International and national guidelines recommend low-molecular-weight heparin for the treatment of venous thromboembolism (VTE) in patients with cancer. The aim of the Caravaggio study is to assess whether oral apixaban is non-inferior to subcutaneous dalteparin for the treatment of acute proximal deep vein thrombosis and/or pulmonary embolism in patients with cancer. The study is an investigator-initiated, multi-national, prospective, randomized, open-label with blind end-point evaluation (PROBE), non-inferiority clinical trial (NCT03045406). Consecutive patients are randomized to receive oral apixaban or subcutaneous dalteparin for 6 months. Apixaban is given at a dose of 10 mg twice daily for the first 7 days and then 5 mg twice daily; dalteparin is given at a dose of 200 IU/kg for the first month and then 150 IU/kg once daily. The primary outcome of the study is objectively confirmed recurrent VTE as assessed by a central independent adjudication committee unaware of study treatment allocation. The primary safety outcome is major bleeding defined according to the guidelines of the International Society of Thrombosis and Haemostasis. Assuming a 6-month incidence of the primary outcome of 7% with dalteparin and an upper limit of the two-sided 95% confidence interval of the hazard ratio below the pre-specified margin of 2.00, 1,168 patients will be randomized considering an up to 20% loss in total patient-years ( = 80%; one-sided = 0.025). The Caravaggio study has the potential, along with other recently performed or on-going studies, to make less cumbersome the management of VTE in patients with cancer by replacing parenteral with oral anticoagulation.

In patients with early gastric neoplasia, ESD is safer and is associated with a positive impact on health-related QoL when compared with gastrectomy, without increasing fear of recurrence and new lesions.

Background Breast cancer (BC) is largely prevalent worldwide. HER2-positive BC account for roughly 20–25% of all BC cases and has an overall survival lower than other BC. Innovation on BC therapeutics is a constant, but novel therapies have higher costs. Therefore, cost-effectiveness research is essential to provide healthcare decision-makers with solid foundations for a resource allocation. This study aims to estimate the average direct medical costs/patient and cost-effectiveness of adding pertuzumab in neoadjuvant treatment (NeoT) for HER2-positive breast cancer (BC). Methods Two retrospective real-world consecutive cohorts of ≥18yo female patients diagnosed with HER2-positive BC treated with NeoT at the Breast Clinic of IPO-Porto were studied. The AC-DH regimen (2012–2015) comprised 8 cycles of neoadjuvant therapy (4 cycles of doxorubicin + cyclosphosphamide followed by 4 cycles ofdocetaxel + trastuzumab), while the AC-DHP regimen (2015–2017) included also pertuzumab as NeoT. NeoT was followed by surgery and adjuvant trastuzumab. Micro-costing technique and a bottom-up approach was used comprising all medical direct costs from the hospital perspective. Unit costs were obtained from government official prices or from IPO-Porto costing system. Costs were adjusted to 2017 and are expressed in euros. Multivariable logistic regression models were used for effectiveness assessment, while generalized linear models with gamma distribution were used for costs. ICER was calculated using the pathological complete response (pCR) as the preferential measure of effectiveness. Sensitivity analysis was also performed. Results AC-DHP (n = 40) and AC-DH (n = 54) cohorts had heterogenous patient profiles (median age 43y/53y; 67.5%/59.3% positive HR; 60.0%/27.8% operable; 25.0%/24.1% inflammatory, respectively). The AC-DHP average total cost/patient was 56,375€, with pertuzumab accounting for 13,978€ (24.79%) and increasing in 15,982€ the average cost/patient (p < 0.001). Clinical staging and hormone receptors (HR) were significantly associated with pCR. ICER was 1.370€ per percentage point of pCR. Conclusions ICER was more favourable in stage III HR negative BC patients compared to other patient profiles. Innovative treatments access is critical to deliver high-quality healthcare, but sustainability must be considered. These results suggest the importance of establishing a cost-effectiveness profile of Pertuzumab in NeoT for HER2-positive BC.

Background Gastrointestinal cancer surgery continues to be a significant cause of postoperative complications and mortality in high-risk patients. It is crucial to identify these patients. Our study aimed to evaluate the accuracy of specific perioperative risk assessment tools to predict postoperative complications, identifying the most informative variables and combining them to test their prediction ability as a new score. Methods A prospective cohort study of digestive cancer surgical patients admitted to the surgical intermediate care unit of the Portuguese Oncology Institute of Porto, Portugal was conducted during the period January 2016 to April 2018. Demographic and medical information including sex, age, date from hospital admission, diagnosis, emergency or elective admission, and type of surgery, were collected. We analyzed and compared a set of measurements of surgical risk using the risk assessment instruments P-POSSUM Scoring, ACS NSQIP Surgical Risk Calculator, and ARISCAT Risk Score according to the outcomes classified by the Clavien-Dindo score. According to each risk score system, we studied the expected and observed post-operative complications. We performed a multivariable regression model retaining only the significant variables of these tools (age, gender, physiological P-Possum, and ACS NSQIP serious complication rate) and created a new score ( MyIPOrisk-score ). The predictive ability of each continuous score and the final panel obtained was evaluated using ROC curves and estimating the area under the curve (AUC). Results We studied 341 patients. Our results showed that the predictive accuracy and agreement of P-POSSUM Scoring, ACS NSQIP Surgical Risk Calculator, and ARISCAT Risk Score were limited. The MyIPOrisk-score , shows to have greater discrimination ability than the one obtained with the other risk tools when evaluated individually (AUC = 0.808; 95% CI: 0.755–0.862). The expected and observed complication rates were similar to the new risk tool as opposed to the other risk calculators. Conclusions The feasibility and usefulness of the MyIPOrisk-score have been demonstrated for the evaluation of patients undergoing digestive oncologic surgery. However, it requires further testing through a multicenter prospective study to validate the predictive accuracy of the proposed risk score.