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A randomized trial evaluated whether resection of lymph nodes that appeared macroscopically normal during surgery for ovarian cancer would lead to improved outcomes. Progression-free and overall survival were unaffected, and resection was associated with longer operations and more complications.

Radical hysterectomy and plus pelvic node dissection are the primary methods of treatment for patients with early stage cervical cancer. During the last decade, growing evidence has supported the adoption of a minimally invasive approach. Retrospective data suggested that minimally invasive surgery improves perioperative outcomes, without neglecting long-term oncologic outcomes. In 2018, the guidelines from the European Society of Gynaecological Oncology stated that a “minimally invasive approach is favored” in comparison with open surgery. However, the phase III, randomized Laparoscopic Approach to Cervical Cancer (LACC) trial questioned the safety of the minimally invasive approach. The LACC trial highlighted that the execution of minimally invasive radical hysterectomy correlates with an increased risk of recurrence and death. After its publication, other retrospective studies investigated this issue, with differing results. Recent evidence suggested that robotic-assisted surgery is not associated with an increased risk of worse oncologic outcomes. The phase III randomized Robotic-assisted Approach to Cervical Cancer (RACC) and the Robotic Versus Open Hysterectomy Surgery in Cervix Cancer (ROCC) trials will clarify the pros and cons of performing a robotic-assisted radical hysterectomy (with tumor containment before colpotomy) in early stage cervical cancer.

Risk of relapse or progression remains high in the treatment of most patients with epithelial ovarian cancer, and development of a molecular predictor could be a valuable tool for stratification of patients by risk. We aimed to develop a microRNA (miRNA)-based molecular classifier that can predict risk of progression or relapse in patients with epithelial ovarian cancer. We analysed miRNA expression profiles in three cohorts of samples collected at diagnosis. We used 179 samples from a Multicenter Italian Trial in Ovarian cancer trial (cohort OC179) to develop the model and 263 samples from two cancer centres (cohort OC263) and 452 samples from The Cancer Genome Atlas epithelial ovarian cancer series (cohort OC452) to validate the model. The primary clinical endpoint was progression-free survival, and we adapted a semi-supervised prediction method to the miRNA expression profile of OC179 to identify miRNAs that predict risk of progression. We assessed the independent prognostic role of the model using multivariable analysis with a Cox regression model. We identified 35 miRNAs that predicted risk of progression or relapse and used them to create a prognostic model, the 35-miRNA-based predictor of Risk of Ovarian Cancer Relapse or progression (MiROvaR). MiROvaR was able to classify patients in OC179 into a high-risk group (89 patients; median progression-free survival 18 months [95% CI 15–22]) and a low-risk group (90 patients; median progression-free survival 38 months [24–not estimable]; hazard ratio [HR] 1·85 [1·29–2·64], p=0·00082). MiROvaR was a significant predictor of progression in the two validation sets (OC263 HR 3·16, 95% CI 2·33–4·29, p<0·0001; OC452 HR 1·39, 95% CI 1·11–1·74, p=0·0047) and maintained its independent prognostic effect when adjusted for relevant clinical covariates using multivariable analyses (OC179: adjusted HR 1·48, 95% CI 1·03–2·13, p=0·036; OC263: adjusted HR 3·09 [2·24–4·28], p<0·0001; and OC452: HR 1·41 [1·11–1·79], p=0·0047). MiROvaR is a potential predictor of epithelial ovarian cancer progression and has prognostic value independent of relevant clinical covariates. MiROvaR warrants further investigation for the development of a clinical-grade prognostic assay. AIRC and CARIPLO Foundation.

