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A randomized trial compared standard chemotherapy plus dostarlimab or placebo. Patients with mismatch repair–deficient tumors had 2-year progression-free survival of 61.4% with dostarlimab and 15.7% with placebo.

Patients with platinum-sensitive relapsed ovarian cancer who had undergone complete resection were assigned to undergo surgery and then receive chemotherapy or to receive chemotherapy alone. The median overall survival was 54 months with surgery and chemotherapy, and 46 months with chemotherapy alone.

ObjectivesPerivascular epitheliod cell tumors (PEComas) are rare mesenchymal neoplasms. Uterine PEComa is extremely rare and only limited evidence is still available.MethodsCharts of consecutive patients who had treatment (between 01/01/2010 and 12/31/2020) for newly diagnosed uterine PEComas were retrieved. Five-year outcomes were assessed using Kaplan-Meier and Cox hazard models.ResultsData of 23 patients with newly diagnosed PEComas were analyzed. Mean (SD) patients‘ age was 52 (14) years. Twenty-two patients had a surgical cytoreductive attempt. In one case surgery was not performed due to the presence of an extra-abdominal spread. Overall, seven (30%) patients had disease outside the uterus at the time of surgery. Complete cytoreduction (no macroscopic residual tumor) was achieved in 19 patients. Eleven (48%) patients had adjuvant treatments, consisting in anthracycline-based chemotherapy (n=4),gemcitabine-based chemotherapy (n=2), mTOR inhibitors (n=4) and hormonal treatment (n=1). Median (range) follow-up as 23 (2, 99) months. Eleven (48%) recurrences occurred with a mean (SD) progression free-survival of 14 (11) months. After a median (range) follow-up of 23 (2–99) months, nine (39%) patients died of disease. Residual tumor at surgery was the only factor correlating with the risk of developing recurrent disease (p=0.023) and worse overall survival (p=0.014). In our small series, stage of disease and adjuvant therapy administration had no impact on survival outcomes.ConclusionsUterine PEComa represents a rare and aggressive entity. Molecular/genomic profiling of the disease is necessary to predict response to treatment. Further collaborative investigations are warranted to assess the role of various prognostic factors and evaluate the most effective surgical and medical treatment modalities

ObjectivesAdvanced/recurrent cervical cancer has limited therapeutic options, with a median progression-free survival (PFS) after the failure of systemic treatments ranging between 3.5 and 4.5 months. Here, we reported our preliminary experience in the use of BUL719 (alpelisib) in advanced/recurrent cervical cancer after failure of at least 2 lines of treatment.MethodsThe Istituto Nazionale dei Tumori di Milano (Italy) approved this prospective investigation. From 04/01/2020 to 09/01/2020, 17 consecutive patients with recurrent cervical cancer underwent NGS to assess the presence of PIK3CA mutation/alteration.ResultsSix patients were included in the study. All patients had been treated with at least 2 previous lines of systemic treatment: 3 patients received >2 prior lines of treatment in the recurrent or metastatic setting; 60% had received prior bevacizumab in combination with chemotherapy. All patients started alpelisib at the daily dosage of 300 mg. Investigator-assessed confirmed objective response rate (ORR) was 33%. The disease control rate (DCR) was 100%. According to the RECIST 1.1, two patients had a partial response (PR), and four patients had stable disease (SD). No complete response was observed. The mean duration of response (DOR) was 6.6 (SD 3.75) months; four patients had PR lasting for >6 months. One patient stopped the treatment at 0.82 months due to the onset of a grade 2 adverse event (AE) (skin rash). Grade 3 treatment-related AEs included: lymphoedema (n=1, 20%) and rash (n=1, 20%). No treatment-related grade 4–5 AEs occurred.ConclusionsFurther trials are needed to assess the safety and effectiveness of alpelisib in PIK3CA-mutated recurrent/advanced cervical cancer.

ObjectivesTo report on the performance of hysteroscopic injection of indocyanine green (ICG) for sentinel lymph node mapping (SNM) in endometrial cancerMethodsThis is a retrospective cohort study of consecutive endometrial cancer patients who had SNM via hysteroscopic injection of IGC between 2013 and 2017. Detection rate, accuracy, and oncologic outcomes were evaluatedResultsCharts of 52 patients were evaluated. At least one sentinel node was detected in 95% of patients. Bilateral pelvic mapping was found in 74% of cases. In 45% of cases, SLNs mapped in both pelvic and para-aortic nodes, and four cases (8%) in the para-aortic area, only. In three patients (6%) sentinel nodes were found in aberrant (parametrial/presacral) areas. Seven (13.5%) patients were diagnosed with nodal involvement. Low volume disease was observed in four (8%) patients (2 with isolated tumor cells and 2 with micrometastasis). After a median (range) follow-up of 34.7 (10, 61) months, five (9.6%) patients developed recurrences: two abdominal/distant, one vaginal, and one nodal (in the para-aortic area in a patient diagnosed with endometrioid G1 endometrial cancer and isolated tumor cells in a pelvic node). No patient died of disease.ConclusionsHysteroscopic injection of ICG ensures delineation of lymphatic drainage from the tumor area, thus achieving accurate detection of sentinel nodes. Further evidence is warranted to assess the role of hysteroscopic injection in identifying extrapelvic sentinel nodes.

