Prediction of non-resectability using the updated Predictive Index Value model assessed by imaging and surgery in tubo-ovarian cancer: a prospective multicenter ISAAC study.

BACKGROUND: A laparoscopy-based scoring system was developed by Fagotti et al (Fagotti or Predictive Index Value (PIV)score) based on the intraoperative presence or absence of carcinomatosis on predefined sites. Later, the authors updated the PIV score calculated only in the absence of one or both absolute criteria of non-resectability (mesenteric retraction and miliary carcinomatosis of the small bowel) (updated PIV model). OBJECTIVE: The aim was to demonstrate the non-inferiority of ultrasound to other imaging methods (contrast enhanced computed tomography (CT) and whole-body diffusion-weighted (WB DWI)/MRI) in predicting non-resectable tumor (defined as residual disease>1 cm) using the updated PIV model in patients with tubo-ovarian cancer. The agreement between imaging and intraoperative findings as a reference was also calculated. STUDY DESIGN: This was a European prospective multicenter observational study. We included patients with suspected tubo-ovarian carcinoma who underwent preoperative staging and prediction of non-resectability at ultrasound, CT, WB-DWI/MRI and surgical exploration. The predictors of non-resectability were suspicious mesenteric retraction and/or miliary carcinomatosis of the small bowel or if absent, a PIV>8 (updated PIV model). The PIV score ranges from 0 to 12 according to the presence of disease in six predefined intra-abdominal sites (great omentum, liver surface, lesser omentum/stomach/spleen, parietal peritoneum, diaphragms, bowel serosa/mesentery). The reference standard was surgical outcome, in terms of residual disease>1 cm, assessed by laparoscopy and/or laparotomy. The area under the receiver operating characteristic curve (AUC) to assess the performance of the methods in predicting non-resectability was reported. Concordance between index tests at detection of disease at six predefined sites and intraoperative exploration as reference standard was also calculated using Cohen's kappa. RESULTS: The study was between 2018 and 2022 in five European gynecological oncology centers. Data from 242 patients having both mandatory index tests (ultrasound and CT) were analyzed. 145/242 (59.9%) patients had no macroscopic residual tumor after surgery (R0) (5/145 laparoscopy and 140/145 laparotomy) and 17/242 (7.0%) had residual tumor ≤1cm (R1) (laparotomy). In 80/242 patients (33.1%), the residual tumor was >1 cm (R2), 30 of them underwent laparotomy and maximum surgery was carried out and 50/80 underwent laparoscopy and cytoreduction was not feasible in all of them. After excluding 18/242 (7.4%) patients operated on but not eligible for extensive surgery, the predictive performance of three imaging methods was analyzed in 167 women. The AUCs of all methods in discriminating between resectable and non-resectable tumor was 0.80 for ultrasound, 0.76 for CT, 0.71 for WB-DWI/MRI and 0.90 for surgical exploration. Ultrasound had the highest agreement (Cohen's kappa ranging from 0.59 to 0.79) compared to CT and WB-DWI/MRI to assess all parameters included in the updated PIV model. CONCLUSIONS: Ultrasound showed non-inferiority to CT and to WB-DWI/MRI in discriminating between resectable and non-resectable tumor using the updated PIV model. Ultrasound had the best agreement between imaging and intraoperative findings in the assessment of parameters included in the updated PIV model. Ultrasound is an acceptable method to assess abdominal disease and predict non-resectability in patients with tubo-ovarian cancer in the hands of specially trained ultrasound examiners.

First-in-human liver transplantation from a centenarian deceased donor after brain death.

Liver transplantation from elderly donors is expanding due to demand for liver grafts, aging of recipients and donors, and introduction of machine perfusion. We report on a liver transplant from a 100-year-old deceased donor after brain death. The liver was transplanted after the use of hypothermic machine perfusion to a 60-year-old recipient with advanced hepatocellular carcinoma undergoing neoadjuvant immunotherapy. Nine months after the transplant, the patient is alive with a functioning graft and no evidence of acute rejection or tumor recurrence.

Real-world analysis of the economic and therapeutic burden in advanced breast cancer patients in Italy.

BACKGROUND: This real-world analysis evaluated drug utilization focusing on wastage and healthcare costs for treatment of patients with advanced breast cancer (aBC) hormone receptor-positive (HR+)/human epidermal growth factor receptor-2 negative (HER2-) in Italy. METHODS: A retrospective analysis was conducted on administrative data covering about 13.3 million health-assisted individuals. Across January/2017-June/2021, all patients with HR+/HER2-aBC were identified by ≥ 1 prescription for cyclin-dependent kinase 4/6 inhibitors (CDK 4/6i). Cost analysis was performed and updated referring to the prices of November 2021. RESULTS: Overall, 3,647 HR+/HER2-aBC patients were included (2,627 palbociclib treated, 729 ribociclib treated, and 291 abemaciclib treated). After 12 months of follow-up, 35% of palbociclib patients had a dose reduction (on average 8.9 wasted pills/patient), 44.7% of abemaciclib patients had a dose reduction (on average 6.7 wasted pills/patient), 22.1% of ribociclib patients had a dose reduction (no wasted pills). Therapy wastage added up to 528,716€ for palbociclib-treated patients (524€/patient) and 5,738€ in abemaciclib-treated patients (151€/patient). No wastage was attributed to ribociclib. CONCLUSIONS: Dose reduction was associated with drug wastage in palbociclib and abemaciclib-treated patients, but not in ribociclib-treated ones. These findings might be helpful to policy decision-makers who, for healthcare strategies implementation, among several variables should consider the possible restraining of drug wastage.