Folate receptor alpha (FRα), a membrane protein involved in folate transport, is a promising therapeutic target for ovarian cancer and other malignancies. The murine Monoclonal antibody (MAb) MOv19, developed in our lab, has pioneered the development of chimeric antibody-drug conjugates currently approved or in clinical trials for the treatment of FRα-positive cancers. To further reduce antibody’s immunogenicity, we engineered and characterized a new fully human IgG1 antibody (AFRA hIgG1) to FRα starting from MOv19. AFRA hIgG1 was constructed and characterized for binding affinity, specificity to purified FRα and various FRα-expressing tumor cells and ability to recruit effector cells in vitro in comparison to the chimeric version of MOv19 (ChiMOv19). AFRA hIgG1 and ChiMOv19 have comparable functional affinities being 10 −9 M and 10 −10 M, respectively although AFRA hIgG1 has an intrinsic constant affinity 10 3 lower than that of ChiMOv19, 2.6 × 10 −7 M vs. 3.5 × 10 −10 M, respectively. Furthermore, AFRA hIgG1 demonstrated a better binding kinetic with an overall efficacy comparable to ChiMOv19 in recruiting effector cell functions. These findings highlight that functional affinity, rather than intrinsic affinity, is a key determinant of biological response. AFRA hIgG1 shows promise as a biologic agent for the treatment of FRα-positive cancers.

Borderline ovarian tumors (BOTs) commonly occur during reproductive years. Given the good prognosis, fertility-sparing surgery can be considered in young women wishing to preserve their fertility. However, conservative management exposes patients to the risk of recurrence. In these cases, the new surgery may be radical (completing the removal of both adnexa) or, when conservative, it may be associated with relevant damage to the ovarian reserve. In this study, we report on two women who decided to perform ovarian hyper-stimulation and oocyte cryostorage at the time of the diagnosis of recurrence, but before undergoing the new surgery. They both obtained a satisfactory number of oocytes, the retrieval was unremarkable, and no main detrimental effects on the ovarian lesions were noticed. These two cases suggest that ovarian hyper-stimulation and oocyte retrieval before planned surgery for BOT recurrence is a feasible option.

Background: Lenvatinib (LEN) is a multikinase inhibitor used for different tumors: advanced differentiated thyroid cancers progressed or resistant to radioiodine (RAIR DTC), adenoid cystic carcinoma of salivary glands (AdCC), hepatocellular carcinoma (HCC), and endometrial carcinoma (EC). In the real-world setting, patients eligible for LEN often have multiple comorbidities and/or impaired Eastern Cooperative Oncology Group performance status (ECOG PS). In HCC, patients with body weight (BW) < 60 kg require a low starting dose of LEN; in thyroid cancers (TC), BW has a clinically relevant effect on steady-state exposure to LEN. It is currently unknown whether BW can vary during LEN treatment across different histologies. Objectives: This study aims to investigate toxicities, duration of treatment (DoT), and to describe BW and body mass index (BMI) intrapatient variations in the real-world setting. Design: Retrospective observational study conducted in a tertiary cancer center. Methods: We collected clinical features and AEs from consecutive adult patients who started LEN for DTC, AdCC, HCC, or EC from January 2015 to April 2023. LEN first and last doses were estimated as a percentage of the standard dose approved for each indication. Differences in the BMI distribution assessed at baseline and end of treatment were assessed with Mann–Whitney test. Differences in intrapatient BMI variation were assessed with Kruskal–Wallis test. DoT and overall survival (OS) were estimated with the Kaplan–Meier method. Results: Over a period of 8 years and 3 months, n.161 patients were included: n.64 DTC, n.31 AdCC, n.41 HCC, and n.25 EC. Median follow-up (mFUP) was 72.8 months. Overall, median age at diagnosis was 61.8 years, with an ECOG PS 2 in 2%–9% of cases. The most frequently observed AE was fatigue. For the net of different cancer types, baseline BW/BMI, LEN doses, and mFUP, the BMI distribution was lower at last LEN administration compared to baseline (p = 0.045). Conclusion: Despite the higher prevalence of elderly subjects and ECOG PS 2, our series confirmed the long-term manageability and effectiveness of LEN in the real world. Patients with a baseline low BMI require special attention, as LEN treatment can be implicated in further BW decrease.

Background To evaluate the performance of a decision support system (DSS) based on radiomics and machine learning in predicting the risk of malignancy of ovarian masses (OMs) from transvaginal ultrasonography (TUS) and serum CA-125. Methods A total of 274 consecutive patients who underwent TUS (by different examiners and with different ultrasound machines) and surgery, with suspicious OMs and known CA-125 serum level were used to train and test a DSS. The DSS was used to predict the risk of malignancy of these masses (very low versus medium-high risk), based on the US appearance (solid, liquid, or mixed) and radiomic features (morphometry and regional texture features) within the masses, on the shadow presence (yes/no), and on the level of serum CA-125. Reproducibility of results among the examiners, and performance accuracy, sensitivity, specificity, and area under the curve were tested in a real-world clinical setting. Results The DSS showed a mean 88% accuracy, 99% sensitivity, and 77% specificity for the 239 patients used for training, cross-validation, and testing, and a mean 91% accuracy, 100% sensitivity, and 80% specificity for the 35 patients used for independent testing. Conclusions This DSS is a promising tool in women diagnosed with OMs at TUS, allowing to predict the individual risk of malignancy, supporting clinical decision making.

