15.9 mmPrevious cone biopsy27.7%47%Mean tumor largest diameter in Pathology Report22.2 mm16.5 mm% of positive pelvic nodes12.7%9.6%Adjuvant therapy after surgery48%37%% of Relapse9.3%13.2%% of Death from any cause4.3%7.1%Abstract – Table 2Characteristics of both groups after the propensity matching scoreVARIABLESOPENMISMean BMI (kg/m2)2626Mean original tumor size by clinical evaluation23 mm21 mmMean MRI largest diameter24 mM22 mmPrevious cone biopsy0%0%Mean tumor largest diameter in Pathology Report23 mm22 mm% of positive pelvic nodes7%7%Adjuvant therapy after surgery50%50%% of Relapse11%22%% of Death from any cause6.4%10.8%
Journal Article
Non-invasive imaging techniques for diagnosis of pelvic deep endometriosis and endometriosis classification systems: an International Consensus Statement
2024
Abstract
The International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) and International Deep Endometriosis Analysis (IDEA) group, the European Endometriosis League (EEL), the European Society for Gynaecological Endoscopy (ESGE), ESHRE, the International Society for Gynecologic Endoscopy (ISGE), the American Association of Gynecologic Laparoscopists (AAGL) and the European Society of Urogenital Radiology (ESUR) elected an international, multidisciplinary panel of gynecological surgeons, sonographers, and radiologists, including a steering committee, which searched the literature for relevant articles in order to review the literature and provide evidence-based and clinically relevant statements on the use of imaging techniques for non-invasive diagnosis and classification of pelvic deep endometriosis. Preliminary statements were drafted based on review of the relevant literature. Following two rounds of revisions and voting orchestrated by chairs of the participating societies, consensus statements were finalized. A final version of the document was then resubmitted to the society chairs for approval. Twenty statements were drafted, of which 14 reached strong and three moderate agreement after the first voting round. The remaining three statements were discussed by all members of the steering committee and society chairs and rephrased, followed by an additional round of voting. At the conclusion of the process, 14 statements had strong and five statements moderate agreement, with one statement left in equipoise. This consensus work aims to guide clinicians involved in treating women with suspected endometriosis during patient assessment, counselling, and planning of surgical treatment strategies.
Journal Article
23 Impact of COVID-19 in gynecologic oncology: a nationwide Italian survey
2020
ObjectiveSeveral attempts are done in order to control COVID-19 and promote a fair allocation of resources during the outbreak. The Italian society of obstetrics and gynecologist (SIGO), and the Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies (MITO) are promoting research activities in the field of gynecologic oncology on a national basis, even in the era of COVID-19.MethodsThe SIGO and MITO group promoted a national survey aiming to evaluate the impact of COVID-19 on clinical activity of gynecologist oncologists and the implementation of containment measures of COVID-19 diffusion.ResultsOverall, 604 participants completed the questionnaire with a response rate of 70%. The results of this survey suggest that gynecologic oncology units had set a proactive approach to COVID-19 outbreak. Triage methods were adopted in order to minimize the in-hospital diffusion of COVID-19. Although 73% of the participants stated that COVID-19 has not significantly modified their everyday practice, 21% declared a decrease in the use of laparoscopy in favor of open (19%) and vaginal (2%) surgery. Interestingly, about 5% of the participants stated that the use of laparoscopic surgery has increased during the COVID-19 outbreak. However, less than 50% of surgeons adopted specific protection against COVID-19. Additionally, responders suggested to delay cancer treatment (10–15%), and to perform less radical surgical procedures (20–25%) during COVID-19 pandemic.ConclusionsInternational cooperation is of paramount importance, as heavily affected nations can serve as an example to find out ways to safely preserve clinical activity during the COVID-19 outbreak
Journal Article
Radiofrequency bipolar coagulation for radical hysterectomy: Technique, feasibility and complications
by
Ercoli, A.
,
Ferrandina, G.
,
Malzoni, C.
in
Adenocarcinoma - pathology
,
Adenocarcinoma - surgery
,
Adult
2003
. This study describes the surgical technique and intra‐ and postoperative complications associated with the use of a radiofrequency bipolar coagulator in a series of 18 Piver type III‐IV radical hysterectomies performed in cervical cancer patients. Preliminary vessel‐by‐vessel dissection of the lateral parametria was possible in 17 out of 18 (94%) cases, and a direct application of a radiofrequency bipolar coagulation instrument was performed to coagulate the posterior and anterior parametrial tissues in all cases. We were able to easily coagulate isolated vessels up to 5 mm of maximal diameter. In no case were clamps or hemoclips necessary to complete hemostasis. We did not observe any parametrial vessel damage or heat‐related injury of the surrounding normal tissue. The median size of the parametria removed was 44 mm (range 31–58) and nodes were detected in 15 cases (83%). Median operative time and estimated blood loss for the whole procedure including systematic pelvic and aortic lymphadenectomy was 250 min (range 200–410) and 550 ml (range 400–2500), respectively. Median follow‐up time was 9 months (range 5–13). No complications specifically related to the use of radiofrequency coagulation were found. In conclusion the radio‐frequency coagulation with this instrument appears to be a safe technique that is particularly useful in reducing blood loss and operative time without affecting radicality in patients undergoing radical hysterectomy.