Introduction/Background*Perivascular epitheliod cell tumors (PEComas) are rare mesenchymal neoplasms. Uterine PEComa is extremely rare and only limited evidence is still available.MethodologyThis is a single-center retrospective study. Charts of consecutive patients who had treatment (from 01/01/2010 to 12/31/2020) for newly diagnosed uterine PEComas were retrieved. Five-year survival outcomes were assessed using Kaplan-Meier and Cox proportional hazard models.Result(s)*Data of 23 patients with newly diagnosed PEComas were analyzed. Mean (SD) patients‘ age was 52 (14) years. Twenty-two patients had a surgical cytoreductive attempt. In one case surgery was not performed due to the presence of an extra-abdominal spread. Overall, seven (30%) patients had disease outside the uterus at the time of surgery. Complete cytoreduction (no macroscopic residual tumor) was achieved in 19 patients. Complete cytoreduction was not completed in three patients who gross extrauterine disease and in the aforementioned patient who had not surgery. Eleven (48%) patients had adjuvant treatments, consisting in anthracycline-based chemotherapy (n=4),gemcitabine-based chemotherapy (n=2), mTOR inhibitors (n=4) and hormonal treatment (n=1). Median (range) follow-up as 23 (2, 99) months. Eleven (48%) recurrences occurred with a mean (SD) progression free-survival of 14 (11) months. After a median (range) follow-up of 23 (2, 99) months, nine (39%) patients died of disease. Residual tumor at surgery was the only factor correlating with the risk of developing recurrent disease (p=0.023) and worse overall survival (p=0.014). In our small series, stage of disease and adjuvant therapy administration had no impact on survival outcomes.Conclusion*Uterine PEComa represents a rare and aggressive entity. Molecular/genomic profiling of the disease is necessary to predict response to treatment. Further collaborative investigations are warranted to assess the role of various prognostic factors and evaluate the most effective surgical and medical treatment modalities.

Introduction/Background*Molecular/genomic profiling is the most accurate method to assess prognosis of endometrial cancer patients. Similarly, the adoption of radiomics showed important results for screening, diagnosis and prognosis, across various radiological systems and oncologic specialties. Here, we aim to correlate radiomic features obtained from ultrasound images with the molecular/genomic profiling to identify new hallmarks for stratification of endometrial cancer patients into different classes of risk.MethodologyThis prospective single-arm observational studyPatients with newly diagnosed endometrial cancer will have ultrasonographic evaluation and radiomic analysis of the ultrasonographic images. Then patients will have surgery followed by molecular/genomic evaluation. We will correlate radiomic features with molecular/genomic profiling to classify prognosis. Major Inclusion/Exclusion Criteria : Consecutive patients (aged 18 years or more) with newly diagnosed endometrial cancer. Patients should have preoperative ultrasonographic evaluation followed by surgery.Result(s)*The central hypothesis is that combining radiomic features with molecular features might allow identifying various classes of risk for endometrial cancer, e.g. predicting unfavorable molecular/genomic profiling. The rationale for the proposed research is that once validated, radiomics applied to ultrasonographic images would be an effective, innovative and cheap method for tailor operative and postoperative treatment modality in endometrial cancer. Primary Endpoint : The main endpoints will: (i) to define the mechanism by which radiomic features predict the classification of endometrial cancer into various classes of risk e.g. predicting unfavorable molecular/genomic profiling as defined by molecular classification; (ii) to determinate the scaled impact of radiomic features assessed on ultrasonographic images of endometrial tumors; and (iii) to assess the intraobserver and interobserver reproducibility of radiomic features on ultrasonographic images of endometrial tumors. Overall, 100 patients for study cohort and 40 for the validation cohort.Conclusion*We expect that the radiomic analysis of ultrasonographic images by means of radiomic classifier of risks will provide comparable results to molecular/genomic. (Trial Registration: GR-2019-12370566 Bando per la Ricerca Finalizzata 2019, Ministero della 24 Salute, Repubblica Italiana)