Background Although surgery represents the cornerstone treatment of endometrial cancer at initial diagnosis, scarce data are available in recurrent setting. The purpose of this study was to review the outcome of surgery in these patients. Methods Medical records of all patients undergoing surgery for recurrent endometrial cancer at NCI Milano between January 2003 and January 2014 were reviewed. Survival was determined from the time of surgery for recurrence to last follow-up. Survival was estimated using Kaplan–Meier methods. Differences in survival were analyzed using the log-rank test. The Fisher’s exact test was used to compare optimal versus suboptimal cytoreduction against possible predictive factors. Results Sixty-four patients were identified. Median age was 66 years. Recurrences were multiple in 38 % of the cases. Optimal cytoreduction was achieved in 65.6 %. Median OR time was 165 min, median postoperative hemoglobin drop was 2.4 g/dl, and median length hospital stay was 5.5 days. Eleven patients developed postoperative complications, but only four required surgical management. Estimated 5-year progression-free survival (PFS) was 42 and 19 % in optimally and suboptimally cytoreduced patients, respectively. At multivariate analysis, only residual disease was associated with PFS. Estimated 5-year overall survival (OS) was 60 and 30 % in optimally and suboptimally cytoreduced patients, respectively. At multivariate analysis, residual disease and histotype were associated with OS. At multivariate analysis, only performance status was associated with optimal cytoreduction. Conclusions Secondary cytoreduction in endometrial cancer is associated with long PFS and OS. The only factors associated with improved long-term outcome are the absence of residual disease at the end of surgical resection and histotype.

The widespread introduction of screening methods allow to identify cervical dysplasia before having invasive cancer. The risk of developing cervical dysplasia persistence/ recurrence following conization represent a major health issue. Although several studies tried to identify predictors for cervical dysplasia persistence/recurrence, no previous study has been conducted to develop a risk calculator. The current study aimed to identify predictors of cervical dysplasia persistence/recurrence among women undergoing primary conization. We aimed to build nomograms estimating the risk of developing cervical dysplasia recurrence. Data of consecutive women with diagnosis of high-risk human papillomavirus (HPV) undergoing conization were retrospectively evaluated (1503 patients). The risk of developing cervical dysplasia persistence/recurrence was assessed with Kaplan–Meier and Cox’s hazard models. Additionally, two nomograms were built to estimate likelihood of cervical dysplasia recurrence: the first based on baseline and operative parameters and the second focusing on type-specific HPV detected. The performance of the above nomograms was assessed using concordance index. A total of 1503 patients were analyzed. After a mean (SD) follow-up of 48.6 ( ± 17.5) months, 84 (5.6%) patients required secondary conization. By multivariate analysis, HIV infection [hazard ratio (HR): 7.78; 95% confidence interval (CI): 2.77–21.81; P < 0.001], positive margins (HR: 26.2; 95% CI: 14.1–48.71; P < 0.001) and persistence of HPV (HR: 6.82; 95% CI: 4.15–11.21; P < 0.001) correlated with cervical intraepithelial neoplasia 2+ persistence/recurrence. The importance of those variables was corroborated by our first nomogram. The second nomogram suggested the impact of type-specific HPV infection in predicting cervical dysplasia persistence/ recurrence. HPV16, HPV18, HPV33, HPV35 and HPV45 were the HPV types most commonly associated with cervical dysplasia persistence/recurrence. The concordance index was greater than 0.70 for both nomograms, thus suggesting the reproducibility of our models. We developed the first two nomograms predicting this risk. The findings of this study require external validation. Once validated our data might be useful to plan a tailored postoperative surveillance of women receiving primary conization.

A Correction to this paper has been published: https://doi.org/10.1007/s10815-021-02150-z