Journal Article
The use of 3D ceramic block graft compared with autogenous block graft for rehabilitation of the atrophic maxilla: a randomized controlled clinical trial
by
Possari, Juliana
,
Gonçalves, Victor
,
de Almeida Malzoni, Carolina Mendonça
in
3-D printers
,
3D printing
,
3D-printed bone graft
2022
Dental implant placement may require a bone graft for vertical and horizontal alveolar ridge augmentation. Due to its osteoconduction, osteoinductive, and osteogenesis, autogenous bone graft characteristics are considered the standard gold treatment. However, autografts can promote postoperative morbidity and implicate difficulties concerning the graft adaptation to the recipient's bone since it can eventually avoid gaps. To overcome these issues, this trial will compare the performance of Plenum.sup.[R] Oss 3D.sub.[beta] fit, an alloplastic graft, and a 3D-printed patient-specific graft based on [beta]-tricalcium phosphate to the autograft procedure. This is a split-mouth randomized clinical study designed to evaluate the performance of personalized (patient-specific) bioceramic bone grafts (Plenum.sup.[R] Oss 3D.sub.[beta] fit) for bone augmentation of the atrophic anterior maxilla in comparison to the autogenous bone graft. We hypothesize that the gain and maintenance of the grafted area volume and the quality of the newly formed bone tissue after eight months postoperative with the synthetic patient-specific graft will be superior to the autogenous bone graft. To assess the quantity and the quality of bone neoformation, volumetric and histological analyses will be performed. The fabrication of medical devices by additive manufacturing presents advantages over conventional manufacturing processes, mostly related to the precision of geometry and anatomy. Additionally, the osteoconductive proprieties of [beta]-tricalcium phosphate enable this synthetic bone substitute as an alternative solution over autogenous graft for bone defect reconstruction. Thus, patient-specific bone grafts can potentially improve patient satisfaction, reducing the need for autogenous bone grafts, consequently avoiding implications related to this type of treatment, such as patient morbidity.
Journal Article
Combination of leukocyte and platelet–rich fibrin and demineralized bovine bone graft enhanced bone formation and healing after maxillary sinus augmentation: a randomized clinical trial
by
Zandim-Barcelos, Daniela Leal
,
de Molon, Rafael Scaf
,
Pichotano, Elton Carlos
in
Alveolar bone
,
Bone biomaterials
,
Bone grafts
2023
Background and objectiveThe resorption of alveolar ridge bone and maxillary sinus pneumatization are challenges to implant-supported prosthetic rehabilitation. Bone regeneration using bone substitutes and growth factors are alternatives for maxillary sinus augmentation (MSA). Therefore, we sought to evaluate the effects of the association between leukocyte and platelet–rich fibrin (L-PRF) and deproteinized bovine bone mineral (DBBM) in MSA procedures.Materials and methodsThirty-six maxillary sinuses from 24 individuals were included in this randomized clinical trial. The maxillary sinuses were randomly grafted with LPRF and DBBM (test group) or grafted only with DBBM (positive control). Dental implants were installed in the test group following two periods of evaluation: after 4 (DBBM+LPRF4) and 8 (DBBM+LPFR8) months of sinus graft healing, while the control group received implants only after 8 months. Cone beam computed tomography (CBCT) was taken 1 week after surgery (T1) and before implant placement (T2). Bone samples were collected during implant placement for histomorphometric and immunohistochemical (IHC) analysis. The primary implant stability was assessed by resonance frequency analysis.ResultsCBCT analysis demonstrated a significant decrease in bone volume from T1 to T2 in all groups without differences among them. Histologically, the test group showed significantly increase in bone neoformation in both periods of evaluation (LPRF+DBBM4: 44.70±14.01%; LPRF+DBBM8: 46.56±12.25%) compared to the control group (32.34±9.49%). The control group showed the highest percentage of residual graft. IHC analysis showed increased staining intensity of osteocalcin (OCN), vascular endothelial growth factor (VEGF), and runt related transcription factor 2 (RUNX-2) in LPRF+DBBM4 group, and osteopontin (OPN) in the L-PRF+DBBM8. Primary implant stability was successfully achieved (above 60 in implant stability quotient) in all the evaluated groups.ConclusionCombination of L-PRF and DBBM increased and accelerated new bone formation allowing early implant placement probably due to the higher protein expression of RUNX2, VEGF, OCN, and OPN. These data suggest that the use of L-PRF might be an interesting alternative to use in combination with DBBM for augment the maxillary sinuses allowing the installation of appropriate length implants in shorter period of time.Clinical relevanceThis study showed improvement in bone neoformation and accelerated healing when associating L-PRF and DBBM for maxillary sinus augmentation procedures.Trial registrationThis study was registered before participant recruitment in Brazilian Registry of Clinical Trials (ReBEC - RBR-95m73t).