Radiomics and Molecular Classification in Endometrial Cancer (The ROME Study): A Step Forward to a Simplified Precision Medicine.

Molecular/genomic profiling is the most accurate method to assess prognosis of endometrial cancer patients. Radiomic profiling allows for the extraction of mineable high-dimensional data from clinical radiological images, thus providing noteworthy information regarding tumor tissues. Interestingly, the adoption of radiomics shows important results for screening, diagnosis and prognosis, across various radiological systems and oncologic specialties. The central hypothesis of the prospective trial is that combining radiomic features with molecular features might allow for the identification of various classes of risks 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 inexpensive method for tailoring operative and postoperative treatment modalities in endometrial cancer. Patients with newly diagnosed endometrial cancer will have ultrasonographic evaluation and radiomic analysis of the ultrasonographic images. We will correlate radiomic features with molecular/genomic profiling to classify prognosis.

Laparoscopic robot-assisted versus open total pancreatectomy: a case-matched study.

BACKGROUND: The enhanced dexterity offered by robotic assistance could be excessive for distal pancreatectomy but not enough to improve the outcome of laparoscopic pancreaticoduodenectomy. Total pancreatectomy retains the challenges of uncinate process dissection and digestive reconstruction, but avoids the risk of pancreatic fistula, and could be a suitable operation to highlight the advantages of robotic assistance in pancreatic resections. METHODS: Eleven laparoscopic robot-assisted total pancreatectomies (LRATP) were compared to 11 case-matched open total pancreatectomies. All operations were performed by one surgeon during the same period of time. Robotic assistance was employed in half of the patients, based on robot availability at the time of surgery. Variables examined included age, sex, American Society of Anesthesiologists score, body mass index, estimated blood loss, need for blood transfusions, operative time, tumor type, tumor size, number of examined lymph nodes, margin status, post-operative complications, 90-day or in-hospital mortality, length of hospital stay, and readmission rate. RESULTS: No LRATP was converted to conventional laparoscopy, hand-assisted laparoscopy or open surgery despite two patients (18.1 %) required vein resection and reconstruction. LRATP was associated with longer mean operative time (600 vs. 469 min; p = 0.014) but decreased mean blood loss (220 vs. 705; p = 0.004) than open surgery. Post-operative complications occurred in similar percentages after LRATP and open surgery. Complications occurring in most patients (5/7) after LRATP were of mild severity (Clavien-Dindo grade I and II). One patient required repeat laparoscopic surgery after LRATP, to drain a fluid collection not amenable to percutaneous catheter drainage. One further patient from the open group required repeat surgery because of bleeding. No patient had margin positive resection, and the mean number of examined lymph nodes was 45 after LRATP and 36 after open surgery. CONCLUSIONS: LRATP is feasible in selected patients, but further experience is needed to draw final conclusions.

Minimally invasive video-assisted thyroidectomy in differentiated thyroid cancer: a 1-year follow-up.

BACKGROUND: There are few reports on the use of minimally invasive video assisted thyroidectomy (MIVAT) technique in the treatment of differentiated thyroid carcinoma. MATERIALS AND METHODS: From January 2007 to September 2007, we treated 227 patients for benign or malignant diseases with a total thyroidectomy. We have selected 68 cases consecutively treated for thyroid carcinoma with a total thyroidectomy. The inclusion criteria considered the patients treated with conventional thyroidectomy and the patients treated with the MIVAT. Our follow-up examination was conducted in agreement with the guidelines of the European Consensus Conference. RESULTS: We have identified a first group of cases; group A, which stored the cases treated with the MIVAT technique. This group contained 9 males and 27 females; the median age was 49.69+/-9.26 years. Group B contained 6 males and 26 females treated with the conventional thyroidectomy; the median age was 44.15+/-11.73 years. The postoperative pain at 24 hours after the surgical procedure in A group was 1.033+/-0.87, whereas in B group it was 1.915+/-1.24 (P<0.05).The neoplastic node diameter was 13.31+/-6.31 mm in group A and 16.36+/-8.15 mm in group B (P=ns). All of the patients were treated with radioiodine. The value of thyroglobulin after 12 months in group A was 0.648+/-0.2 ng/mL whereas the value was 0.705+/-0.2 ng/mL in group B (P=ns). DISCUSSION: We think that MIVAT for the right cases is a safe and valid surgical procedure for differentiated thyroid cancer. This technique has a challenging learning curve, and the surgeons must be experts in conventional thyroid surgery.