Introduction/BackgroundLynch syndrome (LS) is a well know risk factor for developing endometrial carcinoma (EC). Here, we aimed to investigate the impact of gene-specific germline pathogenic variants on clinical features of EC.MethodologyThis is a retrospective case series of consecutive surgically-treated patients with histological diagnosis of EC and with a germline pathogenic variant in mismatch repair genes. Classes of risk are graded per the ESGO-ESGO-ESTRO guidelines.ResultsOverall, 68 patients with EC and LS were evaluated. Ten (14.7%) patients were excluded due to absence of clear information about the gene involved in LS, thus leaving 58 (85.3%) patients available for the final analysis. MLH1, MSH2 and MSH6 pathogenic variants were observed in 19 (32.7%), 33 (56.9%) and 6 (10.3%) cases, respectively. Mean (SD) age at EC diagnosis was 51 (±6.4), 43.5 (±7.4) and 60.3 (±8.8) years (p=0.0002). Prevalence of non-endometrioid EC were 15.7%, 24.2% and 0% in MLH1, MSH2 and MSH6 group, respectively (p=0.345). Focusing on classes of risk we observed that patients harboring a MLH1 or MSH2 pathogenic variant were at higher risk than patients with a MSH6 mutation. In fact, according to the ESMO-ESGO-ESTRO classification, low, intermediate, and high risk EC accounted in 47.3%, 10.5% and 42.1% of MLH1 group, in 57.6%, 3% and 39.4% of MSH2 group and in 50%, 50% and 0% of MSH6 group (p=0.009).ConclusionPatients with MLH1 and MSH2 pathogenic variants are at a higher risk of early onset of EC and are characterized by more aggressive disease than patients with MSH6 pathogenic variants.DisclosureNothing to disclose.

Introduction/BackgroundAccumulating data highlighted that minimally invasive surgery has been associated with higher recurrence rates and worse overall survival than the open approach in women with early-stage cervical cancer. Tumor spread at the time of colpotomy might be advocate as the reason of tumor cells dissemination in the pelvic area. Here, we aimed to investigate if primary conization might overcome the risk of local dissemination in early-stage cervical cancer undergoing laparoscopic radical hysterectomy.MethodologyConsecutive data of 262 early stage cervical cancer patients were retrieved: 88 women had conization followed by radical hysterectomy. A propensity-matched comparison (1:1) was carried out in order to compare laparoscopy and open surgery, minimizing possible selection biases.ResultsData of 35 patients’ pair (total 70 patients) were analyzed. No between-group differences in baseline, disease and pathological variables were observed (p>0.20). Patients undergoing laparoscopy experienced a slightly non-significant longer operative time than patients undergoing open surgery (210.8 (±47.7) vs. 187.9 (±24.7) minutes; p=0.089); while laparoscopic approach correlated whit lower blood loss (50 (range, 30–100) vs. 150 (range, 50–500) ml; p<0.001) and shorter length of stay (3 (±0.8) vs. 5.4 (±1.4) days; p<0.001) in comparison to open surgery. Morbidity rate was similar between groups (p=1.00). One local recurrence was observed per group (p=1.00). Type of surgical approach did not influence site of recurrence (p=1.00) as well as survival outcomes, in term of 10-year disease-free (p=0.549, log-rank test) and overall survivals (p=0.615, log-rank test).ConclusionOur data seems underline that primary conization might overcome the risk of local recurrence following laparoscopic radical hysterectomy in early-stage cervical cancer. Further prospective evidence is needed.DisclosureNothing to disclose.

Introduction/BackgroundTo investigate the impact of laparoscopic surgery on short- and medium-term outcomes of cervical cancer patients undergoing nerve-sparing radical hysterectomy.MethodologyData of consecutive patients affected by locally-advaced cervcial cancer who had neoadjuvant chemotherapy followed by laparoscopic nerve-sparing radical hysterectomy were matched 1:1 with an historical cohort of patients undergoing neoadjuvant chemotherapy followed by open radical hysterectomy, using propensity matching algorithm.ResultsThirty-five patients’ pairs (70 patients: 35 undergoing laparoscopic vs. 35 undergoing open abdominal nerve-sparing radical hysterectomy) were included. Demographic and baseline oncologic characteristics were balanced between groups. Patients undergoing laparoscopic surgery had similar operative time than patients undergoing open abdominal procedures (249 [±91.5] vs. 223 [±65.0] minutes; p=0.066). Laparoscopic approach correlated with lower blood loss (30.5 [±11.0] vs. 190 [90.4] mL; p<0.001) and shorter hospital stay (3.2 [±1.2] vs. 5.4 [2.0] days; p=0.023). Patients undergoing laparoscopy experienced a lower 30-day pelvic floor dysfunction rate than patients having open surgery (p=0.024). Moreover, they experienced shorter recovery of bladder function than patients having open procedures (median, 7 vs. 9 days; p=0.004, log-rank test). After a median follow-up of 51.7 and 14.7 months for open abdominal and minimally invasive procedures, disease-free (p=0.617) and overall (p=0.814) survivals were similar between groups. Using multivariate model, we observed that the adoption of laparoscopic approach did not impact on disease-free (HR: 1.32 (95%CI: 0.58, 3.01); p=0.50) and overall (HR: 1.26 (95%CI: 0.41, 3.81); p=0.67) survivals.ConclusionLaparoscopic nerve sparing radical hysterectomy resulted in improved short-term outcomes, without impacting on medium-term oncologic outcomes. Further prospective trials are needed to assess long-term outcomes of patients having minimally invasive surgery.DisclosureNothing to disclose.