Journal Article
Radiofrequency bipolar coagulation for radical hysterectomy: Technique, feasibility and complications
2003
This study describes the surgical technique and intra- and postoperative complications associated with the use of a radiofrequency bipolar coagulator in a series of 18 Piver type III-IV radical hysterectomies performed in cervical cancer patients. Preliminary vessel-by-vessel dissection of the lateral parametria was possible in 17 out of 18 (94%) cases, and a direct application of a radiofrequency bipolar coagulation instrument was performed to coagulate the posterior and anterior parametrial tissues in all cases. We were able to easily coagulate isolated vessels up to 5 mm of maximal diameter. In no case were clamps or hemoclips necessary to complete hemostasis. We did not observe any parametrial vessel damage or heat-related injury of the surrounding normal tissue. The median size of the parametria removed was 44 mm (range 31–58) and nodes were detected in 15 cases (83%). Median operative time and estimated blood loss for the whole procedure including systematic pelvic and aortic lymphadenectomy was 250 min (range 200–410) and 550 ml (range 400–2500), respectively. Median follow-up time was 9 months (range 5–13). No complications specifically related to the use of radiofrequency coagulation were found. In conclusion the radio-frequency coagulation with this instrument appears to be a safe technique that is particularly useful in reducing blood loss and operative time without affecting radicality in patients undergoing radical hysterectomy.
Journal Article
SENECA study: staging endometrial cancer based on molecular classification
2024
ObjectiveManagement of endometrial cancer is advancing, with accurate staging crucial for guiding treatment decisions. Understanding sentinel lymph node (SLN) involvement rates across molecular subgroups is essential. To evaluate SLN involvement in early-stage (International Federation of Gynecology and Obstetrics 2009 I–II) endometrial cancer, considering molecular subtypes and new European Society of Gynaecological Oncology (ESGO) risk classification.MethodsThe SENECA study retrospectively reviewed data from 2139 women with stage I–II endometrial cancer across 66 centers in 16 countries. Patients underwent surgery with SLN assessment following ESGO guidelines between January 2021 and December 2022. Molecular analysis was performed on pre-operative biopsies or hysterectomy specimens.ResultsAmong the 2139 patients, the molecular subgroups were as follows: 272 (12.7%) p53 abnormal (p53abn, 1191 (55.7%) non-specific molecular profile (NSMP), 581 (27.2%) mismatch repair deficient (MMRd), 95 (4.4%) POLE mutated (POLE-mut). Tracer diffusion was detected in, at least one side, in 97.2% of the cases; with a bilateral diffusion observed in 82.7% of the cases. By ultrastaging (90.7% of the cases) or one-step nucleic acid amplification (198 (9.3%) of the cases), 205 patients were identified with affected sentinel lymph nodes, representing 9.6% of the sample. Of these, 139 (67.8%) had low-volume metastases (including micrometastases, 42.9%; and isolated tumor cells, 24.9%) while 66 (32.2%) had macrometastases. Significant differences in SLN involvement were observed between molecular subtypes, with p53abn and MMRd groups having the highest rates (12.50% and 12.40%, respectively) compared with NSMP (7.80%) and POLE-mut (6.30%), (p=0.004); (p53abn, OR=1.69 (95% CI 1.11 to 2.56), p=0.014; MMRd, OR=1.67 (95% CI 1.21 to 2.31), p=0.002). Differences were also noted among ESGO risk groups (2.84% for low-risk patients, 6.62% for intermediate-risk patients, 21.63% for high–intermediate risk patients, and 22.51% for high-risk patients; p<0.001).ConclusionsOur study reveals significant differences in SLN involvement among patients with early-stage endometrial cancer based on molecular subtypes. This underscores the importance of considering molecular characteristics for accurate staging and optimal management decisions.
Journal Article